Clinical trial NCT02464410: Primary Care Intervention to Reduce Prescription Opioid Overdoses
Official title: Primary Care Intervention to Reduce Prescription Opioid Overdoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-08
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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. Patients with long-term opioid use, defined as treatment for at least 84 days covered within the last 90 days, who are prescribed opioid doses of 20 morphine-equivalent mg/day or greater (an indicator of overdose risk) will be screened and recruited into the study. Participants will then be randomized to either the intervention (n = 225) or an enhanced usual care (EUC) condition (n = 225). Pharmacy records and patient self-report will be assessed at baseline and 3-, 6-, and 12-month follow-ups to measure key outcomes.

The specific aims are:

Aim 1) to examine if patients randomly assigned to a brief opioid safety intervention report reduced overdose risk behaviors (e.g., higher dose, concurrent alcohol use, concurrent other drug/medication use, returning to normal dose after breaks in use) over one year of follow-up compared to patients assigned to equal attention EUC.

Aim 2) to examine if patients randomly assigned to a brief opioid safety intervention have lower total quantities of opioids prescribed (from pharmacy fill records) and aberrant opioid use (e.g., using for reasons other than pain, obtaining opioids from someone other than primary provider) over one year of follow-up compared to patients assigned to equal attention EUC.

The study has two secondary aims: 1) to examine if patients randomly assigned to the brief intervention have fewer non-fatal overdoses and other medication-related adverse events (emergency department visits, over-sedation, injuries), better functioning, and more often store and dispose of opioids safely compared to patients assigned to EUC; and 2) to examine mediators (motivation and self-efficacy) and moderators (OIF/OEF/OND status, baseline mental health) of intervention effects.

Eligibility criteria: Inclusion Criteria:

* 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
* 18 years of age or older

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overdose Risk Behaviors
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Aberrant Opioid Use
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
timeFrame: 3-, 6-, and 12-months post-baseline
Secondary outcomes:
measure: Number of Participants With Non-fatal Overdose Experiences
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Treatment Utilization
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Level of Oversedation as an Opioid Side Effect
timeFrame: 3-, 6-, and 12-months post-baseline
measure: General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
timeFrame: 3-, 6-, and 12-months post-baseline
measure: Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
timeFrame: 3-, 6-, and 12-months post-baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Amy S Bohnert, PhD MHS BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.