Clinical trial NCT01886534: Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)
Official title: A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Heart diseases
Cardiovascular diseases
Health information technology
Disease management
Patient care management
Self care
Informal caregiver
Care partner
Peer support
Transitional care
Patient education
Teach-back
Clinical decision aid
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient self care
timeFrame: 3 months
Secondary outcomes:
measure: Death
timeFrame: 3 months
measure: Heart failure readmission
timeFrame: 3 months
measure: Emergency room heart failure visits
timeFrame: 3 months
measure: Perceived caregiver burden
timeFrame: 3 months
measure: Heart failure knowledge acquisition
timeFrame: 3 months
measure: Medication adherence
timeFrame: 3 months
measure: Referral to heart failure clinic or to long-term care
timeFrame: 3 months
measure: Health beliefs
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Catherine Demers, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: