Alcohol-Related Disorders, Alcohol Use Disorder, Opioid-Related Disorders, Opioid-use Disorder
Conditions
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
Study design
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder | 30-days post-discharge | 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 In-hospital Initiation of Medication for OUD or AUD | During the inpatient stay, an average of 7 days | 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 | 30 days post-discharge | Received 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 Disorder | 30-days post-discharge | Number 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 Disorder | 30 days post-discharge | 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 | 30-days post-discharge | Number of days of any alcohol use in the past 30 days at follow-up among patients with an alcohol use disorder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge | 90 days post-discharge | Patient 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
| Arm | Count |
|---|---|
| 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 |
| Total | 88 |
Baseline characteristics
| Characteristic | START | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 44.5 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 Disorder | 9 Participants | 11 Participants | 20 Participants |
| Days of Alcohol Use among Patients with Alcohol Use Disorder | 18.39 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 Participants | 18 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 32 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heavy Drinking among Patients with Alcohol Use Disorder | 26 Participants | 32 Participants | 58 Participants |
| Number of Drinks per Day among those with Alcohol Use Disorder who Drank in the Past 30 Days | 10.21 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 43 Participants | 74 Participants |
| Region of Enrollment United States | 38 participants | 50 participants | 88 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 26 Participants | 40 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 38 | 0 / 50 |
| other Total, other adverse events | 0 / 38 | 0 / 50 |
| serious Total, serious adverse events | 0 / 38 | 0 / 50 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| START | Average Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder | 4.08 Days of use | Standard Deviation 7.57 |
| Usual Care | Average Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder | 6.24 Days of use | Standard Deviation 9.37 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| START | Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder | 9.82 Drinks per day | Standard Deviation 9.6 |
| Usual Care | Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder | 7.00 Drinks per day | Standard Deviation 7.16 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| START | Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder | 5 Participants |
| Usual Care | Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder | 5 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| START | Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder | 5 Participants |
| Usual Care | Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder | 9 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| START | Number of Patients With In-hospital Initiation of Medication for OUD or AUD | 22 Participants |
| Usual Care | Number of Patients With In-hospital Initiation of Medication for OUD or AUD | 9 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| START | Number of Patients With Linkage to Follow-up Care for OUD or AUD | 24 Participants |
| Usual Care | Number of Patients With Linkage to Follow-up Care for OUD or AUD | 20 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| START | Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge | 7 Participants |
| Usual Care | Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge | 8 Participants |