Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure; With Decompensation
- Sponsor
- The Cleveland Clinic
- Enrollment
- 746
- Locations
- 8
- Primary Endpoint
- Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
- Status
- Completed
- Last Updated
- 12 months ago
Overview
Brief Summary
Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.
Detailed Description
The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.
Investigators
Nancy M. Albert, Ph.D.
Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization,
- •Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed,
- •Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed,
- •Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.
Exclusion Criteria
- •Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration),
- •Plans to discharge to skilled nursing facility or hospice care,
- •Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV HF),
- •Hospitalized but at admission, in New York Heart Association functional class I or II HF
- •Post-cardiac transplantation or ventricular assist device placement,
- •Currently enrolled in another experimental HF research study,
- •Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate \< 15 mL/minute/1.73 m2,
- •A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).
Outcomes
Primary Outcomes
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Time Frame: up to 30 days
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Secondary Outcomes
- Number of Participants With HF-related Hospitalization(up to 180 days)
- Number of Participants With HF-related ED Visit(up to 180 days)
- All-cause Death at 180 Days Post Discharge(up to 180 days)
- Number of Participants With All-cause Hospitalization(up to 180 days)
- Number of Participants With All-cause ED Visits(up to 90 days)
- Number of Participants With All-cause Death(up to 90 days)
- All-cause ED Visits at 180 Days(up to 180 days)
- Number of Participants With HF-related ED Visits(up to 30 days)
- Number of Participants With HF-related Death(up to 180 days)
- Number of Participants With HF-related Healthcare Resource Utilization (HCRU)(up to 180 days)
- Number of Participants With All-cause Healthcare Resource Utilization (HCRU)(up to 180 days)
- Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge(up to 30 days)
- Dyspnea at 30 Days Post Discharge(30 days)
- Fatigue at 30 Days Post Discharge(to 30 days)
- Self-efficacy for Managing Symptoms at 30 Days Post Discharge(30 days)
- Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)(30 days)
- Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)(30 days)