Clinical trial NCT06303778: Combining a Smartphone App With Medications to Manage Heavy Drinking
Official title: Combining a Smartphone App With Medications to Manage Heavy Drinking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: alcohol use disorder
substance use disorder
medications for AUD
smartphone app
primary care
mobile health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-03-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

Detailed description: Background: Alcohol use disorder (AUD) affects 1 in 10 Veterans and is associated with significant morbidity and mortality. However, few individuals receive evidenced-based psychosocial interventions or medications for AUD (MAUD). Common barriers to treatment include long wait times, stigma, and distance from treatment facilities. Despite clinical guidelines and evidence indicating superior outcomes, even fewer individuals receive MAUD and psychosocial interventions conjointly. The VA prioritizes expanding access to AUD interventions in primary care, but it is difficult to deliver psychosocial interventions in primary care, and care often includes MAUD only. Smartphone mobile applications (apps) that deliver psychosocial interventions concurrent with MAUD may address the gap between recommended and current practices for AUD and appeal to Veterans who prefer to receive their AUD care in primary care. Alcohol intervention apps have been associated with improved drinking-related and mental health outcomes. Self-monitoring of alcohol use, a common feature in apps, may also increase MAUD adherence. Step Away, an app for self-management of alcohol use problems, is designed to guide development and use of personalized strategies to moderate or abstain from drinking. In single-arm cohort studies, the investigators assessed the acceptability and usability of Step Away and Stand Down (SD-App), the Veteran version of the app and focus of this proposal, among Veterans with alcohol use problems. The apps received favorable ratings regarding perceived effectiveness, efficiency, and overall satisfaction, and were associated with reductions in heavy drinking days and drinking-related consequences.

Significance: This study has the potential to substantially improve Veterans' receipt of guideline-concordant AUD care and support national VA initiatives to increase access to AUD care in general healthcare clinics.

Innovation \& Impact: To the investigators' knowledge, no prior study has evaluated the effectiveness of an alcohol-related intervention, delivered by smartphone, with MAUD in primary care. Smartphone apps can be scaled up at relatively low cost, potentially saving lives and improving the quality of care of tens of thousands of Veterans.

Specific Aims: The two aims are to: 1) determine whether MAUD plus SD-App offered to primary care patients diagnosed with AUD, compared to MAUD only, results in (a) greater reductions in heavy drinking days, from baseline to 6-months (primary), (b) greater improvements in alcohol consequences, alcohol use risk levels, and mental health outcomes, from baseline to 6-months (secondary), 2) conduct a process evaluation to identify factors that influence the adoption, implementation, and sustainability of SD-App in combination with MAUD in VA primary care from Veterans', clinical pharmacist specialists' and clinical leaders' perspectives. The investigators will also explore whether MAUD plus SD-App increases MAUD 6-month adherence relative to SD-App alone.

Methodology: Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, this Hybrid 1 effectiveness-implementation trial will enroll 330 Veterans across 10 VA sites. Veterans between ages 18-80, meeting AUD criteria, and planning to initiate MAUD will be randomized to MAUD+SD-App or MAUD only. Participants randomized to MAUD+SD-App will receive access to SD-App. MAUD will be prescribed by primary care-based clinical pharmacists per standard clinical care. The primary and secondary outcomes will be assessed at baseline, 3-, 6- and 12-months using participant self-report and electronic medical record data. The investigators will complete qualitative interviews to assess Veterans', clinical pharmacists', and clinical leaders' perspectives on barriers and facilitators to adoption, implementation, and sustainability of SD-App in combination with MAUD in primary care.

Next Steps/Implementation: If MAUD+SD-App improves drinking outcomes, the investigators will work closely with the operations partners to review study findings and to develop a tailored implementation strategy to support widespread implementation across VA primary care.

Eligibility criteria: Inclusion Criteria:

To be eligible, Veterans must be:

* 1) diagnosed with an AUD and report 4 HDD

  * (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days
* 2) enrolled in VA primary care
* 3) planning to initiate MAUD, as determined by a medication order
* 4) between ages 18-80
* 5) willing to be randomized
* 6) Android or iPhone smartphone owners

Exclusion Criteria:

* 1) past 30-day participation in VA or non-VA SUD treatment
* 2) prior episode of MAUD receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed)
* 3) plans to be or are pregnant
* 4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged \>80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter SUD specialty care following randomization will be allowed to continue in the study

Primary outcomes:
measure: Change in Percent Heavy Drinking Days
timeFrame: 6 months post-baseline
measure: Semi-structured qualitative interview data from patients, providers, clinical leaders
timeFrame: 3 months post-baseline
Secondary outcomes:
measure: Change in Short Inventory of Problems - Revised version (SIP-R)
timeFrame: 6 months post-baseline
measure: Change in World Health Organization (WHO) Risk Levels
timeFrame: 6 months post-baseline
measure: Change in Client Satisfaction Questionnaire (CSQ) Scores
timeFrame: 6 months post-baseline
measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
timeFrame: 6 months post-baseline
measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores
timeFrame: 6 months post-baseline
measure: Change in Veterans RAND 12 Item Health Survey Scores
timeFrame: 6 months post-baseline
measure: Change in Percent Heavy Drinking Days
timeFrame: 12-months post-baseline
measure: Change in Short Inventory of Problems - Revised version (SIP-R)
timeFrame: 12-months post-baseline
measure: Change in World Health Organization (WHO) Risk Levels
timeFrame: 12-months post-baseline
measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores
timeFrame: 12-months post-baseline
measure: Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment
timeFrame: 12-months post-baseline
measure: Number of Participants Receiving VA Emergency Department Services
timeFrame: 12-months post-baseline
measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores
timeFrame: 12-months post-baseline
measure: Change in Veterans RAND 12 Item Health Survey Scores
timeFrame: 12-months post-baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System, Phoenix, AZ
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System , Little Rock, AR
state: Arkansas
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: Dublin
country: United States
facility: Carl Vinson VA Medical Center, Dublin, GA
state: Georgia
city: Battle Creek
country: United States
facility: Battle Creek VA Medical Center, Battle Creek, MI
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City VA Medical Center, Kansas City, MO
state: Missouri
city: Omaha
country: United States
facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
state: Nebraska
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Eric J. Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: