Clinical Trial: Primary Care Intervention to Reduce Prescription Opioid Overdoses

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Primary Care Intervention to Reduce Prescription Opioid Overdoses

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.


Detailed Summary:

Adverse outcomes, including overdose, related to opioid use have increased and represent a significant threat to the safety and quality of VHA pain care as well as a national public health concern. Efforts are underway to change opioid prescribing behavior, but concurrent strategies are needed to address patient behaviors that decrease opioid safety and thus increase opioid overdose risk. Overdoses result from a range of behaviors, including taking more than prescribed, using multiple substances with synergistic effects, and injecting/snorting crushed pills to get high. Factors such as having a mental health condition have been found to increase risk of overdose among Veterans receiving opioids for pain. Given the range of risk behaviors and relevant patient factors, tailored opioid risk reduction strategies are urgently needed. Motivational enhancement (ME) is an evidence-based strategy that uses tailoring to enact behavior change through improving self-efficacy and motivation. Recent VHA initiatives to increase behavioral health providers in primary care, such as Primary Care-Mental Health Integration (PC-MHI), provide a clear opportunity to deliver ME interventions to the many patients treated for long-term pain in primary care. Although the impact of ME on overdose risk behavior is unknown, the use of an ME approach to improve opioid safety and reduce risk behaviors is potentially well-suited to the context of long-term opioid pain care, when total and immediate discontinuation of opioid use is often unfeasible.

The proposed Prescription Opioid Safety Trial (POST) study will be a randomized controlled trial of a brief, tailored ME conversation that incorporates cognitive behavioral strategies to increase pain coping and is aimed at improving patients' opioid safety. The study will recruit 450 patients from primary care clinics at the VA Ann Arbor Healthcare System. Pa
Sponsor: VA Office of Research and Development

Current Primary Outcome:

  • Overdose risk behaviors [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Self-reported frequency of specific behaviors from an Overdose Risk Behavior scale
  • Aberrant opioid use [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Self-reported frequency of aberrant opioid use from the Current Opioid Misuse Measure
  • Prescribed opioid use (total days supply and daily dose) based on pharmacy records and questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with non-fatal overdose experiences [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Self-reported in an Overdose Experiences questionnaire
  • Treatment utilization [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Number of visits to the emergency department, mental health and specialty addictions clinics, and specialty pain clinics calculated from responses in the Treatment Services Review questionnaire
  • Other (non-overdose) injuries from the Revised Injury Behavior Checklist questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
  • Scores on an opioid storage and disposal knowledge and behaviors questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
  • Level of oversedation as an opioid side effect [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    From an item in the Numerical Opioid Side Effect scale
  • General physical and mental functioning from Short Form-12 questionnaire scores [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
  • Pain-specific disability score from an adapted version of Roland-Morris questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]


Original Secondary Outcome: Same as current

Information By: VA Office of Research and Development

Dates:
Date Received: May 21, 2015
Date Started: August 4, 2016
Date Completion: May 2019
Last Updated: March 9, 2017
Last Verified: March 2017