Clinical trial NCT05054738: CRP and S&A for Inpatient Veterans
Official title: Impact of Combined Recovery Program and Home Telehealth Among Veterans With Substance Use Disorders in the VA Inpatient Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholism
Substance-related Disorders
Dual Diagnosis
Keywords: Alcoholism
Substance-related disorders
Dual Diagnosis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-23
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between groups randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Standard Ethanol Content Units (SECs) Baseline
timeFrame: Baseline
measure: Standard Ethanol Content Units (SECs) at 1 month
timeFrame: 1 month
measure: Standard Ethanol Content Units (SECs) at 3 month
timeFrame: 3 Month
measure: Peak SEC at Baseline
timeFrame: Baseline
measure: Peak at 1 Month
timeFrame: 30 days
measure: Peak at 3 Month
timeFrame: 3 Month
measure: Alcohol Drink Days at Baseline
timeFrame: Baseline
measure: Alcohol Drink Days at 1 Month
timeFrame: 30 days
measure: Alcohol Drink Days at 3 Month
timeFrame: 3 Month
measure: Binge Drink Days at Baseline
timeFrame: Baseline
measure: Binge Drink Days at 1 month
timeFrame: 1 month
measure: Binge Drink Days at 3 Month
timeFrame: 3 month
measure: Illicit Drug Use Days at Baseline
timeFrame: Baseline
measure: Illicit Drug Use Days at 1 Month
timeFrame: 30 days
measure: Illicit Drug Use Days at 3 month
timeFrame: 3 Month
measure: Substance Use Disorder Treatment Sessions at Baseline
timeFrame: Baseline
measure: Substance Use Disorder Treatment Sessions at 1 month
timeFrame: 30 days
measure: Substance Use Disorder Treatment Sessions at 3 Month
timeFrame: 3 Month
measure: Twelve-Step Sessions Attended at Baseline
timeFrame: Baseline
measure: Twelve-Step Sessions Attended at 1 Month
timeFrame: 30 days
measure: Twelve-Step Sessions Attended at 3 month
timeFrame: 3 Month
measure: Community Participation Activities at Baseline
timeFrame: Baseline
measure: Community Participation Activities at 1 month
timeFrame: 30 days
measure: Community Participation Activities at 3 month
timeFrame: 3 Month
measure: Mental Health Treatment Sessions at Baseline
timeFrame: Baseline
measure: Mental Health Treatment Sessions at 1 month
timeFrame: 30 days
measure: Mental Health Treatment Sessions at 3 month
timeFrame: 3 Month
Secondary outcomes:
measure: Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use
timeFrame: Baseline
measure: Addiction Severity Index-Lite (ASI-Lite) at 1 month for Alcohol Use
timeFrame: 30 days
measure: Addiction Severity Index-Lite (ASI-Lite) at 3 month for Alcohol Use
timeFrame: 3 Month
measure: Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status
timeFrame: Baseline
measure: Addiction Severity Index-Lite (ASI-Lite) at 1 month for Psychiatric Status
timeFrame: 30 days
measure: Addiction Severity Index-Lite (ASI-Lite) at 3 month for Psychiatric Status
timeFrame: 3 Month
measure: Short Inventory of Problems (SIP) at Baseline
timeFrame: Baseline
measure: Short Inventory of Problems (SIP) at 1 month
timeFrame: 30 days
measure: Short Inventory of Problems (SIP) at 3 month
timeFrame: 3 Month
measure: Quality of Life Survey (QOLS) at Baseline
timeFrame: Baseline
measure: Quality of Life Survey (QOLS) at 1 month
timeFrame: 30 days
measure: Quality of Life Survey (QOLS) at 3 month
timeFrame: 3 Month
measure: Brief Symptom Inventory (BSI-18) at Baseline
timeFrame: Baseline
measure: Brief Symptom Inventory (BSI-18) at 1 month
timeFrame: 30 days
measure: Brief Symptom Inventory (BSI-18) at 3 month
timeFrame: 3 Month
measure: Treatment Motivation Questionnaire (TMQ) at Baseline
timeFrame: Baseline
measure: Treatment Motivation Questionnaire (TMQ) at 1 month
timeFrame: 30 days
measure: Treatment Motivation Questionnaire (TMQ) at 3 month
timeFrame: 3 Month
measure: Fagerstrom Test for Nicotine Dependence at Baseline
timeFrame: Baseline
measure: Preventable Healthcare Services at 1 month Baseline
timeFrame: 30 days
measure: Preventable Healthcare Services at 1 month
timeFrame: 30 days
measure: Preventable Healthcare Services at 3 month
timeFrame: 3 Month
measure: Housing Status Inventory at Baseline
timeFrame: Baseline
measure: Housing Status Inventory at 1 month
timeFrame: 30 days
measure: Housing Status Inventory at 3 month
timeFrame: 3 Month
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Elizabeth J. Santa Ana, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References: