search
Back to results

Evaluation of Web-Based Recovery Monitoring With Clinical Alerts

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Intervention
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Clinical Alert, Cognitive Behavioral Intervention, Web-based, 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

Sites / Locations

  • Kent Sussex Counseling Services
  • Brandywine Counseling & Community Services
  • Genesis Counseling Centers
  • Sobriety Through Outpatient

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clinical Alert

Treatment As Usual

Arm Description

Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.

Counselors in this condition will work with the original RecoveryTrack which has not been altered to provide automated Clinical Alerts for High Risk patients. Supervisors will receive no automated help in identifying these clients in the counselors' caseloads. 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 training on assessment and treatment planning, with monthly tips and reminders for six months.

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

Number of treatment sessions
The number of treatment sessions the client attended will be obtained from the treatment program clinical record.
Urine drug screen results
The urine drug screen results for each client will be obtained from the treatment program clinical record.
Number of treatment services
Number of treatment services will be obtained from the client as self report at the 1, 2, and 3 Month follow-up.

Full Information

First Posted
November 1, 2011
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01465555
Brief Title
Evaluation of Web-Based Recovery Monitoring With Clinical Alerts
Official Title
Evaluation of Web-Based Recovery Monitoring With Clinical Alerts
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Phase 1:Our study team completed Phase I of the project in June, 2011. Our initial plans called for our team to analyze RT data that was collected by Delaware treatment programs to determine specific predictors for early attrition from treatment. Eleven counselors were trained to use RT as part of their standard practice in May, 2011. In an effort to generate a predictive algorithm for Phase II, we analyzed data from three datasets available from IRB approved research projects. However, the results were inconclusive, possibly due to small sample sizes and differences in the recruitment and definition of drop out across samples. In order to proceed with Phase II, we created an algorithm based largely on severity of substance use, a consistent predictor of drop-out across the alcohol and illicit substance literature; the algorithm also addresses when clients are not using but their Risk factors greatly outweigh the influence of Protective factors. We determined that the algorithm did work to identify clients who self-reported using substances or high levels of risk. However, the identification rate of high-risk cases was too low, and so we modified the algorithm to identify: 1) clients with high use at baseline, 2) clients with positive urine samples, 3) clients with any use at subsequent [post-baseline] interviews, and 4) clients whose risk factors outweighed their protective factors. This increased our rate of identification of risk cases by about 32%. As part of Phase I, we also completed the programming changes to RT to add a Clinical Alert feature that informs counselors when a client is at high risk based on the algorithm. The CBI intervention and training materials for Phase II was created. We developed the CBI into a brief clinical "toolkit" that enabled counselors to respond to clinical risk based on their judgment. This Toolkit allows counselors to exercise clinical judgment to determine whether clients are generating a Clinical Alert because 1) they are using drugs or alcohol, or are at risk to start using, 2) they have unmet psychosocial needs [i.e., need for psychiatric consultation], or 3) they have a poor alliance with the counselor / treatment provider and need some help building on the relationship. The Clinical Alert Toolkit included a series of exercises / interventions that counselors could deploy once they had determined which of the client's needs were most pressing (either based on their own judgment or in agreement with the client). Phase 2:Three counselors consented to participate in this study and were trained to use RT in May, 2011 and were trained on the CBI intervention in June, 2011. Recruitment of client participants began in July, 2011. The training and intervention materials were well received by the participating counselors. One counselor ended their employment prior to the research staff beginning client recruitment. 30 clients out of 35 who were approached participated in the feasibility trial; 28 clients completed baseline (93%), 23 completed the one month follow up (77%), 21 completed the two month follow up (70%), and 21 completed the three month follow up (70%). Out of these clients, two clients were incarcerated for their 1 month follow up window, 2 clients were incarcerated for their 2 month follow up window, and three clients were incarcerated for their three month follow up window therefore they were not approached to complete the follow-up interview. We used our experiences during Phase II to make several changes in our training and clinical protocol for counselors to follow. We revised several of our Toolkit components (specifically the worksheets to make them more user-friendly and to reduce training burden). We also simplified our feedback strategy which took place during the clinical supervision sessions to focus much less on general therapeutic skills and more specifically on actual compliance with the trained Clinical Alert CBI. Additionally, we found that while our Phase II training counselors verbalized motivation to try to learn to use the CBI techniques, that the learning curve was slower than we desired, and we decided to employ a contingency management feedback strategy to increase their incentive to acquire the basic elements of the CBI more quickly. This revision required IRB approval; in the revised approach, counselors could earn bonuses when a rated audio recorded session showed that they had been at least minimally adherent in delivering the CBI. Finally, during Phase II we completed the Attention Control training (focused on treatment planning) for use in the TAU condition. Phase 3: Because we needed to move the study from Delaware Site 1 (our original clinical site and partner), our team recruited Alternate Site 1 in Philadelphia and Alternate Site 2 in central New Jersey to conduct the Phase III clinical pilot trial. We enrolled 20 counselors who were trained to use RT on a monthly basis with their clients, starting at the first scheduled individual session and monthly thereafter. We randomly assigned these counselors to receive either TAU treatment planning training or to receive Clinical Alert (CA) training. After training, recruitment began. During the trial, three counselors in the CA condition either were noncompliant with the study protocol (N = 2), or never had any clients report any high risk (N = 1). We worked with all three of these counselors to encourage improved engagement with the intervention and study procedures, but this was not successful. Consequently, we decided that we would over-recruit additional counselors into the CA condition, to create additional opportunities to determine whether the Clinical Alerts + Intervention training would impact outcomes. We recruited an additional three counselors, but did not randomize them; rather, we assigned them directly to the CA condition. We enrolled 336 clients in Phase 3. 142 self-reported clinical RT data which would result in a Clinical Alert profile (TAU: N = 78, CA: N = 64). Because of a low recruitment rate, the study was severely underpowered for our subanalyses to examine specific effects of the intervention training on dealing with High Risk cases; this is where we believed our strongest effects would present themselves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Clinical Alert, Cognitive Behavioral Intervention, Web-based, Substance Abuse Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
389 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Alert
Arm Type
Experimental
Arm Description
Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Counselors in this condition will work with the original RecoveryTrack which has not been altered to provide automated Clinical Alerts for High Risk patients. Supervisors will receive no automated help in identifying these clients in the counselors' caseloads. 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 training on assessment and treatment planning, with monthly tips and reminders for six months.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Intervention
Intervention Description
Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
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
3 months post consent
Secondary Outcome Measure Information:
Title
Number of treatment sessions
Description
The number of treatment sessions the client attended will be obtained from the treatment program clinical record.
Time Frame
3 months after consent
Title
Urine drug screen results
Description
The urine drug screen results for each client will be obtained from the treatment program clinical record.
Time Frame
3 months post consent
Title
Number of treatment services
Description
Number of treatment services will be obtained from the client as self report at the 1, 2, and 3 Month follow-up.
Time Frame
3 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam C Brooks, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kent Sussex Counseling Services
City
Dover
State/Province
Delaware
ZIP/Postal Code
19904
Country
United States
Facility Name
Brandywine Counseling & Community Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
Facility Name
Genesis Counseling Centers
City
Collingswood
State/Province
New Jersey
ZIP/Postal Code
08108
Country
United States
Facility Name
Sobriety Through Outpatient
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Web-Based Recovery Monitoring With Clinical Alerts

We'll reach out to this number within 24 hrs