Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes

Abstract

Background The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. Design Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study’s target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? Summary Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Feasibility of recruitment and retention in a remote trial of gatekeeper training for close supports of military veterans: Mixed methods study

“…Specifically, we presented draft recruitment materials to a veteran engagement board, and the study coordinator (AC) is a Navy veteran. However, even more robust stakeholder engagement—and partnering with participant-centric organizations where possible—is recommended for others conducting similar studies to bolster trust and credibility among the target audience [ 33 ]. For instance, stakeholder engagement might identify language such as “mission” and “brotherhood/sisterhood” that can be effectively deployed in veteran-centric studies.…”

Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials

“…The processes and mechanisms for engaging patients or potential subjects in PCTs parallel those for engaging patients in research more generally. For example, in a Veterans Affairs‐funded study of complementary and integrative health therapy interventions for chronic pain, veterans contributed to study design and provided input on intervention components and meaningful study outcomes 14 . In another VA study examining chiropractic care, veterans provided feedback via interviews to inform treatment scheduling protocols 15 .…”

“…For example, in a Veterans Affairs-funded study of complementary and integrative health therapy interventions for chronic pain, veterans contributed to study design and provided input on intervention components and meaningful study outcomes. 14 In another VA study examining chiropractic care, veterans provided feedback via interviews to inform treatment scheduling protocols. 15 Other proposals for patient engagement in embedded PCTs include intentionally engaging patients in ethical decisions about study implementation, including studyspecific decisions about the appropriateness of waivers or alterations of informed consent, and in ensuring research portfolios are responsive to the needs of the patient community, such as through the use of community advisory boards or patient and family councils.…”

Ethical analysis of vulnerabilities in cluster randomized trials involving people living with dementia in long‐term care homes

“…Further, stakeholder engagement is widely viewed as an effective means of increasing external validity by ensuring that the trial design is compatible with the study intervention's setting of intended use. 39,40 Relevant stakeholders include residents, family members, patient care attendants, nurses, physicians, LTC home administrators, LTC ombudsman (representatives of LTC residents and their families who report complaints), and community advocacy groups. 29 The particularities of the intervention and the data collection methods may heighten vulnerability concerns.…”