Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05023317 |
|
Recruitment Status :
Not yet recruiting
First Posted : August 26, 2021
Last Update Posted : January 6, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol-induced Disorders Alcohol Drinking Mental Health | Behavioral: Strengths-based linkage to alcohol care Behavioral: Usual care | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Investigator, Outcomes Assessor) |
| Masking Description: | Research assistants, blinded to condition, will collect baseline and 3-month follow-up data from participants. The investigators will also be blinded to participant group assignment. |
| Primary Purpose: | Treatment |
| Official Title: | Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care |
| Estimated Study Start Date : | March 1, 2023 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Strengths-based linkage to alcohol care (SLAC)
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
SLAC is a behavioral intervention designed to link persons with substance use/misuse to care
Other Name: SLAC |
|
Active Comparator: Usual care
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
Usual care consists of brief screening and intervention and/or standard referral to alcohol care |
- Linkage to alcohol care [ Time Frame: 3-month ]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.
- Utilization of alcohol care [ Time Frame: 3-month ]The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care.
- Utilization of alcohol care options [ Time Frame: 3-month ]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).
- Alcohol consumption [ Time Frame: 3-month ]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.
- Depression [ Time Frame: 3-month ]Depression severity will be measured using the Patient Health Questionnaire-9. Scores range from 0-27. Higher scores indicate more symptoms of depression.
- Posttraumatic stress disorder [ Time Frame: 3-month ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023317
| Contact: Michael A Cucciare, PhD | (501) 257-1068 | Michael.Cucciare@va.gov | |
| Contact: Christine Timko, PhD | (650) 493-5000 ext 23336 | Christine.Timko@va.gov |
| United States, Arkansas | |
| Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | |
| North Little Rock, Arkansas, United States, 72114-1706 | |
| Contact: Richard R Owen, MD 501-257-1710 Richard.Owen2@va.gov | |
| Contact: Jacob T Painter, PhD PharmD (501) 257-1740 Jacob.Painter@va.gov | |
| Principal Investigator: Michael A Cucciare, PhD | |
| United States, California | |
| VA Palo Alto Health Care System, Palo Alto, CA | |
| Palo Alto, California, United States, 94304-1290 | |
| Contact: Christine Timko, PhD 650-493-5000 ext 23336 Christine.Timko@va.gov | |
| Principal Investigator: Christine Timko, PhD | |
| Principal Investigator: | Michael A Cucciare, PhD | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | |
| Principal Investigator: | Christine Timko, PhD | VA Palo Alto Health Care System, Palo Alto, CA |
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT05023317 |
| Other Study ID Numbers: |
IIR 20-058 |
| First Posted: | August 26, 2021 Key Record Dates |
| Last Update Posted: | January 6, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Datasets meeting VA standards for disclosure to the public will be made available post-publication. Prior to distribution, a local privacy officer will certify that all datasets do not contain PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data will be made available following publication of the study results |
| Access Criteria: | see above |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
referral and consultation psychosocial intervention |
|
Alcohol-Induced Disorders Alcohol Drinking Drinking Behavior |
Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |