Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes

This study has been completed.
Sponsor:
Collaborators:
Advocate Medical Group
Baystate Health
William Beaumont Hospitals
Columbia Park Medical Group
Humboldt Del Norte Independent Practice Association
Metropolitan Health
Park Nicollet Clinic
PeaceHealth Medical Group
Sanford Clinic
TriHealth Inc.
University Hospitals Medical Practices
Warren Clinic
Novartis
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00743808
First received: June 9, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

Twelve health organizations from around the US were selected to participate in a chart review Hypertension and Diabetes Initiative with the goal of improving blood pressure control in persons with diabetes.

Hypothesis:

A three-phase quality improvement initiative facilitated and monitored through the International Diabetes Center (IDC) will result in improved population-mean systolic blood pressure in the aggregate data pool of patients from all 12 participating sites at geographically distinct health systems.


Condition Intervention
Hypertension
Other: quality improvement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Hypertension Control in Individuals With Diabetes

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure changes in action taken related to improving blood pressure management as percent of providers reporting changing (initiating or adjusting) blood pressure medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 11510
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: quality improvement
    3-phase quality improvement intervention
Detailed Description:

Phase 1 - Preparation: Each participating site begins to organize itself for the project. Baseline data will be collected and will be used to benchmark where each site is relative to blood pressure control/management of persons with diabetes prior to the implementation of the training programs.

Phase 2 - Implementation: Sites begin to address the gaps they have identified that affect blood pressure outcomes of patients with diabetes. IDC provides two on-site training programs for providers and support staff.

Phase 3 - Follow-up: IDC provides on-going support to each site via individual and collaborative conference calls and resources on the project Web site. Patient and visit data (audit form) will be collected six and 12 months after training. This data will be compared to the site's pre-training data.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • ICD-9 Code 250 (indicates type 1 or type 2 diabetes)
  • ICD- Code 648.0 (indicates pregnancy with type 1 or type 2 diabetes)
  • ICD-9 Code 357.2 or 362.0, indicating complications of diabetes.
  • A prescription for insulin or oral hypoglycemic agents
  • Include those 18-75 years

Exclusion Criteria:

  • Attend a dialysis unit (if the nephrologist is primary care manager)
  • Have gestational diabetes (ICD-9 Code 648.8)
  • Have a terminal illness (e.g., hospice patient)
  • Do not have a documented blood pressure within the past year (this is asked on the audit form)
  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: NCT00743808

Sponsors and Collaborators
Park Nicollet Institute
Advocate Medical Group
Baystate Health
William Beaumont Hospitals
Columbia Park Medical Group
Humboldt Del Norte Independent Practice Association
Metropolitan Health
Park Nicollet Clinic
PeaceHealth Medical Group
Sanford Clinic
TriHealth Inc.
University Hospitals Medical Practices
Warren Clinic
Novartis
Investigators
Principal Investigator: Margaret A Powers, PhD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Robert M Cuddihy, MD International Diabetes Center - Park Nicollet Institute
  More Information

Publications:

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00743808     History of Changes
Other Study ID Numbers: 03527-06-C
Study First Received: June 9, 2008
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
hypertension
diabetes
quality improvement
blood pressure

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014