Physician Uncertainty Reduction for Hypertension

This study has been completed.
Sponsor:
Collaborators:
The University of Texas Health Science Center, Houston
Kelsey Research Foundation
Information provided by (Responsible Party):
David Hyman, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00201084
First received: September 16, 2005
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to test the theory that a major factor in poor blood pressure (BP) control is that physicians fail to intensify antihypertensive therapy for their patients.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Behavioral: Uncertainty reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physician Uncertainty Reduction for Hypertension

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Expressed as the proportion of patients with average clinic BP less than 140/90 mm Hg in the previous two visits (130/80 mm Hg if the patient also has diabetes) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actual measure clinic systolic and diastolic BP, patient physician communication patterns [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient adherence to medication and healthy lifestyle [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Physician knowledge, attitude, and beliefs about JNC-7 goals and barriers to achievement of the treatment goals and cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 670
Study Start Date: September 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Uncertainty reduction tools, at physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling
Behavioral: Uncertainty reduction
At physician discretion, 24 hour ambulatory BP monitoring and/or electronic bottle cap monitoring and/or lifestyle counseling
No Intervention: 2
Usual primary care

Detailed Description:

BACKGROUND:

A large amount of literature suggests that the majority of "uncontrolled" hypertensives are under medical care, and that lack of control is largely explained by physicians not intensifying treatment to achieve the BP targets recommended in the national guidelines. Traditional physician education, feedback, and reminders have a limited effect in promoting a rapid rate of guideline implementation. The theoretical framework of diffusion of innovations suggests that providing physicians with tools to reduce uncertainty about the attributes of a guideline may accelerate the adoption process. The presumed barriers to treatment intensification for uncontrolled hypertension are: 1) uncertainty over the patient's "true" BP; 2) uncertainty over whether the patient is adherent to medications already prescribed; and 3) uncertainty over the benefits of adding medications when patients express preference for lifestyle modification.

DESIGN NARRATIVE:

This cluster randomized trial in 10 primary care clinics (5 intervention and 5 control) will test the hypothesis that an intervention based on diffusion of innovations theory, and targeting provider treatment actions, will increase the prevalence of BP control to Joint National Committee-7(JNC-7) recommended levels in African American patients (greater than 140/90 mm Hg or greater 130/80 mm Hg if the patient has diabetes). The uncertainty reduction tools in the "Uncertainty Reduction to Accelerate Diffusion (URAD)" practices will include: 24-hour ambulatory BP monitoring, electronic bottle-cap monitoring of medication adherence, and medication and lifestyle counseling. The "Usual Practice (UP)" physicians will receive education about the guidelines and a "placebo" chart form indicating the patient is being followed in a BP control study. The 10 participating clinics represent a large, multi-site private group practice and a public health care system. Sixty-seven patients per clinic (670 total) will be enrolled when the intervention is initiated, and their BP and self-reported medication and lifestyle adherence will be monitored for two years. Sixty percent of the sample will be African American, and the study will have 90% power to detect a difference of 20% in the prevalence of hypertension control in the African Americans as a result of the intervention (50% control in URAD clinics vs. 30% control UP clinics). Secondary endpoints will include BP measurements by study staff under standardized conditions, physician treatment intensification actions, patient adherence, characteristics of doctor-patient communication associated with treatment action, use of the URAD components, and physician knowledge and beliefs about the JNC 7 guidelines and their relationship to BP control. Analysis of secondary endpoints will include race. The research team has collaborated with both health systems in previous studies, and is experienced in conducting hypertension control and behavioral intervention studies in the target population.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kept appointment on index visit day (see patient sampling and recruitment methods below)
  • Had one previous visit to the setting within the past year and identified the setting as his/her usual source of care
  • Average clinic BP on index visit and one most recent previous visit was equal to or greater than 140 mm Hg systolic or 90 mm Hg diastolic (130/80 mm Hg if diabetic)
  • Acknowledges understanding of the study goals and methods and gives informed consent to participate in study measurements and other procedures

Exclusion Criteria:

  • Cognitive or other functional impairment sufficient to limit patient's ability to give informed consent, keep follow-up appointments, and participate actively in adherence to his or her treatment regimen
  • Renal insufficiencies or renal failure based on a recent serum creatinine greater than 2.0 or chart diagnosis
  • Planning to leave the Houston area within the next two years
  • Severe, life-threatening illness that makes hypertension treatment a secondary priority
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201084

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77098
Sponsors and Collaborators
Baylor College of Medicine
The University of Texas Health Science Center, Houston
Kelsey Research Foundation
Investigators
Principal Investigator: David J. Hyman, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: David Hyman, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00201084     History of Changes
Other Study ID Numbers: 276, R01HL078589, R01 HL78589
Study First Received: September 16, 2005
Last Updated: July 17, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014