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Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

Primary Purpose

Substance-Related Disorders, Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RecoveryTrack - Extended Care (RT-E)
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Web-based, HIV Assessment, Outreach, Retention, Substance Abuse Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Genesis Counseling Centers, Inc.
  • Genesis Counseling Centers, Inc.
  • New Journeys In Recovery
  • Thomas Jefferson University IOP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RecoveryTrack - Extended Care (RT-E)

Treatment as Usual (TAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of Stay
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
The investigators will compare the two groups' Risk Assessment Battery (RAB) HIV risk scores (i.e., total, sex, drug) at month 9.
Multidimensional Outcomes
We will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.
Rates of Abstinence
Abstinence is a binary variable based on both biological test results and self-reported substance use from the ASI6.
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.

Full Information

First Posted
March 29, 2013
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01831999
Brief Title
Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
Official Title
Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.
Detailed Description
The goal of the RecoveryTrack Extended Care (RT-E) study is to improve attendance and extended care treatment during outpatient substance abuse treatment (SAT). One way we hope to promote and improve retention in outpatient treatment is to allow the primary counselor to systematically monitor client progress and respond accordingly to enhance the client's progress in outpatient treatment. We have developed an intervention using RecoveryTrack software that allows the counselor to monitor the client while s/he is regularly attending and to helps to guide their treatment; as well as reaching out and monitoring the client when s/he has missed sessions or appears to have dropped out in order to support re-engagement in treatment or recovery in other ways. SAT can serve as a gateway to and provide services for HIV/STI prevention and treatment as well. Thus, monitoring and responding to HIV/STI risk behavior and treatment compliance throughout SAT, and increasing attendance in SAT itself, has the potential for additional personal and public health impact. Counselors are trained on the RT-E computer application, and learn to implement the clinical content and procedures of the RT-E intervention. Clients then are asked to use the software with participants twice within the first month, and once monthly for 8 months. If clients drop out of treatment or do not show for an appointment, counselors are asked to do "outreach" with the clients to promote re-entry into treatment. We also ask the counselors to keep track of any time that they spend on the project and how much of their own resources to perform outreach. We ask that all sessions be audio recorded and will be rated at a later time. The TAU counselors also audio record their sessions and document their time on a log any outreach attempts. The counselors are asked to perform their usual outreach attempts if a client drops from treatment, and to complete individual sessions without the RT-E computer application. In total, 25 counselor-participants will be enrolled in RT-E study. All counselors receive incentives throughout participation in the study. The incentives are greater in the RT-E condition reflecting a greater workload than in TAU with payments at the beginning, middle, and end of research participation. The compensation for counselor participants in each condition is as follows: RT-E training takes approximately 4-5 hours over a period of several weeks at the beginning of the study. RT-E counselors are paid $125 upon completing the entire training sequence. RT-E counselors receive supervision by TRI staff in 30 minute sessions about once a month during the 1st 6 months of the study and quarterly thereafter, for a total of approximately 11 sessions. RT-E counselors are paid $15 for each supervision session attended [maximum total = $165].Two times, midway and near the end of the study, RT-E counselors complete the Counselor Acceptability Survey and are reimbursed $20 each time. Each week RT-E counselors completes the Counselor Activity Log and is paid $2 for each one completed during the course of the study [a maximum of $200 for approximately 104 weeks ].RT-E Counselors are paid $30 for each completed and audio-recorded phone outreach session ($25 if completed but not recorded). Total counselor payment for these activities will vary based on number of client participants seen as well as client non-attendance and need for and responsiveness to outreach contact. Two times, midway and near the end of the study, TAU counselors complete the Counselor Acceptability Survey and are reimbursed $20 each time. In total, 150 client-participants will be enrolled in the RT-E study. These participants will complete a baseline research interview and follow-up interviews 3, 6 and 9 months later, as well as provide urine samples for drug screening (UDSs) at each of the research assessments. Clients will be contacted at the midpoint of each follow-up interval to remind them of the upcoming follow-up appointment and obtain updated locator information. Clients are paid $30 for completing the baseline ASI6, urine drug screen (UDS), and Risk Assessment Battery (RAB); $35 for the 3-month follow-up ASI6, UDS, and Client Acceptability Interview; $40 for the 6-month ASI6 & UDS, and $50 for completing the 9-month ASI6, UDS, RAB, & Client Acceptability Survey. At months 2, 5, and 8, participants receive reminder letters or phone calls about their upcoming follow-up and can earn $5 each of those months by calling TRI and updating their Research Locator Form. All payments are be in cash, unless a check or money order is more practical (e.g., if payment needs to be mailed). Clients are randomly assigned to groups based on their primary counselors' assignment to condition in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Mental Disorders
Keywords
Web-based, HIV Assessment, Outreach, Retention, Substance Abuse Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RecoveryTrack - Extended Care (RT-E)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RecoveryTrack - Extended Care (RT-E)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Stay
Description
Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.
Time Frame
9 months post-consent
Secondary Outcome Measure Information:
Title
HIV Risk Scores
Description
The investigators will compare the two groups' Risk Assessment Battery (RAB) HIV risk scores (i.e., total, sex, drug) at month 9.
Time Frame
9 months post-consent
Title
Multidimensional Outcomes
Description
We will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.
Time Frame
3, 6, and 9 months post-consent
Title
Rates of Abstinence
Description
Abstinence is a binary variable based on both biological test results and self-reported substance use from the ASI6.
Time Frame
Months 3, 6, and 9 post-consent
Title
Use of HIV specialist services
Description
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.
Time Frame
9 months post-consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S. Cacciola, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Counseling Centers, Inc.
City
Collingswood
State/Province
New Jersey
ZIP/Postal Code
08108
Country
United States
Facility Name
Genesis Counseling Centers, Inc.
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
New Journeys In Recovery
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19133
Country
United States
Facility Name
Thomas Jefferson University IOP
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients

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