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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henry Fischer, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00827710
First received: January 14, 2009
Last updated: April 29, 2012
Last verified: April 2012
  Purpose

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 Intervention
Diabetes
Behavioral: point of care patient report cards
Behavioral: Provider performance report card

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Percent of patients with HgA1c < 7 [ Time Frame: january 2009 ] [ Designated as safety issue: No ]
  • Percent of patients with LDL < 100 mg/dL [ Time Frame: january 2009 ] [ Designated as safety issue: No ]
  • Percent of patients with BP < 130/80 [ Time Frame: january 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients with A1c checked in last 6 months [ Time Frame: january 2009 ] [ Designated as safety issue: No ]
  • Percent of patients with LDL checked in past year [ Time Frame: january 2009 ] [ Designated as safety issue: No ]
  • Percent of patients with BP checked in past year [ Time Frame: january 2009 ] [ Designated as safety issue: No ]

Enrollment: 5457
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827710

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
Principal Investigator: henry h fischer, md Denver Health and Hospital Authority
  More Information

No publications provided by Denver Health and Hospital Authority

Additional 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
Study First Received: January 14, 2009
Last Updated: April 29, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014