Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the US, racial and ethnic disparities persist, even when income, health insurance and care access are addressed. For example, there is a greater prevalence of chronic heart failure (CHF), higher rates of hospital use and higher death rates in blacks as compared to whites. This is due to many factors including: reduced healthcare access, higher prevalence of hypertension,coronary artery disease, systolic dysfunction, myocardial infarction and obesity. Given the magnitude of this chronic health issue, the growth of the elderly population, and increases in ethnic diversity, providers need to develop new ways of caring for those with chronic conditions living in health disparity communities.
The investigators propose to implement a randomized study with health disparity community-dwelling patients. A bilingual clinician will follow patients for 3 months after hospitalization for CHF to test this approach for the proposed health disparity population. The investigators will obtain patient/caregiver input at multiple points during the research to make necessary adjustments to the intervention to ensure that disparity patients accept/use the system, and are satisfied. To ensure that proposed outcomes have relevance for patients, a Community Advisory Board (CAB) of stakeholders will advise the study team throughout the study process. The investigators believe that studying patient use of TSM over a 3 month period will: 1) identify cost-effective care approaches for patients living with chronic disease; 2) involve the patient in identifying and testing approaches that work for them; 3) enhance provider-patient communication; 4) teach the patient how to self-monitor and explore his/her role in self-care; 5) improve patient education about treatment options and 6) explore how "usable" the patients feel the program is. If our goals are achieved, these strategies will result in patient-led improvements in health, satisfaction and quality of life. Knowledge gained will further understanding of the use of telehealth programs as effective self-management tools.
Disparities in cardiovascular disease have received particular focus, as cardiovascular disease is a major contributor to differences in morbidity and mortality between blacks and whites. African Americans, for example, are hospitalized for chronic heart failure (CHF) at a higher rate than whites and are 30% more likely to die from CHF than white individuals. Community-dwelling patients with CHF typically receive exacerbation-focused care, leading to high rates of emergency department (ED) and hospital utilization. The lack of comprehensive chronic disease management leads to poor patient outcomes, and increased health care costs. Given the larger burden of CHF and the unfavorable disease outcomes in disparity communities, a tailored and more focused management of this clinical condition is warranted.
We propose to:
This research will further our understanding of the use of TSM in the management of CHF for low income, ethnic minority seniors. The proposed research will improve patient outcomes while reducing unnecessary hospitalizations and ED burden. Chronic disease self-management programs have the potential to reduce health care costs while improving patient health status, particularly for medically underserved communities.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Patients in the control group will receive standard of care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicare or sliding scale/uncompensated care). Standard of care patients will be contacted on a weekly basis in order to maintain comparable frequency of contact. |
|
| Telehealth Self Management (TSM) | Experimental | TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Self Management (TSM) | Device | Experimental: Telehealth Self Management (TSM) TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations | Number of hospitalizations during the 90 day observation period | Baseline and Day 90 |
| Emergency Department Visits | Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period | Days 0-90 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life) | Baseline and Day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Renee Pekmezaris, PhD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nassau University Medical Center | East Meadow | New York | 11554 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27343060 | Derived | Pekmezaris R, Schwartz RM, Taylor TN, DiMarzio P, Nouryan CN, Murray L, McKenzie G, Ahern D, Castillo S, Pecinka K, Bauer L, Orona T, Makaryus AN. A qualitative analysis to optimize a telemonitoring intervention for heart failure patients from disparity communities. BMC Med Inform Decis Mak. 2016 Jun 24;16:75. doi: 10.1186/s12911-016-0300-9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Comprehensive Outpatient Management (COM-Standard of Care) | Patients in the control group will receive comprehensive outpatient management (COM)at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact. COM: Patients receiving COM experience chronic care management received by disparity patients at a heart failure clinic. |
| FG001 | Telehealth Self Management (TSM) | Telehealth Self Management (TSM): Experimental: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Comprehensive Outpatient Management (COM) | Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact. COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospitalizations | Number of hospitalizations during the 90 day observation period | Intention to treat population (all participants who are randomized to either COM or TSM. | Posted | Mean | Standard Deviation | participant mean hospitalizations/90 day | Baseline and Day 90 |
|
days 0-90
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comprehensive Outpatient Management (COM) | Patients in the COM group will receive outpatient management at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact. Patients receiving COM experience typical chronic care management received by disparity patients at a heart failure clinic. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renee Pekmezaris, Ph.D., Vice President Community Health & Health Services Research | Northwell Health | 516 465-3161 | rpekmeza@northwell.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2016 | Jul 27, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2016 | Sep 15, 2017 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Open label
Not provided
|
| Standard of Care | Other | Patients receiving standard of care experience typical chronic care management received by Medicare patients. |
|
| BG001 | Telehealth Self Management (TSM) | Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Telehealth Self Management (TSM) |
Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station. |
|
|
| Primary | Emergency Department Visits | Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period | Intention to Treat population (all participants to COM or TSM) | Posted | Mean | Standard Deviation | participants group mean ED visits/90 day | Days 0-90 |
|
|
|
| Secondary | Quality of Life | Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life) | Posted | Mean | Full Range | units on a scale | Baseline and Day 90 |
|
|
|
| 1 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Telehealth Self Management (TSM) | Telehealth Self Management (TSM): Experimental: is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, to the provider station. | 1 | 46 | 0 | 46 | 0 | 46 |
Not provided
Not provided