Substance Use Treatment and Recovery Team (START)

Alcohol Use Disorder Clinical Trial

— START  

Official title:

Pilot Test of a Substance Use Treatment and Recovery Team (START) for Medical Inpatients With Opioid and Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314648
• Other study ID #: HCAAD013
• Secondary ID: 1R34DA047492-01
• Status: Completed
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The specific aims of this three-year R34 are to prepare for a clinical trial by (1) developing the protocol and resources for Substance Use Treatment and Recovery Team (START) to address untreated opioid or alcohol use disorders (OAUDs) among hospitalized inpatients and actively link them to follow-up care, and by (2) conducting a pilot RCT to assess (a) implementation feasibility; and (b) acceptability among patients and providers. The study is of critical importance to public health because millions of people in the United States need, but do not receive, treatment for substance-use disorders. OAUDs are of particular concern because of high rates of morbidity, mortality, hospitalizations, and readmissions, as well as the increasing incidence of opioid-use disorders and associated medical consequences and overdose deaths. Moreover, OAUDs are common substance use disorders among medical inpatients.

However, despite high prevalence, few inpatients with OAUDs receive evidence-based treatments while in the hospital. Most physicians and other providers in acute hospital settings are not trained to assess or manage patients with OAUDs, contributing to low rates of OAUD identification and treatment initiation. Pharmacotherapies to address OAUDs are effective for use across medical settings but are seldom initiated in hospitals or recommended as part of follow-up care. Inpatient hospitalization offers a pivotal opportunity to decrease unmet need. Starting treatment in the hospital and effectively linking patients with follow-up care could not only improve outcomes, but also could decrease high rates of hospital readmission and ultimately lower costs.

The current standard of care for hospitalized patients with OAUD-screening, brief intervention and referral to treatment-is not effective for those with OAUDs, possibly because it does not include initiation of medication or facilitate linkage to follow-up OAUD care. Barriers to OAUD treatment for inpatients may include lack of expertise on the medical team, absence of an organized system for assessing and treating patients with OAUD, patient ambivalence about treatment, and lack of follow-up after discharge. The START will consist of an physician and care manager team with OAUD expertise who provide population-focused monitoring and measurement-based decision-making to support the medical team.

START will use evidence-based components, including a motivational interviewing-based therapeutic intervention, targeted discharge planning, and active referral.

To develop the protocol, we will draw from our prior work in primary care and other evidence-based resources, and obtain input from a stakeholder advisory board comprised of patients and providers. To assess feasibility, we will enroll 80 patients admitted to the hospital over 5 months in a pilot RCT and collect baseline and 1-month follow-up data.

To determine acceptability, we will conduct interviews with providers and patients. The proposed study would be the first to test a consultation-liaison service-based START to improve care for inpatients with OAUD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 31, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol-Related Disorders
• Alcoholism
• Disease
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Substance Use Treatment and Recovery Team (START)
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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Cedars-Sinai Medical Center, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge	Patient was readmitted to Cedars Sinai Medical Center (the same hospital) for any reason, up to 90-days after discharge	90 days post-discharge