ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00827710
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Henry Fischer, Denver Health and Hospital Authority

Brief Summary:
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?

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: point of care patient report cards Behavioral: Provider performance report card Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5457 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : December 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1
patients who received point-of-care report cards and were listed on provider performance report card
Behavioral: point of care patient report cards
gives patient feedback on performance on glycemic, lipid, and blood pressure control relative to expert recommended goals
Behavioral: Provider performance report card
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
Behavioral: point of care patient report cards
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
Behavioral: 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



Primary Outcome Measures :
  1. Percent of patients with HgA1c < 7 [ Time Frame: january 2009 ]
  2. Percent of patients with LDL < 100 mg/dL [ Time Frame: january 2009 ]
  3. Percent of patients with BP < 130/80 [ Time Frame: january 2009 ]

Secondary Outcome Measures :
  1. Percent of patients with A1c checked in last 6 months [ Time Frame: january 2009 ]
  2. Percent of patients with LDL checked in past year [ Time Frame: january 2009 ]
  3. Percent of patients with BP checked in past year [ Time Frame: january 2009 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827710


Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: henry h fischer, md Denver Health and Hospital Authority

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry Fischer, MD, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT00827710     History of Changes
Other Study ID Numbers: AHRQ 290-2006-000-20
AHRQ Contract 290-2006-000-20
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Henry Fischer, Denver Health and Hospital Authority:
diabetes
registry
computer
self management