Evaluation of Web-Based Recovery Monitoring With Clinical Alerts
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | January 2010 |
| End Date: | December 2013 |
| Contact: | Graham T DiGuiseppi, B.S. |
| Email: | gdiguiseppi@tresearch.org |
| Phone: | 215-399-0980 |
The specific aims of the project are to conduct a three-phase study to develop a data-driven
Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and
test its efficacy, as follows:
Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that
predicts early treatment attrition; adapt elements of a cognitive behavioral intervention
(CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence
measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three
monitoring assessments to inform counselors when a client is at High Risk to leave
treatment.
Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the
study measures/procedures.
Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose
counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors
were assigned to TAU (control condition). The primary hypothesis is that clients who
evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts +
CBI condition than High Risk clients in the control condition. Secondary client hypotheses
are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment
sessions, have more drug-free urine results, and receive more ancillary services than High
Risk clients in the control condition.
Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and
test its efficacy, as follows:
Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that
predicts early treatment attrition; adapt elements of a cognitive behavioral intervention
(CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence
measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three
monitoring assessments to inform counselors when a client is at High Risk to leave
treatment.
Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the
study measures/procedures.
Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose
counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors
were assigned to TAU (control condition). The primary hypothesis is that clients who
evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts +
CBI condition than High Risk clients in the control condition. Secondary client hypotheses
are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment
sessions, have more drug-free urine results, and receive more ancillary services than High
Risk clients in the control condition.
In Phase I, data will be analyzed to develop algorithms that predict early attrition from
treatment. RecoveryTrack™ will be modified (programmed) to generate an automated Clinical
Alert to inform counselors that a client is at an increased risk for dropout. This
modification to create RecoveryTrack + Clinical Alerts will be undertaken and beta-tested by
TRI research staff. While programming is taking place, components of a brief
cognitive-behavioral intervention will be adapted for use in tandem with RecoveryTrack +
Clinical Alerts; training and support materials will be developed. Phase I does not include
subject recruitment.
In Phase II, an open feasibility trial will be conducted at one treatment site to test the
RecoveryTrack + Clinical Alert system. The goal of this feasibility trial is to ensure that
the RecoveryTrack Clinical Alert System operates as intended in a clinical setting, and to
test the appropriateness and limitations of the 2-session cognitive behavioral intervention
(CBI) and adherence measures. Approximately three counselors will participate in a
feasibility trial expected to last 7-8 months. Participating counselors will participate in
the one-day training and then will deliver the CBI to clients who trigger a Clinical Alert.
Counselors will audio record individual sessions of participating clients, and complete a
RecoveryTrack CBI Clinician Checklist after each session; counselors will receive expert
feedback on their degree of adherence to the CBI from the audio recording of a randomly
selected client. Counselors will complete a Counselor Interaction Survey monthly to see to
what extent counselors are sharing information about the study with other colleagues at the
facility. At baseline, clients will complete an abridged version of the ASI6, a brief
Research RecoveryTrack assessment, a current treatment enrollment form, a short Readiness to
Change Questionnaire (RTCQ), a Primary Appraisal Measure (PAM), and a urine drug screen.
All baseline instruments will be administered by a research technician. Clients will also
complete monthly follow-up telephone interviews for 3 months in which they will complete a
full RecoveryTrack assessment and a TCU Engagement Form. At the end of the study, research
technicians will review the clinical charts of enrolled clients to measure days retained,
number of sessions attended, results of urine drug screens, and discharge information.
Finally, a focus group with the participating counselors will be conducted to explore how
working with Clinical Alerts impacted their clinical work.
Phase III is a randomized clinical trial (counselors randomized to training conditions
within site) comparing clinical outcomes from 300 clients assigned to counselors following a
standardized CBI employing RecoveryTrack + Clinical Alerts to those of 300 clients assigned
to counselors using RecoveryTrack in its original form (without Clinical Alerts, and without
training in the CBI). The experimental conditions in this trial will be similar in every
respect except for the differences in the type of Web-based software to which counselors are
assigned, and small differences in the type of training which counselors in the two
conditions receive. The two conditions are:
1. Web-Based RecoveryTrack with Clinical Alerts (ALERT): Counselors in this condition
will work with the modified RecoveryTrack tested in the feasibility study which has
been altered to provide automated Clinical Alerts at intake, Month 1, or Month 2
interviews for High Risk clients. Counselors in this condition will receive the
Clinical Alert + CBI training, as well as monthly feedback on their delivery of the CBI
Months 1-3, with a booster session at Month 6.
2. Web-Based RecoveryTrack without Clinical Alerts (TAU): Counselors in this condition
will work with the original RecoveryTrack which has not been altered to provide
automated Clinical Alerts for High Risk clients. The Clinical Alert feature will not
be discussed in the training these counselors receive. Rather, the counselors will
receive an attention-control training, a one-day booster in the use of the Addiction
Severity Index, with monthly ASI tips and reminders.
The investigators will recruit 12 counselors as well as 600 outpatient clients. The measures
in the Phase III randomized clinical trial will be the same as in the Phase II feasibility
study. The program director will complete the Addiction Treatment Inventory. Counselors
will complete the Clinician and Supervisor Survey, audio record sessions with enrolled
clients, and complete RecoveryTrack CBI Clinician Checklists. In addition, counselors will
complete the Counselor Interaction Survey monthly, which is designed to gather information
about any possible counselor between-condition contamination.
treatment. RecoveryTrack™ will be modified (programmed) to generate an automated Clinical
Alert to inform counselors that a client is at an increased risk for dropout. This
modification to create RecoveryTrack + Clinical Alerts will be undertaken and beta-tested by
TRI research staff. While programming is taking place, components of a brief
cognitive-behavioral intervention will be adapted for use in tandem with RecoveryTrack +
Clinical Alerts; training and support materials will be developed. Phase I does not include
subject recruitment.
In Phase II, an open feasibility trial will be conducted at one treatment site to test the
RecoveryTrack + Clinical Alert system. The goal of this feasibility trial is to ensure that
the RecoveryTrack Clinical Alert System operates as intended in a clinical setting, and to
test the appropriateness and limitations of the 2-session cognitive behavioral intervention
(CBI) and adherence measures. Approximately three counselors will participate in a
feasibility trial expected to last 7-8 months. Participating counselors will participate in
the one-day training and then will deliver the CBI to clients who trigger a Clinical Alert.
Counselors will audio record individual sessions of participating clients, and complete a
RecoveryTrack CBI Clinician Checklist after each session; counselors will receive expert
feedback on their degree of adherence to the CBI from the audio recording of a randomly
selected client. Counselors will complete a Counselor Interaction Survey monthly to see to
what extent counselors are sharing information about the study with other colleagues at the
facility. At baseline, clients will complete an abridged version of the ASI6, a brief
Research RecoveryTrack assessment, a current treatment enrollment form, a short Readiness to
Change Questionnaire (RTCQ), a Primary Appraisal Measure (PAM), and a urine drug screen.
All baseline instruments will be administered by a research technician. Clients will also
complete monthly follow-up telephone interviews for 3 months in which they will complete a
full RecoveryTrack assessment and a TCU Engagement Form. At the end of the study, research
technicians will review the clinical charts of enrolled clients to measure days retained,
number of sessions attended, results of urine drug screens, and discharge information.
Finally, a focus group with the participating counselors will be conducted to explore how
working with Clinical Alerts impacted their clinical work.
Phase III is a randomized clinical trial (counselors randomized to training conditions
within site) comparing clinical outcomes from 300 clients assigned to counselors following a
standardized CBI employing RecoveryTrack + Clinical Alerts to those of 300 clients assigned
to counselors using RecoveryTrack in its original form (without Clinical Alerts, and without
training in the CBI). The experimental conditions in this trial will be similar in every
respect except for the differences in the type of Web-based software to which counselors are
assigned, and small differences in the type of training which counselors in the two
conditions receive. The two conditions are:
1. Web-Based RecoveryTrack with Clinical Alerts (ALERT): Counselors in this condition
will work with the modified RecoveryTrack tested in the feasibility study which has
been altered to provide automated Clinical Alerts at intake, Month 1, or Month 2
interviews for High Risk clients. Counselors in this condition will receive the
Clinical Alert + CBI training, as well as monthly feedback on their delivery of the CBI
Months 1-3, with a booster session at Month 6.
2. Web-Based RecoveryTrack without Clinical Alerts (TAU): Counselors in this condition
will work with the original RecoveryTrack which has not been altered to provide
automated Clinical Alerts for High Risk clients. The Clinical Alert feature will not
be discussed in the training these counselors receive. Rather, the counselors will
receive an attention-control training, a one-day booster in the use of the Addiction
Severity Index, with monthly ASI tips and reminders.
The investigators will recruit 12 counselors as well as 600 outpatient clients. The measures
in the Phase III randomized clinical trial will be the same as in the Phase II feasibility
study. The program director will complete the Addiction Treatment Inventory. Counselors
will complete the Clinician and Supervisor Survey, audio record sessions with enrolled
clients, and complete RecoveryTrack CBI Clinician Checklists. In addition, counselors will
complete the Counselor Interaction Survey monthly, which is designed to gather information
about any possible counselor between-condition contamination.
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
We found this trial at
4
sites
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