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

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.