A Patient-Centered Intervention to Improve Opioid Safety (ISOP)

VA Office of Research and Development

Status: Completed

Conditions: Prescription Opioid Misuse; Opioid Safety; Chronic Pain

Treatments: Behavioral: ISOP Intervention with the Nurse Care Manager

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02791399

IIR 14-020

9024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

Control

No Intervention group

Description:

Treatment as usual

ISOP Intervention

Experimental group

Description:

Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring.

Treatment:

Behavioral: ISOP Intervention with the Nurse Care Manager