Combining a Smartphone App With Medications to Manage Heavy Drinking
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Use Disorder (AUD)
- Sponsor
- VA Office of Research and Development
- Enrollment
- 330
- Locations
- 15
- Primary Endpoint
- Semi-structured qualitative interview data from patients, providers, clinical leaders
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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 15 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 VA clinical prescribers per standard 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.
Investigators
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
Outcomes
Primary Outcomes
Semi-structured qualitative interview data from patients, providers, clinical leaders
Time Frame: 3 months post-baseline
\[Qualitative\] Patient, provider, and clinical leader perspectives regarding barriers and facilitators to adoption, implementation, and sustainability of the Stand Down mobile application in combination with medications for AUD in primary care.
Change in Percent Heavy Drinking Days
Time Frame: 6 months post-baseline
Change from baseline to 6-month follow-up in percent heavy drinking days (HDD), defined as \>4 drinks per day for women and \>5 drinks per day for men, was selected as the primary outcome as it combines both frequency and intensity of drinking and is a clinically meaningful measure of change. HDD will be generated from the Timeline Follow Back (TLFB), a retrospective, calendar-based measure that provides information on quantity/frequency of alcohol use in the past 30 days. Percent HDD will be calculated by dividing the number of HDD during a one-month period by 30 days.
Secondary Outcomes
- Change in World Health Organization (WHO) Risk Levels(12-months post-baseline)
- Change in PTSD Checklist for DSM-5 (PCL-5) Scores(12-months post-baseline)
- Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment(12-months post-baseline)
- Change in Short Inventory of Problems - Revised version (SIP-R)(12-months post-baseline)
- Number of Participants Receiving VA Emergency Department Services(12-months post-baseline)
- Change in Client Satisfaction Questionnaire (CSQ) Scores(6 months post-baseline)
- Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores(12-months post-baseline)
- Change in Veterans RAND 12 Item Health Survey Scores(12-months post-baseline)
- Change in Percent Heavy Drinking Days(12-months post-baseline)