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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00012701
Other study ID # HIS 99-042
Secondary ID
Status Completed
Phase N/A
First received March 14, 2001
Last updated April 6, 2015
Est. completion date June 2003

Study information

Verified date July 2005
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.


Description:

Background:

The VA is the largest single provider of HIV care in the United States. The late 1990's have seen a revolution in the quality standards for this disease with the onset of Highly Active Antiretroviral Therapy (HAART) and other developments.

Objectives:

Our purpose in this project is to develop a method for assessing quality in two important areas of HIV care - antiretroviral medications and opportunistic infection screening and prophylaxis - and explore the determinants of high quality care in order to suggest quality improvement strategies.

Methods:

The analysis has four parts. First, it will describe the level of adherence to the indicators in VA HIV patients nationwide and compare VA HIV patients to national benchmarks. Second, it will analyze facility and patient level predictors of adherence to indicators of quality of care and compare them with the predictors in the non VA population using staged logistic regressions. Third, it will seek to validate certain indicators (e.g. HAART therapy) against clinical outcomes like hospitalization and immune status. We will also model the clinical "price" that the VA pays in suboptimal clinical outcomes as a result of current performance levels. Fourth, we will compare the performance of the facilities after one year of an intensive targeted indicator-specific feedback group versus those receiving aggregate data only.

Status:

Data analysis.


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Facilities with HIV clinics

Exclusion Criteria:

Study Design

N/A


Locations

Country Name City State
United States VA San Diego Healthcare System, San Diego, CA San Diego California
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

Asch SM, Fremont AM, Turner BJ, Gifford A, McCutchan JA, Mathews WM, Bozzette SA, Shapiro MF. Symptom-based framework for assessing quality of HIV care. Int J Qual Health Care. 2004 Feb;16(1):41-50. — View Citation

Bozzette SA, Gifford AL. The economic viability of antiretroviral adherence interventions. Am J Med. 2003 Dec 1;115(8):672-3. — View Citation

Bozzette SA, Phillips B, Asch S, Gifford AL, Lenert L, Menke T, Ortiz E, Owens D, Deyton L. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Med — View Citation

Patterson ES, Nguyen AD, Halloran JP, Asch SM. Human factors barriers to the effective use of ten HIV clinical reminders. J Am Med Inform Assoc. 2004 Jan-Feb;11(1):50-9. Epub 2003 Oct 5. — View Citation

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