Early Re-Intervention Experiment 2 (ERI2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Chestnut Health Systems
ClinicalTrials.gov Identifier:
NCT01153594
First received: June 29, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Substance Use Disorders
Behavioral: Recovery Management Checkups (RMC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Re-Intervention (ERI) Experiment 2

Further study details as provided by Chestnut Health Systems:

Primary Outcome Measures:
  • Time to First Alcohol or Drug Treatment Re-Entry [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    Whether the person re-entered treatment between the point of randomization (at 3 months) and last observation.

  • Times Re-entered Treatment Time Frame [ Time Frame: Quarterly from random assignment until month 48 Description: ] [ Designated as safety issue: No ]
    Number of times client re-entered treatment between randomization and the last observation.

  • Total Days of Treatment [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quarterly from random assignment until month 48 ] [ Designated as safety issue: No ]
    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.


Enrollment: 446
Study Start Date: February 2004
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153594

Locations
United States, Illinois
Chestnut Health Systems
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Chestnut Health Systems
Investigators
Principal Investigator: Michael L Dennis, Ph.D. Chestnut Health Systems
Principal Investigator: Christy K Scott, Ph.D. Chestnut Health Systems
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael L. Dennis, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT01153594     History of Changes
Other Study ID Numbers: ERI-2, 5R37DA011323
Study First Received: June 29, 2010
Last Updated: June 29, 2010
Health Authority: United States: Federal Government

Keywords provided by Chestnut Health Systems:
Substance Use Disorders
Relapse
Recovery
Disease Management
Long term outcomes
Addiction Treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014