Can Vignettes Be Used to Improve Practice & Outcome

This study has been terminated.

Sponsor:

Information provided by:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00122148

First received: July 18, 2005

Last updated: February 4, 2010

Last verified: August 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

July 18, 2005

Last Updated Date

February 4, 2010

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Disease-specific patient care indicators, comparing results at six months.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00122148 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Can Vignettes Be Used to Improve Practice & Outcome

Official Title ^ICMJE

Can Vignettes be Used to Improve Practice and Outcomes?

Brief Summary

This is a pilot study to first measure the cross-sectional relationship between variations in physicians� vignette scores and aggregated scores of individual physicians� patient health outcomes; and second to (longitudinally) determine whether feedback of vignette scores improves physicians� clinical performance as measured by vignettes

Detailed Description

Study Design: Physicians will complete computerized vignettes for four conditions � diabetes, coronary artery diseases (CAD), chronic obstructive pulmonary disease (COPD), and depression. We will collect retrospective outcomes data and develop composite outcome measures for on two conditions, Diabetes and CAD. For the longitudinal analysis, only vignette data will be collected and fed back to providers. Feedback will consist of specific data on vignette outcome scores for the individual physicians and for the sites overall.
Site Selection: Primary care clinics at 2 VAMCs
Study Population and Sampling: We will enroll primary care physicians at 2 VAMCs. 30 consenting physicians will be prospectively randomized into two groups. One group will receive feedback of their vignette scores, and the other group will serve as control, receiving no feedback.
Variables and Measurement Instruments: Computerized vignettes measuring clinical practice completed by the physicians for diabetes, CAD, COPD, and Depression and a composite health outcome measures from the medical records of these physicians� patients with diabetes and CAD.
Data Collection Strategy and Timeline: Vignettes will be administered to all physicians at baseline, with feedback of scores 3 months later and readministration of vignettes 9 months thereafter to measure the trend in improvement. The composite outcome data will only be collected at baseline only.
Data Analysis: The statistical analysis will compare the effects within the context of an analysis of covariance (ANCOVA) model. The analyte is the quality of care physicians give to patients with four common conditions. The relationship between vignette scores and patient outcomes will be modeled accounting for clustering effects. The prospective experimental design will be used to quantify possible differences between the intervention and control groups. The data will be analyzed using a three-way crossed, one-way nested ANCOVA model where the covariate is the baseline vignette score. This model can be used to look at case effects, by domain, level of training, and by site.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Behavioral: Feedback on provision of care

Study Arms

Intervention: Behavioral: Feedback on provision of care

Publications *

Peabody JW, Luck J, Jain S, Bertenthal D, Glassman P. Assessing the accuracy of administrative data in health information systems. Med Care. 2004 Nov;42(11):1066-72.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Physician at SF VAMC with panel of primary care patients

Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00122148

Other Study ID Numbers ^ICMJE

IIR 01-189

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Jain, Sharad - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

VA Office of Research and Development

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sharad Jain, MD

San Francisco

PRS Account

VA Office of Research and Development

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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