Addiction Treatment in Primary Care Expansion

NCT03547882 | Withdrawn

• 2 other identifiers: PIX 18-002PII 18-181
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The Veterans Health Administration (VA) is a national leader in addressing the twin epidemics of chronic pain and opioid use, misuse, and opioid use disorder (OUD); but important challenges remain. Both chronic pain and OUD are more common among Veterans compared to the general population.1 As the VA transitions toward a greater emphasis on non-opioid chronic pain treatments, improving access to OUD treatment will be critical for those Veterans with new diagnoses of OUD in the context of long-term opioid therapy. Strong evidence supports the treatment of OUD with medications, including naltrexone, buprenorphine, and methadone.2 Buprenorphine and naltrexone can be prescribed in primary care settings; OUD treatment in primary care is associated with decreased opioid use, higher quality of care, and improved quality of life.3-5 In partnership with VISN19 leadership, this project will address the priority goal of improving access to medication-assisted therapy for OUD treatment. The objective of the VISN Partnered Implementation Initiative startup phase (PHASE 1) is to implement and evaluate the evidence-based, effective practice of medication treatment of opioid use disorder in primary care settings. A subsequent PHASE 2 will study the implementation of strategies from PHASE 1 across the entire VISN19. The investigators propose two specific aims: Aim 1: Evaluate the implementation and impact of a multifaceted provider support initiative at two VA medical centers and four community-based clinics in VISN19 using the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation framework. The multifaceted initiative will leverage existing VA and VISN resources (including e-consults, telementoring and telehealth) to facilitate improved access to OUD treatment in primary care. Aim 2: Create an interactive implementation toolkit with guidance on facilitation and incentive strategies and resources for broader dissemination across the VISN and VA.

Conditions

Opioid Use Disorder (OUD); Chronic Pain

Keywords

Opioid; Buprenorphine; Naltrexone; methadone

Outcome Measures

Primary Outcomes (4)

• Number of patients who receive mediation assisted treatment for opioid use disorder (by facility and community based clinic)

  Electronic health record and Administrative data will be pulled to assess outcomes

  12 Months

• Ratio of patients receiving medication assisted treatment for opioid use disorder to the number of patients with opioid use disorder (by facility and community based clinic)

  Electronic health record and Administrative data will be pulled to assess outcomes

  12 Months

• Change in number of providers prescribing medication assisted treatment for opioid use disorder and patients receiving medication assisted treatment (by facility)

  Interviews to stakeholders facilitated by field note review will be conducted to examine facilitators and barriers of implementation

  baseline through 1 year

• Patients receiving medication assisted treatment (by facility)

  The investigators will be using the VA Academic Detailing Data Tool System which includes different measures with real time patient tracker to identify patients receiving medication assisted treatment. By using different dashboards the investigators will be pulling number of patients with buprenorphine treatment and the number of OUD patients with OUD pharmacotherapy from this dashboards.

  12 Months

Study Arms (2)

Other

Target interviewees will be primary care providers at six facilities and their staff (e.g., nurse care managers).

Patients

Ten interviews were conducted with VA patients receiving ORT.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

VA Medical Providers and VA patients receiving ORT

You may qualify if:

• VA patients receiving ORT

You may not qualify if:

• N/A

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Eastern Colorado Health Care System: collaborator
• University of Colorado, Denver: collaborator
• University of Utah: collaborator

Study Sites (2)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Biospecimen

Retention: NONE RETAINED

No Bio specimen collection

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam J. Gordon, MD MPH

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

• Joseph W Frank, MD MPH

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 6, 2018
• Study Start: May 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)