Clinical trial NCT00201149: Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence
Official title: Hypertension Control and Therapy Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 870
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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

Primary outcomes:
measure: 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)
timeFrame: September 2004 - May 2008
measure: Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment])
timeFrame: September 2004 - May 2008
measure: Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment])
timeFrame: September 2004 - May 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Dr. Nancy Kressin
role: STUDY_CHAIR
References:
citation: Manze MG, Orner MB, Glickman M, Pbert L, Berlowitz D, Kressin NR. Brief provider communication skills training fails to impact patient hypertension outcomes. Patient Educ Couns. 2015 Feb;98(2):191-8. doi: 10.1016/j.pec.2014.10.014. Epub 2014 Oct 27.