Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Treatment Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01831999
First received: March 29, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

Building on the recent advances in telephone supported care, clinical monitoring, and outreach work, the specific aims of the study are to:

  1. Develop RecoveryTrack™- ExtendedCare (RT-E), a modified/new version of RecoveryTrack™. The investigators will adapt and finalize the original Web-based RT system, manual, and training to accommodate use by counselors for clients who are no longer attending Outpatient (OP) treatment.
  2. Conduct a pilot study to determine the preliminary efficacy of RT-E compared to treatment as usual (TAU) for clients entering Intensive Outpatient (IOP) substance abuse treatment (SAT). In this randomized clinical trial, it is hypothesized that RT-E will positively impact treatment attendance and substance use outcomes. In exploratory analyses, the investigators will also evaluate the comparative impact of RT-E versus TAU on HIV related client behaviors.
  3. Evaluate feasibility and counselor and client acceptability of RT-E.
  4. Conduct preliminary cost and cost effectiveness analyses comparing RT-E to TAU.

Hypothesis 1: RT-E clients will attend more days of OP treatment than TAU clients. The investigators will compare the two groups on monthly treatment attendance for months 1 through 9. We expect a main effect of group with RT-E clients displaying more attendance than TAU clients.

Hypothesis 2: RT-E clients will have higher rates of abstinence than TAU clients. The investigators will compare abstinence rates at months 3, 6, and 9. Abstinence is a binary variable based on both biological test results and self-reported substance use from the Addiction Severity Index, Version 6 (ASI6). We expect a main effect of group with RT-E clients displaying higher rates of abstinence than TAU clients.

Secondary Analyses:

HIV Risk Scores: The investigators will compare the two groups' Risk Assessment Battery (RAB) HIV risk scores (i.e., total, sex, drug) at month 9.

Use of HIV specialist services: Client attendance charts will be reviewed to compare the two groups on the number of times clients met with a program HIV Specialist at month 9.

Multidimensional Outcomes: The investigators will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.


Condition Intervention
Substance-Related Disorders
Mental Disorders
Behavioral: RecoveryTrack - Extended Care (RT-E)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

Resource links provided by NLM:


Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Length of Stay [ Time Frame: 9 months post-consent ] [ Designated as safety issue: No ]
    Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.


Secondary Outcome Measures:
  • HIV Risk Scores [ Time Frame: 9 months post-consent ] [ Designated as safety issue: No ]
    The investigators will compare the two groups' Risk Assessment Battery (RAB) HIV risk scores (i.e., total, sex, drug) at month 9.

  • Multidimensional Outcomes [ Time Frame: 3, 6, and 9 months post-consent ] [ Designated as safety issue: No ]
    We will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.

  • Rates of Abstinence [ Time Frame: Months 3, 6, and 9 post-consent ] [ Designated as safety issue: No ]
    Abstinence is a binary variable based on both biological test results and self-reported substance use from the ASI6.

  • Use of HIV specialist services [ Time Frame: 9 months post-consent ] [ Designated as safety issue: No ]
    Client attendance charts will be reviewed to compare the two groups on the number of times clients met with a program HIV Specialist at month 9.


Estimated Enrollment: 165
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RecoveryTrack - Extended Care (RT-E)
Counselors will conduct monitoring and feedback sessions using the RecoveryTrack-Extended Care (RT-E) web-based monitoring system for clients newly admitted to Intensive Outpatient (IOP) treatment. Counselors will be instructed to document their reminders, contact attempts, and scheduling of RT-E appointments within a Contact Log incorporated into RT-E. All RT-E sessions will be audio recorded.
Behavioral: RecoveryTrack - Extended Care (RT-E)
Counselors in this condition will be trained on the RecoveryTrack-Extended Care (RT-E) web-based monitoring system so that they are able to navigate the computer application, and implement the clinical content and procedures of the intervention. Counselors will conduct monitoring and feedback sessions using RT-E for clients newly admitted to IOP over a course of eight months. If the client is not attending treatment, counselors will attempt contact over the phone and via other methods. When contacted, the counselor will conduct the RT-E assessment and, as the situation warrants, provide support to reengage the client in treatment or support recovery in other ways mentioned. HIV risk will be assessed as well, with encouragement of testing and referral to HIV specialists as needed.
No Intervention: Treatment as Usual (TAU)
Counselors will conduct standard treatment during IOP/OP in this condition. Exceptions to this condition are that counselors will: audio record their first 3 biweekly and subsequent 7 monthly individual in-person sessions; document on a Contact Log outreach attempts; and complete a Counselor Activity Log for client participants. There are several steps that counselors typically take when a client misses a session. Clients are called to reschedule for the same week, if the client doesn't return for their next scheduled session, the counselor sends a letter asking the client to return, etc.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
  • Counselor employed at participating facility.

Exclusion Criteria:

  • Client unable to speak English.
  • Client too cognitively impaired to give informed consent.
  • Clients who do not wish to be audio-recorded during individual sessions.
  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: NCT01831999

Contacts
Contact: Katie L Kizina, B.A. (215) 399-0980 ext 109 kkizina@tresearch.org
Contact: John S Cacciola, Ph.D. (215) 399-0980 ext 183 jcacciola@tresearch.org

Locations
United States, New Jersey
Genesis Counseling Centers, Inc. Recruiting
Collingswood, New Jersey, United States, 08108
Contact: Kevin J. Gregan, M.Ed.    856-858-9314    kgregan@genesiscenters.org   
United States, Pennsylvania
New Journeys In Recovery Recruiting
Philadelphia, Pennsylvania, United States, 19133
Contact: Kevin Collier, MBA    215-634-3669      
Thomas Jefferson University IOP Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Robert C. Sterling, Ph.D.    215-790-9942    rsterling@jefferson.edu   
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: John S. Cacciola, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01831999     History of Changes
Other Study ID Numbers: 1R01DA030480-01A1, 1R01DA030480-01A1
Study First Received: March 29, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Web-based
HIV Assessment
Outreach
Retention
Substance Abuse Treatment

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 28, 2014