Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00201149
First received: September 16, 2005
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to test the effect of clinician counseling and cultural competence training on medication compliance and blood pressure (BP) control in patients with high BP.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Behavioral: Patient Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Hypertension Control and Therapy Adherence

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Patient medication adherence (self-reported at baseline and follow-up visit [6-9 months after initial recruitment]and measured with electronic monitoring caps 90 days after baseline visit and 90 days after follow-up visit) [ Time Frame: September 2004 - May 2008 ] [ Designated as safety issue: No ]
  • Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment]) [ Time Frame: September 2004 - May 2008 ] [ Designated as safety issue: No ]
  • Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment]) [ Time Frame: September 2004 - May 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 870
Study Start Date: February 2004
Estimated Study Completion Date: December 2016
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In one team of clinicians we will implement only the patient-centered counseling program.
Behavioral: Patient Counseling
In order to improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and improve doctor-patient communication, we propose a three-armed randomized controlled trial in the general internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement a proven intervention strategy by teaching clinicians to advise and counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support which is critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors (in this case, to improve their adherence with antihypertensive therapy), and which will enhance doctor-patient communication.
No Intervention: 3
The control group will provide usual care
Experimental: 2
In a subset of those clinicians receiving the intervention about patient centered care, we will augment it with cultural competency training.
Behavioral: Patient Counseling
In order to improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and improve doctor-patient communication, we propose a three-armed randomized controlled trial in the general internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement a proven intervention strategy by teaching clinicians to advise and counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support which is critical to facilitating clinicians' use of this strategy. Through this intervention we will provide clinicians with communication skills that are proven to help patients change risk-related behaviors (in this case, to improve their adherence with antihypertensive therapy), and which will enhance doctor-patient communication.

Detailed Description:

BACKGROUND:

Hypertension affects nearly 50 million people in the U.S. and is related to increased medical morbidity and mortality associated with a range of medical disorders. Despite the availability of effective treatments for BP control, less than 25 percent of patients with hypertension demonstrate such control, and researchers have found this to be related to important patient factors associated with pharmacotherapy adherence. Further, research has demonstrated that this adherence problem is greater among African Americans than among Caucasians. The focus of the study is on improvements in adherence among patients with hypertension. The study is most specifically targeted to reducing racial disparities in medication adherence by including an interventional element that specifically targets African American patients in its approach.

DESIGN NARRATIVE:

To improve patients' adherence with prescribed anti-hypertensive medication, BP control, and doctor-patient communication, and to decrease racial disparities in each area, the investigators will conduct a three-armed randomized controlled study in the general internal medicine clinics of a large urban teaching hospital serving many poor African American and white patients. Proven intervention strategies will be implemented by teaching clinicians to use patient-centered counseling, enhancing skills that are known to help patients change health-related behaviors, and enhancing cultural competency among clinicians, thereby further improving clinician-patient communication. One group of clinicians will implement only the patient-centered counseling program. A second group will implement the patient-centered counseling education program, augmenting it with an established method for cultural competency training. A third group (control group) will provide usual care. To assess outcomes, the study will evaluate pre-intervention patient adherence to prescribed medications through patient self-report and the use of electronic pill top monitoring, clinicians' provision of advice and counseling about anti-hypertensive medications and use of cultural competency skills, and the proportion of patients with controlled BP. Subsequent to the interventions, each of these outcomes will be assessed.

The aims of this study are to: 1) improve patients' adherence to prescribed anti-hypertensive therapy; 1a. examine adherence rates at baseline, and examine whether there are racial differences in adherence; 1b. decrease racial disparities in patient adherence with anti-hypertensive therapy from the baseline to the follow-up assessments; and 1c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on patients' medication adherence; 2) increase the proportion of patients with controlled hypertension; 2a. examine the baseline proportion of patients with controlled hypertension, and whether there are racial differences in rates of control; 2b. decrease racial disparities in the proportion of patients with controlled hypertension from the baseline to the follow-up assessments; and 2c. evaluate the relative efficacy of patient-centered counseling compared to patient-centered counseling augmented by cultural competency training on patients' BP control; and 3) improve clinicians' communication with patients regarding medication use, as measured by increased frequency of clinicians' provision of advice and counseling about anti-hypertensive medications and use of culturally competent communication styles; 3a. examine whether there are racial disparities in clinicians' provision of advice and counseling or culturally competent communication patterns about anti-hypertensive medications at baseline; 3b. examine whether the proposed interventions decrease any observed racial disparities in clinician communication over time; and 3c. evaluate the relative efficacy of the patient-centered counseling intervention compared to patient-centered counseling augmented by cultural competency training on clinicians' communication patterns.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presenting for care at least once in the General Internal Medicine clinic
  • Diagnosis of hypertension, as listed on a medical problem list or elsewhere within the medical record
  • Already prescribed antihypertensive medications

Exclusion Criteria:

  • Musculoskeletal problems preventing successful opening of the electronic pill tops
  • Cognitive status limitations, including psychiatric disorders such as schizophrenia
  • Active alcohol or substance abuse problems
  • Does not speak English
  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: NCT00201149

Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02113
Sponsors and Collaborators
Boston Medical Center
Investigators
Study Chair: Dr. Nancy Kressin Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00201149     History of Changes
Other Study ID Numbers: 255, R01HL072814, R01 HL72814
Study First Received: September 16, 2005
Last Updated: August 20, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 22, 2014