Telehealth Management in HF Disparity Patients

NCT ID: NCT02196922

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-04-30

Brief Summary

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.

Detailed Description

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:

1. Assess telehealth self management (TSM) usability, utilizing a mixed-methods approach, focusing on patient and stakeholder input, with the goal of adapting the intervention to facilitate acceptability and feasibility in a population of low-income ethnic minority patients. Prior to intervention implementation, we will determine characteristics of the intervention requiring adaptation to maximize usability through focus groups, with key community stakeholders, patients and caregivers. We will continue the qualitative usability assessment during the intervention with patients enrolled in the study to identify barriers/challenges to usability, to further adapt the intervention. Finally, we will use quantitative methods to assess usability. These quantitative indicators will also be used to make adjustments and inform future wide-scale interventions that will be conducted in this community.

2. Compare hospital utilization of low income ethnic minority patients receiving telehealth technology vs. demographically matched patients receiving standard of care. A randomized controlled clinical trial will be conducted to test the primary hypothesis that health care utilization will be lower in the in the TSM group than the usual-care group. We will specifically compare acute care and ED utilization and quality of life (Minnesota QoL Questionnaire) between groups. We will adjust for potential confounders (demographic, clinical, educational and functional/support variables). The target population is community-dwelling CHF patients discharged home from the Nassau University Medical Center.

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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Telehealth; Self Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Patients receiving standard of care experience typical chronic care management received by Medicare patients.

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.

Group Type: EXPERIMENTAL

Telehealth Self Management (TSM)

Intervention Type: 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.

Interventions

Telehealth Self Management (TSM)

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.

Intervention Type: DEVICE

Standard of Care

Patients receiving standard of care experience typical chronic care management received by Medicare patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chronic Heart Failure (CHF) patients about to be discharged from Nassau University Medical Center (NUMC)
• 18 years and older
• New York Heart Association (NYHA) class of 1-3
• Primary language of Spanish or English
• Access to a phone (land line or cell),
• Folstein Mini Mental Status Exam (MMSE) score of 21 or higher.

Exclusion Criteria

• Patients with heart failure NYHA class 4
• Patients under age 18
• Anyone with a primary language that is not English or Spanish
• Anyone with a Folstein MMSE score under 21 (indicative of cognitive impairment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Renee Pekmezaris

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renee Pekmezaris, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Nassau University Medical Center

East Meadow, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27343060 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NCT02196922

Identifier Type: -

Identifier Source: org_study_id