Clinical trial NCT03547882: Addiction Treatment in Primary Care Expansion
Official title: APEX- Addiction Treatment in Primary Care Expansion (PII 18-181)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Opioid Use Disorder (OUD)
Chronic Pain
Keywords: Opioid
Buprenorphine
Naltrexone
methadone
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Eastern Colorado Health Care System
name: University of Colorado, Denver
name: University of Utah
First posted: 2018-06-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VA Medical Providers and VA patients receiving ORT

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.

Detailed description: Among Veterans receiving healthcare from the Veterans Health Administration (VA), there has been sharp rise in the number of veterans diagnosed with opioid use disorder (OUD). In 2013, 25,031 Veterans had OUD and in 2017, Veterans with OUD nearly tripled to 69,142.6 As the largest direct provider of addiction treatment nationally, VA has taken steps to increase access to medication treatment for OUD, which is recognized as an essential component of evidence-based care.

The treatment of OUD involves several FDA-approved, VA formulary medications including naltrexone, methadone, and buprenorphine/naloxone and buprenorphine (hereafter collectively termed buprenorphine). Strong evidence supports the treatment of OUD with medications, and they are the "gold standard" treatments for OUD. Medications for OUD have been shown to substantially decrease risk for all-cause mortality and overdose mortality in people with opioid use disorder. Unlike methadone, buprenorphine for OUD can be prescribed in office-based settings such as primary care, and buprenorphine delivered in primary care is associated with decreased opioid use, higher quality of care, and improved quality of life. Medication treatment includes dispensation of methadone and buprenorphine in licensed opioid treatment programs (OTPs) and prescriptions of buprenorphine and naltrexone in office-based settings. Because there are only 32 licensed OTPs in the VA, buprenorphine and naltrexone prescriptions are the means to improve access to medication treatment for Veterans with OUD. Uptake of medication treatment, however, has been slow and uneven in the VA. In 2017, 35% of Veterans diagnosed with OUD had received OUD medications.

In VISN19, rates of OUD and OUD treatment are low and heterogeneous across facilities and compared with the national average (35%), fewer patients with OUD are on OUD medications (21%) in VISN19. Multiple initiatives have been instituted to improve access to medication treatment for Veterans with OUD, particularly in non-specialty office-based settings. In 2007, VA introduced the Buprenorphine in the VA Initiative (BIV; Director Gordon), a national consult service, which aimed to improve care processes and patient outcomes associated with buprenorphine. In 2010, VA unrolled Academic Detailing program in which pharmacy specialists take on high-priority pharmaceutical education campaigns. An Academic Detailing campaign specifically targeting the treatment of opioid use disorder was initiated in 2017. Further improving access to evidence-based medication treatment of OUD remains a priority for VA and VISN19.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include health care providers at 2 main VA facilities and four VA community based outpatient clinics
* VA patients receiving ORT

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of patients who receive mediation assisted treatment for opioid use disorder (by facility and community based clinic)
timeFrame: 12 Months
measure: 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)
timeFrame: 12 Months
measure: Change in number of providers prescribing medication assisted treatment for opioid use disorder and patients receiving medication assisted treatment (by facility)
timeFrame: baseline through 1 year
measure: Patients receiving medication assisted treatment (by facility)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
name: Adam J. Gordon, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Joseph W Frank, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: