Early Re-Intervention Experiment 2

NCT ID: NCT01153594

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Substance Use Disorders

Keywords

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Substance Use Disorders Relapse Recovery Disease Management Long term outcomes Addiction Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Recovery Management Checkups (RMC)

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Recovery Management Checkups (RMC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Chestnut Health Systems

OTHER

Sponsor Role lead

Responsible Party

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Chestnut Health Systems

Principal Investigators

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Michael L Dennis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chestnut Health Systems

Christy K Scott, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chestnut Health Systems

Locations

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Chestnut Health Systems

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17195975 (View on PubMed)

Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.

Reference Type BACKGROUND
PMID: 18292710 (View on PubMed)

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.

Reference Type RESULT
PMID: 18198169 (View on PubMed)

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.

Reference Type RESULT
PMID: 19344441 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23961833 (View on PubMed)

Other Identifiers

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5R37DA011323

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ERI-2

Identifier Type: -

Identifier Source: org_study_id