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Primary Care Intervention to Reduce Prescription Opioid Overdoses (POST)

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ClinicalTrials.gov Identifier: NCT02464410
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Pain Drug Overdose Opioid Use Disorders Behavioral: Motivational intervention Behavioral: Psycho-educational control Other: Long-term opioid therapy informed consent Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Primary Care Intervention to Reduce Prescription Opioid Overdoses
Actual Study Start Date : August 4, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: Motivational Intervention
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
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.

Other: Long-term opioid therapy informed consent
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.

Active Comparator: Enhanced Usual Care
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
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.

Other: Long-term opioid therapy informed consent
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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) ]
    Prescribed opioid use will be pulled from the survey and pharmacy records.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Other (non-overdose) injuries from the Revised Injury Behavior Checklist questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Non-overdose injuries (fall, motor vehicle accident, violence, or bicycle related accidents) will be assessed.

  4. Scores on an opioid storage and disposal knowledge and behaviors questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Total scores for opioid storage and disposal will be analyzed.

  5. 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

  6. General physical and mental functioning from Short Form-12 questionnaire scores [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    A modified short-form will assess general health.

  7. Pain-specific disability score from an adapted version of Roland-Morris questionnaire [ Time Frame: Change over time (3-, 6-, and 12-months post-baseline) ]
    Overall pain-specific disability score will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464410


Contacts
Contact: Amy S Bohnert, PhD MHS BA (734) 845-3638 Amy.Bohnert@va.gov
Contact: Laura C Thomas, BA MPH MSW (734) 615-4223 Laura.Thomas5@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Amy S Bohnert, PhD MHS BA    734-845-3638    Amy.Bohnert@va.gov   
Principal Investigator: Amy S Bohnert, PhD MHS BA         
Sub-Investigator: Frederic C. Blow, PhD MA         
Sub-Investigator: Maria J. Silveira, MD MA MPH         
Sub-Investigator: Mark A. Ilgen, PhD         
Sub-Investigator: Michael A Clay, MD         
Sub-Investigator: Paul N Pfeiffer, MD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Amy S Bohnert, PhD MHS BA VA Ann Arbor Healthcare System, Ann Arbor, MI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02464410     History of Changes
Other Study ID Numbers: IIR 13-322
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
Opioid analgesics
Primary care
Veterans
Motivational interviewing
Cognitive behavioral therapy
Self-efficacy
Behavioral symptoms
Injuries
Opioid Safety

Additional relevant MeSH terms:
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents