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Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT—VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom.
Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT).
CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise—death, myocardial infarction, and nonfatal stroke— all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups.
Study start-up is underway and usability testing is scheduled to begin in the fall of 2016.
Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS.
Cardiac and vascular surgeries (CaVS) are performed on seniors [
Collectively as an innovation community we have completed, or are conducting, prospective outcome studies with >65,000 surgical patients, including CaVS patients [
CaVS surgeries affect pain-sensitive structures as they invade muscle and visceral tissues, and involve the harvesting and manipulation of vessels. Such surgical tissue insults lead to pathological nervous system changes, collectively known as sensitization [
The deleterious consequences of CPSP in CaVS—amidst divergent surgical populations—are well-known, with numerous studies reporting associations of CPSP with poor HRQL and depressive disorder [
Meta-analysis: Differences in acute postoperative pain scores between those who do and do not develop chronic postsurgical pain.
Study | Standardized mean difference (SE) | Weight (%) | Standardized mean difference inverse variance random effects (95% CI) |
Choiniere et al 2014 [ |
0.14 (0.04) | 24.2 | 0.14 (0.06 to 0.22) |
King et al 2008 [ |
0.07 (0.11) | 17.3 | 0.07 (-0.15 to 0.29) |
Lahtinen et al 2006 [ |
0.13 (0.06) | 22.7 | 0.13 (0.02 to 0.25) |
Lee et al 2010 [ |
0.96 (0.39) | 3.8 | 0.96 (0.19 to 1.74) |
Steegers et al 2007 [ |
0.86 (0.17) | 12.3 | 0.86 (0.53 to 1.19) |
van Gulik et al 2011 [ |
0.31 (0.17) | 12.6 | 0.31 (-0.02 to 0.63) |
van Gulik et al 2012 [ |
0.27 (0.25) | 7.1 | 0.27 (-0.25 to 0.79) |
Total | N/Aa | N/A | 0.28 (0.12 to 0.44) |
aN/A: not applicable.
CaVS are among the highest-risk surgeries and are associated with substantial postop morbidity and mortality. Following an immediate postop period of intensive care unit (ICU) hemodynamic surveillance, vital signs monitoring after ICU discharge is lacking. Most patients on surgical wards will have vital signs evaluated once per 4-12 hours [
Data from large randomized controlled trials (RCTs) also suggest that blood pressure is a particularly important independent predictor of postop cardiac complications and death. The PeriOperative ISchemic Evaluation (POISE) trial [
CaVS options are changing, with many patients choosing percutaneous coronary interventions (PCIs) to address vasculature blockages. This results in those undergoing CaVS manifesting disease that is either too advanced or too complicated for PCI. As such, CaVS patients—often with multiple comorbidities—are at high risk for surgical site infections (SSIs). In England, for example, SSIs occurred in 4.4% of patients (n=29,144) who underwent coronary artery bypass grafting and 2.2% of patients (n=7256) who underwent vascular surgery—in National Health Service hospitals from April 2008 to March 2013 [
Not only are CaVS among the highest-risk surgeries, they are associated with high rates of hospital readmission. A 2014 prospective, multicenter cohort study—10 centers, 5185 patients—in Canada and the United States reported the rate of all-cause 30-day readmission following cardiac surgery at 18.7% [
This project is being undertaken in Canada and the United Kingdom because (1) the gaps and inefficiencies following CaVS are similar and (2) implementations of eHealth innovations require attention to agile/scalable designs which can be realized through efficient (ie, parallel) integration and effectiveness testing across two health systems.
Guided by the Integrated Vascular Health Blueprint for Ontario [
Initial discussions have centered on eHealth Innovation Partnership Program objectives, CaVS recovery challenges, and potential partners’ orientation to improving patient experience, willingness to codesign, and their match with desired partner criteria. Further discussions reviewed respective technology innovations and desired scope of involvement. As a result of this process, we are fortunate to be working with Philips Canada, QoC Health, XAHIVE, and mPath. These partners are drivers of innovation, ranging from small to medium enterprises, to a multinational organization.
The intervention has been designed according to
SMArTVIEW is an eHealth-enabled service delivery program—based on existing implementable technology and validated interventions—which combines remote monitoring, education, and self-management training (see
The Self-MAnagemenT—VIsion for patient EmpoWerment (SMArTVIEW) eHealth-enabled service delivery program. ECG: electrocardiogram.
Multiple clinicians are involved in seniors’ circles of care in the hospital and the community. Successful implementation, however, requires centralized coordination. Therefore, the “SMArTVIEW Nurse” (SVN), a registered nurse with SVN training, is central. SMArTVIEW is a two-stage intervention program. Stage 1 supports seniors after CaVS in hospital on surgical wards post-ICU, with a view to seamless transition, while Stage 2 supports patients at home during the first 8 weeks of recovery (see
Stage 1 includes remote automated postoperative monitoring (Protect) and pain management education (Protect, Inform).
On the ward, remote monitoring will be implemented by the SVN via Philips’ IntelliVue Guardian early warning system, which includes a centrally located monitor, a portable spot check monitor, and four lightweight cableless devices worn by the patient, with connectivity via short range radio and hotspot transmitters. The four devices are as follows: (1) MX40,a telemetry pack for 8-lead continuous electrocardiogram monitoring; (2) Acquire SpO2, a wrist-worn device applied to the index finger, which provides continuous SpO2 saturation values under various artifact conditions, including motion and low perfusion, as well as pulse rate; (3) Acquire Blood Pressure, a noninvasive blood pressure cuff worn on the brachial aspect of the arm; and (4) Acquire Respiration Pod, a small patch-like device, attached to the left costal arch of the patient’s chest, which derives respiration rate and patient posture via 3D accelerometer [
Education (Inform) is critical to prevent transition from acute postop pain to CPSP. To empower seniors to know how to communicate their postop pain experience and understand options for pain management (Protect), we employ, on ward day 2, Watt-Watson et al’s Pain Relief After Surgery educational intervention [
Stage 2 includes SVN hospital-to-home remote monitoring and support and self-management training.
The eTrAC program is a tablet-based solution that combines clinical software for effective care management with Bluetooth-enabled, patient-monitoring devices measuring SpO2, blood pressure, temperature, blood glucose, and weight [
The SVN will employ the eTrAC program to facilitate daily virtual check-ins and counseling, daily vital signs monitoring and triage, and review of interactive symptom and reflexive surveys (Access, Inform, Protect, Connect) [
As with Stage 1, we are committed in Stage 2, combining improved monitoring with education and support that empowers seniors to proactively prevent transition to CPSP and prevent poor functional recovery. As a team we are experienced in the development/testing of self-management models for people with coronary artery disease [
Both the online interactive elements as well as self-efficacy-enhancing features of Restore will be adapted specifically from the Coventry University Help to Overcome Problems Effectively (HOPE) and Internet-based (iHOPE) programs. As one of the first self-management interventions combining positive psychology and cognitive behavioral therapy theory, iHOPE includes evidence-based and positive psychological activities such as goal setting, action planning, identifying personal strengths, scheduling pleasant activities, mindfulness, relaxation training, and reviewing successes [
To facilitate our adaptation of iHOPE interactive elements, QoC Health’s Engagement Platform will be leveraged to customize and integrate the validated modules (ie, feature sets) from their existing platforms and to develop customized modules to transform Restore from concept to a codesigned interactive digital solution. QoC will apply the principles of user interface and user experience design to create a user-friendly and intuitive solution with reduced interface friction. An iterative, user-centered design framework featuring participatory design will be used to develop the Web-based solution, which will be optimized for tablet. QoC will facilitate codesign development sessions with our patient representatives to ensure Restore is aligned with their recovery needs and that it considers their technical capabilities (eg, digital literacy and technology-savvy level) and design preferences. The cognitive load on users will be minimized by abating unnecessary decisions/steps and inconsistencies in the interface. To offer the end user an enhanced e-learning experience throughout Restore, the design will feature “digital resting spaces.” This will be achieved by applying the concepts of e-learning (eg, pacing and quantity and diversity of content) and using the principles of white space to balance content and segregate sections.
In summary, our technology partners are cutting-edge eHealth innovators for change with evidence-based solutions. For example, Philips’ IntelliVue Guardian has been shown to significantly increase timely clinical response in hospital, based on abnormal vital signs detection, as well as survival after rapid response treatment [
The Self-MAnagemenT—VIsion for patient EmpoWerment (SMArTVIEW) Restore curriculum. CaVS: cardiac and vascular surgery.
SMArTVIEW deploys a highly integrated “system of systems.” Multiple decentralized and heterogeneous subsystems, with operational and managerial independence, are required to provide our end-to-end SMArTVIEW solution. Our end goal for clinical data management is to ensure that the right information is provided to the right person, at the right time. We have consulted extensively with our information technology and clinical informatics experts to leverage existing assets through systems architecture, as opposed to duplicating functionality or existing data. Moreover, our technology partners’ solutions meet Health Level 7 [
Our additional partners, XAHIVE and mPath, serve as our chief stewards of privacy and data aggregation, respectively. With privacy paramount, we espouse a “privacy by design” approach [
With scalability central to our vision, all partner solutions are at technology readiness Level 9, with next to zero time to solution required. Our scalability report will include documentation of (1) unforeseen issues as they arise and problem solving strategies, (2) patient and SVN experience, and (3) results of our comprehensive econometrics evaluation plan, distilled into a projected model of total cost of 1-year SMArTVIEW patient throughput, based on site surgical volumes.
The objectives of the evaluation plan are to refine SMArTVIEW (Phase 1) and conduct an RCT to examine its effectiveness.
Both evaluation plan phases will take place at Hamilton Health Sciences, Hamilton, Canada, and Liverpool Heart and Chest Hospital, the United Kingdom; the coordinating center is the Population Health Research Institute, Hamilton, Canada.
Included participants will be (1) aged ≥65 years, (2) undergoing major CaVS with predicted admission >48 hours, and (3) able to read, speak, and understand English such that reflexive intervention surveys generated by eTrAC can be completed (ie, Grade 6 reading level). Those excluded will have planned postop admission or readmission to a nursing home or long-term care facility.
Rogers’ methods for usability testing [
Two focus groups, one at each site, will each be conducted with 5 CaVS patients and 5 SVNs via an adapted semistructured interview guide [
High-fidelity user testing of SMArTVIEW, focused on intraoperability and flow of information, will involve a human factors analyst, a research assistant (RA) with design ethnography training, and the leadership team. Focus group findings will be embedded into test (ie, simulated) clinical scenarios, representing CaVS recovery issues. Using think-aloud [
Research questions to be addressed in a two-group, parallel-arm RCT (see
Randomized controlled trial flow diagram. IWRS: Interactive Web Randomization System.
Participants will be included according to the inclusion/exclusion criteria outlined in Phase 1, with two additional exclusion criteria: (1) participation in Phase 1 and (2) positive Confusion Assessment Method (CAM) screening upon transfer to the surgical ward.
The components of the SMArTVIEW intervention will be as described under the Intervention Program, Technologies, and Effectiveness section. The intervention delivery protocol, by stage, is presented in
SMArTVIEWa intervention delivery protocol by stage.
Stages | Details | |
Upon transfer to the ward, the IntelliVue Guardian early warning system is established by the SVNb on duty, who connects patient to peripheral, cableless devices; establishes baseline/normal vital signs with spot check monitor; activates IntelliVue Guardian; and performs system checks every shift. | ||
The SVN will receive alerts via mobile device; alerts will be set according to surgeon-sanctioned vital signs parameters programmed into IntelliVue Guardian, which allow for tailoring of profiles for day or night, as well as pre-existing comorbid conditions (eg, atrial fibrillation). | ||
Upon alerts, SVN assessment, intervention, and escalation of care will be according to usual hospital protocols. | ||
The SVN will facilitate a 2.5-hour hospital-to-home orientation session implemented at the convenience of the patient, supports (eg, family, friends, and caregivers), and clinical workflow. | ||
This orientation will focus on the eTrACc tablet-based applications, the PRASd educational video, and Restore. | ||
Following the orientation, the SVN will invite and answer questions. | ||
On the day prior to discharge, patients will receive their hospital-to-home packages from the SVN, including eTrAC tablet-based solutions, instructions for monitoring vital signs at home, eTrAC 30-day application schedule for monitoring vital signs, SVN video visits, and daily recovery symptom and reflexive surveys. | ||
Upon receipt of this hospital-to-home package, the SVN will facilitate a 30-minute checklist-oriented rehearsal of all eTrAC features; the SVN will also invite and answer questions. | ||
Philips’ in-home installation team will work with the SVN to establish the Bluetooth-enabled vital signs monitoring system. | ||
The SVN will then commence monitoring of all incoming data from eTrAC via eCCe. | ||
The SVN will perform daily 15-minute virtual check-ins—eTrAC video visits—with patients at home from the hospital via eCC, per hospital-to-home package instructions. | ||
Virtual check-ins will include review of priorities flagged in eCC, review of vital signs and symptom and reflexive survey data, postop pain assessment, and discussion of any patient/SVN concerns. | ||
Issues identified—via eCC risk stratification or SVN assessment—that require intervention, but are out of the scope of SVN practice, will be escalated to the most responsible clinician. | ||
During recovery, participants will engage the Restore time-release, self-guided, online curriculum (described previously). | ||
Restore is structured according to seven weekly asynchronous modules, consisting of two to seven activities each. | ||
Restore is designed to constitute 2-3 hours of online activity, weekly. |
aSMArTVIEW: Self-MAnagemenT—VIsion for patient EmpoWerment.
bSVN: SMArTVIEW Nurse.
ceTrAC: Transition to Ambulatory Care.
dPRAS: pain relief after surgery.
eeCC: eCare Coordinator.
The primary outcome is
We will capture a composite of complications related to hemodynamic compromise up to 30 days postrandomization, including death, myocardial infarction, and nonfatal stroke. The number of events for the overall composite, as well as number of events per component within the composite, will be reported.
All-cause mortality will be captured up to 1 year postrandomization. We will also monitor for new-onset atrial fibrillation and SSI up to 30 days postrandomization.
The Short-Form 12 version 2 (SF-12v2) is an established, reliable, and valid tool [
The five-question version of the Geriatric Depression Scale (GDS-5) will be used to measure depressive symptoms. This tool is a well-validated instrument in the assessment of depression in hospitalized older adults, with high levels of sensitivity and specificity [
Development of CPSP is defined [
Data on hospital readmission and health care utilization and costs of health service utilization data from the Canadian arm of the trial will be linked with the health administrative Institute for Clinical Evaluative Sciences data repository. Administrative databases used to describe the health service utilization include (1) Registered Persons Database—demographics and vital statistics of all legal residents of Ontario, (2) Discharge Abstract Database—records of inpatient hospitalizations—from the Canadian Institute for Health Information (CIHI), (4) Ontario Health Insurance Plan Database—physician billing claims, and (5) the National Ambulatory Care Reporting System—information on emergency department visits—from CIHI. In addition, to capture data on times spent on the portal by health providers (eg, pharmacists and nurses), costs of health providers’ time will be captured in the system reporting. Costs of health providers’ time on the portal will be calculated by multiplying the time with unit costs from standard costing sources in Ontario.
The Ambulatory and Home Care Record (AHCR) [
Aside from baseline clinical and demographic information, gender-based pain expectations [
Baseline digital literacy will also be assessed using an adapted version of the informational and instrumental support domains of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures. This approach, previously pilot-tested with cardiovascular patients [
The SVN will collect outcome data for intervention and control groups following random allocation through discharge. Once in the community, patients in both groups will record their BPI-SF pain scores daily for 8 weeks using the tablet-based solutions. Data on 30-day event rates (ie, major postop complications) and hospital readmissions for both groups will be collected by a blinded RA via telephone interview at 30 days postoperation. At 3, 6, 9, and 12 months, additional telephone interviews conducted by the RA will assess (1) functional status, (2) depressive symptoms, (3) CPSP, and (4) patient-level cost of recovery (ie, AHCR).
To understand patient experience with CaVS recovery and involvement with the SMArTVIEW intervention, we will conduct telephone interviews with 60 patients and 60 primary support persons in the intervention and control groups and with all SVNs (n=20) using a semistructured interview guide. The interviews will focus on perceptions of usability and ethical, social, and legal issues. Our sample size should ensure data saturation [
Assuming a two-sided type I error (alpha) of .05 and a standard deviation of 20 points in BPI-SF numeric rating scale scores (range 0-100), a total of 128 participants (ie, 64 individuals in each group) are required to provide 80% power to detect a minimally important difference of 10 points. This difference represents a moderate effect size (Cohen’s d=0.50) [
Strategies previously developed will be applied [
Blocked randomization (ie, randomly assigned block sizes) will be used to achieve balanced allocation of intervention and control groups. The randomization allocation list will be prepared by Population Health Research Institute statisticians and integrated into the IWRS system. Upon transfer to the surgical ward (ie, post-ICU), the SVN will assess consented patients using the CAM. If CAM scores do not indicate cognitive impairment or delirium and the patient remains eligible, they will be randomly allocated by the IWRS.
Our technology partners have contributed equipment and personnel time, in-kind, such that we are able to intervene and follow up on 15 patients at one time per site throughout the study until 30 days follow-up, at which time equipment will be returned to each hospital site for cleaning and reset. Therefore, the RCT (Phase 2) will be executed in five serial, parallel waves of approximately 30 patients per site. In 2014, there were 2311 and 1974 CaVS performed at Hamilton Health Sciences, Canada, and the Liverpool Heart and Chest Hospital, the United Kingdom, respectively. Planned recruitment will occur at a rate feasible for SVN time and access to the surgical populations at both sites. Patients will be enrolled during a 3-week period, with the last week of each recruitment month available for additional patient registrations as needed to accommodate those not meeting postop eligibility. Each site will target recruitment of 14 cardiac and 16 vascular patients during 3 weeks of recruitment—10 patients per week, per site. Allowing for a 25% refusal rate, lost opportunities, and competing studies, this still provides access to 20 patients at Hamilton Health Sciences and 17 patients at the Liverpool Heart and Chest Hospital. Since participant recruitment is only limited by prototype availability, our proposed recruitment target and timeline is feasible and recruitment of 300 participants will be completed in 10 months’ time.
Linear mixed models, using an autoregressive [
A secondary analysis will aim to establish the cumulative impact of the components of the intervention (eg, remote monitoring and self-management training) on outcomes and assess “digital retention” and sustained digital device usage in visual and time-sensitive analyses using an N-of-1 design (see
Two types of separate subgroup analyses are planned to determine the impact of gender-based pain expectations and patient sex on intervention effectiveness (see
1. Patients will be stratified into high versus low GREP scores. The primary analyses examining the effect of the intervention on the worst score for the BPI-SF numeric rating scale
2. Similarly, interaction between the intervention and patient sex will be examined.
The cost-effectiveness of implementing the intervention will be determined from two perspectives: (1) the Ministry of Health and Long-Term Care (MoHLTC) (Canada) and (2) society (Canada and the United Kingdom) (see
The first economic analysis outcome is the incremental cost of the intervention compared to usual care. We will analyze the total cost as a dependent variable, using a regression model to estimate the difference in expected health care cost between the two groups. The intervention will be the primary independent variable and the regression model will adjust for potential confounding variables. In theory, an ordinary least squares model produces unbiased estimates even if the data are skewed [
As a secondary cost objective, we will compare the cost and quality-adjusted life years (QALYs) between the two groups using the net benefit regression framework (see
Data on uptake of the SMArTVIEW intervention will be used to explain differences in the outcome measures, determine patterns of use to predict outcomes, and identify users who may require escalated care. Session frequency (ie, times the technology is accessed) and session length (ie, length of time users interact with the technology) [
Summary of outcomes, hypotheses, measures, and methods of analysis.
Analyses | Outcome | Hypothesis | Outcome measure | Method of analysis |
8-week worst postop pain intensity |
Intervention > control | Measured by Brief Pain Inventory-Short Form (BPI-SFa) | Linear mixed model or nonlinear mixed models (if assumptions of normality are violated) | |
Functional status | Intervention > control | Short-Form 12 version 2 | Linear mixed model or nonlinear mixed models (if assumptions of normality are violated) | |
Depressive symptom scores | Intervention > control | Five-question version of the Geriatric Depression Scale | Linear mixed model or nonlinear mixed models (if assumptions of normality are violated) | |
Postop complications related to hemodynamic compromise | Intervention > control | Myocardial infarction and stroke | Nonlinear mixed models | |
Other relevant postop complications | Intervention > control | Surgical site infection, presence of CPSPb | Nonlinear mixed models | |
Heath service utilization-related cost | Intervention > control | Linked with health administrative Institute for Clinical Evaluative Sciences data repository | Linear mixed model or nonlinear mixed models (if assumptions of normality are violated) | |
Patient-level cost of recovery | Intervention > control | Ambulatory and Home Care Record | Linear mixed model or nonlinear mixed models (if assumptions of normality are violated) | |
All outcomes | Effect will differ by gender (male versus female) | Worst postop pain intensity |
Interaction test | |
Effect will differ by GREPc scores (low versus high) | Worst postop pain intensity |
Interaction test |
aBPI-SF: Brief Pain Inventory-Short Form.
bCPSP: chronic postsurgical pain.
cGREP: Gender Role Expectations of Pain.
Data will be digitally recorded, transcribed verbatim, and managed in NVivo 11 (QSR International). Concepts that relate to the usability and value of the intervention will be coded [
To reveal the ethical, legal, and social implications of the intervention, we will apply methods used successfully in previous research [
To limit sampling bias, a recruitment schedule randomly generated to ensure representation from each surgical group will be used. Contamination should not exist between groups as we will control who interacts with the SVN and intervention features. Those allocated to the intervention group will be asked not to share their tablets or demonstrate application features to any peers assigned to the control group. To evaluate cointervention, we will track participant receipt of any monitoring or recovery support-related interventions, outside of expected usual care up to 8 weeks postoperation. RAs responsible for outcome data collection will be separated from randomization procedures, will have no permitted access to IWRS, will not be involved in intervention delivery, and will be blinded to group allocation. An event adjudication committee responsible for adjudication of all clinical outcome data will be blinded to randomized allocation. The team has extensive experience with assiduous follow-up procedures to minimize losses to follow-up.
Integrated knowledge translation strategies will continue to involve stakeholder groups during the project. As part of integrated and end-of-grant knowledge translation, stakeholders will assist in interpreting findings, identifying key results, and reviewing and revising the end-of-grant knowledge translation plan at a final meeting for review of investigator results. End-of-grant knowledge translation goals—generate interest, discussion, and awareness; impart knowledge; and inform research—will be addressed via tailored implementation strategies.
Study start-up is underway and usability testing is scheduled to begin in the fall of 2016.
THE SMArTVIEW, CoVeRed innovation community brings together an international, dedicated group of well-known clinical and eHealth researchers; health economists; clinicians; administrators; patient representatives; engineers, information technology, and clinical informatics experts; as well as leaders in the arenas of health policy, big data and data aggregation, bioethics, knowledge translation, and privacy. Collectively, we possess the requisite skills, experience, and track record to execute the proposed evaluation, disseminate what we learn, and plan for diffusion of innovation.
We are actively engaged in systems integration and change management at both study sites. As a result of planned, shared stewardship of our vision, we have fostered a milieu of co-ownership and investment in SMArTVIEW usability and effectiveness testing. With respect to end-user engagement, we understand well from experience that innovation is not a linear process. We are committed to recursive coinnovation between “solutioner” and end users. Hence, corefinement of SMArTVIEW— via usability testing in context—was a key objective identified during team debriefing, following our patient journey mapping exercise. Akin to the use of “experimentation suites” in the industry sector, our process, as outlined within the Usability Testing section, will be to immerse with participants in high-fidelity rehearsal of SMArTVIEW activities in order to uncover ways we can refine our processes to optimize the experience of recovery for seniors following CaVS. Our team, including patient representatives, is organized into both content and governance committees (see
In collaboration with our industry partners, Canadian and UK hospital sites, we are confident that we have the experience, expertise, infrastructure, and support to realize THE SMArTVIEW, CoVeRed. A copy of our Canadian Institutes of Health Research (CIHR) reviews can be found in
SMArTVIEWa team committees.
Committee type | Committee name |
Clinical Transformation/Change Management | |
Clinical Monitoring | |
Patient Engagement and Experience | |
Economics | |
Knowledge Translation | |
Systems Integration | |
Self-Management | |
Clinician and SVNb Training | |
Ethics | |
Project Office Operations | |
International Operations | |
Steering | |
Outcomes Adjudication | |
External Safety | |
Efficacy and Monitoring | |
Substudy and Publications |
aSMArTVIEW: Self-MAnagemenT—VIsion for patient EmpoWerment.
bSVN: SMarTVIEW Nurse.
Approach to meta-analysis.
Canadian Institutes of Health Research (CIHR) reviews.
Ambulatory Home Care Record
Brief Pain Inventory-Short Form
Confusion Assessment Method
Cardiac
cardiac and vascular surgery
Canadian Institute for Health Information
Canadian Institutes of Health Research
chronic postsurgical pain
eCare Coordinator
electrocardiogram
Transition to Ambulatory Care
early warning score
five-question version of the Geriatric Depression Scale
Gender Role Expectations of Pain
Help to Overcome Problems Effectively
hazard ratio
health-related quality of life
intensive care unit
Internet-based Help to Overcome Problems Effectively
Interactive Web Randomization System
Ministry of Health and Long-Term Care
not applicable
percutaneous coronary intervention
PeriOperative ISchemic Evaluation
postoperative
pain relief after surgery
Patient-Reported Outcomes Measurement Information System
quality-adjusted life year
research assistant
randomized controlled trial
Short-Form 12 version 2
peripheral oxygen saturation
surgical site infection
SMArTVIEW Nurse
TecHnology-Enabled remote monitoring and Self-MAnagemenT—VIsion for patient EmpoWerment following Cardiac and VasculaR surgery
This grant was funded by the Canadian Institutes of Health Research (grant no. 348440). In-kind industry support is provided by the following industry partners: Philips, QoC Health, XAHIVE, and mPath. Dr Michael McGillion holds the Heart and Stroke Foundation/Michael G DeGroote Endowed Chair in Cardiovascular Nursing. Our patient journey mapping process was supported with seed funding from the Michael G DeGroote Institute for Pain Research and Care at McMaster University.
The authors wish to acknowledge Ms Nancy Luck for her assistance with manuscript preparation. The authors also wish to acknowledge the collaboration of Melody Miles from the Hamilton Niagara Haldimand Brant Community Care Access Centre as well as Alison Paprika from the Institute for Clinical Evaluative Sciences. Finally, Janet Parr, Kay Ball, Graham Barker, Graham Densham, Sandra Gartz, and James Ace are patient representatives who provided considerable input into the design of the SMArTVIEW intervention.
In-kind industry support is provided by the following industry partners: Philips, QoC Health, XAHIVE, and mPath. The following authors are employed by Philips: Karsten Russell Wood, Michael Weber, Jolene McNeil, and Robyn Alpert. Sarah Sharpe is Co-Founder and shareholder, QoC Health; Sue Bhella is employed by QoC Health. David Mohajer is Co-Founder, Chief Executive Officer, and Vice President, XAHIVE; Sem Ponnambalem is Co-Founder, Chief Operating Officer, and President, XAHIVE. Naeem Lakhani and Rabia Khan are Co-Founders, mPath.