Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
This study has been completed.
Sponsor:
Park Nicollet 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
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00743808
First received: June 9, 2008
Last updated: August 22, 2013
Last verified: August 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 9, 2008 | ||||||||
| Last Updated Date | August 22, 2013 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Systolic blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00743808 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Primary care clinic |
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| Condition ICMJE | Hypertension | ||||||||
| Intervention ICMJE | Other: quality improvement
3-phase quality improvement intervention |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 11510 | ||||||||
| Completion Date | September 2010 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00743808 | ||||||||
| Other Study ID Numbers ICMJE | 03527-06-C | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Park Nicollet Institute | ||||||||
| Study Sponsor ICMJE | Park Nicollet Institute | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Park Nicollet Institute | ||||||||
| Verification Date | August 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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