- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00798044
Patient Feedback Effectiveness Study
January 18, 2012 updated by: Paul Crits-Christoph, University of Pennsylvania
The purpose of the study is to determine if a semi-automated quality improvement system that provides addiction counselors with feedback on their average treatment satisfaction and therapeutic alliance (as rated by patients currently in treatment) is superior to no feedback in 32 community-based outpatient addiction treatment clinics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Quality improvement (Ql) methods are a cornerstone of business and healthcare management throughout the United States yet there have been few studies of Ql interventions in addiction treatment settings.
The proposed study tests the effectiveness of one Ql system - Patient Feedback (PF) - at increasing outpatient group therapy attendance and self-reported abstinence.
The feasibility and acceptability of PF was established in a six-site study conducted within the National Drug Abuse Treatment Clinical Trials Network.
In the proposed study, 32 community-based outpatient treatment programs with approximately 250 clinicians will be randomly assigned to PF, or usual clinic practices.
In the PF condition, every week fro 12 weeks clinic patients are invited to complete a 12-item, self-administered survey in which they rate therapeutic alliance and treatment satisfaction, and report past week substance use.
These anonymous surveys are faxed by clinic staff to a University of Pennsylvania data center where a custom software application converts the surveys into feedback reports and posts them to a password protected website.
Clinicians can access their caseload feedback reports and aggregated reports for the whole clinic; supervisors can only access the aggregated clinic reports.
On a monthly basis staff meet as a team to review the feedback reports and develop Ql plans intended to yield improvements in select Ql indicators.
The PF website and the monthly PF e-newsletter provide social recognition, clinical resources, and a virtual community for participating clinicians.
After 12 weeks, participants in both conditions complete follow-up measures and then both groups are given open access to PF for 12 additional months.
During "sustainability phase" staff usage of the PF website is monitored.
Alternate versions of the PF Survey are introduced during the sustainability study, including one that monitors HIV risk behavior.
The rapid processing of surveys enables near real time feedback to clinic staff.
Organizations may share their feedback reports with funding sources, regulatory agencies, policy makers, and other stakeholders.
This centralized, semi-automated feedback system eases fulfillment of accreditation requirements and as such, reduces the cost of clinic operations.
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10010
- New York University School of Medicine
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- program: adult, outpatient, non-methadone maintenance substance abuse treatment programs
- clinician: must be leading at least one weekly group with minimum of 5 patients
- must be working at least 20% time at facility
Exclusion Criteria:
- clinics with fewer than 5 clinicians who conduct weekly group counseling
- clinics in which fewer than 50% of clinicians agree to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Feedback to counselors
substance abuse counselors received feedback reports on their average performance and on the average performance of the clinic as a whole.
Feedback reports contained information on average alliance, treatment satisfaction, and drug/alcohol use.
|
Surveys patients regarding treatment experiences.
Weekly feedback reports provided to counselors
|
No Intervention: Treatment as Usual
No feedback reports were provided in this arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinician average weekly caseload patient-rated therapeutic alliance
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Crits-Christoph, Ph.D., University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
November 24, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Estimate)
January 20, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA020799 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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