Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01831999 |
| Other study ID # |
1R01DA030480-01A1 |
| Secondary ID |
1R01DA030480-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2012 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
March 2023 |
| Source |
Public Health Management Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
