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In the health care setting, electronic health records (EHRs) are one of the primary modes of communication about patients, but most of this information is clinician centered. There is a need to consider the patient as a person and integrate their perspectives into their health record. Incorporating a patient’s narrative into the EHR provides an opportunity to communicate patients’ cultural values and beliefs to the health care team and has the potential to improve patient-clinician communication. This paper describes the protocol to evaluate the integration of an adapted person-centered narrative intervention (PCNI). This adaptation builds on our previous research centered on the implementation of PCNIs. The adaptation for this study includes an all-electronic delivery of a PCNI in an outpatient clinical setting.
This research protocol aims to evaluate the feasibility, usability, and effects of the all-electronic delivery of a PCNI in an outpatient setting on patient-reported outcomes. The first objective of this study is to identify the barriers and facilitators of an internet-based–delivered PCNI from the perspectives of persons living with serious illness and their clinicians. The second objective is to conduct acceptability, usability, and intervention fidelity testing to determine the essential requirements for the EHR integration of an internet-based–delivered PCNI. The third objective is to test the feasibility of the PCNI in an outpatient clinic setting.
Using a mixed method design, this single-arm intervention feasibility study was delivered over approximately 3 to 4 weeks. Patient participant recruitment was conducted via screening outpatient palliative care clinic schedules weekly for upcoming new palliative care patient visits and then emailing potential patient participants to notify them about the study. The PCNI was delivered via email and Zoom app. Patient-reported outcome measures were completed by patient participants at baseline, 24 to 48 hours after PCNI, and after the initial palliative care clinic visit, approximately 1 month after baseline. Inclusion criteria included having the capacity to give consent and having an upcoming initial outpatient palliative care clinic visit.
The recruitment of participants began in April 2021. A total of 189 potential patient participants were approached via email, and 20 patient participants were enrolled, with data having been collected from May 2021 to September 2022. A total of 7 clinician participants were enrolled, with a total of 3 clinician exit interviews and 1 focus group (n=5), which was conducted in October 2022. Data analysis is expected to be completed by the end of June 2023.
The findings from this study, combined with those from other PCNI studies conducted in acute care settings, have the potential to influence clinical practices and policies and provide innovative avenues to integrate more person-centered care delivery.
DERR1-10.2196/41787
Health care advances have extended the life span and cured many diseases; however, advanced health care treatments are sometimes discordant with patient preferences, values, and beliefs, which can lead to insufficient symptom control, difficult patient-clinician interactions, and poor psychosocial and spiritual support [
Storytelling (narrative) is an effective way for patients to communicate their cultural values and beliefs. As early as 1542, when Joannes Fernel coined the term physiology, the discussion at that time described the person as a structure of physiological, pathological, and clinical stories [
In the health care setting, the electronic health record (EHR) is one of the primary ways of communicating the status of patients; however, most of this EHR information is clinician centered. There is a need to consider the patient as a person and integrate their perspectives into their health record. Incorporating a patient’s narrative into the EHR provides an opportunity to communicate patients’ cultural values and beliefs to the health care team and has the potential to improve patient-clinician communication [
The integration of the PCNI into the EHR could benefit patients and clinicians interacting in technology-rich environments. Because the EHR is one of the primary modes of communicating health care information about the patient, the integration of patients’ narratives into the EHR has the potential to (1) improve person-centered care by incorporating patients’ values and beliefs, (2) provide opportunities to enhance patient-clinician communication, and (3) positively impact patients’ psychosocial and spiritual well-being. Minimal research has integrated narrative interventions into the EHR in a meaningful and efficient way to test whether the narrative intervention could improve communication between patients and clinicians and impact patients’ overall well-being. Our research program investigates innovative ways to integrate patient values, beliefs, and preferences into EHR through PCNIs [
We developed a PCNI to address existing gaps in the delivery of person-centered palliative care
In this protocol, we aim to further develop the continued testing of the feasibility and efficacy of the EHR integration of PCNI in an outpatient setting using an all-internet-based–delivered platform. The first objective of this study is to identify barriers and facilitators of an internet-based–delivered PCNI from the perspectives of persons living with serious illness and their clinicians. The second objective is to conduct acceptability, usability, and intervention fidelity testing to determine the essential requirements for the EHR integration of an internet-based–delivered PCNI. The third objective is to test the feasibility of the PCNI in an outpatient clinic setting.
This study will use a mixed methods design [
In this phase of our biobehavioral interventional development, both quantitative and qualitative data give necessary information about acceptability, feasibility, and usability for the optimization of the narrative intervention. Quantitative data include longitudinally measured patient-reported outcomes, and qualitative data include (1) patient and clinician exit interviews for triangulation of the quantitative findings and (2) patients’ illness narratives. All data collection and study procedures will be conducted electronically, using secure videoconference, phone, REDCap (Vanderbilt University) [
Purposeful sampling strategies will be used to recruit and enroll 20 patients. The small sample size was chosen to be consistent with both qualitative data analysis techniques [
For the patient participants, the research team will review the outpatient palliative care clinic schedules weekly via the EHR (Epic) to identify persons with upcoming initial new patient visits (NPVs) in the palliative care clinics. These identified persons will receive an initial recruitment email with an institutional review board–approved language and a follow-up email with the initial language approximately 1 week later for those who have not responded. For those who respond to the recruitment email with interest, the research team will arrange a secure videoconference or phone call to discuss the study, review the consent form, and answer questions. When a person opts to participate, the research team will send an email with a link to the electronic consent form (in REDCap) [
For the clinician participants, the research team will identify the assigned clinician of the enrolled patient participant, once the patient’s narrative is uploaded to the EHR. In the same electronic delivery, the research team will contact these clinicians via email to (1) alert them that a narrative was available for one of their newly establishing patients and (2) inquire about their interest in participating in the study using institutional review board–approved language. Because of the nature of the feasibility and usability study, we targeted recruitment efforts to capture the entire interprofessional perspectives of the palliative care clinical team members. For those who respond to the recruitment email with interest, a research team member will arrange a secure videoconference or phone call to discuss the study, review the consent form, and answer questions. When a clinician opts to participate, the research team will send an email with a link to the electronic consent form (in REDCap) [
All procedures were approved by The University of Colorado Institutional Review Board (Colorado Multiple Institutional Review Board 21-2887), and the approval has been maintained in good standing. REDCap is available as a Health Insurance Portability and Accountability Act–compliant secure research data interface [
All participants will be compensated for their time. Patient participants will be provided a US $25 electronic gift card after the completion of PCNI and time point 2 and a second US $25 gift card after the completion of time point 3 for a total of US $50 in remuneration. Clinician participants will be provided one US $25 electronic gift card after the completion of the exit interview. In addition to the confidentiality of patient data, there are some minimal physical, social, or psychological risks to the patient participants. Participants could become fatigued during the 60-to-90–minute narrative interview process, the 30-minute exit interview process, outcome measure data collection procedures. In the event of fatigue, the research team members will encourage rest periods or, if necessary, schedule an additional study visit to complete the interview. For the patient participants, there is a minor, moderate, or severe risk of psychological distress because of the sensitive topics of serious illness. Because of the feasibility of the design, we will ensure that the patient participants understand both orally and in writing that they are free to decline participation in any or all study activities at any time based on their own level of distress [
The enrolled patient participants will participate in a narrative interview. These audio-recorded interviews will be conducted by a research team member using an open-ended interview guide. During the interview, patients will be prompted to share their narrative through probing questions or statements such as: tell me about your illness; tell me how your illness has affected your emotions, your relationships, and your spirituality (
Narrative intervention interview guide
Conversational questions
May I call you?
What is your illness?
Conversational probes throughout intervention
For example
Tell me more about that
Anything else?
Open-ended questions
Tell me what it has been like to have _____ (illness).
Tell me how your illness has impacted you emotionally, your feelings?
Tell me how your illness has impacted your relationships with family, friends, and others?
Tell me how your illness has impacted your spirituality? Your faith, beliefs, your values, or your thoughts about a higher power?
Closing question
Is there anything else we have not talked about that you would like to tell me?
Exit interview guide: patient participants
Describe what you liked about participating in this study.
Describe what you did not like about participating in this study.
Did you have the opportunity to discuss your story with anyone other than the research team?
Who did you discuss it with?
Did you initiate the conversation, or did they?
Describe which parts of the story you discussed.
How did this discussion make you feel?
Why do you think others did not discuss it with you?
Why did not you discuss it with others?
Is there anything you would have changed about the study?
What would you think about participating in a similar intervention in the future?
Is there anything else you would like us to know?
Exit interview guide: clinician participants
What did you think about the intervention?
Were you able to read the patient’s story?
Do you think the study was beneficial to the patients?
Did you notice any particular patient reactions to the intervention?
Was the study beneficial to you in any way?
Describe what was beneficial to you.
If no, follow-up questions
Describe what was not beneficial to you.
What changes could we make to the study for it to be more beneficial to you?
Do you feel like having the patient’s story changed how you delivered care to your patient?
Can you provide an example?
Are there changes we could make that would help with this?
Did the notification system of the story in the medical record work for you?
How could the notification system be improved?
Were there any other study difficulties that you encountered that I have not asked you about?
Are there improvements to the intervention that you would suggest that we have not already discussed?
Is there anything else you would like us to know?
Person-centered narrative intervention (PCNI) workflow figure. EHR: electronic health record.
Using a human, organization, and technology–fit factor [
We will also analyze the intervention uptake and attrition between baseline and follow-up data collection points [
The primary patient-reported outcome measures for this protocol are the PROMIS (patient-reported outcomes measurement information system)-29 Profile v2.0 form [
The primary outcome measures for the patient participants will be collected across 3 time points. After enrollment, the research team will generate participant-specific survey links in REDCap [
For the clinician participants, the research team will conduct exit interviews with clinician participants within 2 to 4 weeks of their initial appointment with a patient participant to collect information about their experience of having and using the patient narrative before the initial consult. At the end of study enrollment, 1 to 2 audio-recorded focus groups (based on scheduling needs) will be cofacilitated by research team members with all the clinician participants to collect additional information and feedback about their experience and facilitate and record group discussion about their use of the patient narratives in their clinical practice. Interviews will be conducted via a secure videoconference or a phone call and audio recorded. See
Participant study activities.
Participant | Outcome | T1: baseline (prenarrative upload) | T2: 24-48 hours after T1 (postnarrative upload to EHRa) | T3: 1 month after T1 |
Patient | Biopsychosocial and spiritual well-being |
PROMISb-29-Profile PROMIS Psychosocial Illness Impact; positive and negative effects |
PROMIS-29-Profile PROMIS Psychosocial Illness Impact; positive and negative effects |
PROMIS-29-Profile PROMIS Psychosocial Illness Impact; positive and negative effects |
Patient clinician | N/Ac |
N/A |
N/A |
Exit interviews |
aEHR: electronic health record.
bPROMIS: patient-reported outcomes measurement information system.
cN/A: not applicable.
Analyses will be performed using SAS software (version 9.4; SAS Institute Inc) [
Qualitative data management software will be used to organize narrative and exit interview data and coding by team members. Notes and transcripts will be collated to provide summaries of patient flow, use of equipment and supplies, perspectives on the PCNI, and ideas about its integration into current practice. A conventional content analysis approach [
The study received funding in January 2021, and ethics approval was received on March 21, 2021. The recruitment of participants began in April 2021. Patient participant recruitment was conducted via weekly screening of the outpatient palliative care clinic schedules for upcoming new palliative care patient visits, and emails were sent to potential patient participants. At this time, some data have been collected and analyzed. A total of 189 potential patient participants were approached via email, and 20 patient participants were enrolled, with data having been collected from May 2021 to September 2022. A total of 7 clinician participants were enrolled, with a total of 3 clinician exit interviews conducted in 2021 and 2022 and 1 focus group (n=5) conducted in October of 2022. Data analysis has been ongoing from the end of data collection in October 2022 to June 2023. Overall, for this feasibility study, we were able to recruit a total of 20 patient participants and 7 clinician participants for data collection. In the initial findings, the electronically delivered person-centered narrative was feasible, acceptable, and usable for both patient and clinician participants. The overall findings are expected to be submitted for publication by the end of June 2023.
Although PCNI is not new [
Using the CFIR as our framework [
In contrast to our acute care studies [
In the last CFIR domain of process, we implemented several strategies and tactics for the successful implementation. As we began email recruitment and electronic consenting, we chose not to enroll any patient participant who was noted to have a medical diagnosis of Alzheimer disease or dementia, or terms of cognitive impairment, confusion, or delirium on their problem lists. For this study, this screening excluded 20% of persons with a new patient palliative care visit. At this stage of data analysis, we would suggest that future PCNI programs should consider cognitive impairment. In future studies, the need for a mental capacity screening can be an important consideration. Alternatively, in future studies, the PCNI would need to consider the cognitive capacity of persons who have a serious illness and include a person’s support individuals to be a part of a dyadic PCNI. It should be noted that the integration of the PCNI into an outpatient palliative care clinic provides systematically more time for palliative care clinicians to engage with the narrative based on the allowed new palliative care patient visit time allotment of 1 hour. In future studies in other clinical settings that are nonpalliative, the acceptability and usability of the person’s narrative will require clinical workflow evaluations of the best strategies for allowing the nonpalliative clinician adequate time to engage with the person’s narrative. As in our other PCNI studies, once a patient participant is enrolled, there are limited withdrawals. Only 1 participant reported mild distress with the narrative interview questions that were being asked and made a choice to withdraw from the study.
Finally, although the overall goal of the PCNI is to consider the improvement of the quality of communication in clinical care, for this protocol, the quality of communication is being analyzed by exit interviews with both patient and clinician participants. In our other PCNI study [
There are known limitations to our mixed methods single-intervention feasibility study. First, it was conducted in 1 geographic location in 1 health care system. This is an important consideration when considering the contextual complexities of health care systems, their EHRs, and the clinical workflows of clinicians. Second, owing to the nature of the internet-based delivery in this study, this study excluded participants who did not have access to email and technology with an internet connection. During the screening for this study, 11 patients did not have email addresses. Therefore, email should not be the only recruitment method. One would need to add an in-person recruitment approach to capture potential participants who do not have an EHR-listed email. During this in-person session in the clinical setting, one could also verify a person’s technology needs and preferences. If the preference or need for technology was identified, the opportunity to conduct the PCNI in person in the outpatient clinical setting could also be used. In this study, participants who expressed less agility with technology were offered more detailed instructions (“click-by-click”) or additional phone calls during which the research team member could help them navigate the required systems.
This 2-year feasibility study will provide a site-specific understanding of barriers to and facilitators of the usability and acceptability of the PCNI from the perspectives of both patient and clinician participants. These barriers and facilitators in the setting of a CFIR framework will provide important knowledge about the scalability of the intervention, process-oriented insights, successful implementation strategies, and modifications that are necessary to improve the integration of a person’s narrative into the clinical workflow for clinicians. The overall long-term research goal is the creation of a PCNI that could be broadly applicable and sustainable outside of the research setting, with implementation in a variety of health care settings in multiple health systems. The knowledge gained will provide necessary information to evaluate future ways to scale PCNIs, with the goal of implementation across health systems, and will continue to inform the integration of person-centered narratives into the patient’s EHR. This feasibility study will provide important information to fully understand the mechanisms of the effects and concurrently contribute to additional knowledge of the key factors of implementation. The knowledge gained from this mixed methods study will contribute to key data for the continued development and refinement of PCNIs.
Consolidated Framework for Implementation Research
electronic health record
new patient visit
person-centered narrative intervention
patient-reported outcomes measurement information system
quality of life
The authors wish to acknowledge the following individuals for their recruitment support in the implementation of the study: Jonathan Treem, MD, and Christina Vaughn, MD. The research reported in this study was supported by the Cambia Health Foundation Sojourns Scholar Award (principal investigator, HC) and K24 AT011995 (principal investigator, AZD). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Cambia Health Foundation or National Institutes of Health.
The data sets generated and analyzed during this study are not publicly available owing to patient participant confidentiality but are available from the corresponding author upon reasonable request.
All authors made substantial contributions to the design of the work, participated in revising this document critically, provided final approval of the version to be published, and agreed to be accountable for the work.
None declared.