Substance Use Treatment and Recovery Team (START)

NCT ID: NCT04314648

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2022-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

START

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

Group Type: ACTIVE_COMPARATOR

Substance Use Treatment and Recovery Team (START)

Intervention Type: 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.

Usual Care

Usual care for people with alcohol or opioid use disorder.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison J Ober, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Itai Danovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34DA047492-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCAAD013

Identifier Type: -

Identifier Source: org_study_id