NCT00743808

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

June 9, 2008

Last Update Submit

November 30, 2015

Conditions

Keywords

hypertensiondiabetesquality improvementblood pressure

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    1 year

Secondary Outcomes (1)

  • Measure changes in action taken related to improving blood pressure management as percent of providers reporting changing (initiating or adjusting) blood pressure medication

    1 year

Interventions

3-phase quality improvement intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 10666428BACKGROUND
  • 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.

    PMID: 12748199BACKGROUND
  • 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.

    PMID: 16585660BACKGROUND
  • 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.

    PMID: 10938049BACKGROUND
  • 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.

    PMID: 10789664BACKGROUND

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Study Officials

  • Margaret A Powers, PhD

    International Diabetes Center - Park Nicollet Institute

    PRINCIPAL INVESTIGATOR
  • Robert M Cuddihy, MD

    International Diabetes Center - Park Nicollet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

August 29, 2008

Study Start

December 1, 2006

Primary Completion

May 1, 2008

Study Completion

September 1, 2010

Last Updated

December 2, 2015

Record last verified: 2013-08