Can Vignettes Be Used to Improve Practice & Outcome

Tracking Information
First Submitted Date ICMJE	July 18, 2005
First Posted Date ICMJE	July 21, 2005
Last Update Posted Date	February 8, 2010
Study Start Date ICMJE	September 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 18, 2005)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
Condition ICMJE	Healthy
Intervention ICMJE	Behavioral: Feedback on provision of care
Study Arms	1; 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
Original Enrollment ICMJE; (submitted: July 18, 2005)	912
Actual Study 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, Older Adult
Accepts Healthy Volunteers	No
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	No
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