Opioid Use Disorder (OUD)APEXNCT03547882
Addiction Treatment in Primary Care Expansion
An observational study of Opioid Use Disorder (OUD) and Chronic Pain, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Use Disorder (OUD), Chronic Pain
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2018to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VA Medical Providers and VA patients receiving ORT
Who may be able to join
- Inclusion criteria include health care providers at 2 main VA facilities and four VA community based outpatient clinics
- VA patients receiving ORT
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: APEX- Addiction Treatment in Primary Care Expansion (PII 18-181)
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.
Read the 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.
- Conditions
- Opioid Use Disorder (OUD), Chronic Pain
- Keywords
- Opioid, Buprenorphine, Naltrexone, methadone
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 May 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Project ended in 2022 and evolved into another grant (VA PII 19-321 (050 HX003009))
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Eastern Colorado Health Care System, University of Colorado, Denver, University of Utah
- Responsible party
- Sponsor
- Investigators
- Adam J. Gordon, MD MPH, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UTJoseph W Frank, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547882
- Sponsor's protocol ID
- PIX 18-002
- Other IDs
- PII 18-181
- Acronym
- APEX
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2018
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APEX- Addiction Treatment in Primary Care Expansion (PII 18-181)
- ClinicalTrials.gov ID
- NCT03547882
- Acronym / sponsor ID
- APEX / PIX 18-002
- Conditions
- Opioid Use Disorder (OUD), Chronic Pain
- Keywords
- Opioid, Buprenorphine, Naltrexone, methadone
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project ended in 2022 and evolved into another grant (VA PII 19-321 (050 HX003009))
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Eastern Colorado Health Care System, University of Colorado, Denver, University of Utah
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VA Medical Providers and VA patients receiving ORT
Key inclusion criteria (2 listed)
- Inclusion criteria include health care providers at 2 main VA facilities and four VA community based outpatient clinics
- VA patients receiving ORT
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who receive mediation assisted treatment for opioid use disorder (by facility and community based clinic)
Time frame: 12 Months
Electronic health record and Administrative data will be pulled to assess outcomes
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)
Time frame: 12 Months
Electronic health record and Administrative data will be pulled to assess outcomes
Change in number of providers prescribing medication assisted treatment for opioid use disorder and patients receiving medication assisted treatment (by facility)
Time frame: baseline through 1 year
Interviews to stakeholders facilitated by field note review will be conducted to examine facilitators and barriers of implementation
Patients receiving medication assisted treatment (by facility)
Time frame: 12 Months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam J. Gordon, MD MPH principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
Joseph W Frank, MD MPH principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder (OUD) and Chronic Pain, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who receive mediation assisted treatment for opioid use disorder (by facility and community based clinic) (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.