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Substance Use Treatment and Recovery Team (START)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04314648
Acronym
START
Enrollment
88
Registered
2020-03-19
Start date
2020-12-04
Completion date
2022-12-31
Last updated
2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

Sponsors

Cedars-Sinai Medical Center
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder30-days post-dischargeFor 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 In-hospital Initiation of Medication for OUD or AUDDuring the inpatient stay, an average of 7 daysReceived medication for an OUD or AUD between admission and discharge (Binary)
Number of Patients With Linkage to Follow-up Care for OUD or AUD30 days post-dischargeReceived at least one visit post-discharge for medication and/or psychosocial care for OUD or AUD (Binary)
Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder30-days post-dischargeNumber of drinks per day among those with alcohol use disorder who drank in the past 30 days at follow-up
Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder30 days post-dischargeAny 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 Disorder30-days post-dischargeNumber of days of any alcohol use in the past 30 days at follow-up among patients with an alcohol use disorder

Secondary

MeasureTime frameDescription
Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge90 days post-dischargePatient was readmitted to Cedars Sinai Medical Center (the same hospital) for any reason, up to 90-days after discharge

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
38
Usual Care
Usual care for people with alcohol or opioid use disorder.
50
Total88

Baseline characteristics

CharacteristicSTARTUsual CareTotal
Age, Continuous44.5 years
STANDARD_DEVIATION 12.9
44.5 years
STANDARD_DEVIATION 13.2
44.5 years
STANDARD_DEVIATION 13
Any Days of Opioid Use among Patients with Opioid Use Disorder9 Participants11 Participants20 Participants
Days of Alcohol Use among Patients with Alcohol Use Disorder18.39 Days of Use
STANDARD_DEVIATION 10.34
21.21 Days of Use
STANDARD_DEVIATION 10.65
20.01 Days of Use
STANDARD_DEVIATION 10.54
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants18 Participants28 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants32 Participants60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Heavy Drinking among Patients with Alcohol Use Disorder26 Participants32 Participants58 Participants
Number of Drinks per Day among those with Alcohol Use Disorder who Drank in the Past 30 Days10.21 Drinks per Day
STANDARD_DEVIATION 7.33
9.97 Drinks per Day
STANDARD_DEVIATION 7.7
10.08 Drinks per Day
STANDARD_DEVIATION 7.49
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Black or African American
4 Participants4 Participants8 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
31 Participants43 Participants74 Participants
Region of Enrollment
United States
38 participants50 participants88 participants
Sex: Female, Male
Female
12 Participants10 Participants22 Participants
Sex: Female, Male
Male
26 Participants40 Participants66 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 380 / 50
other
Total, other adverse events
0 / 380 / 50
serious
Total, serious adverse events
0 / 380 / 50

Outcome results

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

Time frame: 30-days post-discharge

Population: Study participants with alcohol use disorder who received a 1-month follow-up interview.

ArmMeasureValue (MEAN)Dispersion
STARTAverage Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder4.08 Days of useStandard Deviation 7.57
Usual CareAverage Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder6.24 Days of useStandard Deviation 9.37
p-value: 0.43Regression, Linear
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

Time frame: 30-days post-discharge

Population: Study participants with alcohol use disorder who drank in the past 30 days and received a 1-month follow-up interview.

ArmMeasureValue (MEAN)Dispersion
STARTAverage Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder9.82 Drinks per dayStandard Deviation 9.6
Usual CareAverage Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder7.00 Drinks per dayStandard Deviation 7.16
p-value: 0.44Regression, Linear
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)

Time frame: 30 days post-discharge

Population: Study participants with opioid use disorder who received a 1-month follow-up interview.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STARTNumber of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder5 Participants
Usual CareNumber of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder5 Participants
p-value: 0.3595% CI: [0.35, 20.51]Regression, Logistic
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)

Time frame: 30-days post-discharge

Population: Study participants with an alcohol use disorder who received a 1-month follow-up interview.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STARTNumber of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder5 Participants
Usual CareNumber of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder9 Participants
p-value: 0.6495% CI: [0.21, 2.64]Regression, Logistic
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)

Time frame: During the inpatient stay, an average of 7 days

Population: All study participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STARTNumber of Patients With In-hospital Initiation of Medication for OUD or AUD22 Participants
Usual CareNumber of Patients With In-hospital Initiation of Medication for OUD or AUD9 Participants
p-value: <0.00195% CI: [2.38, 16.48]Regression, Logistic
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)

Time frame: 30 days post-discharge

Population: Study participants who received a 1-month follow-up interview.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STARTNumber of Patients With Linkage to Follow-up Care for OUD or AUD24 Participants
Usual CareNumber of Patients With Linkage to Follow-up Care for OUD or AUD20 Participants
p-value: <0.0195% CI: [1.86, 17.86]Regression, Logistic
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

Time frame: 90 days post-discharge

Population: All study participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STARTNumber of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge7 Participants
Usual CareNumber of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge8 Participants
p-value: 0.7795% CI: [0.39, 3.62]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026