Chronic pain affects at least 116 million adults in the United States and exacts a tremendous cost in suffering and lost productivity. While health systems offer specialized pain services, it is in the primary care setting where most patients seek and receive care for pain. However, primary care providers often lack the specific training, not to mention the time, to deliver effective pain-management care. To address this problem, we propose a mixed-methods, cluster-randomized pragmatic clinical trial that will evaluate the integration of psychosocial services into the primary care environment in three Kaiser Permanente regions: Georgia, Hawaii, and the Northwest. Our intervention-the Pain Program for Active Coping and Training, or PPACT-includes a variety of therapeutic modalities delivered by a multidisciplinary team charged with engaging patients in their own care and helping them increasingly self-manage their condition. Through our participation in Collaboratory Work Groups, we will strengthen our work and share resources throughout the two-phase project. In the UH2 phase of the proposed study (Phase I), we will conduct an interview-driven formative evaluation to identify potential facilitators and barriers to successful implementation of our pragmatic clinical trial in the UH3 phase (Phase II);ensure the adequacy of our IT infrastructure and EMR data for full implementation in Phase II;and prepare Phase II intervention materials for use by a broad range of health professionals, such as nurse case managers and behavioral specialists. In Phase II, we will build upon the systematic planning conducted in Phase I to conduct a cluster-randomized clinical trial in 40 primary care clinics. Our primary aim is to compare usual care to the effects of our intervention on a number of measures, including patients'pain symptoms, functional ability, satisfaction with health care services, and receipt of opiate medication. We will also perform a cost and economic-impact analysis of our intervention to maximize its potential for widespread adoption. Phase II will include evaluations of the intervention's reach, effectiveness, adoption, implementation, and maintenance in the participating clinics, and will include the creation and dissemination of an implementation guide. This cross-cutting project, which addresses the multifactorial nature of chronic pain, will provide important data on an intervention that has previously been tested in multiple real-world settings. By testing the PPACT intervention in diverse Kaiser Permanente regions and including federally qualified health centers in our qualitative interviewing process, we will create a highly generalizable resource with strong potential to change the paradigm for the treatment and management of chronic pain.
Chronic pain is a widespread and costly problem in the United States, and the use of opiate drugs to treat pain has increased dramatically in recent years. This study, conducted in primary care settings, will combine a number of treatment approaches, including physical therapy and psychological interventions. Patients will be supported to take a more active role in managing their pain, and primary care providers will receive additional support and guidance in treating patients with chronic pain.
|DeBar, Lynn; Benes, Lindsay; Bonifay, Allison et al. (2018) Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials 67:91-99|
|Weinfurt, Kevin P; Hernandez, Adrian F; Coronado, Gloria D et al. (2017) Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol 17:144|
|Simon, Gregory E; Coronado, Gloria; DeBar, Lynn L et al. (2017) Data Sharing and Embedded Research. Ann Intern Med 167:668-670|
|Cook, Andrea J; Delong, Elizabeth; Murray, David M et al. (2016) Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials 13:504-12|
|Edmond, Sara N; Keefe, Francis J (2015) Validating pain communication: current state of the science. Pain 156:215-9|
|Richesson, Rachel L; Hammond, W Ed; Nahm, Meredith et al. (2013) Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory. J Am Med Inform Assoc 20:e226-31|