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NCARE, Transition to Recovery

Primary Purpose

Alcohol Withdrawal, Substance Use Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient navigation
Motivational interviewing (MI)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Withdrawal focused on measuring transition to substance abuse treatment, readmission, recidivism, patient navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gateway to Recovery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Motivational Interview

Patient navigation and MI

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Transition to substance abuse treatment
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

Readmission to detoxification
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.

Full Information

First Posted
November 7, 2018
Last Updated
April 21, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03737864
Brief Title
NCARE, Transition to Recovery
Official Title
Native Center for Alcohol Research and Education (NCARE), Transition to Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal, Substance Use Disorders
Keywords
transition to substance abuse treatment, readmission, recidivism, patient navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview
Arm Type
Active Comparator
Arm Description
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
Arm Title
Patient navigation and MI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient navigation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing (MI)
Intervention Description
A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
Primary Outcome Measure Information:
Title
Transition to substance abuse treatment
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Readmission to detoxification
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spero M Manson, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway to Recovery
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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NCARE, Transition to Recovery

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