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Clinical Trials/NCT01153594
NCT01153594CompletedPhase 3

Early Re-Intervention (ERI) Experiment 2

Chestnut Health Systems1 site in 1 country446 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
446
Locations
1
Primary Endpoint
Time to First Alcohol or Drug Treatment Re-Entry

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

Recovery Management Checkups (RMC)

Experimental

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.

Intervention: Recovery Management Checkups (RMC) (Behavioral)

Control Group

No Intervention

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 Outcomes

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.

Secondary Outcomes

  • Any Treatment Re-Entry(Quarterly from random assignment until month 48)
  • Times Re-entered Treatment Time Frame(Quarterly from random assignment until month 48 Description:)
  • Total Days of Treatment(Quarterly from random assignment until month 48)
  • Quarters with 7 days Outpatient or 14 days Residential(Quarterly from random assignment until month 48)
  • Quarters Needing Treatment(Quarterly from random assignment until month 48)
  • Successive Quarters Needing Treatment(Quarterly from random assignment until month 48)
  • Substance Problem x Months(Quarterly from random assignment until month 48)
  • Total Days of Abstinence(Quarterly from random assignment until month 48)

Investigators

Sponsor Class
Other

Study Sites (1)

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