Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201084
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2005-09-16
Brief Title:
Physician Uncertainty Reduction for Hypertension
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Physician Uncertainty Reduction for Hypertension
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
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
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 patients 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-7JNC-7 recommended levels in African American patients greater than 14090 mm Hg or greater 13080 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
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 patients 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-7JNC-7 recommended levels in African American patients greater than 14090 mm Hg or greater 13080 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
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 |
|---|---|---|---|
| R01HL078589 | NIH | None | httpsreporternihgovquickSearchR01HL078589 |