NCT02791399

A Patient-Centered Intervention to Improve Opioid Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.

Detailed description

The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to PCPs for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. The investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.

Conditions

• Opioid Safety
• Prescription Opioid Misuse
• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	ISOP Intervention with the Nurse Care Manager	A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.

Timeline

• Start date: 2016-03-23
• Primary completion: 2019-10-15
• Completion: 2020-10-31
• First posted: 2016-06-06
• Last updated: 2023-07-27
• Results posted: 2021-08-06

Locations

1 site across 1 country: United States