Primary Care Intervention to Reduce Prescription Opioid Overdoses

NCT02464410 | Completed Results

• 1 other identifier: IIR 13-322
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a highly common condition among VHA patients, and opioid therapy constitutes a primary mode of pain treatment. This study seeks to address this issue by conducting a randomized controlled trial of a brief conversation to improve opioid safety among Veteran patients receiving long-term opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and randomized to receive either a single session motivational intervention focused on safe opioid use or an equal attention control condition. The primary hypothesis is that the motivational intervention will improve opioid safety, decrease risk behaviors, aberrant opioid use, and total quantities of opioids prescribed relative to the control condition. Study findings will inform efforts to ensure the safety and well-being of Veteran patients with pain.

Conditions

Pain; Drug Overdose; Opioid Use Disorders

Keywords

Opioid analgesics; Primary care; Veterans; Motivational interviewing; Cognitive behavioral therapy; Self-efficacy; Behavioral symptoms; Injuries; Opioid Safety

Outcome Measures

Primary Outcomes (3)

• Overdose Risk Behaviors

  This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 9 in one assessment.

  3-, 6-, and 12-months post-baseline

• Aberrant Opioid Use

  This measure contained 8 self-reported items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)." A sum score took a range of 0 to 32, with higher numbers indicating more non-medical opioid use.

  3-, 6-, and 12-months post-baseline

• Average Number of Days Prescribed Opioid Use Based on Pharmacy Records

  Number of days prescribed opioid use was pulled from pharmacy records. For follow-up periods, times no dose were included to create averages over periods. Patients without medications during their follow-up period were included with a dose of zero.

  3-, 6-, and 12-months post-baseline

Secondary Outcomes (7)

• Number of Participants With Non-fatal Overdose Experiences

  3-, 6-, and 12-months post-baseline

• Treatment Utilization

  3-, 6-, and 12-months post-baseline

• Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire

  3-, 6-, and 12-months post-baseline

• Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire

  3-, 6-, and 12-months post-baseline

• Level of Oversedation as an Opioid Side Effect

  3-, 6-, and 12-months post-baseline

Study Arms (2)

Motivational Intervention

EXPERIMENTAL

The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT) and uses the structure of ME brief interventions. The motivational session is overlaid on the VA long-term opioid therapy informed consent process.

Behavioral: Motivational intervention; Other: Long-term opioid therapy informed consent

Enhanced Usual Care

ACTIVE COMPARATOR

In addition to covering the VHA's long-term OA informed consent process, the enhanced usual care (EUC) condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic. This EUC condition will include some information related to risks of opioid use as part of the informed consent and will consequently have sufficient face validity as an intervention on opioid safety to effectively blind participant to randomization. However, the EUC therapist will not use the motivational enhancement approach of discussing strategies for avoiding these risks. It is designed to be equal in length to the motivational intervention.

Behavioral: Psycho-educational control; Other: Long-term opioid therapy informed consent

Interventions

Motivational intervention BEHAVIORAL

The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.

Motivational Intervention

Psycho-educational control BEHAVIORAL

The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.

Enhanced Usual Care

Long-term opioid therapy informed consent OTHER

The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.

Enhanced Usual Care; Motivational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at the Ann Arbor VA Medical Center receiving treatment in a primary care clinic
• Currently prescribed 20 morphine-equivalent mg (MEM) per day or more of an opioid
• Received opioid therapy for at least 90 days
• years of age or older

You may not qualify if:

• Plans to stop opioids or reduce dose to below 20 MEM/day in the next 6 months
• Use of fentanyl, due to the difficulty in determining morphine equivalency
• A terminal cancer diagnosis
• Acute suicidality requiring immediate treatment
• Moderately severe cognitive impairment
• Inability to give informed consent

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Related Publications (1)

• Humphreys K, Shover CL, Andrews CM, Bohnert ASB, Brandeau ML, Caulkins JP, Chen JH, Cuellar MF, Hurd YL, Juurlink DN, Koh HK, Krebs EE, Lembke A, Mackey SC, Larrimore Ouellette L, Suffoletto B, Timko C. Responding to the opioid crisis in North America and beyond: recommendations of the Stanford-Lancet Commission. Lancet. 2022 Feb 5;399(10324):555-604. doi: 10.1016/S0140-6736(21)02252-2. Epub 2022 Feb 2. No abstract available.

  PMID: 35122753 RESULT

MeSH Terms

Conditions

Pain; Drug Overdose; Opioid-Related Disorders; Behavioral Symptoms; Wounds and Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Behavior

Limitations and Caveats

During the course of this project, the VA changed their opioid prescribing practices in response to the Opioid Safety Initiative. This changed the potential participants for this study (patients prescribed more than 50 MEM), so we updated our enrollment criteria to 20 MEM. We still did not meet our enrollment goal as we had reached saturation of the potential participant pool of patients in primary care at the local VA hospital. At the same time, our overall retention rate is 87.3%.

Results Point of Contact

• Title: Amy Bohnert
• Organization: Veterans Health Administration

amybohne@med.umich.edu

734-845-3638

Study Officials

• Amy S Bohnert, PhD MHS BA

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 8, 2015
• Study Start: August 4, 2016
• Primary Completion: October 1, 2020
• Study Completion: March 31, 2021
• Last Updated: July 27, 2023
• Results First Posted: September 2, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)