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Completed

NCT Number: NCT02791399

A Patient-Centered Intervention to Improve Opioid Safety

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.

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Key information

Conditions

Opioid Safety Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Prescription Opioid Misuse Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISOP Intervention with the Nurse Care Manager

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: ISOP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 6, 2016
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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