Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139490
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2005-08-29
Brief Title:
Home-Based Program to Treat High Blood Pressure in African Americans
Sponsor:
Visiting Nurse Service of New York
Organization:
Visiting Nurse Service of New York
Study Overview
Official Title:
Home-Based Blood Pressure Interventions for African Americans
Status:
COMPLETED
Status Verified Date:
2012-12
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 examine the effectiveness and cost effectiveness of two organizational interventions aimed at improving blood pressure BP control among a high-risk African American home care population
Detailed Description:
BACKGROUND
Home health care is a non-institutional diverse health care setting that provides services to a high-risk population characterized by multiple chronic conditions and significant needs for both medical and self-care management Home health agencies discharged approximately 76 million patients in 1998 of whom approximately 60 to 65 were female and 12 to 15 black US DHHS 2000 Haupt 1998 Home health patients are clinically diverse Individuals with conditions of the circulatory system comprise the single largest share about 22 in 1996 Haupt 1998 while heart failure I-IF diabetes chronic obstructive pulmonary disease and essential hypertension HTN are patients most frequent primary diagnoses Haupt Jones 1999 Most home health patients enter care after a hospitalization and more than two-thirds are discharged to the community Management of HTN has not been a high priority for guideline adoption or quality improvement activities in home health care Peterson 2004 even though approximately 8 of home care patients are admitted with essential HTN as a first second or third diagnosis Haupt Jones 1999 In the words of one clinical nurse specialist home health nurses tend to see elevated BP readings as a set of numbers rather than a condition to be managed despite the fact that their patients may be at high risk of future HTN-related complications by virtue of their comorbidities and history of prior hospitalization
Teaching patients about their conditions promoting patient self-management helping patients adhere to medical regimens established by their physicians and linking them to community resources are central to the role of the home health nurse Clemen-Stone et al 2002 However with the advent of a home health prospective payment system nurses are working under heightened pressure to constrain service use and reduce time in the patients home This pressure in turn may provide a disincentive to focus on high BP management issues particularly when HTN is a second or third diagnosis and not the primary reason for which a person has been admitted to home care Thus home health care represents a segment of the health care system where a significant number of high-risk HTN patients are served where HTN practice likely requires significant improvement and where nursing personnel are uniquely positioned to mobilize their care management and patient education skills to increase the proportion of treated HTN patients who achieve adequate BP control The underlying premise of the project is that organizational change to improve BP management and outcomes will not easily occur in home health care without new intervention models rigorous evaluation of their impact or efforts by opinion leaders in the clinical and research communities to disseminate information on strategies that are efficacious and cost-effective Visiting Nurse Service of New York VNSNY serving over 70000 adult patients per year provides a prominent organizational laboratory for testing promising new models of care
The study is in response to a Request for Applications released in September 2003 on Interventions to Improve Hypertension Control Rates in African Americans
DESIGN NARRATIVE
The study will enroll African American patients with uncontrolled hypertension who are entering the home care program of the VNSNY It will employ a randomized design whereby all VNSNY nurses who are providing direct care to the eligible study population an estimated 300 nurses serving an estimated 1000 African American patients with uncontrolled hypertension will be randomly assigned to a control group or one of two intervention groups upon identification of the first eligible hypertensive patient to whom they provide care during the study period Throughout the study each nurse will continue to administer the same intervention either usual care basic intervention or an augmented intervention so that randomization will be by nurse rather than by patient A nurses initial random assignment to a specific group usual care basic treatment or augmented treatment will determine the status for all new patients allocated to that particular nurses care for the duration of the study
The two interventions to be tested include the following 1 a basic intervention delivering key evidence-based information to nurses physicians and patients while the patient is receiving traditional post-acute home health care and 2 an augmented intervention transitioning patients to a Home-Based HTN Support Program that extends the information monitoring and feedback available to patients and primary care physicians for a 12-month period beyond an index home care admission The interventions will be assessed relative to usual care and to each other The analysis will estimate the impact of the basic and augmented interventions on nursing practices and processes of care patient hypertension management eg medication adherence BP outcomes and overall costs Behaviors and outcomes will be measured at fixed points in time Measures will be derived from a combination of primary and secondary data including patient records patient assessment instruments patient interviews home BP monitors urine tests and administrative files Multivariate regression analyses will be conducted to determine intervention effects on study outcomes adjusting for selected nurse and patient characteristics Nurse level risk-adjustment will include demographics and other measures that might influence practice or processes of care such as experience and education Patient-level risk adjustment will include demographics social support and other characteristics that might influence behavior service use BP or other health outcomes Estimates of treatment-control group differences for both treatments generated by these models will be tested to determine the extent to which observed differences at the nurse and patient levels are attributable to the alternative intervention strategies
Home health care is a non-institutional diverse health care setting that provides services to a high-risk population characterized by multiple chronic conditions and significant needs for both medical and self-care management Home health agencies discharged approximately 76 million patients in 1998 of whom approximately 60 to 65 were female and 12 to 15 black US DHHS 2000 Haupt 1998 Home health patients are clinically diverse Individuals with conditions of the circulatory system comprise the single largest share about 22 in 1996 Haupt 1998 while heart failure I-IF diabetes chronic obstructive pulmonary disease and essential hypertension HTN are patients most frequent primary diagnoses Haupt Jones 1999 Most home health patients enter care after a hospitalization and more than two-thirds are discharged to the community Management of HTN has not been a high priority for guideline adoption or quality improvement activities in home health care Peterson 2004 even though approximately 8 of home care patients are admitted with essential HTN as a first second or third diagnosis Haupt Jones 1999 In the words of one clinical nurse specialist home health nurses tend to see elevated BP readings as a set of numbers rather than a condition to be managed despite the fact that their patients may be at high risk of future HTN-related complications by virtue of their comorbidities and history of prior hospitalization
Teaching patients about their conditions promoting patient self-management helping patients adhere to medical regimens established by their physicians and linking them to community resources are central to the role of the home health nurse Clemen-Stone et al 2002 However with the advent of a home health prospective payment system nurses are working under heightened pressure to constrain service use and reduce time in the patients home This pressure in turn may provide a disincentive to focus on high BP management issues particularly when HTN is a second or third diagnosis and not the primary reason for which a person has been admitted to home care Thus home health care represents a segment of the health care system where a significant number of high-risk HTN patients are served where HTN practice likely requires significant improvement and where nursing personnel are uniquely positioned to mobilize their care management and patient education skills to increase the proportion of treated HTN patients who achieve adequate BP control The underlying premise of the project is that organizational change to improve BP management and outcomes will not easily occur in home health care without new intervention models rigorous evaluation of their impact or efforts by opinion leaders in the clinical and research communities to disseminate information on strategies that are efficacious and cost-effective Visiting Nurse Service of New York VNSNY serving over 70000 adult patients per year provides a prominent organizational laboratory for testing promising new models of care
The study is in response to a Request for Applications released in September 2003 on Interventions to Improve Hypertension Control Rates in African Americans
DESIGN NARRATIVE
The study will enroll African American patients with uncontrolled hypertension who are entering the home care program of the VNSNY It will employ a randomized design whereby all VNSNY nurses who are providing direct care to the eligible study population an estimated 300 nurses serving an estimated 1000 African American patients with uncontrolled hypertension will be randomly assigned to a control group or one of two intervention groups upon identification of the first eligible hypertensive patient to whom they provide care during the study period Throughout the study each nurse will continue to administer the same intervention either usual care basic intervention or an augmented intervention so that randomization will be by nurse rather than by patient A nurses initial random assignment to a specific group usual care basic treatment or augmented treatment will determine the status for all new patients allocated to that particular nurses care for the duration of the study
The two interventions to be tested include the following 1 a basic intervention delivering key evidence-based information to nurses physicians and patients while the patient is receiving traditional post-acute home health care and 2 an augmented intervention transitioning patients to a Home-Based HTN Support Program that extends the information monitoring and feedback available to patients and primary care physicians for a 12-month period beyond an index home care admission The interventions will be assessed relative to usual care and to each other The analysis will estimate the impact of the basic and augmented interventions on nursing practices and processes of care patient hypertension management eg medication adherence BP outcomes and overall costs Behaviors and outcomes will be measured at fixed points in time Measures will be derived from a combination of primary and secondary data including patient records patient assessment instruments patient interviews home BP monitors urine tests and administrative files Multivariate regression analyses will be conducted to determine intervention effects on study outcomes adjusting for selected nurse and patient characteristics Nurse level risk-adjustment will include demographics and other measures that might influence practice or processes of care such as experience and education Patient-level risk adjustment will include demographics social support and other characteristics that might influence behavior service use BP or other health outcomes Estimates of treatment-control group differences for both treatments generated by these models will be tested to determine the extent to which observed differences at the nurse and patient levels are attributable to the alternative intervention strategies
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 |
|---|---|---|---|
| R01HL078585 | NIH | None | httpsreporternihgovquickSearchR01HL078585 |