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NCARE, Transition to Recovery

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ClinicalTrials.gov Identifier: NCT03737864
Recruitment Status : Not yet recruiting
First Posted : November 12, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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 700 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : January 31, 2023

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.




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.



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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 detoxifcation discharge nurses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737864


Contacts
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Contact: Ursula Running Bear, PhD 303-724-1452 ursula.runningbear@ucdenver.edu

Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Spero M Manson, PhD University of Colorado - Anschutz Medical Campus

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03737864     History of Changes
Other Study ID Numbers: 18-2421
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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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:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders