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Patient Feedback: A Quality Improvement Study in Outpatient Settings
This study is ongoing, but not recruiting participants.
First Received: February 7, 2008   Last Updated: October 28, 2008   History of Changes
Sponsors and Collaborators: University of Pennsylvania
New York University School of Medicine
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00622154
  Purpose

The purpose of this study is to assess whether the use of a performance improvement intervention (Patient Feedback) increases clinician performance (as assessed by average clinician caseload rates of reduced drug and alcohol use and attendance) in community-based substance abuse treatment programs.


Condition Intervention
Substance Abuse
Behavioral: Patient Feedback system

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Patient Feedback: A Quality Improvement Study in Outpatient Settings

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reduction of drug and alcohol use [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient ratings of therapeutic alliance [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
  • Patient ratings of treatment satisfaction [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
  • Quality of clinician/supervisor interactions [ Time Frame: Baseline (week 1) and week 12 ] [ Designated as safety issue: No ]
  • Patient attendance [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention: Experimental
Clinics which utilize the full patient feedback system for a 12 week period.
Behavioral: Patient Feedback system
Patient Feedback is a bundled intervention designed to rapidly capture and feed back patient ratings of therapeutic alliance, treatment satisfaction, and patient attendance rates. Additionally, the Patient Feedback News and website provide social recognition for organizational achievements. Patient Feedback is composed of seven interrelated components: 1) Patient Feedback Survey; 2) Attendance Form; 3) Feedback Reports; 4) Team Meetings; 5) Patient Feedback News; 6) Patient Feedback Website; and 7) Internet-based Conferencing
Delayed: Active Comparator
Clinics which experience a 12 week delay before having access to the full patient feedback system.
Behavioral: Patient Feedback system
Patient Feedback is a bundled intervention designed to rapidly capture and feed back patient ratings of therapeutic alliance, treatment satisfaction, and patient attendance rates. Additionally, the Patient Feedback News and website provide social recognition for organizational achievements. Patient Feedback is composed of seven interrelated components: 1) Patient Feedback Survey; 2) Attendance Form; 3) Feedback Reports; 4) Team Meetings; 5) Patient Feedback News; 6) Patient Feedback Website; and 7) Internet-based Conferencing

Detailed Description:

Using clinician performance data obtained from the PF Survey, patient attendance data, and staff measures, we propose to achieve the following specific aims:

  1. Primary Objective Determine the degree to which there is a reduction in drug and alcohol use for the experimental condition clinicians examining baseline (week 1) to end of treatment (week 12), relative to the drug and alcohol use of patients in the corresponding control condition clinicians' caseload.
  2. Secondary Objective #1 Determine the degree to which clinicians' average patient ratings of therapeutic alliance in the PF condition improve, as compared to those in the control condition.
  3. Secondary Objective #2 Determine the degree to which clinicians' average patient ratings of treatment satisfaction in the PF condition improve, as compared to those in the control condition.
  4. Secondary Objective #3 Determine the degree to which the quality of clinician/supervisor interactions in the PF condition improves compared to those of staff in the control condition.
  5. Secondary Objective #4 When applicable and the data is available, determine the degree to which clinicians' average patient attendance in the PF condition improves during the Intervention Phase of the study, as compared to average patient attendance for clinicians in the control condition.

The primary endpoints to be measured in this study include:

1. Levels of patient drug and alcohol use per clinician. Patients report their own substance abuse within the past week on items 11 and 12 of the PF survey. The weekly averaged drug and alcohol use, averaged for all patients (and for the subset of patients in treatment for 1 month or less) for each clinician, will be used.

The secondary endpoints to be measured in this study include:

  1. Therapeutic Alliance. Ratings of therapeutic alliance are measured by items 1-4 on the PF survey. Measures are obtained on the same assessment schedule as the measures for the primary endpoint. Average patient alliance scores for each clinician are calculated and used as a dependent variable.
  2. Treatment Satisfaction. Ratings of treatment satisfaction are measured by items 5-7 on the PF survey. Measures are obtained on the same assessment schedule as the measures for the primary endpoints. Average patient treatment satisfaction ratings for each clinician are calculated and used as a dependent variable.
  3. Quality of clinician/supervisor interactions. Clinician/supervisor interactions measures are obtained from a total average of the LMX-7 measure, at the pre- and post-intervention time points.
  4. Patient Attendance rates per clinician. A member of the clinic support staff extracts attendance data from the clinic's administrative record and enters those data on to the Attendance Form (see Appendix A). Attendance rates will be calculated as the average weekly proportion of scheduled sessions attended by the patients assigned to each clinician during each of the 12 weeks of the intervention phase. Averages for all patients, and for the subset of patients who have been in treatment for 1 month or less, will be calculated.

The study consists of a pre-intervention phase lasting several weeks and an intervention phase lasting 12 weeks (or as many weeks as is necessary to collect 12 assessments, noting that clinic closures may occur for holidays, etc.). A final optional sustainability phase examines clinic use of the PF system over a one year period.

Individual clinics will be initiated on a rolling enrollment basis, in three cohorts of 10-12 clinics each.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinics are outpatient, non-methadone maintenance substance abuse treatment programs in the Philadelphia and New York City areas with clinicians who conduct group counseling at least weekly.
  • Clinicians are those working at participating clinics, treating adult (age 18 or above) clients, who give informed consent.
  • To participate, a clinician must be leading at least one weekly group with a minimum of 5 patients in the group.
  • Clinicians must work a minimum of 20% of time at clinic and be available to participate in internet based conference trainings during the hours of 9-5.

Exclusion Criteria:

  • Clinics with fewer than four clinicians who conduct group counseling at least weekly.
  • Clinics in which fewer than 50% of eligible clinicians agree to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622154

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10010
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
New York University School of Medicine
Investigators
Principal Investigator: Paul F Crits-Christoph, Ph.D. University of Pennsylvania
Principal Investigator: John Rotrosen, M.D. New York University School of Medicine
  More Information

No publications provided

Responsible Party: University of Pennsylvania ( Paul Crits-Christoph, PhD )
Study ID Numbers: 804615, 1-R01-DA-020799-01, 1-R01-DA-020809-1
Study First Received: February 7, 2008
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00622154     History of Changes
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Substance abuse
Quality control
Patient Feedback
Community mental health

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 03, 2009