A Patient-Centered Intervention to Improve Opioid Safety

Not Applicable

Completed

• Conditions: Opioid Safety; Prescription Opioid Misuse; Chronic Pain

• Registration Number: NCT02791399
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Study Timeline

• Study Start: 2016-03-23
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-06
• Primary Completion: 2019-10-15
• Study Completion: 2020-10-31
• Results First Submitted: 2021-04-26
• Results First Submitted QC: 2021-07-14
• Results First Posted: 2021-08-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Enrollment in primary care at the VA Portland Health Care System
• Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease
• Able to read and write in English

Exclusion Criteria

• Age younger than 18 years old
• On opioid therapy for palliative or end-of-life care
• Current enrollment in an opioid substitution program
• Lack of access to a telephone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Current Opioid Misuse Measure (COMM)	Data collected at baseline, 6 months, and 12 months.	The Current Opioid Misuse Measure (COMM) is an assessment of self-reported risk of prescription opioid misuse. There are 17 items, each rated on a scale of 0 (never) to 4 (very often). Total scores range from 0 - 68, with higher scores indicating a greater risk of prescription opioid misuse.
Urine Drug Test	Data collected at baseline, 6 months, and 12 months	Participants will complete urine drug tests (UDTs) to evaluate for presence of substances. UDTs will evaluate for cannabis, cocaine, amphetamines, benzodiazepines, barbiturates, opioids, and opiates. Study results are dichotomous.

Secondary Outcome Measures

Name	Time	Method
Chronic Pain Grade	One year	The Chronic Pain Grade is a 7-item self-report measure that provides global scores of pain intensity and function. Scores for each subscale range from 0 - 100. Higher scores indicate more severe pain or more impairment in function. Pain intensity and function were tested in a non-inferiority analysis.

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States