Article Title

Stakeholder Engagement in a Patient‐Activation Behavioral Intervention for Prescription Opioid Patients (ACTIVATE)

Publication Date



primary care, pragmatic trials, engagement of stakeholders, substance abuse and addiction, qualitative research


Background: The complexity of the prescription opioid epidemic has highlighted the need to address opioid use and pain management using a multifaceted patient-centered approach. This Patient-Centered Outcomes Research Institute (PCORI)-funded study uses multiple strategies to leverage the experience and expertise of patient and clinical stakeholders.

Methods: This pragmatic randomized trial of a behavioral intervention was conducted in two busy primary care clinics in an integrated health care system. Adult patients using prescription opioids for at least 3 months were identified using electronic health records. After consent, patients were randomized into either the intervention arm or the usual care arm. The intervention consisted of four group sessions, led by a clinical psychologist, focusing on patient activation skills, pain management, opioid education and communication strategies with providers. Baseline and follow-up telephone interviews at 6 and 12 months measure patient-centered outcomes, including quality of life, pain severity, functional status, opioid use, patient satisfaction and self-management strategies. We engaged stakeholders in study design, curriculum development, data collection, data interpretation and dissemination. Our stakeholder panel consists of 5 patients with pain (3 from Kaiser Permanente and 2 from a federally qualified health center), clinicians from primary care, emergency medicine, psychiatry, pain management and pharmacy, a patient advocate and an external researcher. A small number of qualitative interviews will be conducted with providers in primary care about their experience prescribing opioids.

Results: More than 2,400 potentially eligible patients were screened, and 377 patients were enrolled over 13 months. Six- and 12-month follow-up interviews are currently being conducted. Qualitative findings suggest difficulties in recruiting this complex patient population, which face considerable barriers to participation. Patients report distress over a more conservative prescribing environment, difficulties obtaining opioids, living with chronic pain and challenges communicating with providers. Qualitative findings and baseline data will be presented. Methodological considerations for conducting patient-centered research in primary care will be addressed, and the benefits of engaging stakeholders in pragmatic trials will be discussed.

Conclusion: By collaborating with a wide range of stakeholders, we hope to measure the effectiveness of a behavioral intervention on patient-centered outcomes and extend the impact of the findings beyond the health care system.




June 30th, 2017


August 10th, 2017