- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827710
Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our federally qualified health care center serves over 7000 diabetic patients, many of whom are uninsured (43%) or on medicaid (18%) or medicare (26%). The population is 54% Latino, 25% Caucasian, and 14% African American. We excluded patients older than 75; those without English or Spanish as a first language; and the homeless. The remaining 5457 patients were randomized to this one-year study which ended January 1, 2009. One-half of the enrolled patients received quarterly mailed report cards on their HgA1c, blood pressure, and lipid performance. They were asked to pick from a list of self-management goals and to see their provider if their last visit was more than 2 months prior to the mailing. In a 2x2 design, our eight clinics were randomized to i) on-site printing of patient report cards or no on-site printing and ii) standard provider performance report cards or enhanced provider report cards. The standard provider report cards included data on provider performance on HgA1c, LDL, and blood pressure compared to other providers. The enhanced provider report card also included a list of up to 10 patients not at HgA1c, LDL, or blood pressure goal. The provider report cards were distributed on a quarterly basis, and the point of care patient report cards were distributed at every clinic visit.
We are analyzing the impact of the intervention on the percent of patients at expert recommended goals for glycemic, lipid, and blood pressure control. We are also performing a qualitative analysis to describe provider and patient attitudes toward the interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver Health Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- icd9 code for diabetes
- primary care visit in the past 18 months
- English or Spanish as primary language
Exclusion Criteria:
- age more than 75
- No working address
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
patients who received point-of-care report cards and were listed on provider performance report card
|
gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals
Gives provider feedback on performance on their diabetes panel of patients and includes patient level data
|
|
Active Comparator: 2
Patients who received point-of-care diabetes report cards but were not listed on provider performance report card
|
gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals
|
|
Active Comparator: 3
Patients who did not receive point-of-care report card but who were listed on provider performance report card
|
Gives provider feedback on performance on their diabetes panel of patients and includes patient level data
|
|
No Intervention: 4
Patients who did not receive point of care report card and who did were not listed on provider performance report card
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent of patients with HgA1c < 7
Time Frame: january 2009
|
january 2009
|
|
Percent of patients with LDL < 100 mg/dL
Time Frame: january 2009
|
january 2009
|
|
Percent of patients with BP < 130/80
Time Frame: january 2009
|
january 2009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent of patients with A1c checked in last 6 months
Time Frame: january 2009
|
january 2009
|
|
Percent of patients with LDL checked in past year
Time Frame: january 2009
|
january 2009
|
|
Percent of patients with BP checked in past year
Time Frame: january 2009
|
january 2009
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: henry h fischer, md, Denver Health and Hospital Authority
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHRQ 290-2006-000-20
- AHRQ Contract 290-2006-000-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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