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.