Substance Use Treatment and Recovery Team (START)

NCT04314648 | Completed Results

• 2 other identifiers: HCAAD0131R34DA047492-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Despite high prevalence, few hospitalized inpatients with opioid or alcohol use disorders (OAUDs) receive evidence-based treatments while in the hospital or get linked with appropriate follow-up care, leading to poor clinical outcomes and high readmission rates and costs. The purpose of this study is to evaluate whether a physician and care manager with addiction expertise, both members of the Substance Abuse Treatment and Recovery Team (START), can help improve initiation of treatment in the hospital and linkage to follow-up care upon discharge. START members have expertise in the treatment of substance use disorders. START will work with the medical or surgical team to ensure appropriate care is received. That care will include therapy, focused discharge planning, and medication treatment options. START will also help establish a follow-up plan for continuation of treatment after hospital discharge. To assess feasibility, the study will enroll 80 patients admitted to the hospital over 5 months in a pilot randomized clinical trial and collect baseline and 1-month follow-up data. To determine acceptability, the study will conduct semi-structured interviews with 40 providers. Results of this pilot study will inform a larger clinical trial.

Conditions

Opioid-use Disorder; Opioid-Related Disorders; Alcohol Use Disorder; Alcohol-Related Disorders

Keywords

Collaborative Care; Hospital; Addiction; Opioid Use Disorder; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• Number of Patients With In-hospital Initiation of Medication for OUD or AUD

  Received medication for an OUD or AUD between admission and discharge (Binary)

  During the inpatient stay, an average of 7 days

• Number of Patients With Linkage to Follow-up Care for OUD or AUD

  Received at least one visit post-discharge for medication and/or psychosocial care for OUD or AUD (Binary)

  30 days post-discharge

• Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder

  For men, consuming an average of more than two drinks per day; for women, consuming an average of more than one drink per day during the reporting period of 30 days, extended from the NIAAA definition of this level of drinking over 14 days), among patients with alcohol use disorder at follow-up (National Institute on Alcohol Abuse and Alcoholism, 2022). Obtained by combining the separate survey questions of # of days drinking and # of drinks per day in past 30 days) (binary)

  30-days post-discharge

• Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder

  Any days using opioids at follow-up, based on NSDUH 30-day substance use questions (Center for Behavioral Health Statistics and Quality, 2018), (binary)

  30 days post-discharge

• Average Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder

  Number of days of any alcohol use in the past 30 days at follow-up among patients with an alcohol use disorder

  30-days post-discharge

• Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder

  Number of drinks per day among those with alcohol use disorder who drank in the past 30 days at follow-up

  30-days post-discharge

Secondary Outcomes (1)

• Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge

  90 days post-discharge

Study Arms (2)

START

ACTIVE COMPARATOR

START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare. The components of the START intervention are as follows: 1. Triage 2. Engage, Assess, and Plan 3. Treat 4. Communicate and Coordinate 5. Follow up 6. Monitor

Behavioral: Substance Use Treatment and Recovery Team (START)

Usual Care

NO INTERVENTION

Usual care for people with alcohol or opioid use disorder.

Interventions

Substance Use Treatment and Recovery Team (START) BEHAVIORAL

Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.

START

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient at CSMC
• Age 18 and older
• Screens positive for moderate to severe OAUDs based on the alcohol and opioid questions on the
• World Health Organization (WHO) Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST).
• Speaks English as primary language
• The usual attending physician agrees to patient's participation
• Has decision-making capacity and is not gravely disabled

You may not qualify if:

• Currently receiving FDA-approved medication treatment for an opioid or alcohol use disorder
• Gravely disabled (per clinical judgement)
• Does not have decision-making capacity (per clinical judgement)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• RAND: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Alcoholism; Alcohol-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Limitations and Caveats

The pilot sample size is small and combines individuals with AUD and OUD. The follow-up period was only one month after hospital discharge. Readmission was measured at only the admitting hospital. While the ASSIST, used to assess OUD and AUD, has been validated in the primary care setting, it has not be validated in the hospital setting. Use of the NSDUH 30-day use questions to measure self-reported opioid and alcohol use may have resulted in underreporting at both baseline and follow-up.

Results Point of Contact

• Title: Dr. Allison Ober
• Organization: RAND

ober@rand.org

3103930411

Study Officials

• Allison J Ober, PhD

  RAND

  PRINCIPAL INVESTIGATOR

• Itai Danovitch, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: December 4, 2020
• Primary Completion: September 15, 2021
• Study Completion: December 31, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available upon completion of analyses until five years after study completion.
• Access Criteria: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

Locations

US (1)