Combining a Smartphone App With Medications to Manage Heavy Drinking

Alcohol Use Disorder (AUD) Clinical Trial

Official title:

Combining a Smartphone App With Medications to Manage Heavy Drinking

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06303778
• Other study ID #: IIR 22-141
• Secondary ID: HX003742-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Eric J Hawkins, PhD
• Phone: (206) 764-2743
• Email: eric.hawkins[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism

Intervention

Other:
• Stand Down mobile app
The Stand Down mobile app is a smartphone-based stand-alone intervention designed to help persons manage drinking and alcohol-related problems on their own. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support.
• Standard Care
Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.

Locations

Country	Name	City	State
United States	Battle Creek VA Medical Center, Battle Creek, MI	Battle Creek	Michigan
United States	Carl Vinson VA Medical Center, Dublin, GA	Dublin	Georgia
United States	Kansas City VA Medical Center, Kansas City, MO	Kansas City	Missouri
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	Central Alabama Veterans Health Care System West Campus, Montgomery, AL	Montgomery	Alabama
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee
United States	Phoenix VA Health Care System, Phoenix, AZ	Phoenix	Arizona
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent Heavy Drinking Days	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.	6 months post-baseline
Primary	Semi-structured qualitative interview data from patients, providers, clinical leaders	[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.	3 months post-baseline
Secondary	Change in Short Inventory of Problems - Revised version (SIP-R)	Change from baseline to 6-month follow-up in the Short Inventory of Problems - Revised version (SIP-R), a 17-item questionnaire used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 1= Once or a Few Times, 2 = Once or Twice a Week, 3 = Daily or Almost Daily), which yields a total score. Higher scores reflect greater severity of alcohol-related problems.	6 months post-baseline
Secondary	Change in World Health Organization (WHO) Risk Levels	Change from baseline to 6-month follow-up in WHO risk levels, which are defined by average grams of alcohol consumed per day as calculated for each participant 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. Participants are categorized into five levels: abstinent (0 g of alcohol/day), low risk (1-40 g/1-20 g of alcohol/day), medium risk (41-60 g/21-40 g of alcohol/day), high risk (61-100 g/41-60 g of alcohol/day), and very high risk (>101 g/>61 g of alcohol/day), with 14g of alcohol being equivalent to 1 standard drink. Reductions in WHO risk levels have been associated with significant improvements in liver function, AUD severity, and functioning among persons with AUD. WHO risk levels are reported as the percentage of participants in each study group representing each risk level.	6 months post-baseline
Secondary	Change in Client Satisfaction Questionnaire (CSQ) Scores	Change from baseline to 6-month follow-up in the Client Satisfaction Questionnaire (CSQ), an 8-item questionnaire used to assess patient satisfaction with substance use treatment. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.	6 months post-baseline
Secondary	Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores	Change from baseline to 6-month follow-up in the PHQ-9, a 9-item instrument used to screen, diagnose, and monitor the severity of depression. Each item is rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.	6 months post-baseline
Secondary	Change in PTSD Checklist for DSM-5 (PCL-5) Scores	Change from baseline to 6-month follow-up in the PTSD Checklist for DSM-5 (PCL-5), a 20-item instrument used to measure presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely). The total score can range from 0 to 80, with higher scores indicating greater severity of PTSD.	6 months post-baseline
Secondary	Change in Veterans RAND 12 Item Health Survey Scores	Change from baseline to 6-month follow-up in the Veterans RAND 12 Item Health Survey, a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	6 months post-baseline
Secondary	Change in Percent Heavy Drinking Days	Change from baseline to 12-month follow-up in in percent 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.	12-months post-baseline
Secondary	Change in Short Inventory of Problems - Revised version (SIP-R)	Change from baseline to 12-month follow-up in the Short Inventory of Problems - Revised version (SIP-R), a 17-item questionnaire used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 1= Once or a Few Times, 2 = Once or Twice a Week, 3 = Daily or Almost Daily), which yields a total score. Higher scores reflect greater severity of alcohol-related problems.	12-months post-baseline
Secondary	Change in World Health Organization (WHO) Risk Levels	Change from baseline to 12-month follow-up in WHO risk levels, which are defined by average grams of alcohol consumed per day as calculated for each participant 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. Participants are categorized into five levels: abstinent (0 g of alcohol/day), low risk (1-40 g/1-20 g of alcohol/day), medium risk (41-60 g/21-40 g of alcohol/day), high risk (61-100 g/41-60 g of alcohol/day), and very high risk (>101 g/>61 g of alcohol/day), with 14g of alcohol being equivalent to 1 standard drink. Reductions in WHO risk levels have been associated with significant improvements in liver function, AUD severity, and functioning among persons with AUD. WHO risk levels are reported as the percentage of participants in each study group representing each risk level.	12-months post-baseline
Secondary	Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores	Change from baseline to 12-month follow-up in the PHQ-9, a 9-item instrument used to screen, diagnose, and monitor the severity of depression. Each item is rated on a 4-point scale (0=Not at all; 1=Several days; 2=More than half the days; and 3=Nearly every day). The total score can range from 0 to 27, with higher scores indicating greater severity of depression.	12-months post-baseline
Secondary	Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment	The total number of participants who received VA outpatient substance use disorder treatment as assessed from visits documented in the VA electronic health record data.	12-months post-baseline
Secondary	Number of Participants Receiving VA Emergency Department Services	The total number of participants who received VA emergency department services as assessed from visits documented in the VA electronic health record data.	12-months post-baseline
Secondary	Change in PTSD Checklist for DSM-5 (PCL-5) Scores	Change from baseline to 12-month follow-up in the PTSD Checklist for DSM-5 (PCL-5), a 20-item instrument used to measure presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely). The total score can range from 0 to 80, with higher scores indicating greater severity of PTSD.	12-months post-baseline
Secondary	Change in Veterans RAND 12 Item Health Survey Scores	Change from baseline to 12-month follow-up in the Veterans RAND 12 Item Health Survey, a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	12-months post-baseline