Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care

Study Overview
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Brief Summary
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This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.

Detailed Description
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Background: It is important for Veterans with hazardous drinking to link to evidence-based alcohol care given high rates of comorbid mental health symptoms (PTSD, depression). Veterans with symptoms of PTSD who engage in hazardous drinking are at high risk for developing more severe drinking problems and depression. And Veterans with PTSD or depression are three to four times more likely to report hazardous drinking than Veterans without either of these disorders. This project will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC) to link Veterans, identified as hazardous drinkers in VHA primary care (PC), to alcohol care. Significance/Impact: Existing VHA options, referral by a PC provider or mental health provider co-located in PC, for linking Veterans with hazardous drinking in PC to alcohol care are largely ineffective. Therefore, this proposal directly addresses HSR&D priorities in the areas of Access to Care, Mental Health, and Primary Care by testing a novel approach to linking Veterans engaging in hazardous drinking, in the PC setting, to VA and non-VA alcohol care, to improve their drinking and mental health outcomes. Innovation: This project is highly innovative because it offers a solution to the critical gap in VHA care in which PC patients with hazardous drinking are not receiving alcohol care. It tests a strategy to increase linkage to alcohol care that is both intensive enough to produce change, yet feasible to use in busy clinical settings with too-high demand on too-few staff members. In addition, the intervention proposed (SLAC) targets Veterans with the entire spectrum of hazardous drinking, including those with mental health symptoms. A highly innovative feature of SLAC is that it teaches PC providers how to link Veterans to evidence-based alcohol care instead of teaching providers how to treat hazardous drinking in the PC setting. Providers' lack of knowledge on how to treat hazardous alcohol use is a substantial obstacle to Veterans receiving alcohol care. Additional unique and innovative features of SLAC are that it uses patients' self-identified strengths, abilities, and skills to help them link to alcohol care. Specific Aims: (Aim 1): To adapt SLAC for use among Veterans with hazardous drinking who may also have comorbid mental health symptoms, and for delivery by telephone in the VHA PC setting. The investigators will conduct qualitative interviews with Veterans, PC staff, and the VACO partners to ensure that the content and format of SLAC are adapted so they are relevant and acceptable to these stakeholders. (Aim 2): To determine (a) the feasibility of conducting a larger scale randomized controlled trial (RCT) to test SLAC's effectiveness and (b) SLAC's acceptability among hazardous drinking Veterans in PC, and to explore (c) the efficacy of SLAC among hazardous drinking Veterans in PC. To achieve Aim 2, the investigators will conduct a multi-site pilot RCT of SLAC at two VA medical facilities (Little Rock, AR and Palo Alto, CA). To achieve Aims 2a-b, the investigators will measure the feasibility (e.g., rates of enrollment and follow-up, fidelity to the SLAC intervention) of conducting a subsequent larger RCT (to test SLAC's effectiveness) and SLAC's acceptability (SLAC completion rates, satisfaction with SLAC) among Veterans. To achieve Aim 2c, the investigators will explore the efficacy of SLAC to improve Veterans' linkage and engagement in alcohol care, and their alcohol and mental health outcomes, at 3-month follow-up. Methodology: The investigators will use (Aim 1) qualitative interviews to adapt SLAC for Veterans and for the PC setting, and (Aim 2) conduct a multi-site, pilot RCT. Implementation/Next Steps: Should the findings justify a subsequent project, the investigators plan to propose a fully powered, multi-site study, using a Hybrid design, to test SLAC's clinical effectiveness when delivered in VHA PC while observing and gathering information on the implementation potential of SLAC in this setting.

Official Title
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Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care

Conditions
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Alcohol-induced Disorders, Alcohol Drinking, Mental Health

Intervention / Treatment
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* Behavioral: Strengths-based linkage to alcohol care
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have screened positive for hazardous drinking (AUDIT-C score > 5) PTSD (PC-PTSD-5 score > 3) and/or depression (PHQ-2 score > 3) in the prior 12 months and have positive rescreens Not have received specialty SUD treatment or participated in weekly mutual-help groups in the past 90-days Not have significant cognitive impairment Have ongoing access to a mobile or landline telephone Provide at least one contact who will know the Veteran's contact information Exclusion Criteria: Not meeting any of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of two conditions-(a) strengths based linkage to alcohol care plus usual care or (b) usual care only
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strengths-based linkage to alcohol care (SLAC)<br>SLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option | Behavioral: Strengths-based linkage to alcohol care<br>* SLAC is a behavioral intervention designed to link persons with substance use/misuse to care<br>* Other names: SLAC;|
| Active Comparator: Usual care<br>Usual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy) | Behavioral: Usual care<br>* Usual care consists of brief screening and intervention and/or standard referral to alcohol care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to alcohol care | This outcome is a dichotomous variable (yes/no), with yes defined as the participant reporting at least one of the following: attended an initial meeting with an outpatient (primary care, specialty care) or residential program; attended a mutual-help group meeting; received > 30-days' supply of AUD medication; or went online to access e-health for alcohol information. | 3-month | 
| Utilization of alcohol care | The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care. | 3-month | 
| Utilization of alcohol care options | We will measure the total number of alcohol care options participants obtained over the past 90-days; scores will range from 0 (no care) to 4 (obtained all types of care: outpatient/residential, mutual-help, medication (>30-days' supply), e-health). | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol consumption | The quantity and frequency of alcohol consumed will be measured using the 90-day Time Line Follow-Back (TLFB) instrument. The TLFB is a calendar that tracks alcohol consumed each day. We will combine frequency data (days of alcohol consumed) and quantity data (number of drinks consumed each day) to derive a variable measuring harmful drinking days - or days in which alcohol consumed is above NIAAA recommended limits for men and women. | 3-month | 
| Depression | Depression severity will be measured using the Patient Health Questionnaire-9. Scores range from 0-27. Higher scores indicate more symptoms of depression. | 3-month | 
| Posttraumatic stress disorder | Posttraumatic stress disorder severity will be measured using the PTSD Checklist-5. Scores range from 0-80, with higher scores indicating more symptoms of PTSD. | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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referral and consultation, psychosocial intervention