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Substance Use Treatment and Recovery Team (START) (START)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Substance Use Treatment and Recovery Team (START)
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Collaborative Care, Hospital, Addiction, Opioid Use Disorder, Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

START

Usual Care

Arm Description

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: Triage Engage, Assess, and Plan Treat Communicate and Coordinate Follow up Monitor

Usual care for people with alcohol or opioid use disorder.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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
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

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2020
Last Updated
March 29, 2023
Sponsor
RAND
Collaborators
Cedars-Sinai Medical Center, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04314648
Brief Title
Substance Use Treatment and Recovery Team (START)
Acronym
START
Official Title
Pilot Test of a Substance Use Treatment and Recovery Team (START) for Medical Inpatients With Opioid and Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Cedars-Sinai Medical Center, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid-Related Disorders, Alcohol Use Disorder, Alcohol-Related Disorders
Keywords
Collaborative Care, Hospital, Addiction, Opioid Use Disorder, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
START
Arm Type
Active Comparator
Arm Description
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: Triage Engage, Assess, and Plan Treat Communicate and Coordinate Follow up Monitor
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care for people with alcohol or opioid use disorder.
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Treatment and Recovery Team (START)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients With In-hospital Initiation of Medication for OUD or AUD
Description
Received medication for an OUD or AUD between admission and discharge (Binary)
Time Frame
During the inpatient stay, an average of 7 days
Title
Number of Patients With Linkage to Follow-up Care for OUD or AUD
Description
Received at least one visit post-discharge for medication and/or psychosocial care for OUD or AUD (Binary)
Time Frame
30 days post-discharge
Title
Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder
Description
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)
Time Frame
30-days post-discharge
Title
Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder
Description
Any days using opioids at follow-up, based on NSDUH 30-day substance use questions (Center for Behavioral Health Statistics and Quality, 2018), (binary)
Time Frame
30 days post-discharge
Title
Average Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder
Description
Number of days of any alcohol use in the past 30 days at follow-up among patients with an alcohol use disorder
Time Frame
30-days post-discharge
Title
Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder
Description
Number of drinks per day among those with alcohol use disorder who drank in the past 30 days at follow-up
Time Frame
30-days post-discharge
Secondary Outcome Measure Information:
Title
Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge
Description
Patient was readmitted to Cedars Sinai Medical Center (the same hospital) for any reason, up to 90-days after discharge
Time Frame
90 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison J Ober, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Itai Danovitch, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will make the data and associated documentation available to users under a data-sharing agreement that provides for: (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.
IPD Sharing Time Frame
IPD will be available upon completion of analyses until five years after study completion.
IPD Sharing 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.

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Substance Use Treatment and Recovery Team (START)

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