NCT01465555

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 RecoveryTrackâ„¢ 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

November 1, 2011

Last Update Submit

March 27, 2023

Conditions

Keywords

Clinical AlertCognitive Behavioral InterventionWeb-basedSubstance Abuse Treatment

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.

    3 months post consent

Secondary Outcomes (3)

  • Number of treatment sessions

    3 months after consent

  • Urine drug screen results

    3 months post consent

  • Number of treatment services

    3 months post consent

Study Arms (2)

Clinical Alert

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Intervention

Treatment As Usual

NO INTERVENTION

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.

Interventions

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.

Clinical Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
  • Counselor employed at participating facility.

You may not qualify if:

  • Client unable to speak English
  • Client too cognitively impaired to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kent Sussex Counseling Services

Dover, Delaware, 19904, United States

Location

Brandywine Counseling & Community Services

Wilmington, Delaware, 19805, United States

Location

Genesis Counseling Centers

Collingswood, New Jersey, 08108, United States

Location

Sobriety Through Outpatient

Philadelphia, Pennsylvania, 19132, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Adam C Brooks, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 7, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations