nctId: NCT06303778 id: IIR 22-141 id: HX003742-01A1 type: OTHER_GRANT domain: VA HSR&D briefTitle: Combining a Smartphone App With Medications to Manage Heavy Drinking overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-06-01 date: 2028-06-01 date: 2024-03-12 date: 2024-03-12 name: VA Office of Research and Development class: FED briefSummary: 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. conditions: Alcohol Use Disorder (AUD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 330 type: ESTIMATED name: Stand Down mobile app name: Standard Care measure: Change in Percent Heavy Drinking Days measure: Semi-structured qualitative interview data from patients, providers, clinical leaders measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Client Satisfaction Questionnaire (CSQ) Scores measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores measure: Change in Percent Heavy Drinking Days measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment measure: Number of Participants Receiving VA Emergency Department Services measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL city: Montgomery state: Alabama zip: 36109 country: United States name: Sebastian Skordallos, PharmD role: CONTACT email: Sebastian.Skordallos@va.gov lat: 32.36681 lon: -86.29997 facility: Phoenix VA Health Care System, Phoenix, AZ city: Phoenix state: Arizona zip: 85012 country: United States name: Courtney Speaks, PharmD role: CONTACT email: Courtney.Speaks@va.gov lat: 33.44838 lon: -112.07404 facility: VA Northern California Health Care System, Mather, CA city: Sacramento state: California zip: 95655-4200 country: United States name: Christine Johnston, PharmD role: CONTACT email: Christine.Johnston2@va.gov lat: 38.58157 lon: -121.4944 facility: Carl Vinson VA Medical Center, Dublin, GA city: Dublin state: Georgia zip: 31021 country: United States name: Deborah Hobbs, PharmD role: CONTACT email: Deborah.Hobbs@va.gov lat: 32.54044 lon: -82.90375 facility: Battle Creek VA Medical Center, Battle Creek, MI city: Battle Creek state: Michigan zip: 49037 country: United States name: Elizabeth Ratti, PharmD role: CONTACT email: Elizabeth.Ratti@va.gov lat: 42.3173 lon: -85.17816 facility: Minneapolis VA Health Care System, Minneapolis, MN city: Minneapolis state: Minnesota zip: 55417-2309 country: United States name: Elizabeth Welch, PharmD role: CONTACT phone: 612-618-8725 email: Elizabeth.Welch@va.gov lat: 44.97997 lon: -93.26384 facility: Kansas City VA Medical Center, Kansas City, MO city: Kansas City state: Missouri zip: 64128-2226 country: United States name: Kyleigh Gould, PharmD role: CONTACT email: Kyleigh.Gould@va.gov lat: 39.09973 lon: -94.57857 facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN city: Nashville state: Tennessee zip: 37212-2637 country: United States name: Matthew Phillips, PharmD role: CONTACT email: Matthew.Phillips1@va.gov lat: 36.16589 lon: -86.78444 facility: South Texas Health Care System, San Antonio, TX city: San Antonio state: Texas zip: 78229-4404 country: United States name: Cynthia Mascarenas, PharmD role: CONTACT email: Cynthia.Mascarenas@va.gov lat: 29.42412 lon: -98.49363 facility: VA Salt Lake City Health Care System, Salt Lake City, UT city: Salt Lake City state: Utah zip: 84148-0001 country: United States name: Chad Nelson, PharmD role: CONTACT email: Chad.Nelson@va.gov lat: 40.76078 lon: -111.89105 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Thomas S Bundt, FACHE role: CONTACT phone: 253-583-3500 email: thomas.bundt@va.gov name: Susan Perez, BA role: CONTACT phone: (202) 461-6910 email: susan.perez@va.gov name: Eric J. Hawkins, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False