A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT)

Background: Interventions to reduce harms related to prescription opioids are needed in primary care settings. Objective: To determine whether a multicomponent intervention, Improving the safety of opioid therapy (ISOT), is efficacious in reducing prescription opioid harms. Design: Clinician-level, cluster randomized clinical trial. (ClinicalTrials.gov: NCT02791399) Setting: Eight primary care clinics at 1 Veterans Affairs health care system. Participants: Thirty-five primary care clinicians and 286 patients who were prescribed long-term opioid therapy (LTOT). Intervention: All clinicians participated in a 2-hour educational session on patient-centered care surrounding opioid adherence monitoring and were randomly assigned to education only or ISOT. ISOT is a multicomponent intervention that included a one-time consultation by an external clinician to the patient with monitoring and feedback to clinicians over 12 months. Main Measures: The primary outcomes were changes in risk for prescription opioid misuse (Current Opioid Misuse Measure) and urine drug test results. Secondary outcomes were quality of the clinician-patient relationship, other prescription opioid safety outcomes, changes in clinicians’ opioid prescribing characteristics, and a non-inferiority analysis of changes in pain intensity and functioning. Key Results: ISOT did not decrease risk for prescription opioid misuse (difference between groups = −1.12, p = 0.097), likelihood of an aberrant urine drug test result (difference between groups = −0.04, p=0.401), or measures of the clinician-patient relationship. Participants allocated to ISOT were more likely to discontinue prescription opioids (20.0% versus 8.1%, p = 0.007). ISOT did not worsen participant-reported scores of pain intensity or function. Conclusions: ISOT did not impact risk for prescription opioid misuse but did lead to increased likelihood of prescription opioid discontinuation. More intensive interventions may be needed to impact treatment outcomes.