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. (: 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.

Automated summary

The multicomponent intervention ISOT did not reduce the risk of prescription opioid misuse, but it did increase the likelihood of discontinuing prescription opioids. More powerful interventions may be needed to impact treatment outcomes.