A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Patient self care
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria >= 5 points
- •60 years of age or older
Exclusion Criteria
- •Residence in, or planned discharge to a long-term care facility (LTC)
- •Life expectancy less than 3 months
- •Patient transferred to Geriatric Rehabilitation unit
- •No caregiver
- •Residence is more than a 30 minute rive from hospital of discharge
- •Patient refused to participate
- •Caregiver refused to participate
- •Patient referred for CV surgery prior to hospital discharge
- •Patient on IV Lasix at or bumetamide at hospital discharge
- •Not on PO Lasix at hospital discharge
- •Patient currently on dialysis
- •Caregiver unavailable during daytime hours
- •Caregiver has disability, serious mental illness or cognitive dysfunction
- •Patient discharged early
- •Patient enrolled in another randomized controlled trial
- •Patient expired
- •Patient and caregiver unable to speak and read English (Patient may be enrolled if nurse can converse minimally with patient and caregiver. S-TOFHLA will not be done for reading comprehension and questionnaires will be administered orally.)
- •Severe aortic stenosis or severe mitral stenosis
Outcomes
Primary Outcomes
Patient self care
Time Frame: 3 months
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
Secondary Outcomes
- Emergency room heart failure visits(3 months)
- Perceived caregiver burden(3 months)
- Heart failure readmission(3 months)
- Heart failure knowledge acquisition(3 months)
- Medication adherence(3 months)
- Referral to heart failure clinic or to long-term care(3 months)
- Health beliefs(3 months)
- Depression(3 months)
- Death(3 months)
Investigators
Catherine Demers
Associate Professor
McMaster University