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Completed

NCT Number: NCT01153594

Early Re-Intervention 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chestnut Health Systems

Chicago, Illinois, 60610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recovery Management Checkups (RMC)

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Chestnut Health Systems

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Early Re-Intervention (ERI) Experiment 2

Acronym: ERI2

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Jun 30, 2010
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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