Substance-Related DisordersNCT01831999
Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
A study testing RecoveryTrack - Extended Care (RT-E) in people with Substance-Related Disorders and Mental Disorders, run by Treatment Research Institute at 4 sites in United States.
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™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders, Mental Disorders
- What is being tested?
- RecoveryTrack - Extended Care (RT-E)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
- Counselor employed at participating facility.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Genesis Counseling Centers, Inc.
Collingswood, New Jersey, 08108
Genesis Counseling Centers, Inc.
Marlton, New Jersey, 08053
New Journeys In Recovery
Philadelphia, Pennsylvania, 19133
Thomas Jefferson University IOP
Philadelphia, Pennsylvania, 19146
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Substance-Related Disorders, Mental Disorders
- Being tested
- RecoveryTrack - Extended Care (RT-E)
- Keywords
- Web-based, HIV Assessment, Outreach, Retention, Substance Abuse Treatment
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoveryTrack - Extended Care (RT-E)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RecoveryTrack - Extended Care (RT-E) | Experimental | 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. Receives: Behavioral: RecoveryTrack - Extended Care (RT-E) |
| Treatment as Usual (TAU) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.
Measured: 9 months post-consent
Secondary outcomes (4)
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.
Measured: 9 months post-consent
Multidimensional Outcomes
We will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.
Measured: 3, 6, and 9 months post-consent
Rates of Abstinence
Abstinence is a binary variable based on both biological test results and self-reported substance use from the ASI6.
Measured: Months 3, 6, and 9 post-consent
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.
Measured: 9 months post-consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- John S. Cacciola, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831999
- Sponsor's protocol ID
- 1R01DA030480-01A1
- Other IDs
- 1R01DA030480-01A1
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2013
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Monitoring to Facilitate Continuous Care for Substance Abusing Clients
- ClinicalTrials.gov ID
- NCT01831999
- Acronym / sponsor ID
- 1R01DA030480-01A1
- Conditions
- Substance-Related Disorders, Mental Disorders
- Keywords
- Web-based, HIV Assessment, Outreach, Retention, Substance Abuse Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RecoveryTrack - Extended Care (RT-E) | Experimental | Behavioral: 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. |
| Treatment as Usual (TAU) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
- Counselor employed at participating facility.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | RecoveryTrack - Extended Care (RT-E) |
Primary outcome
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.
4 secondary outcomes
HIV Risk Scores
Time frame: 9 months post-consent
Multidimensional Outcomes
Time frame: 3, 6, and 9 months post-consent
Rates of Abstinence
Time frame: Months 3, 6, and 9 post-consent
Use of HIV specialist services
Time frame: 9 months post-consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S. Cacciola, Ph.D. principal investigator
Treatment Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveryTrack - Extended Care (RT-E) in people with Substance-Related Disorders and Mental Disorders, run by Treatment Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: 9 months post-consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.