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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00798044
Other study ID # R01DA020799
Secondary ID R01DA020799
Status Completed
Phase N/A
First received November 24, 2008
Last updated January 18, 2012
Start date November 2006
Est. completion date April 2009

Study information

Verified date January 2012
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Other known NCT identifiers
  • NCT00622154

Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date April 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Other: quality improvement feedback system
Surveys patients regarding treatment experiences.
Patient Feedback
Weekly feedback reports provided to counselors

Locations

Country Name City State
United States New York University School of Medicine New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinician average weekly caseload patient-rated therapeutic alliance 12 weeks No
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