Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

This study is currently recruiting participants.
Verified April 2013 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: April 10, 2013
Last verified: April 2013

March 29, 2013
April 10, 2013
June 2012
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01831999 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

Building on the recent advances in telephone supported care, clinical monitoring, and outreach work, the specific aims of the proposed 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 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 Addiction Severity Index, version 6 (ASI6) summary scores at months 3, 6, and 9.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance-Related Disorders
  • Mental Disorders
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.
  • 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.
    Intervention: Behavioral: RecoveryTrack - Extended Care (RT-E)
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Graham T DiGuiseppi, B.S. (215) 399-0980 ext 133 gdiguiseppi@tresearch.org
Contact: John S Cacciola, Ph.D. (215) 399-0980 ext 183 jcacciola@tresearch.org
United States
 
NCT01831999
1R01DA030480-01A1, 1R01DA030480-01A1
Yes
Treatment Research Institute
Treatment Research Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: John S. Cacciola, Ph.D. Treatment Research Institute
Treatment Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP