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

July 19, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Treatment as usual
Experimental: ISOP Intervention
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current Opioid Misuse Measure (COMM)
Time Frame: 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.
Data collected at baseline, 6 months, and 12 months.
Urine Drug Test
Time Frame: 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.
Data collected at baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Pain Grade
Time Frame: 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.
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trust in Physician Scale
Time Frame: Data collected at baseline, 6 months, and 12 months
The Trust in Physician Scale is an 11-item self-report measure. Scores range from 0 - 100, with higher scores indicating greater interpersonal trust between patients and their clinician
Data collected at baseline, 6 months, and 12 months
Participatory Decision Making Style
Time Frame: Data collected at baseline, 6 months, and 12 months
The Participatory Decision Making Style is a 4-item self-report measures. Scores range from 0 - 100, where higher scores indicate greater patient involvement in medical decision making.
Data collected at baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Benjamin J. Morasco, PhD MA, VA Portland Health Care System, Portland, OR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2016

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimated)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 14-020
  • 9024 (Other Grant/Funding Number: VA - Health Services R&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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