Opioid-use DisorderSTARTNCT04314648
Substance Use Treatment and Recovery Team (START)
A study testing Substance Use Treatment and Recovery Team (START) in people with Opioid-use Disorder and Opioid-Related Disorders, run by RAND at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Opioid-Related Disorders, Alcohol Use Disorder
- What is being tested?
- Substance Use Treatment and Recovery Team (START)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Pilot Test of a Substance Use Treatment and Recovery Team (START) for Medical Inpatients With Opioid and Alcohol Use Disorders
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.
Read the 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
- Being tested
- Substance Use Treatment and Recovery Team (START)
- Keywords
- Collaborative Care, Hospital, Addiction, Opioid Use Disorder, Alcohol Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Alcoholism, Alcohol-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance Use Treatment and Recovery Team (START)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| START | Active comparator | 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 Receives: Behavioral: Substance Use Treatment and Recovery Team (START) |
| Usual Care | No intervention | Usual care for people with alcohol or opioid use disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the inpatient stay, an average of 7 days
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)
Measured: 30 days post-discharge
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)
Measured: 30-days post-discharge
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)
Measured: 30 days post-discharge
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
Measured: 30-days post-discharge
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
Measured: 30-days post-discharge
Secondary outcomes (1)
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
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start4 Dec 2020
- Primary completion15 Sep 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Allison J Ober, PhD, Principal investigator, RANDItai Danovitch, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314648
- Sponsor's protocol ID
- HCAAD013
- Other IDs
- 1R34DA047492-01
- Acronym
- START
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2020
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of a Substance Use Treatment and Recovery Team (START) for Medical Inpatients With Opioid and Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT04314648
- Acronym / sponsor ID
- START / HCAAD013
- Conditions
- Opioid-use Disorder, Opioid-Related Disorders, Alcohol Use Disorder, Alcohol-Related Disorders
- Keywords
- Collaborative Care, Hospital, Addiction, Opioid Use Disorder, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START | Active comparator | Behavioral: Substance Use Treatment and Recovery Team (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 |
| Usual Care | No intervention | –Usual care for people with alcohol or opioid use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | START |
Primary outcome
Number of Patients With In-hospital Initiation of Medication for OUD or AUD
Time frame: 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
Time frame: 30 days post-discharge
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
Time frame: 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 Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder
Time frame: 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
Time frame: 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
Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder
Time frame: 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
1 secondary outcome
Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge
Time frame: 90 days post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison J Ober, PhD principal investigator
RAND
Itai Danovitch, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substance Use Treatment and Recovery Team (START) in people with Opioid-use Disorder and Opioid-Related Disorders, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With In-hospital Initiation of Medication for OUD or AUD (time frame: During the inpatient stay, an average of 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.