Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA)

Background Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. Methods A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project’s duration. Results The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. Conclusions Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. Trial Registration: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.


Background
Actively engaging patient and community stakeholders in the design of clinical trials is crucial to addressing questions and bridging gaps in patient-centered research that are relevant to both the investigator and target populations [1,2].Specifically, patients and stakeholders can steer the design of clinical trials to be effective in disseminating and implementing findings into standard practice [1].This adds to overall patient satisfaction and uses genuine feedback to continuously improve patient outcomes [3,4].The patient and community perspective prioritizes patient goals, which may not always be apparent to researchers, and ensures studies hold up to their ethical standards [4].Furthermore, there is a moral imperative to include patient and community perspectives in research to ensure patients are protected during research.Healthcare organizations that represent and advocate for illness groups such as heart failure give valuable insight into how these patients will be best served by the study.Payor involvement can give insights into study design and dissemination that can improve payor uptake of results upon study completion.As healthcare models further aim to implement patient-centered care, examination of the impact of patient and community perspectives on research design and implementation is crucial.
The Patient-Centered Outcomes Research Institute (PCORI) has transformed clinical research with its unique commitment to funding comparative clinical effectiveness research and mandating a plan for stakeholder engagement [5].PCORI defines patient and stakeholder engagement as the meaningful involvement of patients and stakeholders in developing the research question, relevant outcomes to be studied, participant characteristics, protocols, data collection, interpretation of results, and dissemination of conclusions [6].While many studies understand the importance of incorporating the patient perspective, the use of patient and community stakeholder committees and their impact on the conduct of a multicentered clinical trial have been understudied and underreported [7].
The Emergency Medicine Palliative Care Access (EMPallA) trial is a randomized, pragmatic clinical trial comparing the effectiveness of specialty, outpatient to nurse-led telephonic palliative care for older adults with advanced illness initiated in the emergency department (ED).The EMPallA trial recruited 1,350 patients across eighteen EDs (nine states across the United States (US)) and their respective caregivers.The parent EMPallA study evaluated the effectiveness of each intervention by comparing patient quality of life, healthcare utilization, loneliness, symptom burden, as well as caregiver strain, quality of life, and bereavement [8].
A Study Advisory Committee (SAC) was assembled at the project's inception and consisted of a variety of patient and community stakeholders (patients with palliative care experience, members of healthcare organizations, and payers).The goal of the SAC was to assist in all stages of the research, including the trial design and planning, recruitment, implementation, and dissemination of study conclusions [8].Using a thematic analysis approach, we describe recommendations the SAC provided that were implemented over the course of EMPallA.

Methods
This study was approved by the New York University Grossman School of Medicine Institutional Review Board (ID# s17-01211 and s19-00419).

Study design
We used a descriptive case study research design to describe SAC recommendations that have been implemented throughout the EMPallA trial.We completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize the data.After themes were identified, we used a pre-existing framework, Shippee et al. to classify our findings into three study phases (preparatory, execution, translational) [9].The goal of using the Shippee et al. framework was to better understand when in the research project most types of recommendations occurred (ex.Did all study design related recommendations occur in year 1 and/or preparatory phase?).We engaged in an iterative process to generate patterns in the data until data was deemed saturated.Our four major themes demonstrate how SAC recommendations translated to impactful study modifications.

Study participants and recruitment
A purposive sampling method was used.Initial stakeholders from all three stakeholder categories were recruited to participate on the EMPallA SAC based on (1) their history of commitment to patient-centered outcomes research (2) previous collaboration with the EMPallA Principal Investigator (PI) (co-author CRG) and (3) in accordance with the need for demographically and geographically diverse representation.
Further stakeholders were identified by word-of-mouth recommendation.
EMPallA's SAC consisted of 18 members from across the US (n = 7 Eastern US, n = 8 Pacific US, n = 3 Central US) representing three major stakeholder categories: patients (n = 3) experiencing serious diseases or their caregivers (n = 4), members of healthcare organizations involved with study-related illnesses and/or palliative care (n = 5), and payers (n = 6).Examples were officers of associations such as the American Heart Association and the American Cancer Society, the chief medical officer of a Medicare Managed Care plan, officers of healthcare foundations, and community faculty of a historically black university.The SAC was composed of 12 women and six men representing Black, Asian, and Latino communities (50% White non-Hispanic, 28% Black non-Hispanic, 17% Asian, 6% White Hispanic).

Study procedures
Data were collected between December 2017 and November 2020 and included SAC meeting notes from quarterly, annual, and ad-hoc meetings along with supplemental audio and video recordings.Since the EMPallA project's inception (10/30/2017), the SAC met both quarterly and annually, with all meetings facilitated and led by the New York University (NYU) research team (CRG, MD, female, clinician and researcher).The quarterly meetings occurred three times per year via conference call (either Webex or Zoom) for approximately 60-90 min.Annual meetings were longer and ranged between 4 and 8 h.Annual meetings originally occurred in-person (2017-2019) and transitioned to virtual thereafter due to the COVID-19 pandemic.All meetings followed a general structure: presentations and updates by research team members; discussion of current barriers and facilitators; open forum discussion.Ad hoc meetings also occurred and ranged from 30 to 60 min.
The research team was responsible for writing and disseminating meeting notes to the SAC within 48 h after each SAC meeting to facilitate transparency and to allow member checking for additional reflection and feedback.We did not record which individual in the SAC voiced a specific recommendation, but all final recommendations were made by consensus of the full SAC group.Given the pre-established level of trust and rapport leveraged from previous work experiences, patients and caregivers were very engaged during the meetings, often directing the discussion more than the payers and healthcare organization participants.Members of the SAC were contracted as paid consultants which allowed them to receive stipends for their support and travel reimbursement, when applicable.

Analysis
All sixteen available SAC meeting notes, audio, and video recordings were transcribed.The coders, two EMPallA Project RCs (co-authors SR, IC) received the full dataset in 2021 and coding and data analysis took place between August 2021 and July 2022.The Senior Research Project Manager (SRPM)(AMC), a trained qualitative researcher, oversaw the qualitative research process.Both RCs (SR, IC) independently reviewed all sources of data, then coded the content highlighting potentially relevant phrases and sentences related to the research question (study modifications and recommendations), and initial codes were generated.The development of the codebook was an iterative process and the team (AMC, SR, IC) came together to reach a consensus for coding interpretation.If necessary, the SRPM would make the final decision if consensus on coding was not reached.Deductive themes and subthemes were generated.Using the Shippee et al. framework the team indexed the coded recommendation into relevant study phases [9].Codes were condensed into meaningful themes.Upon completion of the thematic analysis and classification into relevant Shippee study phase, the coding team next completed a crosswalk exercise to match which specific approved Institutional Review Board (IRB) modifications were a direct result from a coded SAC recommendation.Results were compiled and organized into a single table (Table 1).Participant checking was accomplished via e-mail with all members of the SAC.

Theoretical framework
The Shippee, et al. framework, (Fig. 1) was used to understand longitudinally at what phase within the project the recommendations occurred [9].Specifically, this framework standardizes the structure of reporting the SAC's recommendations into three broad research design phases: preparatory, execution, and translational.The preparatory phase focuses on agenda setting by ensuring the study's novelty and relevance, as well as creating effective protocols to explore research questions.The execution phase focuses on subthemes of study design and procedures, study recruitment, data collection, and analysis.Lastly, the translational phase focuses on dissemination, implementation, and evaluation of the study's conclusions.Each phase is further categorized into stages to delineate research activities impacted by stakeholder engagement.

Results
Sixteen SAC meetings occurred between December 29, 2017-November 13, 2020.All meetings were used in the analysis.In half of the meetings (8/16) the SAC members provided discrete recommendations.The remaining meetings were used to discuss implementation of the suggested recommendations, barriers/facilitators, or other project related topics.A total of 41 recommendations, which subsequently resulted in 26 distinct IRB study modifications were made during the specified timeframe.All study protocol modifications were accepted by the funder to ensure the main research question, subsequent aims, and overall study design remained consistent and had the same scientific rigor as proposed in the original grant application.As such, despite changes made to the study protocol, patients recruited at the end of the study were not demonstrably different in terms of age, race/ethnicity, gender, or disease category.
Four major themes emerged in the data (Scientific, Pragmatic, Resource and Dissemination) and all coded data were organized using the Shippee, et al. framework.Results reflect both the major themes through the thematic analysis and also the Shippee framework three main study phases: Preparatory, execution, and translation [9].Data demonstrating the non-linear nature of SAC recommendations (organized by meeting year) and engagement throughout the project can be found depicted in Fig. 2. Data in Fig. 2 were not mutually exclusive to a specific phase or stage and thus, were included in multiple categories.A vast majority (94%) of IRB modifications made due to SAC recommendations were indexed in the execution phase of the framework.Few recommendations were related to the preparatory or translational Phases.The translational phase of the framework includes the stages of dissemination (Fig. 1) [9].Given the SAC members were funded on the EMPallA project for a specific timeframe (study design through the end of data collection phases), only one recommendation during the data collection period pertained to the translational phase (Recommendation #41, Table 1).This occurred during the first SAC meeting when the SAC suggested study updates and results be disseminated to patients in real-time.No IRB adaptations were made based on this recommendation as the research team could not analyze or disseminate results until recruitment and data collection were complete (July 2023).
Below we describe exemplary SAC recommendations within each coded theme and subthemes and how each recommendation was translated to meaningful changes, or "actions, " in the implementation of the EMPallA trial.The full list of SAC recommendations (including recommendations both made and not made), their associated IRB modifications, Shippee framework phase classifications, and themes and subthemes can be found in Table 1.Within Table 1 we also provide details related to which modifications did not require an IRB modification and/or the rationale on why a recommendation was not implemented.

Theme 1-Scientific
The Scientific theme was related to changes that would have impacted the original research plan, scientific design, or items related to describing the study to participants.The most common subthemes were design advice and recommendations for supplementary study materials.

SAC recommendation
In setting research priorities, the SAC proposed the research team measure how caregivers cope with their caregiver's (relative, friend, partner etc.) illness as they believed it would be a beneficial variable to include when comparing the effectiveness of each palliative care arm (Preparatory Phase).
Research team action Based on the recommendation to measure caregiver's coping mechanisms, the research team incorporated the validated Zarit Caregiver Burden Interview into the initial assessment and subsequent patient follow-up surveys at 3, 6 and 12 months [10,11].

SAC recommendation
The SAC suggested the EMPallA trial address loneliness, a specific concern of the seriously ill older adult population (Execution Phase).

Research team action As a result, the research 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 [8,12,13].This added an additional quality of life measure to reflect intervention effects.
SAC recommendation Due to project start up timeline and logistic barriers, the initial study design solely included English speaking patients.The SAC strongly recommended the EMPallA trial expand enrollment inclusion criteria to include Spanish-speaking patients as this would assist with increasing the generalizability and minimize disparities (Execution Phase).

Research team action
To effectively make this change the research team leveraged the original SAC members to specifically recruit a Latinx community partner to join the SAC.Once the Latinx SAC member was recruited, they assisted in developing Spanish patient-facing materials to be submitted to the IRB for approval.This recommendation also required the research team collaborate with each Spanish-speaking recruitment site to ensure a native Spanish-speaking RC was available for the enrollment and consent process to ensure cultural and linguistic sensitivity.The research team also updated their protocol to incorporate the use of a translator phone in recruitment and intervention delivery when a native Spanish-speaking team member was unavailable.This major study modification focused on ensuring the study population was

SAC recommendation
The SAC expressed an interest in ensuring data collection instruments were included to address patients' and caregivers' health as a whole.SAC members also continued to express the need to prioritize the patient perspective and requested the research team remain sensitive to conditions that impact the specific study participants, such as Alzheimer's Disease and Dementia which may have been uncovered after enrollment (Execution Phase).
Research team action As a result from these conversations, the validated, 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10) was incorporated, with questions specific to caregiver physical, mental, and social health [14].In this screening tool, a dementia question which indicates whether dementia was included in the patient's active problem list was also documented.This question excluded participants at baseline, however, if a participant developed dementia throughout the course of the study, RCs were trained to use a dynamic approach to obtaining data from this population.For example, RCs prioritized certain questions within the follow-up surveys or requested the presence of a caregiver during survey completion to aid patients in their responses.
SAC recommendation During the November 16, 2020, meeting, the SAC recommended the specialty, outpatient palliative care intervention arm expand services to be delivered via telehealth, due to the COVID-19 pandemic and subsequent epidemiological waves occurring throughout the country (Execution Phase).

Research team action
The research team collaborated with each of the subcontracted enrollment and implementation sites to understand state, local, and health system policies and procedures for delivering palliative care via telehealth and requested this service be offered for patient safety to EMPallA enrolled patients.From there, each local RC coordinated with the Outpatient Co-Investigator to understand and adapt the research protocols to local clinic scheduling practices.The expansion of providing a telehealth visit option to those enrolled in the specialty outpatient palliative care arm was a major protocol change for the EMPallA trial.

Subtheme: recommendation for supplementary study materials SAC recommendation
Prior to beginning recruitment, the SAC members reviewed a draft of the EMPallA Enrollment Welcome Packet and recommended changes to the language, length, and overall appearance (Execution Phase).

Research team action
The research team updated the Enrollment Welcome Packet to ensure it was written in plain language and incorporated the SAC member's feedback regarding terminology and the use of specific palliative care words and phrases.Additionally, the SAC assisted in ensuring the materials were sensitive to the prospective study participants.They assisted in identifying which stock images would be most inclusive to use on the recruitment materials.Lastly, they assisted in partnering with the research team to ensure the consent process and benefits of palliative care were appropriately described in the developed of patient-facing materials.

SAC recommendation
Halfway through the EMPallA study, all sites were experiencing challenges in reaching targeted recruitment goals.To overcome this barrier, the SAC recommended the research team revisit and update previously developed patient-facing documents to emphasize what palliative care means and outline the goals and importance of the EMPallA study (Execution Phase).

Research team action
A one-page plain language, large font poster designed for older adults describing palliative care benefits and services was developed and incorporated into the recruitment packet materials.

Theme 2-pragmatic
The Pragmatic theme was related to practical changes that could be made to deliver the intervention more effectively.All SAC recommendations within this theme were related to implementation advice such as suggestions and feedback to facilitate implementation strategies.

SAC recommendation
During the November 16, 2020, meeting, the research team expressed challenges in reaching caregiver recruitment goals and requested this meeting focus on potential strategies and solutions for overcoming set barriers.
The SAC members encouraged the research team to focus on strategies related to increasing research coordinators (RCs) confidence and expertise on the topic area (e.g., implementing more role-playing trainings) and collaborating on enhancing patient/caregiver recruitment related materials (Execution Phase).

Research team action
RCs were re-trained to not only use more sensitive language, but also to emphasize the importance of EMPallA and the feasibility of caregiver responsibilities in the study.In addition, study materials were updated to be more inclusive of the challenges caregivers may experience when caring for someone with a life-limiting illness.
Examples of using more compassionate and empathetic language posed by the SAC included using terms and phrases such as "supportive care, " "companion, " and "support system" instead of "caregiver" and "caregiver burden".

SAC recommendation
The COVID-19 pandemic posed multiple challenges to patient recruitment and retention due to the lack of inperson contact between the research teams and patients.
The research team heard feedback during telephonic follow-up survey calls that patients often did not remember the initial recruitment call.To aid in retention, the SAC recommended implementing re-introductory phone calls after initial recruitment to remind patients of the study goals, timelines, and expectations.(Execution Phase).

Research team action
To increase engagement and retention, the research team incorporated refresher calls (1 month after initial recruitment) to study participants to remind them of the study goals and expectations.

Theme 3-Resource
The Resource theme was related to suggestions and recommendations that the SAC members provided specifically leveraging resources to enhance patient-centeredness.

SAC recommendation
After the trial had received approval for recruitment of Spanish-speaking patients, the SAC suggested the research team increase cultural competence by dedicating more training and learning opportunities for the RCs who were responsible for patient recruitment and enrollment (Execution Phase).

Research team action
RCs participated in meetings with a SAC member of Latinx descent to conduct mock recruitment/enrollment training sessions to ensure RC cultural and linguistical sensitivity.The RCs also participated in ongoing peer-topeer learning collaboratives.This enhanced the RCs' ability to effectively enroll by building trust and rapport with a diverse, seriously ill population.

Theme 4-Dissemination
The final theme, Dissemination was specifically related to recommendations having to do with dissemination advice.The timeline of the study and partnership with the SAC likely impacted the number of recommendations emerging within this theme.

SAC recommendation
The SAC encouraged the research team to keep the enrolled patient and caregivers informed throughout the active study.They suggested the research team develop a public website for participants to see enrollment numbers, target goals, and study results.(Translation Phase).

Research team action
Unfortunately given the scope of the study the research team was unable to move forward with this suggestion.
The research team did explore potential avenues for dissemination and communicated with their local IRB to see if it would be appropriate to house such a website, but it was deemed not appropriate until study completion.A mutual agreement was decided upon between the SAC group and the research team to disseminate plain language study results via mail in both English and Spanish to all participants after the study analysis had concluded.The SAC assisted in drafting this one-pager of study results and approved the final version that was disseminated to all participants.

Discussion
Patients, caregivers, and community as research partners, not simply participants, the SAC as a model for future trials Although previous literature on best practices for engaging in participatory research has identified the need to involve stakeholders throughout the research process, there is limited literature illustrating the consistent impact of stakeholder involvement at each stage of the research process [15][16][17][18].Literature on stakeholder involvement in clinical research has also been largely descriptive and lacking clear examples of how stakeholder involvement directly ties to changes in research procedures [19].Our results demonstrate how continual involvement of a SAC in a clinical trial generated significant recommendations and IRB modifications from beginning to later stages of a large trial.Our SAC members assisted in providing key recommendations related to the scientific design, development of study materials, pragmatic implementation, prioritization of leveraging resources to enhance patient-centeredness, and dissemination.
EMPallA's partnership with the SAC provides an example of successful patient and community incorporation in the conduct of a major multicenter randomized controlled trial.Multiple meetings over years resulted in many recommendations, over half of which resulted in IRB modifications.Most SAC recommendations in the first meeting were related to the execution phase of the trial, specifically in the study recruitment stage.As the trial progressed, the largest proportion of the SAC recommendations were still associated with the execution phase but shifted toward data collection stage within this phase.The consistent engagement of the SAC throughout the entire research process allowed real-time problem solving and led to meaningful changes at all phases of the trial.The SAC made the most impact in the execution phase of the project, specifically in the stages of study design and study recruitment.Many of the execution phase recommendations were related to both the science and pragmatic themes.The SAC improved study recruitment and retention by improving inclusivity and representation and by focusing on the patient perspective [15].Overall their recommendations addressed accessibility of trial materials, cultural competency of research personnel, diversity of our participants, design of patientfacing materials, measurability of study variables, and study design and protocol.When possible, the research team made every effort to incorporate all the SAC recommendations and advice.However, It is important to note not all SAC's suggestions led to formal IRB modifications in the study due to feasibility, study restrictions, and the privacy of the participants.Additionally, some recommendations could be made but did not require a formal IRB modification.Typically, formal IRB modifications are only required if items such as inclusion/exclusion criteria, procedures, recruitment, consent forms, questionnaires are modified.The research team always consulted their local IRB if they had any questions related to if they needed to submit a formal modification or not.
Through their focus on inclusivity and cultural competency, the SAC made suggestions improving study recruitment, a major tangible benefit to the study [20].In particular, older adults, especially those with substantial health problems, can be difficult to recruit to research and continue to be underrepresented in clinical research despite their increasing population across all demographics in the United States [21,22].Key approaches identified in recruiting and retaining patients include early in-depth planning, study advisory boards, and a sensitive approach to eligible patients [22].This may motivate funders and systemic support for SAC involvement in research [23].Bringing the patient perspective into recruitment led to practical suggestions for creating clearer, plain language patient facing materials and processes.
Our experience demonstrates how engaging a SAC can be a successful method for improving inclusivity, accessibility, and representation in clinical trials [24].Improving cultural competence and inclusion in clinical trials is crucial for translating clinical research into the realworld practice.A 2021 review of clinical trial literature identified three main recommendations for promoting inclusion in clinical trials: improving the cultural competency and sensitivity of all clinical trial staff, establishing a diverse community advisory panel, and increasing recruitment of staff from under-served groups [20].The EMPallA SAC accomplished these recommendations by advocating for inclusion and recruitment of caregivers in research [20], and by increasing access to translated documents and translation services.Integrating these strategies benefited the overall study.Members serving on the SAC were of different ethnic groups and backgrounds, providing diverse inputs from various cultures and religions.
Shippee and colleagues [9] also delineate four components of patient and public involvement in research that are beyond the levels of patient and service user engagement in research.These four components are: 1. patient and service user initiation, 2. building reciprocal relationships, 3. co-learning, and 4. re-assessment and feedback.Components 2-4 were the focus of the SAC's research involvement since their project involvement occurred after the grant was obtained.While the research team's activities related to these four components are outside the scope of this article and will be described elsewhere, the research team supported the SAC members' diversity by ensuring inclusive equitable access to the research process.Examples include ensuring study materials were in large-font printed materials, close captioning during videoconferencing calls, and travel arrangements for reduced mobility when meeting in person [5].

Limitations
We measured the impact of the SAC using study adjustments and modifications as a metric but were unable to quantitatively evaluate how the recommendations impacted patient recruitment, retention, or study outcomes.For example, once we implemented a change, we did not have a control group to test the effectiveness (i.e.we could not quantify if updating our study materials increased recruitment or not).Future multi-method research should be performed to explore how stakeholder engagement influences the experience of participants in similar trials.This could be accomplished via surveys, focus groups or other research methodologies to participants regarding stakeholder-recommended changes and their overall study experiences.
We did not identify which recommendations came from specific people or stakeholder groups.Based on our lived experiences, conversations during SAC meetings were often led by the patient and caregiver members.While their voice and recommendations were extremely valuable in improving the patient's experience in research, it is possible other groups were not able to contribute to the same degree.To ensure all stakeholder groups' feedback was considered we circulated the notes immediately after the meeting and provided all participants an opportunity to individually write via e-mail any questions/comments/concerns/ reflections.Other SACs have structured their meetings by separate groups which is more labor intensive but could lead to focused involvement of all stakeholder groups [24].We intentionally chose to not silo the groups as we felt there would be incredible value (brainstorming ideas, learning from each other, networking etc.) in meeting consistently as one large group and creating a sense of trust and community.Reflecting back, at times a mixed structure approach where meetings are held partially with the entire SAC, and in three individual groups, could have been beneficial to accomplish the desired outcomes.Future research should explore the ideal format of SAC meetings with individuals from different backgrounds.
Few recommendations were made in the preparatory and translation themes of the Shippee, et al., framework.First, the lack of recommendations pertaining to the preparatory phase can be attributed to the nature of a peer-reviewed grant.Specifically, the Principal Investigator (CRG) was primarily responsible for writing the grant and setting the research agenda.However, CRG did collaborate with several of the SAC members before the official formation of the committee to gain insight when writing the initial application.It would have been helpful to have had SAC input earlier in the preparatory phase, but there was no mechanism to reimburse them for their time prior to obtaining the grant funding.However, future studies should explore potentially a volunteer SAC earlier in the grant writing phase.Moreover, at the time of this thematic analysis the EMPallA trial was currently in the data analysis phase of the overall parent project, therefore fewer conversations about the translational phase stages had been discussed.However, we anticipate more translational phase recommendations by the SAC will emerge as the implementation phase ends.

Future Implications
As more studies incorporate "patient-centered" foci stakeholders may offer more pragmatic ways to ensure multiple, diverse patient perspectives are integrated into research [1].Future research should utilize the patient perspective in a direct manner and quantify its effectiveness in contributing to the value of the trial.Further analysis of the impact of patient and community stakeholders on the translational phase of the trial could provide a complete picture of the efficacy of the SAC in this analysis.This will give insight into how stakeholders can impact the adoption of study findings into standard care.In addition, the perspective of the SAC members on their efficacy should be evaluated, as well as that of the research team's opinions of the SAC to evaluate cooperation and satisfaction between these two groups.

Conclusion
Actively engaging patient and community stakeholders in clinical trials offers a strategic way to ensure the conduct of a clinical trial is patient-centered, addresses unmet clinical needs, and facilitates patient recruitment and retention.The SAC has demonstrated to be not only feasible, but instrumental in the design and conduct of EMPallA.Overall, the SAC possessed the ability to positively advocate for patient safety, cultural competence, representation, and protection of vulnerable populations.

Fig. 1
Fig. 1 Shippee et al. framework for patient and service user engagement

Fig. 2
Fig. 2 Longitudinal breakdown of the number of SAC recommendations across meetings (by calendar year) and organized by Shippee et al. framework categories.*Data is not mutually exclusive and recommendations were coded in more than one category

Table 1
Crosswalk of Study Advisory Committee (SAC) recommendations, Coded Themes/Subthemes, Shippee framework phase and Institutional Review Board (IRB) modification