Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial.

Abstract

Background/aims

Embedded pragmatic clinical trials are increasingly recommended for non-pharmacological pain care research due to their focus on examining intervention effectiveness within real-world settings. Engagement with patients, health care providers, and other partners is essential, yet there is limited guidance for how to use engagement to meaningfully inform the design of interventions to be tested in pain-related pragmatic clinical trials. This manuscript aims to describe the process and impacts of partner input on the design of two interventions (care pathways) for low back pain currently being tested in an embedded pragmatic trial in the Veterans Affairs health care system.

Methods

Sequential cohort design for intervention development was followed. Engagement activities were conducted with 25 participants between November 2017 and June 2018. Participants included representatives from multiple groups: clinicians, administrative leadership, patients, and caregivers.

Results

Partner feedback led to several changes in each of the care pathways to improve patient experience and usability. Major changes to the sequenced care pathway included transitioning from telephone-based delivery to a flexible telehealth model, increased specificity about pain modulation activities, and reduction of physical therapy visits. Major changes to the pain navigator pathway included transitioning from a traditional stepped care model to one that offers care in a feedback loop, increased flexibility regarding pain navigator provider type, and increased specificity for patient discharge criteria. Centering patient experience emerged as a key consideration from all partner groups.

Conclusion

Diverse input is important to consider before implementing new interventions in embedded pragmatic trials. Partner engagement can increase acceptability of new care pathways to patients and providers and enhance uptake of effective interventions by health systems.

Trial registration

NCT#04411420. Registered on 2 June 2020.

Department

Description

Provenance

Subjects

Partner engagement, care pathways, non-pharmacological, pain navigator, pragmatic clinical trial

Citation

Published Version (Please cite this version)

10.1177/17407745231178789

Publication Info

Ballengee, Lindsay A, Heather A King, Corey Simon, Trevor A Lentz, Kelli D Allen, Catherine Stanwyck, Micaela Gladney, Steven Z George, et al. (2023). Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clinical trials (London, England). p. 17407745231178789. 10.1177/17407745231178789 Retrieved from https://hdl.handle.net/10161/28284.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Ballengee

Lindsay Ballengee

Research Scholar

Dr. Lindsay Ballengee is a two-time graduate of Duke University, earning her Doctor of Physical Therapy in 2011 and a PhD in Population Health Sciences in 2024. Her research focuses on developing and evaluating strategies to promote evidence-based care, particularly for conditions like low back pain where both overuse and underuse are common. She is especially interested in improving care delivery within complex health systems.

Dr. Ballengee uses mixed methods and emphasizes community engagement to support health system change. She values cross-disciplinary and cross-sector collaboration and is always eager to connect with others who are committed to making healthcare more effective, equitable, and patient-centered.

King

Heather Alyse King

Assistant Professor in Population Health Sciences

Areas of expertise: Implementation Science, Health Services Research, and Health Measurement

Simon

Corey B. Simon

Associate Professor in Orthopaedic Surgery
Lentz

Trevor A. Lentz

Assistant Professor in Orthopaedic Surgery
Allen

Kelli Dominick Allen

Adjunct Professor in the Department of Medicine
  • Improving care and outcomes for individuals with osteoarthritis and other musculoskeletal conditions with an emphasis on non-pharmacological therapies including physical activity, weight management, rehabilitation services, and pain coping
    * Understanding rand reducing disparities in musculoskeletal conditions
    * Musculoskeletal conditions in U.S. military Veterans
    * Pragmatic clinical trials
    * Adaptive interventions
George

Steven Zachary George

Laszlo Ormandy Distinguished Professor of Orthopaedic Surgery

Dr. George’s primary interest is research involving biopsychosocial models for the prevention and treatment of chronic musculoskeletal pain disorders.  His long term goals are to 1) improve accuracy for predicting who is going to develop chronic pain; and 2) identify non-pharmacological treatment options that limit the development of chronic pain conditions.  Dr. George is an active member of the American Physical Therapy Association, United States Association of the Study of Pain, and International Association for the Study of Pain. 

Dr. George’s research projects have been supported by the National Institutes of Health, Department of Defense, and Orthopaedic Academy of the American Physical Therapy Association.  Dr. George and his collaborators have authored over 330 peer-reviewed publications in leading medical, orthopaedic surgery, physical therapy, rehabilitation, and pain research journals.  He currently serves as Editor-in-Chief for the Physical Therapy & Rehabilitation Journal. Dr. George has also been involved with clinical practice guideline development for the Academy of Orthopaedic Physical Therapy and the American Psychological Association. 

Dr. George has been recognized with prestigious research awards from the American Physical Therapy Association, American Pain Society, and International Association for the Study of Pain. For example from the American Physical Therapy Association: he was named the  21st John H.P. Maley Lecturer, recognized as a Catherine Worthingham Fellow in 2017, and selected for the Marian Williams Award for Research in Physical Therapy in 2022.    

Hastings

Susan Nicole Hastings

Professor of Medicine

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