Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
NCT ID: NCT00743808
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11510 participants
OBSERVATIONAL
2006-12-31
2010-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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quality improvement
3-phase quality improvement intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Advocate Medical Group
OTHER
Baystate Health
OTHER
William Beaumont Hospitals
OTHER
Columbia Park Medical Group
OTHER
Humboldt Del Norte Independent Practice Association
UNKNOWN
Metropolitan Health
UNKNOWN
Park Nicollet Clinic
OTHER
PeaceHealth Medical Group
OTHER
Sanford Clinic
UNKNOWN
TriHealth Inc.
OTHER
University Hospitals Medical Practices
UNKNOWN
Warren Clinic
UNKNOWN
Novartis
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Margaret A Powers, PhD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center - Park Nicollet Institute
Robert M Cuddihy, MD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center - Park Nicollet Institute
References
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Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group; Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb 10;342(6):381-9. doi: 10.1056/NEJM200002103420603.
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
Saaddine JB, Cadwell B, Gregg EW, Engelgau MM, Vinicor F, Imperatore G, Narayan KM. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med. 2006 Apr 4;144(7):465-74. doi: 10.7326/0003-4819-144-7-200604040-00005.
Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000 Aug 12;321(7258):412-9. doi: 10.1136/bmj.321.7258.412.
Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). ALLHAT Collaborative Research Group. JAMA. 2000 Apr 19;283(15):1967-75.
Other Identifiers
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03527-06-C
Identifier Type: -
Identifier Source: org_study_id