NCT03737864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

November 7, 2018

Last Update Submit

March 21, 2025

Conditions

Alcohol WithdrawalSubstance Use Disorders

Keywords

transition to substance abuse treatmentreadmissionrecidivismpatient navigation

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (1)

  • Readmission to detoxification

    1 year

Study Arms (2)

Motivational Interview

ACTIVE COMPARATOR

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)

Patient navigation and MI

EXPERIMENTAL

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

Interventions

Patient navigationBEHAVIORAL

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.

Patient navigation and MI
Motivational interviewing (MI)BEHAVIORAL

A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.

Motivational Interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • discharge destination prison or jail
  • already enrolled in substance abuse treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gateway to Recovery

Fairbanks, Alaska, 99701, United States

Location

Related Publications (1)

  • Running Bear U, Poole EM, Muller C, Hanson JD, Noonan C, Trojan J, Rosenman R, Manson SM. The use of patient navigation to transition detoxification patients to substance use treatment in the Alaska Interior. Public Health Pract (Oxf). 2023 Aug 6;6:100418. doi: 10.1016/j.puhip.2023.100418. eCollection 2023 Dec.

    PMID: 37635913DERIVED

MeSH Terms

Conditions

Substance-Related DisordersRecidivism

Interventions

Patient NavigationMotivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCriminal BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services AdministrationDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Spero M Manson, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Michael McDonell, PhD

    Washington State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 13, 2018

Study Start

June 17, 2019

Primary Completion

May 15, 2023

Study Completion

November 30, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)