The I-HEAL proposal includes 4 synergistic projects with the goal of addressing key knowledge gaps that will improve access and engagement in high-quality, evidence-based health care services for V/SMs with TBI morbidity.

Collectively, the 4 projects propose to accomplish the following overarching objectives of the FPA: (1) adapt existing interventions to promote access and engagement in health care; (2) engage stakeholder communities to maximize uptake and translation; (3) promote research translation that informs policy and practice through knowledge translation products and deliverables targeting key partners (clinicians, V/SMs, caregivers, policymakers, and other researchers); (4) facilitate research and implementation to enhance access to high-quality health care for V/SMs with TBI-related morbidity; and (5) foster development of early/mid-career researchers in advancing implementation science research on access to care for V/SMs with TBI to expand the implementation science workforce in this understudied, underutilized field.

The proposed studies will be organized around a patient-centered conceptual framework of accessing evidence-based health care services to achieve optimal health outcomes [10]. The framework highlights how the health care environment (supply side, top) and the community that it supports (demand side, bottom) are multidimensional and interact to influence health care access [10]. The core elements of this model include having a health care need, the perception of the health care need, the desire for treatment, seeking and reaching health care, and utilizing health care to achieve an optimal outcome. The projects have unique interventional targets in the health care system (provider, team, system, and policy) to improve access and increase impact aligned with the best practices for addressing disparities [11]. The studies proposed in the FPA will target health care access dimensions on either the health care supply or consumer demand side that are known to be barriers arising from TBI-related morbidity, such as cognitive impairment and behavioral dysregulation. Each study will target a health care access dimension with primary and secondary targets. The interventions address TBI morbidity (impaired cognition and behavioral dysregulation) and high-frequency polytrauma comorbid conditions for military-related TBI, such as chronic pain, sleep disorders, and psychological health [12]. Project deliverables will be used to inform translational steps to promote dissemination and uptake across health care settings (ie, future implementation studies involving federal agencies such as VA, Agency for Healthcare Research and Quality, National Institutes of Health [NIH], and Patient-Centered Outcomes Research Institute [PCORI]). The framework and alignment with proposed projects are presented in Table 1.

The I-HEAL FPA will extend the successful collaboration among study investigators to advance implementation science within the field of TBI. The goals of the ISC are as follows:

The ISC will support mentorship, training, and professional development for the next generation of rehabilitation scientists to support the development of a TBI implementation science workforce. Our objectives are to (1) provide mentorship and training for the next generation of TBI-focused implementation scientists to democratize implementation and knowledge translation expertise in the field of TBI research and (2) identify and facilitate implementation-focused training and professional activities for I-HEAL investigators, which are available within and beyond the VA/DOD network.

These 2 training objectives will be accomplished using the following strategies:

Our goal is to spread I-HEAL’s impact, focusing on health systems and the delivery of TBI care within VA/DOD and beyond. I-HEAL’s dissemination efforts will be led by the ISC, with strategic planning that targets audiences and channels with consideration of the impact. Target audiences are (1) I-HEAL partners, leadership, CEC partners, and investigators; (2) DOD and VA funding agencies; (3) associated VA leadership; (4) university and educational affiliates; (5) policy groups such as professional organizations and federal agencies; (6) local communities; and (7) V/SM service organizations through the CEC. The channels of communication will minimally include (1) written communication (eg, peer-reviewed publications, issue briefs, formal reports, national magazines, and newsletters), (2) oral communication (eg, scheduled and ad hoc face-to-face and telephone meetings with operations partners and steering committee members, professional meetings, annual VA research day, cyber seminars, and grand rounds), (3) electronic communication (eg, social media and the I-HEAL Toolshed; I-HEAL will have a social media presence and explore implementation and dissemination strategies to amplify dissemination), and (4) product development (eg, toolkits, playbooks, and multimedia products). To optimize dissemination, the ISC has developed a publication pipeline protocol that strategizes and documents benchmarks, timelines, and roles to support accountability and productivity. Impacts of these broad-based efforts include but are not limited to increased awareness, trust, and veteran and employee engagement; distribution of knowledge; and relationship building and networking with stakeholder groups, study participants, mentees, and potential new investigators.

An overview of the potential impact is provided in Figure 2. Across cores and projects, this proposal has gathered a transdisciplinary team of scientists who have collectively demonstrated a history of rapid development and implementation of projects with the ability to rapidly pivot and assemble strong approaches to evaluate priorities in TBI and implementation. I-HEAL projects will contribute to (1) improving access and outcomes for persons with TBI and relevant partners; (2) tailoring policy recommendations, products, and outcomes for persons with TBI, hosted on the I-HEAL Toolshed; (3) advancing the science of implementation, translation, and dissemination; and (4) expanding the implementation and dissemination of science expertise for I-HEAL TBI scientific team members, which will ultimately support the implementation of professional development for workforces that specialize in TBI research.

This proposal was developed by our team of investigators, policy and professional partners (PPPs), and lived experience partners (LEPs). We have extensive experience engaging in CBPR together. The partnerships outlined here are built on long-term relationships and ongoing collaborations. Aligning with the principles of CBPR, we ground our work in the shared values of co-learning, mutual benefit, and community-driven solutions and practices for addressing the collaboratively identified problem of access to care for persons with TBI [21,22]. The current proposal grew out of years of working closely with professionals and LEPs who identified access to care as the most pressing problem facing V/SMs with TBI and their caregivers. Members of our team have collaborated on several successful projects over many years, including a large-scale randomized controlled trial of a patient-centered care management intervention for persons with TBI (PCORI R-1511‐33005), the BeHEALTHY model for chronic brain injury care (NIH-NINDS U24NS095871), Improved Understanding of Medical and Psychological Needs (I-MAP) in V/SMs with chronic TBI (DHA Contracting Office W91YTZ-13-C-0015, HT0014-19-C-0004, HT0014-21-C-0012, and HT0014-22-C-0016), and the BRITE Study (improving transition from inpatient rehabilitation following TBI; NCT03422276).

Building on these existing partnerships and the previously identified priority problem of access to care, we convened in 2022 in Tampa, FL, for a 2-day intensive retreat to develop the I-HEAL objectives, develop the proposed studies, solidify the partnership plan, develop the dissemination and outreach plan, and outline the functions of the CEC. See the CBPR statement for an overview of our engagement process, beginning with our existing partnerships and continuing throughout the stages of the proposal (Multimedia Appendix 4).

The CEC partners, purpose, and processes for achieving deliverables, functions, and specific deliverables are outlined below. We have structured our partnership plan to reflect the importance of engagement with a broad range of individuals working to improve the lives of V/SMs with TBI. We have conceptualized the CEC to have 3 core partner groups with synergistic purposes. Important aspects of impactful science to address access to care for V/SMs with TBI are the voices of persons with lived experience of TBI, the system-level and disciplinary knowledge of successful policy and dissemination strategies, and the presence of individuals with expertise on the specific study issues. We have developed a CEC with expertise in each of these core areas. Each partner brings passion and commitment to improving the lives of V/SMs with TBI. They bring unique and complementary knowledge and will engage with all cores and individual projects to achieve the overall I-HEAL objectives.

The composition of the CEC is presented in Figure 3. We have established a CEC comprised of persons from influential organizations representing professionals who will engage with I-HEAL products (PPPs) and individuals who can speak about their lived experience of TBI or caregiving for a loved one with TBI (LEPs). We have representation from members of key professional groups involved in health care policy development for VA and the DOD, and providers representing professional organizations (physiatry, social work, psychology, rehabilitation, and nursing) involved in the care of persons with TBI. We have engaged with a diverse group of LEPs with military service backgrounds and with experience navigating health care in military and civilian environments. Members include persons with TBI (V/SMs and civilians) with greater neurologic morbidity and their spouses. Each member has been selected because of their lived experience of the challenges being addressed in this proposal (individuals with brain injury and cognitive morbidity, legal guardians of V/SMs without decision-making capacity, caregivers of veterans with severe maladaptive behaviors living in the community, and individuals experiencing challenges in navigating the health care system). Many have served as engagement partners on other TBI research projects or as members of the Tampa VA Veteran Engagement Council. The PPPs will focus on dissemination and policy development, and the LEPs will focus on the impact to those with lived experience and the identification of potential facilitators and barriers to successful implementation and outcomes. In addition, individual project engagement partners (PEPs) have been identified by each proposed project team to support the specific needs of the projects.

The CEC will be involved in all aspects of the proposed research implementing the I-HEAL objectives. Drs John Corrigan, MM, and Chaady Radwan will co-chair the council. Dr John Corrigan will be responsible for chairing the PPP quarterly meetings. The LEPs will elect a chair who will co-lead the monthly LEP meetings with Drs MM and Chaady Radwan. This group will meet more frequently to ensure that each member feels prepared to participate in the co-learning process and has adequate time to contribute their expertise to the research process using a CBPR approach (Multimedia Appendix 4). In years 1 and 4, all members of the council will meet in person with all other participants in center activities to allow for interaction as the studies begin (year 1) and allow for collaboration as results emerge and dissemination and policy development plans are solidified (year 4).

Information on the meeting schedule is provided in Multimedia Appendix 5. First, Dr MM (multiple principal investigator [MPI]) will oversee ongoing, bidirectional communication between the cores, the study teams, and the CEC by attending the all-hands calls, executive committee, steering committee, and core meetings. The co-chair of the LEP group will attend these meetings monthly. Second, Dr John Corrigan, MM, or Chaady Radwan will attend quarterly meetings with the project teams to monitor engagement needs. In addition, the study teams will rotate attending the meetings of the PPPs and LEPs based on their engagement needs as described in their project methodology below. The proposed engagement from study teams will be incorporated into regularly scheduled CEC meetings. It is expected that communication via email will occur between regularly scheduled meetings and that partners will be available on an as-needed basis between regular meetings. These meetings will be in addition to the in-person meetings in years 1 and 4.

The CEC will be involved in all aspects of the proposal, including the planning, conduct, and dissemination of results. The planning of this proposal is based on over 25 years of patient-centered research conducted by our team members, an extensive literature review, discussions with our CEC partners, and a 2-day intensive retreat used to solidify the plan and partnership roles. Priority problems and outcomes have been identified through these processes. Moving forward and prior to the initiation of each study, the CEC will advise on consent forms, recruitment processes, study rollout, advertisements, and other materials provided to study participants. The CEC will participate in problem-solving for each study as issues arise. In particular, the LEPs will assist in the identification of barriers and facilitators to successful outcomes via engagement with the study design, progress, and data interpretation. They will provide their views on the results and data interpretation. The PPPs will provide insights into the policies and priorities of the constituents they represent as relating to each study and to the overall access to care for persons with TBI. The overarching goal of their collaboration is to ensure that the study results will be relevant, practical, and acceptable to members belonging to their respective professional organizations. Their involvement will be especially critical to the dissemination and policy development activities described later. The CEC will also assist in community outreach, dissemination, and policy implications. The LEPs will advise on the development of dissemination materials for individuals who have had a TBI and their family members. Together with our outreach and media specialist, they will co-develop social media posts, print materials, and brief multimedia presentations that will be used to disseminate study materials and findings throughout the course of the 4-year project (see the Outreach Plan subsection below). The PPPs will advise on successful dissemination strategies as well as relevant financing or other policy-related issues that influence the implementation and sustainability of products. We will leverage the significant leadership platforms in organizations within the VA and professional trade groups and the leadership of brain injury researchers to understand and advance policy and clinical practice guidelines emanating from the study results. We will work closely with the CEC to ensure engagement remains rooted in the principles of CBPR. We will utilize standard metrics of engagement success, including meeting attendance, self-reported empowerment within the group, and objective measures of engagement success pertinent to the completion of each study (see details in the CBPR statement in Multimedia Appendix 4).

Specifically, we will disseminate project updates and results via Twitter, Facebook, and outlets specific to V/SMs recommended by our LEPs. We will utilize multimedia, including video clips and visuals, which are accessible to a wide audience. These outreach efforts will occur at a minimum of once per quarter and as needed when exciting results emerge or other information is determined by the CEC and study teams to need dissemination. The CEC will work with the research teams for traditional academic outreach and dissemination via peer-reviewed papers, conferences, and reports to funders. A focus of our outreach plan is to work closely with our social media specialist to develop materials for social media and community-focused dissemination.

The CEC has both process- and outcome-related deliverables. Process-related deliverables include measurable successful engagement via meeting attendance, participation, and self-reported empowerment. Co-learning, as measured by successful participation in research processes by CEC partners and successful incorporation of CEC advice and suggestions into projects, is a key deliverable. Outcome-related deliverables include inclusive consent and recruitment processes and documents that lead to optimal recruitment for each study; collaborative data analysis that results in meaningful use of data; community-informed dissemination materials to increase reach; and policy and practice guidance for successful dissemination. In addition, each study has identified key needs and deliverables that need to be met by the CEC. See Table 2 for an overview of the deliverables for the CEC and for each project’s engagement plan.

The proposed series of projects will leverage the NIDILRR and VA TBIMS research network infrastructure. The TBIMS program is a longitudinal multicenter study that examines the course of recovery and outcomes following inpatient rehabilitation. This epidemiologic lifetime study, analogous to the Framingham study, has been funded for the past 30 years, with over 18,000 participants enrolled across 16 centers during inpatient rehabilitation for moderate to severe TBI. An elaborate administrative infrastructure developed by the TBIMS investigators supports collaboration via committees (ie, planning, research, knowledge translation, and data) and special interest groups (eg, disorder of consciousness and behavioral health). In addition, multicenter collaborative studies (module studies) are conducted in each funding cycle as part of infrastructure grants. In 2008, the NIDILRR and VA developed an interagency agreement to present the same program as the TBIMS at specialized rehabilitation hospitals within VA. Five polytrauma rehabilitation centers (PRCs) represent the rehabilitation arm of DOD trauma care. Owing to a memorandum of understanding between VA and the DOD, TBI rehabilitation care occurs at these 5 PRCs (Tampa, Richmond, Minneapolis, San Antonio, and Palo Alto). These 5 additional sites have been funded, increasing the TBIMS network to 21 centers, with over 19,000 civilians, veterans, and active-duty service members enrolled in TBIMS research. Most study PIs and co-investigators work within this infrastructure.

In addition to the network sites, the NIDILRR and VA fund the National Data and Statistical Center (NDSC) in each funding cycle. The research program at Craig Hospital in Denver, CO has successfully competed and won the NDSC award for the past 5 funding cycles (20 years) under senior leadership, including Drs Dave Mellick (director) and Jessica Ketchum (senior biostatistician). Craig Hospital has served as the data coordinating center for several extramural and intramural projects leveraging the TBIMS network. Moreover, it has served as the data management center for 36 module (multicenter) studies within the TBIMS network. Furthermore, it has served as the data coordinating center for 10 other multicenter studies funded by the DOD, VA, PCORI, NIDILRR, and NIH. The data management infrastructure and experience of investigators at Craig Hospital will be leveraged for this study.

The staff will plan, develop, manage, and secure the implementation of data systems and conduct all statistical analyses for the successful completion of relevant individual studies. The core will (1) work closely with the individual study PIs to ensure successful execution of the protocol and follow-up of all participants enrolled in individual quantitative data collection efforts across projects through the use of multiple communication strategies; (2) obtain, manage, and analyze data from relevant individual projects; (3) ensure adherence to the research protocol by participants and research staff through in-person and virtual data collector trainings alongside the ISC, regular teleconferences, and constant data validation to monitor the quality of data collection, record keeping, and documentation, and the accuracy of data entry; (4) provide statistical support, expertise, and oversight for the duration of the proposed studies; (5) coordinate communication between individual projects and cores as outlined in the implementation plan; (6) provide administrative and logistical support for the study; and (7) organize, maintain, and submit study data and deidentified study resources to a study repository upon the completion of the study.

We intend to create a web presence as a landing space for public and private dissemination of information [23]. The study website will allow for centralized storage of standard operating procedures (SOPs), manuals of operations, IRB documents, form versions, and contact information for staff across all study sites, obviating the need to solely rely on email to deliver information to project members. The study website will also allow all study personnel to securely access up-to-date dynamic study reports for information on the status of enrollment, data errors, and missing data. Automatic email reminders will be sent to all relevant personnel when new participants consent to the study, which will prompt them to schedule focus groups or key informant interviews. Moreover, personnel will receive notifications on the completion of data collection and other data quality updates.

The NDSC is funded until September 2026 (fifth 5-year funding cycle). The NDSC has had many accomplishments and innovations, including moving the TBIMS National Database to a web-based data management system; providing a web-based database and analytic support for TBIMS Collaborative Module studies; introducing new and innovative statistical techniques for analyzing the TBIMS National Database; developing a structured interview for TBIMS research follow-up; conducting intense quality support visits to individual TBIMS sites; achieving several data collection certifications, including certification for this study’s primary outcome; creating a dashboard of dynamic annual data reports; generating several data quality reports; implementing hundreds of computerized data checks; and maintaining an extensive SOP manual. Many of these technical and data management innovations will be incorporated into the procedures of this proposed study.

The WDMC will follow the best reporting standards to effectively display quantitative information visually. Based on the teaching of Tufte [24] and using the statistical package R and Shiny Server, we will produce a dynamic array of data and process reports that can best be understood by the data consumer.

The TBIMS environment is already functioning and is based on the best practices for a public web application, in which the web server sits outside the network in a demilitarized zone on a virtualized server. There will be only one connection between the web server and the database that flows through the firewall, which acts as a logical filter of traffic between the networks. In between these connections is an F5 web application firewall, which provides threat detection. Furthermore, the framework is 100% data-driven, meaning that the data entry forms are derived from information in the data dictionary.

Because the user interface is completely controlled by data, no code needs to be written to roll out a new data collection form, enabling a speedier and more efficient development-to-production time frame. These systems utilize a web front end (Linux web servers using ASP.NET Core, Angular, and web API) and a Microsoft SQL Server, which is encrypted using a FIPS 140.2 algorithm (the necessary level for government databases) and is consistent with the Federal Information Security Modernization Act legislation. Transmission of the data will also be encrypted using Transport Layer Security (TLS). Our technology solution is built on the security model of the CIA triad (confidentiality, integrity, and availability) using web technologies as a front-end system (where data are entered) and a SQL server as a back-end system (where data are stored).

Confidentiality of the participants will be ensured through multiple measures. First, the database records will contain limited personal identifiers for use in contacting participants (eg, phone number). The web data system is set up in such a way that only authorized individuals using token protocols from ASP.NET 4.0 can access the study website. Additionally, each end user will have specific privileges to read/add/delete the data that are authorized by that center’s PI. Staff at the NDSC will have limited access to the data through the use of SQL server roles and active directory group membership. The staff will follow the method of least privilege permissions, in which all users have the minimum amount of system access that still allows them to perform their job functions. Any hardcopy data forms will be stored at the individual study sites and will follow IRB confidentiality protocols.

Representatives of the study sponsor are eligible to review study records, and this will be addressed with potential study participants during the enrollment and informed consent process. No sensitive information that is required to be reported to state or local authorities will be captured as part of this study. We will leverage the Craig Hospital Information Technology disaster recovery model, in which there are redundancies throughout the system, such as automatic and encrypted backups and co-location of servers in separate areas of the Denver metro area.

Information on the communication strategy is provided in Multimedia Appendix 6. The management of operations for this proposed study requires close coordination of multiple functions carried out by numerous staff with distinctive qualifications. Forming executive and steering committees is essential to the management process. The executive committee (study MPIs and the overall project manager [PM]; see Multimedia Appendix 7 for project leadership) will oversee overall progress, communication with the funding agency, regulatory issues, and fiscal issues. The steering committee will be comprised of the study MPIs, PIs from all individual studies, core directors, and the centralized PM, who will provide support to both committees. An all-hands call will be established to include all study leaders (MPIs, cores, and study PIs) with all core and co-investigator personnel across the FPA. Individual projects and cores have their own meeting schedule and purpose. In-person meetings will be held in years 1 and 4 to provide an in-depth orientation and review of each project’s focus and progress to optimize CEC member input. The WDMC will establish an online secure website and dashboard that will alert the study team to consented participants for scheduling and follow-up.

To ensure that the project will begin without delay, components of the proposal are included in the implementation plan as best practices/innovations by the NIH. Gantt charts for the overall FPA and for individual projects are included in the statement of work (Multimedia Appendix 2).

Regarding the utilization of project management software for milestone tracking for the overall program and individual studies, each core and individual study will utilize software, such as Click-Up or Microsoft Project, as a project management system. The PM will enter goals and tasks based on study milestone tasks (and due dates) and assign responsibility as appropriate. The project will be used for planning, management, tracking meeting agendas and notes, monitoring progress on a regular basis, and supporting other continuous QI activities. This system will be used to ensure that study milestones are met on time and to implement the evaluation plan. Additionally, the project will be linked to Microsoft Outlook and Microsoft Teams, which are available across all study sites for communication of study progress and upcoming events. The Microsoft Teams platform and dashboard will be used to conduct study meetings (to record content for later accessibility) and make available files, documents, and notes during all study-related meetings requiring the use of full-team review features. Decisions made and follow-up actions will be documented and archived for access by all team members. The PM will generate monthly reports to ensure the quality and timeliness of each task and identify tasks (at the PI, site PI, or core level) that require additional attention or staff adjustments. See the statement of work for detailed milestones and work activities across cores and individual projects (Multimedia Appendix 2).

Over its 20-year history, the TBIMS NDSC has developed 31 SOPs for all aspects of study conduct (eg, identification of participants with TBI, guidelines for medical record abstraction, strategies for maximizing follow-up, handling unexpected events at follow-up, prevention and investigation of falsification of data, submission processes, performance target monitoring, branding, and authorship policies). Data quality and representativeness are monitored via 15 on-demand reports (eg, enrollment, follow-up, missing data, and underrepresented population recruitment and follow-up). All project PIs and the contact PI RN-R are currently funded TBIMS investigators and are familiar with these processes, which will be adapted for the proposed FPA. The data management infrastructure and SOPs developed at Craig Hospital will be leveraged for this study.

During routinely scheduled meetings, as outlined in our communication strategy (Multimedia Appendix 6), updates regarding fiscal and logistical issues will be addressed. Project leadership teams will meet weekly during study initiation and transition to monthly meetings when study operations are well underway. Increased frequency will be added as needed. During these routinely scheduled meetings, the MPIs will resolve fiscal and logistical issues in a timely manner, including plans to proactively evaluate and prioritize study risks and issue corrective responses using TBIMS best practices. During these meetings, progress toward study milestones will be reviewed with the PMs to identify potential risks and issue corrective responses. On-demand reports are available to proactively identify risks. Study-specific reports are generated “on demand” regarding milestone tracking, including screening, enrollment, and the degree of data collection completion. Additionally, the DCC will generate monthly reports regarding follow-up rates, data missingness, and adverse event monitoring, if relevant. These reports will be reviewed during the executive committee meeting, with follow-up during the steering committee meeting. Project teams will also review reports weekly or as generated by the WDMC to proactively address potential risks. This mechanism of feedback has been highly successful in past trials completed in the TBIMS network with regard to the completion of data collection on schedule and the achievement of all study milestones well within the funding period.

For underperforming sites, TBIMS SOPs describe that remediation plans should be developed by site PIs to encourage review of local practices by study staff and individually developed plans in order to reach expected benchmarks for enrollment, follow-up data collection, and overall data quality. Remediation plans are expected for sites missing any of the benchmarks (eg, enrollment, follow-up, and missing data), using TBIMS data quality standards. The steering committee will review remediation plans for approval. Once executed, individual project performance will be monitored monthly for a quarter to determine improvement. If no improvement is observed, the study teams will engage one of the study cores (CEC, WDMC, or ISC) for additional engagement to overcome project challenges. Sites are accustomed to these standards and have had success in overcoming missed benchmarks with a remediation plan policy. RN-R has used this method across several trials, with success in achieving study milestones.

The ISC, CEC, and WDMC will collaborate throughout the funding period to facilitate communication of findings for various stakeholder communities. Consistent with our history, the overall FPA scientific products will be submitted for publication in leading scientific journals in sleep medicine (eg, Chest, Sleep, and Journal of Clinical Sleep Medicine) and rehabilitation (Journal of Head Trauma Rehabilitation, Journal of Neurotrauma, and Archives of Physical Medicine and Rehabilitation). Utilizing the infrastructure of the TBIMS Study Network, which includes a separately funded Knowledge Translation Center with an international web presence, the study team will propose and develop fact sheets on the Model Systems Knowledge Translation Center (MSKTC) website. These fact sheets are accessed by patients, caregivers, and clinicians from around the world for consumer-friendly information about TBI. Dissemination success is evidenced by the number of downloads annually. The broad reach of the MSKTC is evident by the 21,967 external web pages linked to the MSKTC site from over 4000 unique domains, with 39% in the area of TBI. From January 2022 through October 31, 2022, the MSKTC website was accessed 1,825,439 times (752,047 for TBI-only content). Among those accessing the MSKTC website, 332,065 were from the United States, with the remaining from 48 other countries, highlighting the international success of the MSKTC as a dissemination venue. Many of the products are now available in Spanish and formatted in HTML to be cell-phone accessible. We will propose updates to existing relevant fact sheets and new content in year 4. Finally, standard dissemination activities include presentations at the DOD’s annual professional conference, Military Health System Research Symposium, and other venues as indicated by the steering committee.

The strategic selection of partners in the CEC will facilitate the rapid translation of knowledge products developed in the proposal. We have partnered with end users of the products to maximize usability and implementation in real-world VA, DOD, and civilian health care settings. We have partnered with professional organizations that provide guidance to end users in the field to maximize adoption by those professional communities. These include rehabilitation professionals and those in physiatry, social work, rehabilitation psychology, nursing, and neuropsychology. The LEP group is comprised of persons with lived experience of TBI who have navigated VA, DOD, and civilian health care settings. The LEP perspective will be incorporated into all products developed to maximize acceptability by patients with TBI and their families. The PPP group is comprised of representatives from federal agencies (VA, DOD, NIDILRR, and MSKTC) to help align products with policies and vice versa.

Data from this project will be made available to the TBI research community by depositing deidentified research data into a nationally available biorepository at the end of the study. Primary data collection will be from providers in the form of qualitative data collection, and the corresponding data will be made available. Qualitative data from our prior work funded by NIDILRR will be archived at the Inter-university Consortium for Political and Social Research Biorepositories. The TBIMS NDSC, which will serve as the WDMC for this study, already has procedures in place to submit its core data to national biorepositories (via previous DOD funding and ongoing NIDILRR funding). They will work with the ISC on qualitative data submission. Funds have been set aside in year 4 for this submission.

Once the data collection phase of individual studies has ended and the datasets have been cleaned and locked for analysis, the data will be deidentified, merged, and securely stored for all study analyses. The final deidentified merged datasets will be securely sent to the study contact MPI (RN-R). The final datasets and documentation will be stripped of identifiers prior to release for sharing to any participating study sites by request once the project has been completed. The datasets will reside with the study contact MPI. Data will be provided in a timely manner to those requesting information for research purposes once a data sharing agreement is in place that meets all the data sharing requirements of all participating sites. To fully protect the human participants, we will evaluate each data request to ensure that special circumstances do not exist that would permit anyone to deduce the identity of individuals from the data. In any such cases, we will share the data based on an agreement stating that (1) the data will be used solely for research, and no individuals will be identified in any manner; (2) the data will be secured by electronic safeguards; and (3) once data analysis is complete, the data will be returned or destroyed.

A semistructured survey developed in collaboration with our CEC members (PEPs and LEPs) will be conducted with the goals to: (1) determine current practices that identify persons with cognitive impairments after TBI and policies that require it across health care settings; (2) determine current practices for identifying medical decision-making capacity or inability to participate in health care encounters independently; (3) identify documentation practices and locations in medical record systems for identifying previous goals (1 and 2); (4) review innovative practices for ensuring persons with TBI have health care proxy assistance in medical encounters (open-ended question); and (5) assess provider attitudes regarding satisfaction with existing practices and willingness to trial new approaches to ensure health care proxy assistance in medical encounters. Questions will be developed using both the open-ended (qualitative) approach and the Likert scale rating.

The CFIR guide will be used to inform the implementation determinants (facilitators and barriers) of the cognitive nudge intervention to determine the extent to which the cognitive nudge intervention is viewed as suitable and likely to be used, and how it can be successfully delivered. The CFIR guide has been used internationally to study all types of health conditions in military and civilian health care settings [60,61]. The overarching access framework domains from the supply/organization side and consumer/demand side will also inform the focus group questions and have been successfully used in our own TBI research [6,46,47,58]. The focus group guide will be pilot tested with people representing those we will engage to ensure comprehension of questions and content.

Recruitment flyers, emails, social media posts, and telephone scripts will be developed and approved during study initiation. Project 1 team members and PPPs will hold monthly meetings during quarters 3‐4 of year 1 to develop and field test the survey, which will be deployed (quarter 1 of year 2) to members of professional health care organizations (eg, American Congress of Rehabilitation Medicine, Association of American Physicians, National Academy of Neuropsychology, American Psychological Association’s Division of Rehabilitation Psychology, VA, and DOD) via organizational email distribution groups and personal network emails of the research team and core groups. Survey links will be sent up to three times via email. Up to 20 respondents will be randomly selected to receive a US $50 gift card for participation.

Recruitment flyers, emails, social media posts, and telephone scripts will be developed and approved during study initiation. Up to 10 focus groups (5 focus groups per stakeholder type [professionals and persons with lived TBI experience] will be conducted, with ≤8 people for each focus group). Each focus group will be scheduled for 90 minutes, conducted on online conferencing platforms (eg, Microsoft Teams and Zoom), digitally recorded, and professionally transcribed with quality checks by the study team. Participants will receive a US $50 gift card for participation if permissible.

Survey data will be summarized descriptively using means, SDs, and percentiles for continuous data, and frequency counts and proportions for categorical data. Survey data will be summarized for the overall sample and by provider type and health care setting. Responses will be compared across provider types and health care systems using chi-square tests, ANOVA, and nonparametric alternatives as necessary (Fisher exact test and Wilcoxon rank sum test). Open-ended survey responses will be exported to an Excel file. Individual responses will be analyzed using a rapid matrix analysis approach by comparing similar responses and grouping them to create categories [62]. For both the qualitative and quantitative data, sensitivity analyses will examine responses by demographics (age, gender, race, ethnicity, and years in practice).

Focus group and individual interview transcripts will be analyzed using matrix analysis, a rapid assessment approach, to summarize and identify themes. Rapid assessment is a team-based approach to iteratively collect and analyze qualitative data that emphasizes speed of data collection and analysis in relation to focused programmatic questions or problems [62]. Two experienced qualitative researchers will conduct the matrix analysis. Together, they will create codes both deductively from known constructs and inductively from the data, and use matrices to categorize responses under domain names, applying codes that emerge from the data. Codes and preliminary themes will be reviewed by the research team and partners to establish consensus. A matrix analysis approach will facilitate a rapid turnaround of the results to provide immediate feedback to inform the cognitive nudge and supportive implementation materials, such as the implementation blueprint.

Using a CBPR approach that strengthens knowledge translation efforts [63,64], we will schedule a series of meetings to review the triangulation of aim 1 findings with the CEC, identify needs informing toolkit product development (Multimedia Appendix 8), and evaluate the usability of toolkit content.

Project 1 engagement partners represent key partners in the eventual implementation of the cognitive nudge decision support tool. They will review aim 1 findings to identify needs from their unique perspectives and make suggestions for the content, structure, and language used in products in the toolkit.

Project 1 IEPs (VA hospital administration and national VA physical medicine and rehabilitation policy leads) will review product suggestions and prioritize content development. Existing national policies for the use of nudge interventions and products that exist for other clinical reminders in the EMR will be used as a starting point for all products, such that most products will be adaptations to maximize feasibility and acceptability, and to optimize integration into the existing health care system. The study team will then utilize feedback across engagement partner communities to adapt existing content and develop new content for the toolkit.

The ISC will conduct semistructured interviews with the CEC and IEPs for user testing of toolkit products. No formal analyses will be conducted, and feedback will be used by project investigators to finalize the content.

We will work with project 1 team members (hospital administration and national physical medicine and rehabilitation EMR leads) to pilot the implementation of the cognitive nudge decision support tool for final refinement prior to dissemination.

The study team will follow recommendations for implementing a category 2 patient record flag (ie, nudge) in compliance with Veterans Health Administration Directive 2010‐05 and Patient Record Software Patch v5.3 (March 2019). These directives outline policy and guidance for the proper use of patient record flags to enhance safety for patients, employees, and visitors. Category 2 flags are for nonimmediate risk that can be implemented at a facility level. Category 2 flags denote risk factors (eg, cognitive impairment) that must be known in the initial moments of a patient encounter. Facility-level partners responsible for the implementation of a category 2 flag are involved as IEPs in this proposal. Software patches in the VA EMR system permit entry, editing, and monitoring of patient flags. The team and IEPs will work with the Tampa VA Patient Safety Office, overseeing EMR flags to trial the cognitive nudge intervention.

Veterans Health Administration Directive 2010‐05 requires training on any element of software utility, activation, continuation, and deactivation of the cognitive nudge. Additional areas of training include confidentiality and appropriate responses to a cognitive nudge. Training in these areas will follow the toolkit and implementation plan developed in aim 2. Training for Tampa VA TBI rehabilitation providers and primary consultants will be delivered via existing staff meetings across services. As noted, chiefs of those services serve as project I engagement partners to facilitate local training and unique needs across services. Following training, the cognitive nudge will be piloted for a 4-month period in the inpatient polytrauma rehabilitation unit (18/56 inpatient beds) at the Tampa VA, the largest rehabilitation facility in the VA Healthcare System.

At the conclusion of the pilot, ISC staff will conduct semistructured interviews with providers who interacted with the cognitive nudge during the pilot (Medical Director of the brain injury inpatient program and 2 unit neuropsychologists) using key informant interviews. The ISC will also conduct focus groups with allied health providers (case management providers, rehabilitation therapists, nurses, and family therapists). Key informant interviews and focus groups will use the CFIR Interview Guide to identify facilitators and barriers to implementation. Codebook development will include key implementation constructs of acceptability, relative advantage, usability, and complexity. Data will inform final revisions to the toolkit and the implementation plan tailored to rehabilitation settings in the VA/DOD system. Persons with TBI receiving care during the pilot and their health care proxies will also be approached and consented to complete a semistructured interview with the ISC to understand whether the cognitive flag nudge intervention enhanced health care proxy engagement in the health care encounters during the pilot. Findings will be integrated into the finalization of the toolkit.

Following project approval as a QI project, the team will commence a comprehensive environmental scan using a CBPR approach. First, the team will review project goals with CEC members to facilitate identification of provider resources for modifying behavioral health treatments for persons with cognitive impairment. Professional partners will be asked to help identify existing online materials and utilize their professional contacts for finding additional materials and tools. Next, an anonymous Qualtrics survey that queries providers about resources used to provide adaptations for persons with cognitive impairment will be developed. The survey will include a request to submit content to the project (if permitted) to complete the environmental scan. The PPPs within the CEC will be asked to help disseminate the survey to their constituency using professional and email listserv platforms available within their organizations. Social media content will be developed by our social media specialist and shared to help increase the reach of the survey. The WDMC will develop an online platform to store and organize relevant materials about adaptations.

Research staff guided by MPIs (AMM, JMH, and Daniel Goldschmidt) will work with the ISC to conduct the comprehensive environmental scan process by (1) compiling collected materials from SMEs on a secure drive, (2) searching extensively via compiled sources (eg, organization websites) and web searches for additional leads on tools, and (3) conducting a literature review with search terms to capture adaptations for cognitive deficits for behavioral health treatments (eg, chronic pain, PTSD, and insomnia). A study research associate will begin this process in quarter 1 of year 1, as they will already be onboarded at the start of the project. Materials identified through the environmental scan will be entered into an Excel document using a product grid template. The product grid, developed by the MPI JNH, uses rows and columns to review, organize, and rate materials (1 product per row) by preestablished qualities or domains (column descriptors). Research staff will review each resource and preliminarily complete a review of products in the product grid. SMEs will serve as IEPs for project 2 to aid in product grid validation. IEPs represent content expertise across commonly comorbid conditions in military personnel after TBI (Multimedia Appendix 9). IEPs will partner with the project team to validate adaptations proposed and their impacts on specific evidence-based treatment content.

Once the product grid is populated based on a preliminary review by the study team, a secondary SME review will be conducted. The product grid will include general accommodations for cognitive difficulties and be organized by psychological health condition (ie, PTSD, depression, chronic pain, and sleep disorders). SME review panel members will be assigned products corresponding to their primary area of expertise to review. All panel members will review general accommodations. Each line item in the product grid will be evaluated by 2 SMEs, and for any product where there is a discrepancy in ratings, a third SME will evaluate to help reach consensus. Products will be assigned to and independently reviewed by the SME review panel along the following domains: (1) verification of the intended audience (eg, licensed therapist), (2) quality of accommodations made (rating appropriateness from 0 [poor] to 5 [excellent]), and (3) complexity of using the tool (0 [very difficult] to 2 [very easy to implement]).

Once the SMEs complete their individual reviews of the product grid, the SME review panel will convene to review the products identified as being of high quality, which can be implemented with the greatest ease. Prioritized products will be translated into tools or components of the toolkit. SMEs will collaborate to (1) identify gaps in tools that may require development and (2) provide guidance on how to create tools that need to be developed.

In tandem with the SME review, the LEPs will convene to review the identified products to be included in the toolkit to inform appropriateness for the target patient population. Additionally, the LEPs will discuss the appropriateness of language use and orientation for providers when working with persons with TBI. The LEPs will be specifically asked about the appropriateness of language regarding the introduction of tools and the overall approach to guiding providers/end users of the toolkit on integrating modifications. Gaps in the toolkit will be identified through discussions with LEPs based on lived experiences of engaging with behavioral health providers and treatments. For example, feedback about the importance of having a toolkit like this or the frustrations experienced when interacting with behavioral health providers as a person with TBI will be invaluable to the project team for creating content in the “introduction” and “purpose of the toolkit” sections.

The project team will triangulate feedback from aim 2.1a to develop the initial prototype of the toolkit, tentatively titled “The Provider Toolkit for Accommodating Cognitively Impaired Persons.” The team will partner with the ISC product designer to compile tools in the product grid and develop additional tools or toolkit components (see Table 3 for possible components of the toolkit). Details outlined in the product grid categories will inform background narratives, applications, and other framing aspects for each tool.

A formative review will be conducted to review, provide overall impressions, and make recommendations to improve the toolkit [96]. The toolkit prototype completed in aim 2.2b will be circulated several weeks prior to review sessions. Review sessions will take place online, and a facilitator and notetaker will be present. The team will engage the PPPs of the CEC to address organizational insight and high-order messaging, framing, and usability of the tools, as well as identify targets for future dissemination within organizations, educational institutions, and health care systems. The provider SME review panel will assist in validating the toolkit in terms of content validity, treatment fidelity, and usability of the tools across and within EBT approaches. The team will engage the LEPs of the CEC to provide final validation of the appropriateness and sensitivity of the language to guide providers/end users on integrating modifications in a way acceptable to patients and families. Any items still needing resolution will also be reviewed.

Data will be analyzed using the rapid assessment process [62], a team-based approach, which allows for quick turnaround of qualitative data analysis and provides prioritized findings. Review session notes alongside spot checks of audio recordings to clarify any missed notes or important reviewer quotes will be processed and cleaned with quick turnaround (within 3 days of data collection). This data analysis approach uses triangulation and iterative data analysis to quickly generate insights from qualitative data, and intensive team interaction to analyze the data will help to quickly translate reviewer feedback into prioritized modifications for the team to address in aim 2.3b [97].

The study team will integrate findings from the formative review to finalize toolkit compilation. The team will work with the social media specialist to create awareness of the project, and milestone completion will be highlighted on social media. The team will work with the WDMC to highlight project milestone completion on the overall FPA online dashboard. The study team will publish data collected across study aims in rehabilitation journals specializing in psychological health and as advised by the PPP members (eg, Rehabilitation Psychology, Archives of Physical Medicine and Rehabilitation, and Provider Informational Education Page). The toolkit and implementation plan (playbook) will be published on the study Toolshed Site hosted by the WDMC. The team will work with professional engagement partners and individual professional engagement partners to create a communication plan for the toolkit with various professional organizations, including those issuing clinical guidance to the field. Future work will evaluate the dissemination and implementation of the toolkit, and the outcome of toolkit use to benefit V/SMs with TBI.

The participants in the focus groups will include veterans with brain injury and their family members/care partners. The inclusion criteria are as follows: (1) age 18 or older, (2) participants with TBI who have received rehabilitation and family members/care partners of veterans with TBI who have received rehabilitation within the past 5 years, and (3) online access to participate in a virtual meeting.

We will be conducting focus groups with a homogeneous composition. There will be 3‐6 focus groups with veterans having TBI and 3‐6 focus groups with their family members/care partners. Each focus group will have 6‐8 participants, resulting in a total sample size of approximately 64 participants. The sample size was determined based on the understanding of what it will take to reach thematic saturation in the field [127-129].

The sample will be recruited with the assistance of the CEC, IEPs, and VA PRCs. We will seek to recruit at least 25% of participants representing a racial/ethnic minority and oversample female veterans.

Participants will include at least 30 rehabilitation professionals in team leadership roles that align with program development and implementation. While we anticipate that most will be employed at a VA PRC, some will also be drawn from civilian facilities that serve veterans. Each included participant must (1) be a rehabilitation professional in one of the key leadership roles for TeamBI program implementation (team leader, administrator, behavioral health provider, and nurse manager) or hold a position that includes program development and implementation in job duties, (2) be employed in a TBI inpatient rehabilitation setting that serves V/SMs, and (3) have online access.

Participants will be recruited with assistance from the CEC. To ensure diversity, we will call upon volunteers from the CEC to assist with outreach. Consent will be obtained online prior to commencement of study procedures.

A sample size of n=30 has at least 80% power at 5% significance to detect a change in means associated with an effect size as small as 0.53 (change in mean/pretest SD) [140,141], which is considered to be a medium effect size.

The Capability, Opportunity, Motivation to Implement a Team-Based Behavioral Intervention (COM-TBI) model, a pre/posttest instrument based on the COM-B model [142,143], will be used to evaluate the impact of exposure to the playbook on rehabilitation professionals’ likelihood to implement the TeamBI program. The COM-B model purports that in order for change to occur, the individual needs to be motivated; however, motivation will not lead to behavior change unless the individual perceives themselves as capable and having the opportunity to perform the behavior. Typically, studies of behavior change, including the likelihood that an individual will implement a specific program, require the construction of a study-specific measure. However, a generic 6-item measure was developed specifically for adaptation across different studies [138].

The generic questionnaire was tested with health care professionals and a sample of individuals with low socioeconomic status, and was found to be acceptable, understandable, reliable, and valid [138]. Scores on the scale significantly predicted actual behavior change (delivery of opportunistic behavior change interventions by health care professionals). Confirmatory factor analysis indicated a well-fitting 3-factor model aligning with the 3 constructs (capability, opportunity, and motivation). The Bayesian information criterion and Akaike information criterion indicated that the 3-factor model was superior to a unidimensional model. We will adapt this generic measure, tailoring items to be relevant to the implementation of a team-based behavioral intervention program. Since the participants will not have been exposed to the playbook at the time of the baseline pretest, they will be asked to respond based on the implementation of a generic team-based behavioral intervention program for patients with TBI. The CEC and IEPs will assist with item development and piloting prior to use with the study sample. The psychometrics of the adapted instrument will also be evaluated with the study sample.

The CFIR Interview Guide will be used to identify open-ended questions for use in evaluating implementation readiness and the identification of any determinants (barriers and facilitators) that may not have been sufficiently addressed in the playbook. The CFIR guide has been used internationally to study all types of health conditions in military and civilian health care settings [59,60]. The overarching access framework domains from the supply/organization side and consumer/demand side will also inform the focus group questions, and they have been successfully used in our own TBI research [6,46,47,58]. The interview guide will be pilot tested with people representing those we will engage to ensure comprehension of the questions and content. We will include questions about the TeamBI program’s adaptability, complexity, and cost; the design quality and packaging; and the implementation climate at their settings. We will also use the guide’s questions about the individual’s knowledge and beliefs about the TeamBI program, self-efficacy, and the individual stage of change to implement the program. Responses will be used to further refine the playbook.

Information will be obtained from participants regarding age, gender, race, profession/discipline, job title, type of facility where they are employed, whether the facility routinely serves veterans with TBI, whether the facility is a VA or civilian facility, and whether they have online access.

Participants will be sent a link to the consent form, and after they have successfully completed the consent, a link will open a screening form to ensure they meet the inclusion criteria. Participants who meet the inclusion criteria will be linked to the baseline version of the COM-TBI to evaluate capability, motivation, and opportunity to implement a generic team-based behavioral intervention. Upon completing the COM-B, they will be sent the playbook; a link to the online webinar that reviews the playbook’s contents; and a link to the postexposure version of the COM-TBI to evaluate capability, motivation, and opportunity to implement the TeamBI program. They will also be sent the open-ended questions from the CFIR Interview Guide. Upon completion of the postexposure measures, the participants will receive continuing education credit and a financial incentive (US $50). The total time involved is estimated to be 2 hours per participant.

The sample will be used to test the hypothesis that participants’ perceptions of their capability, opportunity, and motivation will improve from baseline after exposure to the playbook. Means, SDs, and percentiles will be used to summarize continuous data and frequency counts, and percentages will be used to summarize categorical variables. Sample characteristics (eg, age, gender, race, setting [type and civilian vs VA], job title, and discipline) will also be collected and summarized for participants in this sample. Paired t tests will be used to test for a change in capability (hypothesis 1), opportunity (hypothesis 2), and motivation (hypothesis 3) from baseline to postexposure at a significance level of α=.05. We will also explore whether setting (VA vs civilian and facility type) has an impact on improvements in knowledge, confidence, and motivation by examining the means, SDs, and effect sizes of each of the outcome variables using analysis of covariance models.

For aim 3.2b, data from the implementation readiness survey will be compiled to identify barriers that may need to be addressed with additional implementation strategies. Our preliminary study yielded a wealth of information from open-ended questions about determinants to implementing behavior programs, and we anticipate that we will receive similarly detailed responses in this study. Open-ended responses will be analyzed using matrix analysis, a rapid assessment approach, to summarize and identify themes. Rapid assessment is a team-based approach to iteratively collect and analyze qualitative data that emphasize the speed of data collection and analysis in relation to focused programmatic questions or problems [81]. Two experienced qualitative researchers will conduct the matrix analysis. Together, they will create codes both deductively from known constructs and inductively from the data, and use matrices to categorize responses under domain names, applying codes that emerge from the data. Codes and preliminary themes will be reviewed by the research team and CEC to establish consensus.

For aim 3.2c, in consultation with the ISC, investigators will refine the playbook based on the findings from aims 3.2a and 3.2b. Strategies will be added for any barriers that were not sufficiently addressed. Any setting-specific barriers will be called out in the playbook with strategies targeted to the setting. Approval of the final playbook will be obtained from the CEC version of the playbook before moving to wider dissemination via the project toolshed.

This project will use HCD and CBPR approaches, adopting sequential mixed methods to complete the QI project. Leveraging existing qualitative interview data from the NIDILRR study provides a unique opportunity to conduct secondary analyses to understand specific barriers to treatment and delivery for persons with TBI and chronic pain [46,47]. Investigators and analysts from the parent study are the investigators for the proposed project, who have familiarity with the dataset leveraged for secondary analyses and methods, thus maximizing the success of the study objectives.

In alignment with the I-HEAL theoretical framework, HCD and CBPR approaches, using sequential mixed methods, will be used to complete the QI project. Descriptive qualitative methods will be used to conduct the secondary qualitative data analysis of semistructured provider interview data that have been recently collected (October 2020-November 2021) as part of the NIDILRR-funded “Characterization and Treatment of Chronic Pain after Moderate to Severe TBI” study. CBPR will be used to facilitate stakeholder engagement activities for partnering with key CEC partners throughout the proposed project activities to complete the project aims.

Two data sources will be utilized to conduct the secondary analysis. First, transcripts of semistructured interviews will query providers about their treatment and referral practices for patients with TBI and co-morbid chronic pain, including what improves or impedes access to treatment. These semistructured interviews consist of 14 questions that are informed by the Access to Healthcare Framework [10]. The qualitative data collection team will utilize probing to ensure important concepts related to access are fully discussed. Second, a provider questionnaire consisting of 14 questions will characterize the provider sample, including information on work settings and the types of patients they treat. No new data will be collected for aim 4.1.

Aim 4.1 will be conducted in 3 phases. In aim 4.1a, data will be accessed and managed for analysis. Dr Bridget A Cotner, an anthropologist and qualitative research expert at Tampa VA who led the primary data collection activities and analysis, will lead aim 1 of this project. The qualitative team, consisting of 2 trained qualitative researchers and led by Dr Bridget A Cotner, has access to the interview data and qualitative analysis software, ATLAS.ti (v.22) [149], to be used for the proposed analyses. Data are housed on a secure password-protected network that is accessible only by qualified research team members. In aim 4.1b, codebook development will be completed. To adequately capture virtual health care access barriers among those with TBI, a qualitative codebook will be developed using deductive codes generated from relevant constructs reflected in the Access to Healthcare Framework and CFIR framework (see Figure 2), and it will be developed inductively from interview data and input from CEC partners, including PPPs, LEPs, and IEPs. As such, once the team develops the initial codebook constructs with definitions and 10% of the transcripts are analyzed, Drs JNH and Bridget A Cotner will facilitate an initial 90-minute virtual or in-person stakeholder panel meeting (n=10‐15) for codebook construct definition review and interpretation of the initial data findings. The stakeholder panel will drive the analytic process to ensure relevance, accuracy, and usefulness of the data findings.

The maximum number of potential participants (PPP, LEP, and IEP group members) is 15, which is beyond the size of a typical group for facilitating a focused group discussion with activities. If the project team determines that the codebook constructs, definitions, and initial analyses are broad and/or complex, the team may opt to divide the PPPs and IEPs into one panel group and the LEPs into another stakeholder panel group. Collectively, the CEC panel meeting review and feedback will inform the analysis of the remaining 90% of the data transcripts.

In aim 4.1c, coded transcripts will be used to create a taxonomy of data findings. Interview transcripts will be recoded by the qualitative team using the codebook augmented by our CEC partner feedback to determine barriers and facilitators to virtual care delivery. Additional codes will emerge inductively from the interview data. The coding team will read one interview transcript separately and discuss the addition of new codes with examples. This process will continue with subsequent transcripts until no new codes are generated. Interrater reliability will be established when the coding team reaches at least 80% coding agreement. Intercoder reliability will be routinely monitored to ensure consistency and limit potential drift in coding. Any discrepancies will be discussed and resolved among PIs, co-investigators, and study staff during weekly meetings to ensure coding and analysis are completed on schedule. Analysts will adopt a constant comparative approach to conduct a matrix analysis [150], a rapid assessment approach [62], which will be used to develop themes for the overall sample by system of care (VA/DOD: n=26; civilian: n=37) and by provider discipline (rehabilitation therapists: n=28; mental health provider: n=15; medical provider: n=15). This analysis will be organized into taxonomies of domains and subdomains that reach saturation. Development of a taxonomy relevant to the informed use of virtual health resources among persons with TBI will provide a formal system for classifying a set of common conceptual domains and dimensions to this multifaceted complex topic. This taxonomy will inform a multilayered approach to understanding: (1) mandated versus actual use of virtual health resources, (2) facilitators and barriers, (3) opportunities and recommendations for virtual health resources for persons with TBI, (4) identified dissemination and implementation strategies, and (5) other factors that surface as relevant to the topic throughout data analysis. A second 90-minute virtual or in-person stakeholder panel meeting will engage them in review of the final data summaries and taxonomy to provide input on product development and dissemination planning. Stakeholder input will inform stakeholder-driven product development (eg, executive summary, briefing, presentation slide deck, white paper, testimonial, etc).

Qualitative data analysis relies on the saturation of data to validate findings, that is, when no new information emerges. The larger parent study, Characterization and Treatment of Chronic Pain after Moderate to Severe Traumatic Brain Injury: A Qualitative Study (PR00039496), provided a sample size justification based on the principle of “saturation.” Due to the specificity of the proposed analysis and interview participants who are knowledgeable of this topic [128], a smaller sample size is needed. As such, for this secondary analysis, themes are expected to reach saturation for the overall sample by system of care (VA/DOD: n=26; civilian: n=37) and by provider discipline (rehabilitation therapist: n=28; mental health provider: n=15; medical provider: n=15) due to a sample size that is more than adequate.

Aim 4.2 will be conducted in a multiphase stakeholder engagement process to drive product and dissemination plan development. This aim will involve 3 phases. In aim 4.2a, a gap analysis will be conducted based on aim 4.1 findings and previous experience to inform the development of a product grid to inform accommodations and recommendations for virtual health resource use among persons with TBI. Based on previous experience, the team anticipates that a collective group of products (eg, executive summary, briefing, presentation slide deck, white paper, testimonial, etc) will be required for development to inform clinical and policy decision support relevant to the appropriate use of virtual health resources among persons with TBI. The product development product grid will take a preliminary approach to prioritizing (1) products and deliverable items, (2) target audiences, (3) purpose, (4) content needed, (5) format, (6) complexity, (7) readiness, (8) weighted score (complexity × readiness), (9) pain points, (10) designated roles of developers, and (11) potential impact.

In aim 4.2b, CEC PPP and IEP partners from aim 4.1 will be re-engaged for a third 90-minute in-person or virtual panel meeting (n=8‐10) to present data summaries, the taxonomy, and the preliminary list of products and dissemination activities. Re-engagement efforts will focus on PPPs, those with leadership experience in the areas of virtual care delivery and TBI, and other panel members, as deemed appropriate by the aim 4.1 data findings. The aim 4.2b panel meeting will be recorded, and the facilitators (led by JNH and Bridget A Cotner) will use methods with a semistructured interview script to solicit respondents’ perceptions about the information and marketing needs and preferences to inform and solicit respondents’ recommendations. During the panel meeting, data summaries and the taxonomy will be reviewed and evaluated for validity among panel members, and the proposed products and dissemination activities will be reviewed. The team will work with partners to ensure that the dissemination plan includes (1) products for engaging partners with targeted messages, (2) an overview of scheduled communication activities, and (3) anticipated outcomes for stakeholder groups. During this panel meeting, the team will address the identification of all partners and specific contact information to ensure all potential influencing partners are identified. Troubleshooting barriers and discussing workarounds for current policies on the use of virtual health care delivery for persons with TBI will be specifically addressed. JNH and other team members will prepare and anticipate potential barriers and troubleshooting, as these topics tend to arise during policy development and implementation. During the panel meeting, the team will conduct an “activity” with panel members to prioritize products by level of complexity, readiness, and potential impact. Data received during the panel and field notes will be documented and integrated using an established qualitative rapid content analysis process. Audio recordings will also be transcribed and analyzed using rapid content analysis. Initial analyses from the panel meeting will be converged with the analyzed transcribed data, and this approach will support the validity of the findings. This approach will also maximize the relevance and feasibility of recommendation adoption and policy change throughout the DOD, VA, and civilian health care systems.

Brief follow-up calls may be conducted as needed with panel partners (or small groups of 3‐4 members) to finalize or clarify any unresolved topics that might arise during the virtual panel meeting or during subsequent analysis. This iterative development process allows for the emergence of data and/or recommendations, which, although unforeseen, reflect stakeholder values throughout the study process. Once all data are reviewed and compiled, data and product priority rankings will be used to finalize the project product grid and inform and finalize product and dissemination plan development. In aim 4.2c, product development and dissemination planning will be completed.

In aim 4.3, the team will re-engage CEC partners to validate the clinical and policy decision-making support products and the dissemination plan. This process will ensure that the products and plan are relevant and useful, and have optimal potential for high impact. Given the professional roles of PPPs, as key DOD, VA, and civilian health care system representatives, this group will be the “front line” of leaders who are uniquely positioned to support dissemination and policy impact. As such, this aim will be the “soft launch” of the dissemination plan, as this aim will rely on those who are positioned to champion planned dissemination efforts.

Aim 4.3 will be conducted in 3 phases. In aim 4.3a, before the third and final panel meeting is conducted, the product grid, content, and dissemination plan will be sent to panel members as a compiled “package,” with instructions for preliminary review in preparation for the third and final panel meeting. Subsequently, in aim 4.3b, the fourth 90-minute panel meeting (in-person or virtual) with CEC PPP and IEP members (n=8‐10) will be scheduled to formally present the final product grid (with ratings, product content, and the dissemination plan) to the panel to prompt discussion, collective review, and synthesis of feedback and recommended revisions. As in previous aims, the facilitators will use a semistructured script to guide major discussion points and activities to ensure that all topics are addressed and planned activities are completed. The team will finalize the product grid, products, and dissemination plan with panelists. Other issues, such as stakeholder contacts, will be confirmed as current, and opportunities for troubleshooting and workarounds will be reconfirmed. As in aim 4.2, this iterative process will allow for the emergence of data and/or recommendations, which may be unforeseen but reflect stakeholder values throughout the project phases. As with aim 4.2b, data received during the panel, data from field notes, and information from transcribed data will be converged and analyzed using rapid content analysis to optimize validity and maximize the relevance and feasibility of recommendation adoption and policy change throughout the DOD, VA, and civilian health care systems. In aim 4.3c, once all data are reviewed and compiled, Drs JNH and Bridget A Cotner will work with ISC team members, particularly Mrs Margeaux Chavez, to take a rapid, systematic approach for finalizing the product grid, products, and dissemination plan to prepare for the launch of the dissemination plan with our panel of CEC partners.