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

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_2) ◽  
pp. S13-S20
Author(s):  
Lori A Bastian ◽  
Steven P Cohen ◽  
Lily Katsovich ◽  
William C Becker ◽  
Bradley R Brummett ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pain Management ◽  
Stakeholder Engagement ◽  
Military Service ◽  
Work Group ◽  
Pragmatic Trial ◽  
Implementation Challenges ◽  
Stakeholder Relationships ◽  
Pragmatic Clinical Trials ◽  
System Leaders

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.

Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

2021 ◽  
Author(s):  
Joseph Ali ◽  
Margaret Antonelli ◽  
Lori Bastian ◽  
William Becker ◽  
Cynthia A Brandt ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pain Management ◽  
Pragmatic Trial ◽  
Dissemination And Implementation ◽  
Large Network ◽  
Military Health ◽  
Healthcare Needs ◽  
Unmet Healthcare Needs ◽  
Pragmatic Clinical Trials ◽  
The Impact

ABSTRACT Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the “whole is greater than the sum of the parts.” Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, “real-world,” settings.

scholarly journals Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mary Geda ◽  
◽  
Steven Z. George ◽  
Diana J. Burgess ◽  
Dylan V. Scarton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pain Management ◽  
Research Effort ◽  
Health Care Systems ◽  
Lessons Learned ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Recruitment Methods ◽  
Research Site ◽  
Pragmatic Clinical Trials

Abstract Background The Pain Management Collaboratory (PMC) is a multi-site network of pragmatic clinical trials (PCTs) focused on nonpharmacological approaches to pain management, conducted in health care systems of the US Department of Defense (DoD) and Department of Veterans Affairs (VA) and co-funded by the National Institutes of Health (NIH). Concerns about potential research-site overlap prompted the PMC investigator community to consider strategies to avert this problem that could negatively affect recruitment and contaminate interventions and thus pose a threat to trial integrity. Methods We developed a two-step strategy to identify and remediate research-site overlap by obtaining detailed recruitment plans across all PMC PCTs that addressed eligibility criteria, recruitment methods, trial settings, and timeframes. The first, information-gathering phase consisted of a 2-month period for data collection from PIs, stakeholders, and ClinicalTrials.gov. The second, remediation phase consisted of a series of moderated conference calls over a 1-month time period to develop plans to address overlap. Remediation efforts focused on exclusion criteria and recruitment strategies, and they involved collaboration with sponsors and stakeholder groups such as the Military Treatment Facility Engagement Committee (MTFEC). The MTFEC is comprised of collaborating DoD and university-affiliated PIs, clinicians, and educators devoted to facilitating successful pragmatic trials in DoD settings. Results Of 61 recruitment sites for the 11 PMC PCTs, 17 (28%) overlapped. Four PCTs had five overlapping Military Treatment Facilities (MTFs), and eight PCTs had 12 overlapping VA Medical Centers (VAMCs). We developed three general strategies to avoid research-site overlap: (i) modify exclusion criteria, (ii) coordinate recruitment efforts, and/or (iii) replace or avoid any overlapping sites. Potential overlap from competing studies outside of the PMC was apparent at 26 sites, but we were not able to confirm them as true conflicts. Conclusion Proactive strategies can be used to resolve the issue of overlapping research sites in the PMC. These strategies, combined with open and impartial mediation approaches that include researchers, sponsors, and stakeholders, provide lessons learned from this large and complex pragmatic research effort.

Patient and Stakeholder Engagement in Designing Pragmatic Clinical Trials

2017 ◽  
pp. 137-152
Author(s):  
Anna Hung ◽  
Carole Baas ◽  
Justin Bekelman ◽  
Marcy Fitz-Randolph ◽  
C. Daniel Mullins
Keyword(s):  
Clinical Trials ◽  
Stakeholder Engagement ◽  
Pragmatic Clinical Trials

scholarly journals INTEREST GROUP SESSION—ALZHEIMER'S DISEASE AND RELATED DIMENTIAS: OPPORTUNITIES AND CHALLENGES TO DEVELOPING AND TESTING PRAGMATIC ADRD INTERVENTIONS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S363-S363
Author(s):  
Abraham A Brody ◽  
Laura N Gitlin
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Real World ◽  
Psychological Symptoms ◽  
Wide Spectrum ◽  
Pragmatic Trial ◽  
Intervention Development ◽  
Pragmatic Trials ◽  
Pragmatic Clinical Trials

Abstract Many clinical trials have been performed to develop the evidence for caring for persons with Alzheimer’s Disease and Related Disorders (ADRD) in tightly controlled settings. These trials have found efficacy of a wide spectrum of interventions to address issues from advanced care planning to behavioral and psychological symptoms of dementia (BPSD). However, few ADRD interventions have been tested in wide-scale pragmatic fashion in long term supportive settings (LTSS) such as nursing homes, primary care clinics, hospices, or community based organizations. This is due to a variety factors, principle amongst them are the difficulty in implementing pragmatic trials, and that many of the interventions developed in tightly controlled settings are not directly translatable to real-world settings. Without translating and testing interventions in real world settings, the evidence base remains largely inaccessible to the end user, the persons with ADRD and their caregivers. Moreover, effectiveness remains unclear. The lack of pragmatic trials in ADRD exists despite significant recent investment from the NIH Office of the Director in a health systems collaboratory to support pragmatic clinical trials. In 2018, NIA therefore released a call for 2-phase intervention development and pragmatic trial testing via an R61-R33 mechanism (PAR-18-585). Four proposals were funded in September 2018 from this PAR. This symposium will explore the opportunities and challenges present in developing and testing pragmatic interventions in ADRD in LTSS. The speakers will also share specific scientific methodological and implementation questions that need to be addressed in applying for pragmatic trial awards.

scholarly journals Principles and procedures for data and safety monitoring in pragmatic clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Gregory E. Simon ◽  
Susan M. Shortreed ◽  
Rebecca C. Rossom ◽  
Robert B. Penfold ◽  
Jo Ann M. Sperl-Hillen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pragmatic Trial ◽  
Mental Health Research ◽  
Study Data ◽  
Research Network ◽  
Pragmatic Trials ◽  
Study Staff ◽  
Pragmatic Clinical Trials ◽  
Effective Delivery ◽  
Trial Monitoring

Abstract Background All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials. Methods/Results Appropriate monitoring of clinical trials typically includes assessing rate of recruitment or enrollment; monitoring safe and effective delivery of study treatments; assuring that study staff act to minimize risks; monitoring quality and timeliness of study data; and considering interim analyses for early detection of benefit, harm, or futility. Each of these responsibilities applies to pragmatic clinical trials. Just as design of pragmatic trials typically involves specific and necessary departures from methods of explanatory clinical trials, appropriate monitoring of pragmatic trials typically requires specific departures from monitoring procedures used in explanatory clinical trials. We discuss how specific aspects of pragmatic trial design and operations influence selection of monitoring procedures and illustrate those choices using examples from three ongoing pragmatic trials conducted by the Mental Health Research Network. Conclusions Pragmatic trial investigators should not routinely adopt monitoring procedures used in explanatory clinical trials. Instead, investigators should consider core principles of trial monitoring and design monitoring procedures appropriate for each pragmatic trial.

scholarly journals Development and Implementation of the Military Treatment Facility Engagement Committee (MTFEC) to Support Pragmatic Clinical Trials in the Military Health System

2021 ◽  
Vol 186 (Supplement_1) ◽  
pp. 70-75
Author(s):  
Dylan V Scarton ◽  
William T Roddy ◽  
Jerika A Taylor ◽  
Mary Geda ◽  
Cynthia A Brandt ◽  
...  
Keyword(s):  
Health Care ◽  
Chronic Pain ◽  
Clinical Trials ◽  
Pain Management ◽  
Service Members ◽  
Treatment Facility ◽  
Pragmatic Clinical Trials ◽  
Military Treatment Facility ◽  
The Military ◽  
The Impact

ABSTRACT Introduction Within the population of military service members and veterans, chronic pain is highly prevalent, often complex, and frequently related to traumatic experiences that are more likely to occur to members of this demographic, such as individuals with traumatic brain injury or limb loss. In September 2017, the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veterans Affairs (VA) Pain Management Collaboratory (PMC) was formed as a significant and innovative inter-government agency partnership to support a multicomponent research initiative focusing on nonpharmacological approaches for pain management addressing the needs of service members, their dependents, and veterans. Methods A Pain Management Collaboratory Coordinating Center (PMC3) was also established to facilitate collective learning across 11 individually funded pragmatic clinical trials (PCTs) designed to optimize the impact of the PMC as an integrated whole. Although the DOD and VA health care systems are ideal sites for the enactment of PCTs, executing these trials within the local context of DOD military treatment facilities (MTFs) can present unique challenges. The Military Treatment Facility Engagement Committee (MTFEC) was created to support the efforts of the PMC3 in its role as a national resource for development and refinement of innovative tools, best practices, and other resources in the conduct of high impact PCTs. Results The MTFEC is composed of experts from each service who bring experiences in executing clinical pain management trials that can enhance the planning and execution of the PCTs. It provides expertise and leadership in the execution of research studies at within MTFs and within the DOD health care system, with guidance from PMC3 Directors and in collaboration with NIH, DOD, and VA program and scientific officers. Discussion/Conclusion Considering the importance of enacting large-scale, pragmatic studies to implement effective strategies in clinical practice for chronic pain management, the MTFEC has begun to actualize its purpose by identifying potential barriers and challenges to study implementation and exploring how the PMC can support and aid in the execution of PCTs by applying similar approaches to stakeholder and subject matter engagement for their research.

Children’s Oncology Group (COG) clinical trials as exemplars of pragmatism in clinical research.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18188-e18188
Author(s):  
Nupur Mittal ◽  
Anil George ◽  
Lizette Leanos ◽  
Paul Kent
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Pragmatic Trial ◽  
Standard Of Care ◽  
The United States ◽  
Phase Iii ◽  
President Obama ◽  
Explanatory Trial ◽  
Phase Iii Clinical Trials ◽  
Pragmatic Clinical Trials

e18188 Background: In 2016, President Obama announced the “Moonshot Cancer Initiative” to advance cancer research. One of the key components of this initiative is promoting enrollment in pragmatic clinical trials and data sharing. As described in 2009 by Thorpe et al, using the 9-domian PRECIS-2 tool, a ‘pragmatic’ trial, as opposed to an ‘explanatory’ trial used to confirm a physiologic hypothesis, is one in which the intervention can be immediately applied into real-world clinical practice (J of Clin Epi:2009). In the US, 60%-90% children are enrolled on COG research trials. State-of-the-art treatment for a child is derived from superior therapy identified in prior trials which then serves as the standard arm of subsequent phase-III trials and becomes the de facto practice guideline and ‘standard of care’ .To accomplish this goal, COG shares its data among the 242 member institutions.Our objective is to assess “pragmatism” in COG trials. Methods: We analyzed the 158 COG phase III clinical trials between 2006-2016 for all 9 domains of the PRECIS-2 (Table 1) and graded them from 1-5 (most explanatory to most pragmatic). Results: Out of 152 phase III clinical trials on the COG website, 138 (91%) scored 5/5 for all 9 PRECIS pragmatic domains and 148 (98%) scored >4. The scoring for all 9 domains is in table 1. Conclusions: COG provides nearly all children in the United States access to pragmatic phase III research as outlined in the Moonshot Goals. Goal of merging evidence-based standard care accessible to all and conducting well- designed clinical research to identify the best therapies has been accomplished by COG and should serve as an example to other cancer organizations. 9 domains of PRECIS-2 to assess pragmatism in clinical trials. [Table: see text]

scholarly journals The Pragmatic Turn in Clinical Research

2021 ◽  
Vol 34 (2) ◽  
pp. 6-24
Author(s):  
Olga Zvonareva
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Research ◽  
Pragmatic Trial ◽  
Limited Ability ◽  
Actual Treatment ◽  
Medical Experimentation ◽  
Pragmatic Clinical Trials ◽  
Pragmatic Turn

How does knowledge obtained in clinical trials apply to the actual treatment of patients? This question has recently acquired a new significance amidst complaints about the limited ability of trial results to improve clinical practice. Pragmatic clinical trials have been advocated to address this problem. In this article, I trace the emergence of the pragmatic turn in clinical research, starting from the first mention of ‘pragmatic trial’ in 1967, and analyse the changes to how pragmatism has been conceived. I argue that contemporary version of pragmatism risks missing the mark by focusing exclusively on establishing similarity between the trial and the clinic for the purpose of greater generalizability. This focus eclipses the move for carefully aligning medical experimentation with conditions, needs and concerns in the clinic aimed at greater usefulness. 

scholarly journals Designing Trials with Purpose: Pragmatic Clinical Trials of Nonpharmacological Approaches for Pain Management

Pain Medicine ◽  
2020 ◽  
Vol 21 (Supplement_2) ◽  
pp. S7-S12
Author(s):  
Kirsha S Gordon ◽  
Peter Peduzzi ◽  
Robert D Kerns
Keyword(s):  
Clinical Trials ◽  
Pain Management ◽  
Lessons Learned ◽  
Patient Centered ◽  
Care Plans ◽  
Pragmatic Clinical Trials ◽  
Key Features ◽  
Management Approaches ◽  
Nonpharmacological Pain Management ◽  
Practice Questions

Abstract Objective Pain is one of the most significant causes of morbidity and disability worldwide. The efficacy of several nonpharmacological approaches for pain management has been established, but significant gaps exist between this evidence and their limited availability and use in routine clinical practice. Questions remain about their effectiveness and how best to integrate them in usual care to optimize patient-centered outcomes. Pragmatic clinical trials (PCTs) may help address this gap. Informed by the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2), we sought to describe the key features of optimized PCTs of nonpharmacological approaches for the management of pain and common co-occurring conditions. Methods To accomplish this objective, we searched the published literature on PCTs of nonpharmacological pain management approaches from 2010–2019 and applied the PRECIS-2 criteria. We discuss key PRECIS-2 domains of interest for designing and performing PCTs and cite specific examples from the published literature as potential models for future PCTs. Results We found 13 nonpharmacological PCTs. They were heterogeneous in size, recruitment, follow-up time, and location. The lessons learned from these studies led us to explicate key features of trials on the explanatory–pragmatic continuum across the PRECIS-2 domains that can be used by future investigators when designing their clinical trials of nonpharmacological approaches to pain management. Conclusions We encourage the increased application of PCTs to produce timely and valuable results and products that will inform the development of safe and effective integrated pain care plans that optimize important patient-centered outcomes.

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