Recommendation number | SAC recommendations and suggestions | Theme | Subtheme | Shippee framework phase* | Modification made based on SAC recommendation | Required IRB modification |
---|---|---|---|---|---|---|
1 | Investigate how caregivers cope | Scientific | Design advice | I.1 | Implemented the short-form Zarit Caregiver Burden survey into screening tool at 3, 6, and 12-month follow-up surveys | Yes |
2 | Consider the geographic location differences of the enrolled sites. How do you reach patients in rural areas where outpatient palliative care clinics are not available? | Scientific | Conceptual suggestion | I.1 | This recommendation was provided prior to the implementation of telehealth outpatient visits as enrolling sites are all primarily located in urban or suburban locations. In the patient enrollment forms the research team captured information related to the patient’s home address and the address of the outpatient clinic and the team is anticipating analyzing if distance to/from the clinic was a barrier. Additionally, the pandemic provided an opportunity to revisit care delivery techniques and allowed patients to receive outpatient palliative care via telehealth | Yes |
3 | Explore the potential barriers to palliative care access that may impact engagement across the intervention arms (e.g. distance from clinic/services, income etc.) | Scientific | Design advice | I.1, II.2, II.3, II.4 | This recommendation was incorporated into data collection and analysis plans. For example, survey instruments were updated to ensure potential barriers were collected and analysis plans were updated to account for different barriers | Yes |
4 | Update materials to include more exciting terms so patients do not associate palliative care with death | Scientific | Recommendation for supplementary study materials | II.1 | RCs were trained on the appropriate methods of describing palliative care with patients and caregivers | No |
5 | Implement a satisfaction survey for patients in an effort to improve the intervention | Scientific | Design advice | II.1 | No patient satisfaction survey was formally collected as this was outside the scope of the research study. Nonetheless, any time study participants provided feedback it was brought to the research team’s attention and discussed | No |
6 | Expand inclusion criteria to Spanish Speaking participants | Scientific | Design advice | II.1 | The recruitment criteria was expanded to include Spanish Speaking participants | Yes |
7 | Consider adjusting protocols for patients with disabilities specifically mental disabilities and other conditions that impact this group of study participants (ex. Dementia) | Scientific | Design advice | II.1 | In the screening tool, a dementia question was added to assess whether dementia was included on the patients’ active problem list in Epic, signaling exclusion. RCs made accommodations for any patients who required by prioritizing certain questions within the follow-up surveys, requesting presence of caregiver during survey completion etc | Yes |
8 | Explore how the outpatient study arm will measure loneliness | Scientific | Design advice | II.1 | The team incorporated the validated University of California Los Angeles (UCLA) Three-Item Loneliness Scale into the 3, 6, and 12 month patient follow up surveys to measure loneliness for both study arms | Yes |
9 | Ensure patients or caregivers are familiar with the study and a telephonic nurse may be calling them (if enrolled in that study arm) | Scientific | Recommendation for supplementary study materials | II.1, II.2 | A welcome packet was developed and sent to each patient and caregiver enrolled | Yes |
10 | Provide each patient with a welcome packet that is bright and at an appropriate reading level | Scientific | Recommendation for supplementary study materials | II.1, II.2 | A patient facing brochure was developed in partnership with the SAC members | Yes |
11 | Enrolled caregivers should feel part of the research process | Scientific | Design advice | II.1, II.2 | A separate caregiver screener with questions specific to caregivers’ emotions, feelings, health was implemented | Yes |
12 | Shorten welcome letters, as drafts were too lengthy | Scientific | Recommendation for supplementary study materials | II.1, II.2 | With the SAC’s feedback, the patient facing brochure was updated to include a shortened welcome letter. All patient facing materials were reviewed by the SAC | Yes |
13 | Have patient-facing visuals for palliative care at the time of recruitment to provide patients and caregivers with an overview of the study | Scientific | Recommendation for supplementary study materials | II.1, II.2 | In partnership with the SAC members, the research team created a visual describing palliative care that is reader friendly | Yes |
14 | Include more images than text in patient facing materials | Scientific | Recommendation for supplementary study materials | II.1, II.2 | RCs continued to assist patients where needed, and incorporated visuals of the study timeline alongside EMPallA descriptors that were required to be provided by regulatory guidelines | No |
15 | Replace the use of the word "caregiver" with other similar words that are more sensitive to the population | Scientific | Recommendation for supplementary study materials | II.1, II.2 | Theae changes were implemented throughout study materials and communicated to research coordinators. Instead of “caregiver, the terms supportive care, companion, helper, support system were used | Yes |
16 | Use the terminology “stress” instead of “burden” when communicating with patients and caregivers | Scientific | Recommendation for language use | II.1, II.2 | Language was adapted in the REDCap screener, scripts, and subsequent follow-up surveys | Yes |
17 | Implement telehealth video option during pandemic when clinics were significantly limiting in-person visits to reduce risk of COVID-19 for this vulnerable population | Scientific | Design advice | II.1, II.2 | This recommendation resulted in a major protocol change. Originally, outpatient clinics only met patients randomized in this study arm in-person, but the study was adapted to allow telehealth visits | Yes |
18 | Create a video to introduce the study to the patient and caregiver to enhance recruitment | Scientific | Recommendation for supplementary study materials | II.2 | Due to limited resources a video could not be developed, but the research team created resources summarizing the study for all patients and caregivers, including visual timelines and full descriptions | No |
19 | Shorten recruitment scripts | Scientific | Recommendation for supplementary study materials | II.2 | As scripts were developed with IRB regulatory guidelines in mind and could not be modified as consistent recruitment processes had to be standardized across all sites | No |
20 | Be mindful of resources available in each enrolling Emergency Department | Pragmatic | Implementation advice | I.1 | Research teams were encouraged to train RCs on respective sites’ available resources. RCs were also encouraged to share unique resources during peer-to-peer meetings that may be helpful to their partnering sites | No |
21 | Understand the impact of spiritual differences | Pragmatic | Implementation advice | I.1 II.1 | A standard religion question was added in the screening survey. The specific question added was “Are you a member of a faith community?” | Yes |
22 | Be conscientious of where the patient is from and their unique healthcare needs | Pragmatic | Implementation advice | I.1, II.1 | Each RC was provided open user rights within the electronic health record to better understand each patient enrolled (example, a RC was able to see if the patient was currently in the hospital, or if they had a recent encounter with a physician etc.) | Yes |
23 | Develop a phone script that adequately addresses caregiver duress | Pragmatic | Recommendation for language use | II.1 | Research Coordinators (RCs) were trained by SAC members on appropriate language to use while speaking with caregivers | No |
24 | Implement pre-visit reminder calls | Pragmatic | Implementation advice | II.1 | Before each Outpatient visit, the RCs would remind patients of their upcoming appointment. This data was documented in the REDCap Outpatient Log | Yes |
25 | Do not e-mail gift cards to participants | Pragmatic | Advice about dissemination | II.1 | Given the unique patient population recruited for this study, the research team worked with their internal finance team to provide incentive gift-cards either in-person or physically sent in the mail | Yes |
26 | Provide more resources directly to caregivers to help them understand the benefits of palliative care | Pragmatic | Implementation advice | II.1 | SAC members who served as caregiver advocates trained the RCs the most appropriate ways to interact with caregivers | No |
27 | Integrate the use of a translator services as they are used during emergency department visits, and Spanish-speaking patients should be able to use this mode of communication | Pragmatic | Implementation advice | II.1, II.2 | The research coordinator protocol was updated with information related to using the translator phone | Yes |
28 | When recruiting in-person (with patient’s verbal permission), use their phone to contact their caregiver to see if they are interested in participating in the study. This was to avoid barriers related to robo and spam calls, and the caregivers not picking up their phone from an unknown telephone number | Pragmatic | Implementation advice | II.1, II.2 | This suggestion was adapted and research coordinators across all recruitment sites when appropriate would use the patient’s telephone to directly call their caregiver to see if they were interested in participating in the study | Yes |
29 | Follow-up with each participant after study enrollment to keep patient engaged for the duration of the 6-month intervention and 12-month data collection | Pragmatic | Implementation advice | II.1, II.2, II.3 | A postcard was created and was mailed and or provided to each participant after enrollment reminding them about the study benefits and expectations. Research coordinators would also call participants | Yes |
30 | Explain to the patient the definition of a caregiver before asking patient if s/he has a caregiver who wants to participate in the study | Pragmatic | Recommendation for language use | II.1, II.3 | Recruitment scripts were updated, and discussions related to overcoming hurdles in recruiting caregivers were covered in biweekly peer-to-peer research coordinator learning collaboratives | Yes |
31 | Have research staff assist in coordinating with patient’s other physicians | Pragmatic | Implementation advice | II.2 | During the recruitment process, each RC would enter the contact information for the patient’s providers in the study’s secure database REDCap. If the patient was enrolled in the telephonic study arm the nurse would assist with care coordination processes | Yes |
32 | Ensure that Outpatient Palliative Care clinics are well staffed | Resource | Staffing infrastructure suggestion | I.1 | No changes could be made to the staffing infrastructures at each external outpatient clinic, but the research team worked with outpatient palliative care clinics to understand staffing trends, hiring updates and strategic interim plans to ensure that capacity will allow for EMPallA patient care | No |
33 | Hire additional Spanish speaking research coordinators at each enrolling site | Resource | Staffing infrastructure suggestion | II.1, II.2 | Due to budgetary constraints and inability to find appropriate staff this was not feasible at each enrolling institution. Nonetheless, the research team recommended that bi-lingual qualifications be included in hiring criteria. Where this could not be accommodated, research teams made use of hospital translator phones to ensure that the Spanish-speaking population could accurately be reached | No |
34 | Ensure all Spanish patient facing materials are culturally sensitive | Resource | Patient-centered suggestion | II.1, II.2 | All materials were directly translated from original documents to maintain a standardized tone and reviewed by Spanish speaking Latinx SAC member | Yes |
35 | Implement mock Spanish recruitment trainings | Resource | Patient-centered suggestion | II.1, II.2 | Leveraging our SAC member with expertise in recruiting Spanish-speaking participants, the research team implemented focused trainings on recruiting Spanish-Speaking participants between the SAC member and each individual research coordinator responsible for recruitment | Yes |
36 | Implement mock recruitment training for new enrollment sites that were added to the study design | Resource | Patient-centered suggestion | II.1, II.2 | The research team scheduled time between SAC members and not only new enrollment sites, but also newly hired RCs to conduct mock recruitment | No |
37 | Involve Patient stakeholders to train new research team members via WebEx conferencing on the research study pitch language used to describe palliative care | Resource | Patient-centered suggestion | II.1, II.2 | SAC members trained RCs on a routine basis to ensure that staff on the ground was provided with updated resources throughout study enrollment | No |
38 | Assess the feasibility of covering patient’s physician costs | Resource | Patient-centered Suggestion | II.2 | Patient Centered Outcome Research Institute (PCORI) funded project cannot cover physician related costs, but this conversation was the impetus of adding “insurance status” as a variable in the patient screening process | Yes |
39 | When reviewing data internally (SAC and research team), update bar graphs to include patient and caregiver enrollment numbers on the same bar graph | Dissemination | Advice about dissemination | II.4 | The research team’s Data Analyst updated this figure to consistently report patient and caregiver enrollment targets and goals on the same bar graph for visual ease | No |
40 | When reviewing data internally (SAC and research team), always include ethnicity enrollment breakdown for patients and caregivers | Dissemination | Advice about dissemination | II.4 | The research team’s Data Analyst consistently provides race/ethnicity data when presenting enrollment updates during the internal team meeting | No |
41 | Disseminate study progress to patients while the study is ongoing. One Suggestion included having a website for patients to see enrollment numbers and target goals, results etc | Dissemination | Advice about dissemination | III.1 | Once primary data collection and analysis concludes, study results will be disseminated to study participants | No |