The yin and yang of pragmatic clinical trials of behavioral interventions for chronic pain

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

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

Military Medicine ◽

10.1093/milmed/usaa368 ◽

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.

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A primary care-based interdisciplinary team approach to the treatment of chronic pain utilizing a pragmatic clinical trials framework

Translational Behavioral Medicine ◽

10.1007/s13142-012-0163-2 ◽

2012 ◽

Vol 2 (4) ◽

pp. 523-530 ◽

Cited By ~ 27

Author(s):

Lynn L DeBar ◽

Lindsay Kindler ◽

Francis J Keefe ◽

Carla A Green ◽

David H Smith ◽

...

Keyword(s):

Primary Care ◽

Chronic Pain ◽

Clinical Trials ◽

Interdisciplinary Team ◽

Team Approach ◽

Pragmatic Clinical Trials

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Improving pragmatic clinical trial design using real-world data

Clinical Trials ◽

10.1177/1740774519833679 ◽

2019 ◽

Vol 16 (3) ◽

pp. 273-282 ◽

Cited By ~ 4

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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Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain

Pain ◽

10.1016/j.pain.2007.09.002 ◽

2008 ◽

Vol 137 (2) ◽

pp. 276-285 ◽

Cited By ~ 270

Author(s):

Dennis C. Turk ◽

Robert H. Dworkin ◽

Dennis Revicki ◽

Gale Harding ◽

Laurie B. Burke ◽

...

Keyword(s):

Chronic Pain ◽

Clinical Trials

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Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies

Healthcare ◽

10.1016/j.hjdsi.2020.100432 ◽

2021 ◽

Vol 8 ◽

pp. 100432

Author(s):

Leah Tuzzio ◽

Catherine M. Meyers ◽

Laura M. Dember ◽

Corita R. Grudzen ◽

Edward R. Melnick ◽

...

Keyword(s):

Clinical Trials ◽

Quality Improvement ◽

Case Studies ◽

Healthcare Systems ◽

Pragmatic Clinical Trials

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

Military Medicine ◽

10.1093/milmed/usab458 ◽

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.

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