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Early Re-Intervention Experiment 2 (ERI2)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Recovery Management Checkups (RMC)
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Substance Use Disorders, Relapse, Recovery, Disease Management, Long term outcomes, Addiction Treatment

Eligibility Criteria

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

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.

Sites / Locations

  • Chestnut Health Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovery Management Checkups (RMC)

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to First Alcohol or Drug Treatment Re-Entry
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.

Secondary Outcome Measures

Any Treatment Re-Entry
Whether the person re-entered treatment between the point of randomization (at 3 months) and last observation.
Times Re-entered Treatment Time Frame
Number of times client re-entered treatment between randomization and the last observation.
Total Days of Treatment
Based on the sum of days an individual received outpatient, intensive outpatient, residential, or inpatient treatment reported at each interview for a given period.
Quarters with 7 days Outpatient or 14 days Residential
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.
Quarters Needing Treatment
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).
Successive Quarters Needing Treatment
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.
Substance Problem x Months
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.
Total Days of Abstinence
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.

Full Information

First Posted
June 29, 2010
Last Updated
June 29, 2010
Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01153594
Brief Title
Early Re-Intervention Experiment 2
Acronym
ERI2
Official Title
Early Re-Intervention (ERI) Experiment 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance Use Disorders, Relapse, Recovery, Disease Management, Long term outcomes, Addiction Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery Management Checkups (RMC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Management Checkups (RMC)
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to First Alcohol or Drug Treatment Re-Entry
Description
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.
Time Frame
Quarterly from random assignment until month 48
Secondary Outcome Measure Information:
Title
Any Treatment Re-Entry
Description
Whether the person re-entered treatment between the point of randomization (at 3 months) and last observation.
Time Frame
Quarterly from random assignment until month 48
Title
Times Re-entered Treatment Time Frame
Description
Number of times client re-entered treatment between randomization and the last observation.
Time Frame
Quarterly from random assignment until month 48 Description:
Title
Total Days of Treatment
Description
Based on the sum of days an individual received outpatient, intensive outpatient, residential, or inpatient treatment reported at each interview for a given period.
Time Frame
Quarterly from random assignment until month 48
Title
Quarters with 7 days Outpatient or 14 days Residential
Description
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.
Time Frame
Quarterly from random assignment until month 48
Title
Quarters Needing Treatment
Description
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).
Time Frame
Quarterly from random assignment until month 48
Title
Successive Quarters Needing Treatment
Description
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.
Time Frame
Quarterly from random assignment until month 48
Title
Substance Problem x Months
Description
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.
Time Frame
Quarterly from random assignment until month 48
Title
Total Days of Abstinence
Description
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.
Time Frame
Quarterly from random assignment until month 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Dennis, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chestnut Health Systems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17195975
Citation
Scott CK, Sonis J, Creamer M, Dennis ML. Maximizing follow-up in longitudinal studies of traumatized populations. J Trauma Stress. 2006 Dec;19(6):757-69. doi: 10.1002/jts.20186.
Results Reference
background
PubMed Identifier
18292710
Citation
Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.
Results Reference
background
PubMed Identifier
18198169
Citation
Rush BR, Dennis ML, Scott CK, Castel S, Funk RR. The interaction of co-occurring mental disorders and recovery management checkups on substance abuse treatment participation and recovery. Eval Rev. 2008 Feb;32(1):7-38. doi: 10.1177/0193841X07307532.
Results Reference
result
PubMed Identifier
19344441
Citation
Scott CK, Dennis ML. Results from two randomized clinical trials evaluating the impact of quarterly recovery management checkups with adult chronic substance users. Addiction. 2009 Jun;104(6):959-71. doi: 10.1111/j.1360-0443.2009.02525.x. Epub 2009 Mar 13.
Results Reference
result
PubMed Identifier
23961833
Citation
McCollister KE, French MT, Freitas DM, Dennis ML, Scott CK, Funk RR. Cost-effectiveness analysis of Recovery Management Checkups (RMC) for adults with chronic substance use disorders: evidence from a 4-year randomized trial. Addiction. 2013 Dec;108(12):2166-74. doi: 10.1111/add.12335. Epub 2013 Oct 9.
Results Reference
derived

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Early Re-Intervention Experiment 2

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