Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback

April 29, 2012 updated by: Henry Fischer, Denver Health and Hospital Authority
Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?

Study Overview

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

Interventional

Enrollment (Actual)

5457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: henry h fischer, md, Denver Health and Hospital Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 29, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

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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