Clinical trial NCT05473598: Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
Official title: Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol use disorder
Mobile health
Peer Support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-07-26
Enrollment: 221
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hazardous drinking is common among Veteran primary care patients and increases risk for more costly and complex medical problems over the long-term. Yet, the vast majority of these Veterans go untreated. By providing an option for care that is easily accessible, private, and self-directed, mobile applications (apps) circumvent many barriers to alcohol use treatment. However, poor patient engagement remains the Achilles' heel of these apps. Through supportive accountability, Peer Specialists can maximize the reach and engagement of these apps with patients and improve drinking outcomes. The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom Peer-Supported-Stand Down is more effective than the app alone. If successful, the proposed research has the potential to transform care and increase access to alcohol-related services for Veterans who engage in hazardous drinking but rarely seek treatment, and, in turn, mitigate the adverse health outcomes that stem from untreated hazardous drinking.

Detailed description: One in four Veterans presenting to VA primary care screen positive for hazardous drinking. However, due to barriers such as Veterans' stigma about seeking alcohol use treatment and challenges with traveling to VA, most of these Veterans do not receive any alcohol-related care. Mobile applications (apps) are an innovative means of expanding access to alcohol use treatment. The evidence for mobile apps, such as "Step Away", to improve drinking outcomes is emerging. Nevertheless, poor patient engagement remains the Achilles' heel of these apps. Peer Specialists ("Peers") can facilitate Veterans' engagement with mobile apps intended for self-management of hazardous drinking by helping to orient patients to these apps and by providing technical support and accountability. In a VA HSR\&D pilot study, the investigators created a Veteran version of the Step Away app ("Stand Down: Think Before You Drink") and conducted an open trial in which Veterans with hazardous drinking used the app while receiving Peer phone support. The intervention ("Peer-Supported \[PS\]-Stand Down") was highly acceptable to patients, and patients reported significant improvements in drinking outcomes. These data provide a strong foundation for a larger pragmatic trial to test the effectiveness of the Stand Down app and PS-Stand Down to reduce hazardous drinking among Veterans seen in primary care, relative to the current standard of care that these patients receive.

In the current study, the investigators will evaluate whether the Stand Down app reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom PS-Stand Down is more effective than the app alone. Aim 1: Test whether Stand Down (vs. Usual Care; UC) and PS-Stand Down (vs. UC and vs. app only) predicts better drinking outcomes, and test mediators of these effects. Aim 2: Test for differences in satisfaction with care across conditions, and conduct qualitative interviews with patients and PACT staff to understand potential barriers/facilitators to implementing PS-Stand Down in primary care. Aim 3: Explore baseline moderators to elucidate for whom PS-Stand Down (vs. app only) is most beneficial.

In a 3-group RCT at the Palo Alto and Syracuse VAs, 274 Veteran primary patients who screen positive for hazardous drinking, received a brief intervention following a positive screen, and are not currently in alcohol use treatment will complete a baseline interview, be randomized to either (i) UC, (ii) UC plus Stand Down, or (iii) UC plus PS-Stand Down (four phone sessions with a Peer over 8 weeks to enhance app engagement), and be re-interviewed at 8, 20, and 32 weeks. For Aim 2, the CFIR framework will guide key informant interviews with 12 patients and 12 PACT providers from each site.

Eligibility criteria: Inclusion Criteria:

Veterans will be eligible if they:

* had a positive AUDIT-C screen (score of \> 5) during a primary care visit in the past month at a clinic at either the VA Palo Alto Health Care System or the Syracuse VA Medical Center
* have documentation in their medical records of receipt of a BI following a positive screen
* did not receive any outpatient, inpatient, or residential care for alcohol use in the month after their positive AUDIT-C
* own a smartphone

Exclusion Criteria:

* Veterans who have active diagnoses of a psychotic disorder or a cognitive disorder (e.g., dementia) will be excluded
* Veterans who do not agree to be randomized will be excluded as well

Primary outcomes:
measure: Total standard drinks
timeFrame: 32 weeks post-baseline
Secondary outcomes:
measure: Drinks Per Drinking Day (DPDD)
timeFrame: 32 weeks post-baseline
measure: Heavy Drinking Days (HDD)
timeFrame: 32 weeks post-baseline
measure: Percent Days Abstinent (PDA)
timeFrame: 32 weeks post-baseline
measure: Negative Consequences from Drinking
timeFrame: 32 weeks post-baseline
measure: Readiness to Change Drinking
timeFrame: 32 weeks post-baseline
measure: Self-Efficacy to Reduce Drinking
timeFrame: 32 weeks post-baseline
measure: Drinks Per Week
timeFrame: 32 weeks post-baseline
measure: World Health Organization (WHO) drinking risk levels
timeFrame: 32 weeks post-baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Daniel M. Blonigen, PhD MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blonigen DM, Hawkins EJ, Kuhn E, Timko C, Dulin PL, Boothroyd D, Possemato K. Stand Down-Think Before You Drink: protocol for an effectiveness-implementation trial of a mobile application for unhealthy alcohol use with and without peer support. BMJ Open. 2023 Apr 13;13(4):e072892. doi: 10.1136/bmjopen-2023-072892.