search
Back to results

Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence (HCTA)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-centered Counseling
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

1

3

2

Arm Description

In one team of clinicians we will implement only the patient-centered counseling program.

The control group will provide usual care

In a subset of those clinicians receiving the patient-centered counseling program intervention, we will augment it with cultural competency training.

Outcomes

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)
Proportion of patients with controlled hypertension (measured at baseline and follow-up visit [6-9 months after initial recruitment])
Use of communication strategies by clinicians (measured at baseline and follow-up visit [6-9 months after initial recruitment])

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
April 6, 2016
Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00201149
Brief Title
Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence
Acronym
HCTA
Official Title
Hypertension Control and Therapy Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
870 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
In one team of clinicians we will implement only the patient-centered counseling program.
Arm Title
3
Arm Type
No Intervention
Arm Description
The control group will provide usual care
Arm Title
2
Arm Type
Experimental
Arm Description
In a subset of those clinicians receiving the patient-centered counseling program intervention, we will augment it with cultural competency training.
Intervention Type
Behavioral
Intervention Name(s)
Patient-centered Counseling
Intervention Description
To improve patients' adherence with prescribed anti-hypertensive medication, improve blood pressure control and doctor-patient communication, we propose a three-armed randomized controlled trial in the internal medicine clinics of a large metropolitan teaching hospital which serves a large percentage of poor African American and white patients. We will implement an intervention strategy by teaching clinicians to counsel patients about hypertension control through the use of patient-centered counseling and by providing office-based support; 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, and which will enhance doctor-patient communication.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nancy Kressin
Organizational Affiliation
Boston University
Official's Role
Study Chair
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25468397
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2841788/?tool=pubmed
Description
2. Kressin, NR, Orner, MB, Manze, M, Glickman, ME, Berlowitz, D. (2010). Understanding contributors to racial disparities in blood pressure control. Circulation: Quality and Outcomes: Mar;3(2):173-80.
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2896595/?tool=pubmed
Description
3. Manze, M, Rose, AJ, Orner, MB, Berlowitz, DR, Kressin, NR (2010). Understanding Racial Disparities in Treatment Intensification for Hypertension Management. Journal of General Internal Medicine; 25 (8), 819-25.
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2801893/?tool=pubmed
Description
4. Rose, AJ, Berlowitz, DR, Manze, M, Orner, MB, Kressin, NR (2009). Comparing methods of measuring treatment intensity in hypertension care. Circulation: Quality and Outcomes: 2; 385-391
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2739677/?tool=pubmed
Description
5. Rose, AJ, Berlowitz, DR, Manze, M, Orner, MB, Kressin, NR (2009). Intensifying Therapy for Hypertension Despite Suboptimal Adherence. Hypertension: 54(3): 524-529.

Learn more about this trial

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

We'll reach out to this number within 24 hrs