McMaster University
Hamilton, Ontario, L8N3Z5, Canada
NCT Number: NCT01886534
Close to ninety percent of older heart failure (HF) patients have some cognitive deficits at hospital discharge which may impact their ability to make effective decisions about their healthcare. However, informal care partners (CPs) may assist in managing HF when provided with appropriate education and support. The goal of this randomized clinical trial (RCT) is to evaluate an intervention which will provide 1) additional teaching on management of HF to the patient and CP following hospital discharge, 2) improved communication with the family physician, 3) a HF decision support tool for oral diuretic management, and 4) a digital talking scale. The investigators believe this intervention will improve outcomes and be cost saving.
The investigators hypothesize that enhanced education and support for the CPs to assist older HF patients following hospital discharge, combined with improved communication with family physicians, contact with a HF nurse, and simple decision support tools, will lead to earlier recognition of clinical deterioration, and improved patient outcomes. Innovative and cost-effective approaches to manage HF patients following hospital discharge are urgently needed in Canada.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8N3Z5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At hospital discharge, in addition to usual care, the Study Nurse will fax an introduction letter and a 1-page comprehensive Standardized Heart Failure Discharge Summary to Primary Care Physicians© integrating Canadian Cardiovascular Society HF guideline recommendations to the patient's family physician.
Following baseline data collection, and prior to hospital discharge or within 72 hours of discharge, all patient/caregiver dyads in the intervention group will receive a 45-60-minute standardized education session with the study nurse according to individualized patient learning needs, aimed to ensure similar baseline level of heart failure self-care knowledge. Verbal (teach-back) and written information from the Trial of Education And Compliance in Heart dysfunction (TEACH) RCT will be provided to all patient/caregiver dyads. Information regarding self-care such as dietary restrictions, exercise guidelines, weight and symptom monitoring (shortness of breath, swelling of the ankles) included in the education package will be reviewed. The teaching sessions will occur at 1 week, 2 weeks, 1 month and 2 months post-discharge.
Each patient/caregiver dyad will be provided a paper-based Heart Failure Diuretic Decision Support Tool for Patient Self Management© at hospital discharge assisting in the titration of their oral furosemide. The purpose of this tool will be to assist the patient/caregiver in keeping track of signs and symptoms of worsening heart failure. The family physician will also be provided an access to similar decision support tool for management of clinical deterioration.
Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.
Patients allocated to the usual care group will receive the hospital-approved heart failure management booklet which meets evidence-based requirements for outpatient heart failure management. Patients will meet with the hospital HF nurse-clinician (standard at this institution) to review heart failure symptoms and signs, diet and exercise recommendations. They will also meet with the ward pharmacist prior to hospital discharge to review medications and side effects. Referral to the HF clinic and any HF initiative will be left to the discretion of the most responsible physician.
Time frame: 3 months
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
Time frame: 3 months
Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge
Time frame: 3 months
Heart failure readmission (>= 24 hour hospital stay including the time spent in the emergency room with clinical evidence of heart failure) during 3 months after hospital discharge
Time frame: 3 months
Emergency room heart failure visits (< 24 hour hospital stay) during 3 months after hospital discharge
Time frame: 3 months
Modified Oberst Caregiver Burden Scale (CBS)
Time frame: 3 months
Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers
Time frame: 3 months
Medication Possession Ratio (MPR)
Time frame: 3 months
Time frame: 3 months
Health Beliefs Questionnaire (HBQ) for patients and caregivers
Time frame: 3 months
Geriatric Depression Scale 8 (GDS-8) for the patient
McMaster University
Other
A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
Acronym: CEASE-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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