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Primary Care Intervention to Reduce Prescription Opioid Overdoses (POST)

Primary Purpose

Pain, Drug Overdose, Opioid Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational intervention
Psycho-educational control
Long-term opioid therapy informed consent
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Opioid analgesics, Primary care, Veterans, Motivational interviewing, Cognitive behavioral therapy, Self-efficacy, Behavioral symptoms, Injuries, Opioid Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Intervention

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Number of Participants With Non-fatal Overdose Experiences
This scale is the number of overdose experiences as self-reported in the Overdose Experiences questionnaire. This item is a number of participants whom endorsed having experienced an overdose at that time period.
Treatment Utilization
Number of visits to the emergency department, for medical, mental health or substance use visits, across VA and non-VA hospitals from the Treatment Service Utilization Questionnaire. The numbers reported are the mean number of visits among those participants that had any emergency department visits at each time point.
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
This scale is the number of non-overdose injuries assessed through the Revised Injury Behavior Checklist questionnaire, focusing on 4 topics (Injury 1. by violence or by being physically attacked; 2. By falling; 3. By a motor vehicle or by being hit by a moving vehicle while walking; 4. While riding a bicycle, skateboard, or rollerblading). This item is a count of participants who responded that they were injured during any of these types of activities and received treatment.
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
This scale assesses safe storage and disposal of prescription opioid medications with 6 items. 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 24, with higher numbers indicating less safe practices. The sum of the score of the 6 items was used to find the mean scores for those in each arm.
Level of Oversedation as an Opioid Side Effect
The level of oversedation as an opioid side effect was assessed using two items from the Pain Treatment Satisfaction Scale looking at side effects of opioid medications (excessive fatigue and drowsiness). Items were assessed on a scale of 0 (did not experience) to 5 (extremely bothered). A sum score ranged from 0 to 10 with a higher score indicating the potential for more oversedation.
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
A modified Veterans RAND 12-item health survey was used to assess general health. One item was scored from 1 (Excellent) to 5 (Poor). Score means were compared at baseline and each follow-up.
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
This scale is a sub-section of the Brief Pain Inventory that assesses the impact of pain on functioning across 7 different activities. Activities are assessed on a Likert scale from "Does not interfere (0)" to "Completely interferes (10)". BPI pain interference was scored as the mean of the seven interference items, scores range from 0 to 10, with a mean score of 10 (maximum score) indicating a complete interference in all activities.

Full Information

First Posted
May 21, 2015
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02464410
Brief Title
Primary Care Intervention to Reduce Prescription Opioid Overdoses
Acronym
POST
Official Title
Primary Care Intervention to Reduce Prescription Opioid Overdoses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2016 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Drug Overdose, Opioid Use Disorders
Keywords
Opioid analgesics, Primary care, Veterans, Motivational interviewing, Cognitive behavioral therapy, Self-efficacy, Behavioral symptoms, Injuries, Opioid Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educational control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Long-term opioid therapy informed consent
Intervention Description
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 Measure Information:
Title
Overdose Risk Behaviors
Description
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.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Aberrant Opioid Use
Description
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.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Average Number of Days Prescribed Opioid Use Based on Pharmacy Records
Description
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.
Time Frame
3-, 6-, and 12-months post-baseline
Secondary Outcome Measure Information:
Title
Number of Participants With Non-fatal Overdose Experiences
Description
This scale is the number of overdose experiences as self-reported in the Overdose Experiences questionnaire. This item is a number of participants whom endorsed having experienced an overdose at that time period.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Treatment Utilization
Description
Number of visits to the emergency department, for medical, mental health or substance use visits, across VA and non-VA hospitals from the Treatment Service Utilization Questionnaire. The numbers reported are the mean number of visits among those participants that had any emergency department visits at each time point.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire
Description
This scale is the number of non-overdose injuries assessed through the Revised Injury Behavior Checklist questionnaire, focusing on 4 topics (Injury 1. by violence or by being physically attacked; 2. By falling; 3. By a motor vehicle or by being hit by a moving vehicle while walking; 4. While riding a bicycle, skateboard, or rollerblading). This item is a count of participants who responded that they were injured during any of these types of activities and received treatment.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire
Description
This scale assesses safe storage and disposal of prescription opioid medications with 6 items. 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 24, with higher numbers indicating less safe practices. The sum of the score of the 6 items was used to find the mean scores for those in each arm.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Level of Oversedation as an Opioid Side Effect
Description
The level of oversedation as an opioid side effect was assessed using two items from the Pain Treatment Satisfaction Scale looking at side effects of opioid medications (excessive fatigue and drowsiness). Items were assessed on a scale of 0 (did not experience) to 5 (extremely bothered). A sum score ranged from 0 to 10 with a higher score indicating the potential for more oversedation.
Time Frame
3-, 6-, and 12-months post-baseline
Title
General Physical and Mental Functioning From Short Form-12 Questionnaire Scores
Description
A modified Veterans RAND 12-item health survey was used to assess general health. One item was scored from 1 (Excellent) to 5 (Poor). Score means were compared at baseline and each follow-up.
Time Frame
3-, 6-, and 12-months post-baseline
Title
Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire
Description
This scale is a sub-section of the Brief Pain Inventory that assesses the impact of pain on functioning across 7 different activities. Activities are assessed on a Likert scale from "Does not interfere (0)" to "Completely interferes (10)". BPI pain interference was scored as the mean of the seven interference items, scores range from 0 to 10, with a mean score of 10 (maximum score) indicating a complete interference in all activities.
Time Frame
3-, 6-, and 12-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Bohnert, PhD MHS BA
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35122753
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.
Results Reference
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Primary Care Intervention to Reduce Prescription Opioid Overdoses

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