Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
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|ClinicalTrials.gov Identifier: NCT01831999|
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : September 2, 2016
Building on the recent advances in telephone supported care, clinical monitoring, and outreach work, the specific aims of the study are to:
- 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.
- 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.
- Evaluate feasibility and counselor and client acceptability of RT-E.
- 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.
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 or disease||Intervention/treatment||Phase|
|Substance-Related Disorders Mental Disorders||Behavioral: RecoveryTrack - Extended Care (RT-E)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||May 2016|
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.
- Length of Stay [ Time Frame: 9 months post-consent ]Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.
- HIV Risk Scores [ Time Frame: 9 months post-consent ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831999
|United States, New Jersey|
|Genesis Counseling Centers, Inc.|
|Collingswood, New Jersey, United States, 08108|
|Genesis Counseling Centers, Inc.|
|Marlton, New Jersey, United States, 08053|
|United States, Pennsylvania|
|New Journeys In Recovery|
|Philadelphia, Pennsylvania, United States, 19133|
|Thomas Jefferson University IOP|
|Philadelphia, Pennsylvania, United States, 19146|
|Principal Investigator:||John S. Cacciola, Ph.D.||Treatment Research Institute|