Clinical trial NCT01153594: Early Re-Intervention Experiment 2
Official title: Early Re-Intervention (ERI) Experiment 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance Use Disorders
Keywords: Substance Use Disorders
Relapse
Recovery
Disease Management
Long term outcomes
Addiction Treatment
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-30
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to First Alcohol or Drug Treatment Re-Entry
timeFrame: Quarterly from random assignment until month 48
Secondary outcomes:
measure: Any Treatment Re-Entry
timeFrame: Quarterly from random assignment until month 48
measure: Times Re-entered Treatment Time Frame
timeFrame: Quarterly from random assignment until month 48 Description:
measure: Total Days of Treatment
timeFrame: Quarterly from random assignment until month 48
measure: Quarters with 7 days Outpatient or 14 days Residential
timeFrame: Quarterly from random assignment until month 48
measure: Quarters Needing Treatment
timeFrame: Quarterly from random assignment until month 48
measure: Successive Quarters Needing Treatment
timeFrame: Quarterly from random assignment until month 48
measure: Substance Problem x Months
timeFrame: Quarterly from random assignment until month 48
measure: Total Days of Abstinence
timeFrame: Quarterly from random assignment until month 48
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chestnut Health Systems
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Michael L Dennis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chestnut Health Systems
name: Christy K Scott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.