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.

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.

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 Exploring the Patient-Provider Relationship in Older Adult Pain Management

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 945-946
Author(s):  
Sophia Sheikh ◽  
Natalie Spindle ◽  
Jennifer Brailsford ◽  
Jason Beneciuk ◽  
Monika Patel ◽  
...  
Keyword(s):  
Older Adults ◽  
Pain Management ◽  
Older Adult ◽  
Pain Treatment ◽  
Healthcare Providers ◽  
Educational Interventions ◽  
Structured Interviews ◽  
Patient Centered ◽  
Study Objective ◽  
Management Approaches

Abstract Successful health outcomes in older patients are linked to the quality of the patient-provider relationship. Our study objective was to further understand the role of this relationship specific to pain management through perspectives from older adults and healthcare providers. Semi-structured interviews and focus groups were conducted with 9 older adults and 11 multidisciplinary healthcare providers. Transcripts were analyzed using a thematic analysis. Three main concepts emerged: (1) defining pain management goals — differences in providers and patients’ goals for pain and function, with sub-themes of realistic goal setting and a shift in pain treatment to minimize opioids as a first-line medication; (2) communication — perceived gap in providers communicating and coordinating across disciplines and with patients, with sub-themes of improving positive communication and inconsistent messaging among providers; and (3) therapeutic alliance — all parties feel that developing a relationship is built on consistent trust and open dialogue. Although providers and older adults often expressed similar perspectives, there were several areas of misalignment identified within each concept, representing areas of disconnect within the patient-provider pain management relationship. Our findings indicate providers could benefit from education on improving communication around realistic goals and patient-centered outcomes and incorporation of more holistic pain management approaches when working with older adult patients. Further study should focus on developing educational interventions to address the identified shortcomings.

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.

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.

scholarly journals Improving pragmatic clinical trial design using real-world data

2019 ◽  
Vol 16 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Susan M Shortreed ◽  
Carolyn M Rutter ◽  
Andrea J Cook ◽  
Gregory E Simon
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Suicide Attempts ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Pragmatic Clinical Trial ◽  
Pragmatic Clinical Trials ◽  
Sample Size Calculations ◽  
Record Data ◽  
Electronic Health

Background Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Methods Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations. Results Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05. Conclusions Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.

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