Expired Study
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Iowa City, Iowa 52242


Purpose:

The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.


Study summary:

BACKGROUND: The Healthy People 2010 target calls for controlled BP in 50% of the 50 million Americans with hypertension. BP is currently controlled in only 27% of the population. These population figures are in contrast to data from clinical trials (efficacy) in which BP has been controlled in 70 to 80% of study participants. Poor BP control exists in spite of six sets of guidelines generated over the last 30 years in the United States. While there are many causes for poor control, several studies have found that physicians are frequently satisfied with uncontrolled BPs. Numerous strategies exist to assist physicians with achieving better BP control, but a consistent, effective approach to solving the problem has not been found. DESIGN NARRATIVE: The objective of this study is to test whether BP control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams. The rationale for this proposal is generated from studies demonstrating that physician knowledge, quality of prescribing, and attainment of treatment goals can be improved when physicians collaborate with clinical pharmacists. Previous studies have suffered from insufficient sample size and controls and did not include a structured intervention. This study will address these gaps in knowledge by conducting a randomized, prospective study in 5 clinics (2 intervention and 3 control) with 27 physicians who care for 180 patients with uncontrolled BP. The structured intervention will involve clinical pharmacists who evaluate BP therapy and treatment strategies and make specific recommendations to the physician. Patients will be seen at baseline and at 2, 4, 6, 8, and 9 months, at which time random zero BP measurements will be performed. The specific aims of this study are (1) to determine if better BP control can be achieved by the use of physician/pharmacist teams that utilize physician education and feedback when compared to usual care, (2) to determine if improvements in BP control are related to an increase in physician knowledge of and adherence to BP guidelines when they are involved in physician/pharmacist teams, and (3) to determine if changes in BP control are associated with the level and scope of the physician/pharmacist relationships. This model utilizes an innovative system approach to improve BP control. This intervention has the potential to achieve marked improvements in BP control. This model could become one additional strategy to help achieve the BP goals for Healthy People 2010.


Criteria:

Inclusion Criteria: - Males or females, age 21-85 - Taking 0-3 antihypertensive medications with no changes in regimen or dose within the past 4 weeks - Non-diabetic with clinic BP 145-179 / 95-109 or diabetic with BP greater than 135/85 Exclusion Criteria: - Previous 24 hour BP monitoring consult service within the past 6 months - Stage 3 hypertension greater than 180/110 - Recent MI or stroke within the past 6 months - Class III or IV congestive heart failure - Unstable angina - Uncontrolled atrial fibrillation - Serious renal disease (serum creatinine greater than 3.5) - Serious hepatic disease (total bilirubin greater than 3.0) - Pregnancy - Poor prognosis with less than a 3 year life expectancy


Study is Available At:


Original ID:

271


NCT ID:

NCT00201045


Secondary ID:

R01HL069801


Study Acronym:


Brief Title:

Team Management of High Blood Pressure


Official Title:

Collaborative Management of Hypertension


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Iowa


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

179


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barry L. Carter
Study Chair
University of Iowa

Study Dates

Start Date:July 2003
Completion Date:October 2006
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:March 26, 2014
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Physician knowledge
Time Frame:Measured at the beginning and at the end of the study.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Side effect score
Time Frame:Measured when each patient completed the study.
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Mean number of antihypertensives
Time Frame:Measured when each patient completed the study.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Blood pressure control
Time Frame:Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Physician/Pharmacist Collaborative Teams
Description:The patient's physician collaborates with a clinical pharmacist to improve management of hypertension
Arm Name:Intervention

Study Arms

Study Arm Type:No Intervention
Arm Name:Control
Description:Control patients receive usual care and do not have a clinical pharmacist included in their care.
Study Arm Type:Experimental
Arm Name:Intervention
Description:Intervention patients receive care from a clinical pharmacist to improve blood pressure.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Iowa
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Carter BL, Hartz A, Bergus G, Dawson JD, Doucette WR, Stewart JJ, Xu Y. Relationship between physician knowledge of hypertension and blood pressure control. J Clin Hypertens (Greenwich). 2006 Jul;8(7):481-6.
PMID:16849901
Reference Type:Reference
Citation:Carter BL. Antihypertensive prescribing: do we have reason to celebrate? Hypertension. 2006 Nov;48(5):816-7. Epub 2006 Sep 18. Review. No abstract available.
PMID:16982966
Reference Type:Reference
Citation:Carter BL & Sica DA. Strategies to improve the cardiovascular risk profile of thiazide-type diuretics as used in the management of hypertension. Expert Opin Drug Saf. 2007 September; 6(5):583-594
Reference Type:Reference
Citation:Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009 Oct 26;169(19):1748-55.
PMID:19858431
Reference Type:Results Reference
Citation:Carter BL, Bergus GR, Dawson JD, Farris KB, Doucette WR, Chrischilles EA, Hartz AJ. A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control. J Clin Hypertens (Greenwich). 2008 Apr;10(4):260-71.
PMID:18401223

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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