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

Primary Purpose

Alcohol-induced Disorders, Alcohol Drinking, Mental Health

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Strengths-based linkage to alcohol care
Usual care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-induced Disorders focused on measuring referral and consultation, psychosocial intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, ARRecruiting
  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strengths-based linkage to alcohol care (SLAC)

Usual care

Arm Description

SLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option

Usual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy)

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

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.
Depression
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
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.

Full Information

First Posted
August 17, 2021
Last Updated
April 6, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05023317
Brief Title
Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
Official Title
Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-induced Disorders, Alcohol Drinking, Mental Health
Keywords
referral and consultation, psychosocial intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strengths-based linkage to alcohol care (SLAC)
Arm Type
Experimental
Arm Description
SLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy)
Intervention Type
Behavioral
Intervention Name(s)
Strengths-based linkage to alcohol care
Other Intervention Name(s)
SLAC
Intervention Description
SLAC is a behavioral intervention designed to link persons with substance use/misuse to care
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care consists of brief screening and intervention and/or standard referral to alcohol care
Primary Outcome Measure Information:
Title
Linkage to alcohol care
Description
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.
Time Frame
3-month
Title
Utilization of alcohol care
Description
The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care.
Time Frame
3-month
Title
Utilization of alcohol care options
Description
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).
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Alcohol consumption
Description
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.
Time Frame
3-month
Title
Depression
Description
Depression severity will be measured using the Patient Health Questionnaire-9. Scores range from 0-27. Higher scores indicate more symptoms of depression.
Time Frame
3-month
Title
Posttraumatic stress disorder
Description
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.
Time Frame
3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Cucciare, PhD
Phone
(501) 257-1068
Email
Michael.Cucciare@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Timko, PhD
Phone
(650) 493-5000
Ext
23336
Email
Christine.Timko@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Cucciare, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Timko, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard R Owen, MD
Phone
501-257-1710
Email
Richard.Owen2@va.gov
First Name & Middle Initial & Last Name & Degree
Jacob T Painter, PhD PharmD
Phone
(501) 257-1740
Email
Jacob.Painter@va.gov
First Name & Middle Initial & Last Name & Degree
Michael A Cucciare, PhD
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Timko, PhD
Phone
650-493-5000
Ext
23336
Email
Christine.Timko@va.gov
First Name & Middle Initial & Last Name & Degree
Christine Timko, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be made available following publication of the study results
IPD Sharing Access Criteria
see above

Learn more about this trial

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

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