NCARE, Transition to Recovery

• ClinicalTrials.gov Identifier: NCT03737864
• Recruitment Status: Recruiting
• First Posted: November 13, 2018
• Last Update Posted: September 29, 2021
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

This study tests the effectiveness of patient navigation for increasing enrollment in substance abuse treatment programs and preventing readmission to detoxification. Participants will be randomized to receive motivational interviewing or motivation interviewing plus patient navigation.

Condition or disease	Intervention/treatment	Phase
Alcohol Withdrawal; Substance Use Disorders	Behavioral: Patient navigation; Behavioral: Motivational interviewing (MI)	Not Applicable

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:

1. 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.
2. Test patient navigation's effectiveness in preventing readmission to detoxification.
3. 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Native Center for Alcohol Research and Education (NCARE), Transition to Recovery
• Actual Study Start Date: June 17, 2019
• Estimated Primary Completion Date: May 15, 2023
• Estimated Study Completion Date: November 30, 2023

Arms and Interventions

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.	Behavioral: Motivational interviewing (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.
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.	Behavioral: Patient navigation; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Erin Poole, MS; 303-724-0177; erin.poole@cuanschutz.edu

Locations

United States, Alaska

Gateway to Recovery; Recruiting

Fairbanks, Alaska, United States, 99701

Contact: Callie Noomah, BA 907-987-8489 callienoomah@CUAnschutz.edu

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Spero M Manson, PhD; University of Colorado - Anschutz Medical Campus

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03737864
• Other Study ID Numbers: 18-2421
• First Posted: November 13, 2018
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

transition to substance abuse treatment; readmission; recidivism; patient navigation

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders