Clinical trial NCT00743808: Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
Official title: Improving Hypertension Control in Individuals With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: hypertension
diabetes
quality improvement
blood pressure
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Advocate Medical Group
name: Baystate Health
name: William Beaumont Hospitals
name: Columbia Park Medical Group
name: Humboldt Del Norte Independent Practice Association
name: Metropolitan Health
name: Park Nicollet Clinic
name: PeaceHealth Medical Group
name: Sanford Clinic
name: TriHealth Inc.
name: University Hospitals Medical Practices
name: Warren Clinic
name: Novartis
First posted: 2008-08-29
Enrollment: 11510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.

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 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)

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 1 year
Secondary outcomes:
measure: Measure changes in action taken related to improving blood pressure management as percent of providers reporting changing (initiating or adjusting) blood pressure medication
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: International Diabetes Center - Park Nicollet Institute
name: Margaret A Powers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Robert M Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.