NCT00201019

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
623

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4.7 years

First QC Date

September 12, 2005

Last Update Submit

November 30, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Adherence to hypertension guidelines

    Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study

Secondary Outcomes (4)

  • Blood pressure control

    Measured at baseline, 3 months, and 6 months

  • Physician knowledge

    Measured prior to the start of the study and at the end of the study

  • Patient medication adherence

    Measured at the time of enrollment and when the participant completes the study

  • Physician-pharmacist relationship

    Measured prior to the start of the study and at the end of the study

Study Arms (3)

1

EXPERIMENTAL

Active intervention participants receive a physician-pharmacist collaborative intervention.

Behavioral: Physician-pharmacist collaborative intervention

2

NO INTERVENTION

Control participants do not receive recommendations from a clinical pharmacist.

3

NO INTERVENTION

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.

Interventions

Physician-pharmacist collaborative interventionBEHAVIORAL

Participants receive assessment and medication and lifestyle recommendations from a clinical pharmacist.

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa College of Pharmacy

Iowa City, Iowa, 52242, United States

Location

Related Publications (8)

  • 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. doi: 10.1161/01.HYP.0000144100.29945.5e. Epub 2004 Sep 20.

    PMID: 15381676BACKGROUND

  • 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. doi: 10.1038/sj.jhh.1002005.

    PMID: 16543909BACKGROUND

  • 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. doi: 10.1111/j.1524-6175.2006.05601.x.

    PMID: 16849901BACKGROUND

  • Carter BL. Antihypertensive prescribing: do we have reason to celebrate? Hypertension. 2006 Nov;48(5):816-7. doi: 10.1161/01.HYP.0000240978.77934.3a. Epub 2006 Sep 18. No abstract available.

    PMID: 16982966BACKGROUND

  • 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. doi: 10.1111/j.1524-6175.2007.06112.x.

    PMID: 17268216BACKGROUND

  • 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. doi: 10.1517/14740338.6.5.583.

    PMID: 17877445BACKGROUND

  • 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.

    PMID: 19858431BACKGROUND

  • Carter BL, Ardery G, Dawson JD, James PA, Bergus GR, Doucette WR, Chrischilles EA, Franciscus CL, Xu Y. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009 Nov 23;169(21):1996-2002. doi: 10.1001/archinternmed.2009.358.

    PMID: 19933962DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Barry L. Carter, PharmD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Primary Completion

April 1, 2008

Study Completion

July 1, 2009

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)