Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Iowa City, Iowa 52242


Purpose:

The purpose of this study is to evaluate the impact of physician/pharmacist collaborative teams on hypertension guideline adherence for patients with uncontrolled hypertension in six family medicine practice sites in Iowa.


Study summary:

BACKGROUND: Hypertension is a prevalent chronic condition that, if left untreated, can lead to significant cardiovascular morbidity and premature mortality. There are established, evidence-based guidelines for the treatment of hypertension. However, these guidelines are not routinely adhered to by all providers for reasons that are not well known or understood. In addition, inadequate control of BP nationwide has been well documented. This study will explore barriers to guideline adherence (Phase I) and evaluate, via a randomized controlled trial, a new approach to enhancing guideline adherence and ultimately BP control. DESIGN NARRATIVE: The long-range goal of the principal investigator is to develop and evaluate collaborative relationships between physicians and pharmacists that improve pharmacotherapy. This will be a 5-year, multicenter study to evaluate the impact of physician/pharmacist collaborative teams on adherence to hypertension guidelines (JNC-VI) in six community-based family practice sites. There will be two study phases. Phase I comprises a needs assessment to identify barriers to guideline adherence and design intervention implementation refinement strategies. Phase II will be a prospective, randomized trial to assess the impact of physician/pharmacist collaborative teams on hypertension guideline adherence and BP control. The specific aims of Phase I are (1) to identify the scope and nature of physician and patient variables that may contribute to poor guideline adherence and (2) to refine the intervention implementation strategy and design tools for assessing guideline adherence and barriers to adherence. The specific aims of Phase II are (1) to determine if there is a change in guideline adherence and knowledge of hypertension when physicians are involved in physician/pharmacist teams and 2) to determine if physician/pharmacist teams can achieve better BP control compared to usual care. The investigators expect that the improvement in guideline adherence and reduction in BP with this intervention will significantly impact patients with hypertension. Because there are more than 37 million Americans with uncontrolled hypertension, this model has the potential to become an important strategy to help achieve the BP goals for Healthy People 2010.


Criteria:

Inclusion Criteria for Phase II: - Poorly controlled blood pressure based on clinic blood pressures - Males or females, over 21 years of age - Taking zero to three BP medications with no change in the regimen or dose within the past 4 weeks - Have established medical care at the Family Medicine Clinic - Nondiabetic patients with clinic BP values (average of the last three clinic readings during the previous 12 months) of 140 to 179 mm Hg systolic BP or 90 to 109 mm Hg diastolic BP, or diabetic patients with clinic BP values of 130 to 179 systolic or 80 to 109 diastolic Exclusion Criteria for Phase II: - Stage 3 hypertension (BPs greater than 180/110 mm Hg), or any evidence of hypertensive urgency or emergency - Recent myocardial infarction or stroke (within the past 6 months prior to enrollment) - New York Heart Association Class III or IV congestive heart failure - Unstable angina - Serious renal or hepatic disease, including greater than or equal to 1 gram of proteinuria per day - Pregnancy - Poor prognosis with a life expectancy estimated at less than 3 years - Dementia or cognitive impairment


Study is Available At:


Original ID:

272


NCT ID:

NCT00201019


Secondary ID:

R01HL070740


Study Acronym:


Brief Title:

Improving Adherence to Blood Pressure Guidelines


Official Title:

Improving Adherence to Blood Pressure Guidelines


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


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:

3


Number of Groups:

0


Total Enrollment:

623


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barry L. Carter, PharmD
Principal Investigator
University of Iowa

Study Dates

Start Date:August 2003
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 30, 2015
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Physician-pharmacist relationship
Time Frame:Measured prior to the start of the study and at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient medication adherence
Time Frame:Measured at the time of enrollment and when the participant completes the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Physician knowledge
Time Frame:Measured prior to the start of the study and at the end of the study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood pressure control
Time Frame:Measured at baseline, 3 months, and 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Adherence to hypertension guidelines
Time Frame:Measured for two 6 month periods: the first is prior to the participant's enrollment in the study an
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Physician-pharmacist collaborative intervention
Description:Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.
Arm Name:1

Study Arms

Study Arm Type:No Intervention
Arm Name:3
Description:Passive intervention participants receive care by the same physicians caring for participants in the active intervention arm but are not seen by a clinical pharmacist. They are not actively enrolled in the study and do not have study visits for measuring blood pressure.
Study Arm Type:No Intervention
Arm Name:2
Description:Control participants do not receive recommendations from a clinical pharmacist.
Study Arm Type:Experimental
Arm Name:1
Description:Active intervention participants receive a physician-pharmacist collaborative intervention.

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, 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. doi: 10.1001/archinternmed.2009.316. Review.
PMID:19858431
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 Sep;6(5):583-94. Review.
PMID:17877445
Reference Type:Reference
Citation:Ardery G, Carter BL, Milchak JL, Bergus GR, Dawson JD, James PA, Franciscus C, Kim Y. Explicit and implicit evaluation of physician adherence to hypertension guidelines. J Clin Hypertens (Greenwich). 2007 Feb;9(2):113-9.
PMID:17268216
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.
PMID:16982966
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:Milchak JL, Carter BL, Ardery G, Black HR, Bakris GL, Jones DW, Kreiter CD. Development of explicit criteria to measure adherence to hypertension guidelines. J Hum Hypertens. 2006 Jun;20(6):426-33.
PMID:16543909
Reference Type:Reference
Citation:Milchak JL, Carter BL, James PA, Ardery G. Measuring adherence to practice guidelines for the management of hypertension: an evaluation of the literature. Hypertension. 2004 Nov;44(5):602-8. Epub 2004 Sep 20. Review.
PMID:15381676

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.