CRP and S&A for Inpatient Veterans

Substance-related Disorders Clinical Trial

— CRP and S&A  

Official title:

Impact of Combined Recovery Program and Home Telehealth Among Veterans With Substance Use Disorders in the VA Inpatient Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054738
• Other study ID #: IIR 19-395
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Elizabeth J Santa Ana, PhD MA BA
• Phone: (843) 789-7168
• Email: Elizabeth.SantaAna2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how well three types of treatments work to improve the outcomes for people with substance use problems. Veterans admitted to the Charleston VA Psychiatric inpatient unit may be invited to participate. The three types of treatments that will be evaluated are:

1. Combined Recovery Program (CRP), a six-session treatment group delivered on the inpatient unit.

2. A Home Telehealth program, called Stable and Able (S&A), provided just prior to discharge and provides additional support for up to 3 months

3. Treatment-as-usual (TAU), which is the treatment currently provided on the unit, consisting of various mental health topics and sessions designed to help with recovery.

Participation begins on the inpatient unit, beginning with CRP and/or TAU, and may continue with S&A post discharge. Participants will be followed up at 1 and 3- months post treatment.

Description:

Background:

High inpatient readmissions among Veterans with substance use disorders (SUD) constitutes a costly and persistent healthcare problem. Studies demonstrate that patients with SUDs return to inpatient treatment multiple times and that high inpatient service utilization in this population is associated with high rates of co-occurring mental illness (SUD/MI), homelessness, suicidality, and continued impairment in health and social functioning. A significant proportion (21%) of Veterans with SUD/MI are homeless, at high-risk for suicide, and represent one of the largest, most chronic groups of psychiatric patients treated in the VA Healthcare System. In effort to ameliorate inpatient readmission rates, VHA Handbook 1160.06, drafted in 2013, espouses the development and implementation of uniform recovery-oriented mental health (MH) services, which include treatment of SUDs addressing goals of recovery, improved quality of life, and community integration. The three types of treatments that will be evaluated are:

1. Combined Recovery Program (CRP), a six-session treatment group designed to explore goals, values, and personal strengths about making a change for overall quality of life, health and well-being combined with skill building designed for helping to live a more stable life in their own home that will include money management for financial success and home maintenance.

2. A Home Telehealth program, called Stable and Able (S&A), designed to help maintain skills to stay sober and allows continued communication with one of the mental health staff on a daily basis to provide additional support for the next 3 months after discharge.

3. Treatment-as-usual (TAU), which is the treatment currently provided on the unit, consisting of various mental health topics and sessions designed to help with recovery.

All participant will receive TAU.

Objectives:

Specific Aim I: Assess the relative effects of Treatment Engagement and Substance Use [and SUD-related problems] between CRP+S&A+TAU vs. CRP+TAU and CRP+S&A+TAU vs. TAU only by 3-mos follow-up.

Primary Hypothesis 1a: Treatment Engagement: Participants in CRP + S&A+TAU will attend more outpatient SUD treatment sessions and general MH treatment sessions compared to participants in CRP and to TAU.

Primary Hypothesis 1b: Substance Use: Participants in CRP + S&A+TAU will lower quantity and frequency of substance use and SUD-related problems compared to participants in CRP+TAU and to TAU only.

Secondary Hypothesis 1c: Preventable Services: Participants in CRP + S&A+TAU will reduce Preventable Healthcare Services (hospital readmissions and emergency department visits) compared to participants in CRP+TAU and to TAU only.

Secondary Hypothesis 1d: Participants in CRP + S&A+TAU will report Greater QoL; # of Days Living in Stable Housing; and # of Days Engaging in Community Events and/or Activities compared to CRP+TAU and to TAU only.

Specific Aim II: Conduct Veteran participant and Staff thematic interviews and to assess qualitative facilitators and barriers to implementation.

Methods:

195 Veterans with SUDs admitted into the Charleston VAMC inpatient unit will be recruited. Participants will be randomly assigned to: (1) CRP + S&A + TAU; (2) CRP+TAU; and (3) TAU. All participants will be followed-up at 1 and 3-months and data analyzed using mixed methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: December 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meeting DSM-V criteria for current SUD diagnosis of alcohol and/or illicit drug use disorder

• Use of substances in past 30 days prior to date of index inpatient admission

• Able to comprehend English

• Able to provide informed consent

• Functioning at an intellectual level sufficient to allow accurate completion of all assessments

• Willing to commit to 6 group inpatient therapy sessions, telehealth S&A, as well as baseline, and 1-and 3-month follow-up assessments

Exclusion Criteria:

• Auditory or visual impairment that would interfere with study procedures

• Inability to speak or understand English

• Acutely psychotic patients

Related Conditions & MeSH terms

• Alcoholism
• Dual Diagnosis
• Substance-related Disorders

Intervention

Behavioral:
• Combined Recovery Program
A six-session treatment group designed to explore goals, values, and personal strengths about making a change for overall quality of life, health and well-being combined with skill building designed for helping to live a more stable life in their own home that will include money management for financial success and home maintenance.
• Stable & Able (S&A)
A 90-day Home Telehealth program designed to help maintain skills to stay sober.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

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	Standard Ethanol Content Units (SECs) Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol at Baseline (e.g., the past 30 days is defined as 'Baseline'). Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.	Baseline
Primary	Standard Ethanol Content Units (SECs) at 1 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.	1 month
Primary	Standard Ethanol Content Units (SECs) at 3 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.	3 Month
Primary	Peak SEC at Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to baseline. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.	Baseline
Primary	Peak at 1 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.	30 days
Primary	Peak at 3 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.	3 Month
Primary	Alcohol Drink Days at Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days any alcohol was consumed within the stated time period.	Baseline
Primary	Alcohol Drink Days at 1 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. This measure represents the number of days any alcohol was consumed within the stated time period.	30 days
Primary	Alcohol Drink Days at 3 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.	3 Month
Primary	Binge Drink Days at Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days the participant binge drank.	Baseline
Primary	Binge Drink Days at 1 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after the first day of treatment. This measure represents the number of days the participant binge drank within the stated time period.	1 month
Primary	Binge Drink Days at 3 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days after the 1-month follow-up. This measure represents the number of days the participant binge drank within the stated time period.	3 month
Primary	Illicit Drug Use Days at Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 30 days prior to Baseline. This measure represents the number of illicit drug use days within the stated time period.	Baseline
Primary	Illicit Drug Use Days at 1 Month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 30 days after the first day of treatment. This measure represents the number of illicit drug use days within the stated time period.	30 days
Primary	Illicit Drug Use Days at 3 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 60 days after the 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.	3 Month
Primary	Substance Use Disorder Treatment Sessions at Baseline	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days prior to Baseline. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.	Baseline
Primary	Substance Use Disorder Treatment Sessions at 1 month	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days after the first day of treatment. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.	30 days
Primary	Substance Use Disorder Treatment Sessions at 3 Month	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Electronic Health Record System for the 30 days after the 1-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.	3 Month
Primary	Twelve-Step Sessions Attended at Baseline	A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to Baseline.	Baseline
Primary	Twelve-Step Sessions Attended at 1 Month	A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days after the first day of treatment.	30 days
Primary	Twelve-Step Sessions Attended at 3 month	A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days after the 1-month follow-up.	3 Month
Primary	Community Participation Activities at Baseline	A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days prior to Baseline.	Baseline
Primary	Community Participation Activities at 1 month	A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days after the 1st day of treatment.	30 days
Primary	Community Participation Activities at 3 month	A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game)in the 60 days after the 1-month follow-up.	3 Month
Primary	Mental Health Treatment Sessions at Baseline	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline. Treatment sessions included individual sessions with outpatient mental health staff.	Baseline
Primary	Mental Health Treatment Sessions at 1 month	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days after discharge. Treatment sessions included individual sessions with outpatient mental health staff.	30 days
Primary	Mental Health Treatment Sessions at 3 month	A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days after the 1-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.	3 Month
Secondary	Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	Baseline
Secondary	Addiction Severity Index-Lite (ASI-Lite) at 1 month for Alcohol Use	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	30 days
Secondary	Addiction Severity Index-Lite (ASI-Lite) at 3 month for Alcohol Use	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	3 Month
Secondary	Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	Baseline
Secondary	Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	30 days
Secondary	Addiction Severity Index-Lite (ASI-Lite) at 3 month for Psychiatric Status	The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity	3 Month
Secondary	Short Inventory of Problems (SIP) at Baseline	Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use	Baseline
Secondary	Short Inventory of Problems (SIP) at 1 month	Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use	30 days
Secondary	Short Inventory of Problems (SIP) at 3 month	Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use	3 Month
Secondary	Quality of Life Survey (QOLS) at Baseline	Min value:16 Max value:112 Higher score indicates higher quality of life	Baseline
Secondary	Quality of Life Survey (QOLS) at 1 month	Min value:16 Max value:112 Higher score indicates higher quality of life	30 days
Secondary	Quality of Life Survey (QOLS) at 3 month	Min value:16 Max value:112 Higher score indicates higher quality of life	3 Month
Secondary	Brief Symptom Inventory (BSI-18) at Baseline	Min value:0 Max value:72 Higher score indicates higher psychological distress	Baseline
Secondary	Brief Symptom Inventory (BSI-18) at 1 month	Min value:0 Max value:72 Higher score indicates higher psychological distress	30 days
Secondary	Brief Symptom Inventory (BSI-18) at 3 month	Min value:0 Max value:72 Higher score indicates higher psychological distress	3 Month
Secondary	Treatment Motivation Questionnaire (TMQ) at Baseline	The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged; External: Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system); Internal: Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)	Baseline
Secondary	Treatment Motivation Questionnaire (TMQ) at 1 month	The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged; External: Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system); Internal: Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)	30 days
Secondary	Treatment Motivation Questionnaire (TMQ) at 3 month	The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged; External: Min value:1 Max value:7 External: Higher score indicates higher external reasons for attending treatment (e.g. referred to treatment by legal system); Internal: Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)	3 Month
Secondary	Fagerstrom Test for Nicotine Dependence at Baseline	Min:0 Max:10 Higher score indicates higher level of nicotine dependence	Baseline
Secondary	Preventable Healthcare Services at 1 month Baseline	A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline.	30 days
Secondary	Preventable Healthcare Services at 1 month	A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 30 days after discharge.	30 days
Secondary	Preventable Healthcare Services at 3 month	A Treatment Attendance Calendar was used to record the number of separate psychiatric inpatient admissions and emergency department visits documented in each participants VA Computerized Patient Record System for the 60 days after the 1-month follow-up.	3 Month
Secondary	Housing Status Inventory at Baseline	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 30 days prior to Baseline.	Baseline
Secondary	Housing Status Inventory at 1 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 30 days after discharge.	30 days
Secondary	Housing Status Inventory at 3 month	The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of housing status for the 60 days after the 1-month follow-up	3 Month