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

November 30, 2015 updated by: HealthPartners Institute

Improving Hypertension Control in Individuals With Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

11510

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

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

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

Sponsor

HealthPartners Institute

Collaborators

Novartis
TriHealth Inc.
William Beaumont Hospitals
Advocate Medical Group
Baystate Health
Columbia Park Medical Group
Humboldt Del Norte Independent Practice Association
Metropolitan Health
Park Nicollet Clinic
PeaceHealth Medical Group
Sanford Clinic
University Hospitals Medical Practices
Warren Clinic

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

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.

General Publications

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, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03527-06-C

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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