Early Re-Intervention Experiment 2 (ERI2)

June 29, 2010 updated by: Chestnut Health Systems

Early Re-Intervention (ERI) Experiment 2

The objective of this study was to evaluate the relative effectiveness of quarterly Recovery Management Checkups (RMC) on long-term outcomes of adult chronic substance users over 4 years.

Study Overview

Status

Completed

Detailed Description

CONTEXT: While drug abuse is the 10th leading cause of mortality in the US, the disorder remains an orphan of the public health care system. Unlike cancer, diabetes, and other chronic diseases, the detection, re-emergence, and progression of which we have learned to respond with aggressively timed monitoring and interventions, drug abuse remains isolated from adoption into the "chronic condition" model of care.

OBJECTIVES AND HYPOTHESES: The objective of this study was to evaluate the relative effectiveness of quarterly checkups on long-term outcomes of adult chronic substance users over 4 years. Relative to participants randomly assigned to the control group, we predicted that RMC participants would: H1) return to treatment sooner, H2) receive more treatment, H3) decrease substance use, and H4) increase days of abstinence.

METHOD: Participants were recruited from sequential intakes at the largest addiction treatment agency in Illinois between February and April of 2004. Inclusion criteria were: any substance use in the past 90 days and any past-year symptoms of substance use disorders. For logistical reasons, participants were excluded if they were: under 18, lived or planned to move outside Chicago within 12 months, sentenced to a confined environment most of the next 12 months, mandated to treatment because of a driving under the influence offense, were not fluent in English or Spanish, or were cognitively unable to provide informed consent. To evaluate efficacy of quarterly Recovery Management Checkups (RMC) on treatment reentry and substance use, 446 adults (88% with dependence criteria) were randomly assigned quarterly RMCs, or, an outcome monitoring only control group and followed quarterly for 4 years (94% completion).

INTERVENTION. After interviewers completed the quarterly research interview and determined participants' eligibility and need for early re-intervention, they transferred RMC participants who were eligible and in need to a Linkage Manager. Using motivational interviewing, the Linkage Manager: a) provided feedback to participants regarding their current substance use and related problems, b) discussed implications of managing addiction as a chronic condition, c) discussed treatment barriers and solutions, d) assessed and discussed level of motivation for treatment, e) scheduled treatment appointments, f) accompanied participants to treatment intake and stayed through the process, and g) implemented Engagement and Retention Protocol during the 14 days of treatment. Detailed procedures and forms are available in the RMC manual(Scott & Dennis, 2003; http://www.chestnut.org/LI/downloads/Scott_&_Dennis_2003_RMC_Manual-2_25_03.pdf ).

OUTCOME MEASURES: Days to first treatment, days of treatment, successive quarters of needing treatment, number of substance problem months, days of abstinence.

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60610
        • Chestnut Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any substance use in the past 90 days
  • any past-year symptoms of substance use disorders.

Exclusion Criteria:

  • under 18
  • lived or planned to move outside Chicago within 12 months
  • sentenced to a confined environment most of the next 12 months
  • mandated to treatment because of a driving under the influence offense
  • were not fluent in English or Spanish
  • were cognitively unable to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recovery Management Checkups (RMC)
Participants in the RMC group are interviewed quarterly. When they were found to be in need of treatment, the participant was transferred from the interviewer to a linkage manager to receive the intervention (described next). They were also able to re-enter treatment on their own and naturally cycle through multiple periods of substance use, treatment, incarceration and recovery.
After interviewers completed the quarterly research interview and determined participants' eligibility and need for early re-intervention, they transferred RMC participants who were eligible and in need to a Linkage Manager. Using motivational interviewing, the Linkage Manager: a) provided feedback to participants regarding their current substance use and related problems, b) discussed implications of managing addiction as a chronic condition, c) discussed treatment barriers and solutions, d) assessed and discussed level of motivation for treatment, e) scheduled treatment appointments, f) accompanied participants to treatment intake and stayed through the process, and g) implemented Engagement and Retention Protocol during the 14 days of treatment
No Intervention: Control Group
Participants in the control group are interviewed quarterly. While they do not receive any active intervention from the research team, they are able to re-enter treatment on their own and naturally cycle through multiple periods of substance use, treatment, incarceration and recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Alcohol or Drug Treatment Re-Entry
Time Frame: Quarterly from random assignment until month 48
Days to readmission was calculated as the number of days from the date of the quarterly follow-up interview where the client first reported being in need of treatment (see below) to the date of the first subsequent intake to alcohol or other drug treatment following that interview.
Quarterly from random assignment until month 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Treatment Re-Entry
Time Frame: Quarterly from random assignment until month 48
Whether the person re-entered treatment between the point of randomization (at 3 months) and last observation.
Quarterly from random assignment until month 48
Times Re-entered Treatment Time Frame
Time Frame: Quarterly from random assignment until month 48 Description:
Number of times client re-entered treatment between randomization and the last observation.
Quarterly from random assignment until month 48 Description:
Total Days of Treatment
Time Frame: Quarterly from random assignment until month 48
Based on the sum of days an individual received outpatient, intensive outpatient, residential, or inpatient treatment reported at each interview for a given period.
Quarterly from random assignment until month 48
Quarters with 7 days Outpatient or 14 days Residential
Time Frame: Quarterly from random assignment until month 48
The number of quarters a participant received treatment at least 7 days of outpatient or 14 days of residential treatment, regardless of whether it is due to retention, step down or readmission.
Quarterly from random assignment until month 48
Quarters Needing Treatment
Time Frame: Quarterly from random assignment until month 48
Defined as a participant living in the community (vs. in incarcerated) who was not already in treatment and had been intoxicated or used alcohol or drugs on 13 or more of the past 90 days; had any symptoms of abuse, dependence, or withdrawal in the past month; or currently felt the need to return to treatment. Within quarter these criteria for need are internally consistent (alpha=.85) and the average person in need endorsed 3.3 of 6 of the items (80% endorsed 2 or more).
Quarterly from random assignment until month 48
Successive Quarters Needing Treatment
Time Frame: Quarterly from random assignment until month 48
The number of quarters in which the individual started and ended the period "in need of treatment" (see definition above) where missing data were replaced with status at prior wave.
Quarterly from random assignment until month 48
Substance Problem x Months
Time Frame: Quarterly from random assignment until month 48
Count of 16 past-month item related to weekly use, hiding using, complaints about use, 4 symptoms of abuse, 7 symptoms of dependence, substance induced health or mental health asked for the month before each quarterly interview times 3 and summed over observations; using mean score for any missing observations.
Quarterly from random assignment until month 48
Total Days of Abstinence
Time Frame: Quarterly from random assignment until month 48
Sum of days abstinent from alcohol or other drugs in months 4 to 48 (max=1350 days); using the mean days per quarter for any missing observations.
Quarterly from random assignment until month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christy K Scott, Ph.D., Chestnut Health Systems
  • Principal Investigator: Michael L Dennis, Ph.D., Chestnut Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • ERI-2
  • 5R37DA011323 (U.S. NIH Grant/Contract)

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.

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