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

Morasco BJ, Adams MH, Hooker ER, Maloy PE, Krebs EE, Lovejoy TI, Saha S, Dobscha SK. A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT). Journal of general internal medicine. 2022 Nov 1; 37(15):3805-3813.

Related HSR&D Project(s)

• IIR 14-020 – A Patient-Centered Intervention to Improve Opioid Safety

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Abstract:

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.