- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03737864
NCARE, Transition to Recovery
Native Center for Alcohol Research and Education (NCARE), Transition to Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary goal of alcohol detoxification is to medically manage acute intoxication and withdrawal. Its secondary goal of fostering entry into longer-term alcohol treatment post-detoxification is often overlooked. This leads to a revolving door characterized by a cyclical pattern of discharges and re-admissions to detoxification. This pattern is observed across the US among alcohol detoxification patients and is even more prevalent among Alaska Native people; few transition to alcohol treatment following detoxification and approximately 40% are readmitted within 1 year. The revolving door is costly to patients and providers. Current estimates associated with the cost of detoxification are not available. A study over 25 years ago indicated the average inpatient detoxification stay was over $3,300. Although the Substance Abuse and Mental Health Administration recognizes that better linkages are needed to transition people to treatment following detoxification, few interventions have tested ways to improve this transition; none of these prior studies included either Alaska Natives or American Indians.
This study proposes to use patient navigators to guide and assist patients in their transition to the appropriate levels of treatment, and to help eliminate barriers that obstruct treatment entry. This is a randomized controlled trial of the patient navigation intervention with 612 patients. We will estimate the costs of implementing and sustaining this intervention as well as its economic value. The control condition will include 1 session of motivational interviewing lasting approximately 45 minutes to 1 hour. The intervention group will also receive motivational interviewing and in addition will work with a patient navigator to facilitate entry into the appropriate level of care and provide ongoing support until the patient is admitted to treatment or the intervention period ends.
Specific Aims:
- Adapt patient navigation (Transitions to Recovery) to fit the patient population and test its effectiveness in increasing successful transition to post-detoxification substance abuse treatment.
- Test patient navigation's effectiveness in preventing readmission to detoxification.
- Perform a comprehensive economic evaluation of patient navigation (Transition to Recovery) by using cost-benefit analyses.
If effective, this intervention may be a cost-effective means of transitioning detoxification patients to treatment across health care systems nationally.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erin Poole, MS
- Phone Number: 303-724-0177
- Email: erin.poole@cuanschutz.edu
Study Locations
-
-
Alaska
-
Fairbanks, Alaska, United States, 99701
- Gateway to Recovery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older.
- successful completion of the detoxification process (completion of the detoxification process is a necessary step in order to transitions to substance abuse treatment) from our partnering detoxification facility.
- no comorbid physical or mental health condition (e.g., cancer, severe suicidality) that would delay transition to alcohol treatment.
- willing and cognitively able to provide informed consent and complete all study procedures assessed by detoxification discharge nurses.
- not currently admitted to a substance abuse treatment program
Exclusion:
- discharge destination prison or jail
- already enrolled in substance abuse treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Motivational Interview
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
|
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
|
Experimental: Patient navigation and MI
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification plus patient navigation for 30 days, or until the patient is successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first.
|
The patient navigator will provide support to patients upon discharge and will maintain regular contact either in person or by phone at a minimum of once per week for 30 days, or until the patient successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transition to substance abuse treatment
Time Frame: 30 days
|
The date of entry into a substance abuse treatment program will be collected.
A calculated a variable that reflects the number of days between detoxification discharge and transition to substance abuse treatment, and a binary indicator of successful transition to treatment within 0 to 30 days.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission to detoxification
Time Frame: 1 year
|
Extract the date of the first readmission (if one occurs) or collect at 6 and 12 month follow-up following discharge from detoxification and calculate a variable indicating total days to readmission within one year.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Spero M Manson, PhD, University of Colorado - Anschutz Medical Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-2421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance Use Disorders
-
Woebot HealthNational Institute on Drug Abuse (NIDA); Stanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use Disorder | Cocaine Use DisorderUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Substance Use Disorders | Cannabis Use | Alcohol Use, UnspecifiedUnited States
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingSubstance Use | Substance Use Disorders | Substance DependenceUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Wake Forest University Health SciencesNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Opioid Use | Drug Use | Substance MisuseUnited States
-
Istanbul UniversityCompletedSubstance Use | Substance Use Disorders | Substance AbuseTurkey
-
Centre for Addiction and Mental HealthUniversity of Missouri, St. LouisCompletedSubstance Use Disorders | Alcohol Use DisorderCanada
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)CompletedPTSD | Alcohol Use Disorders | Substance Use DisordersUnited States
Clinical Trials on Motivational interviewing (MI)
-
Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedEnd Stage Renal Disease on DialysisUnited States
-
Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingEnd Stage Renal Disease on DialysisUnited States
-
University of IowaCompletedSelf-efficacyUnited States
-
Chinese University of Hong KongThe University of Hong KongCompleted
-
Western University, CanadaNot yet recruitingHead and Neck Cancer | Survivorship
-
University of Illinois at Urbana-ChampaignUniversity of WashingtonNot yet recruiting
-
Northeastern UniversityCompleted
-
Brigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedOsteoarthritis | Degenerative Joint DiseaseUnited States
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed