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

Tracking Information
First Submitted Date	June 9, 2008
First Posted Date	August 29, 2008
Last Update Posted Date	December 2, 2015
Study Start Date	December 2006
Actual Primary Completion Date	May 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 28, 2008)	Systolic blood pressure [ Time Frame: 1 year ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00743808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: August 28, 2008)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
Official Title	Improving Hypertension Control in Individuals With Diabetes
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Primary care clinic
Condition	Hypertension
Intervention	Other: quality improvement; 3-phase quality improvement intervention
Study Groups/Cohorts	Not Provided
Publications *	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. Erratum in: N Engl J Med 2000 May 4;342(18):1376.; 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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197.; 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.; 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.; 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. Erratum in: JAMA 2002 Dec 18;288(23):2976.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: August 22, 2013)	11510
Original Actual Enrollment; (submitted: August 28, 2008)	1
Actual Study Completion Date	September 2010
Actual Primary Completion Date	May 2008 (Final data collection date for primary outcome measure)
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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT00743808
Other Study ID Numbers	03527-06-C
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	HealthPartners Institute
Study Sponsor	HealthPartners Institute
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
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
PRS Account	HealthPartners Institute
Verification Date	August 2013