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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors
Medical Center Navicent Health
Macon, Georgia, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic main campus
Cleveland, Ohio, United States
Cleveland Clinic Marymount Hospital
Garfield Heights, Ohio, United States
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
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.
Time frame: up to 30 days
Number of Participants With HF-related Hospitalization
Total number of participants post-discharge with HF-related hospitalization
Time frame: up to 30 days
Number of Participants With HF-related ED Visits
Number of participants with post-discharge HF-related ED visits
Time frame: up to 30 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 30 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Time frame: up to 90 days
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Time frame: up to 90 days
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DOUBLE
Enrollment
746
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, United States
Cleveland Clinic Medina Hospital
Medina, Ohio, United States
Cleveland Clinic South Pointe Hospital
Warrensville Heights, Ohio, United States
WellSpan Health
York, Pennsylvania, United States
Time frame: up to 90 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 90 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Time frame: up to 180 days
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Time frame: up to 180 days
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
Time frame: up to 180 days
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 180 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Time frame: up to 30 days
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Time frame: up to 30 days
Number of Participants With All-cause ED Visits
Number of participants with post-discharge all-cause ED visits
Time frame: 30 days
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause deaths
Time frame: up to 30 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Time frame: up to 90 days
Number of Participants With All-cause Hospitalization
Number of participants with post-discharge all-cause hospitalization
Time frame: up to 90 days
Number of Participants With All-cause ED Visits
Number of participants post-discharge with all-cause ED visits
Time frame: up to 90 days
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause death
Time frame: up to 90 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Time frame: up to 180 days
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Time frame: up to 180 days
All-cause ED Visits at 180 Days
Number of participants post-discharge with all-cause ED visits
Time frame: up to 180 days
All-cause Death at 180 Days Post Discharge
Number of participants post-discharge with all-cause death
Time frame: up to 180 days
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.
Time frame: up to 30 days
Dyspnea at 30 Days Post Discharge
PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.
Time frame: 30 days
Fatigue at 30 Days Post Discharge
10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).
Time frame: to 30 days
Self-efficacy for Managing Symptoms at 30 Days Post Discharge
PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy
Time frame: 30 days
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times
Time frame: 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)
Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).
Time frame: 30 days