Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201149
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2005-09-16
Brief Title:
Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Hypertension Control and Therapy Adherence
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCTA
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 US 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
Hypertension affects nearly 50 million people in the US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072814 | NIH | None | httpsreporternihgovquickSearchR01HL072814 |