Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Standardized Heart Failure Discharge Summary to Primary Care Physicians©; Behavioral: Standardized education sessions; Other: Heart Failure Diuretic Decision Support Tool for Patient Self Management©; Other: Digital talking scale; Other: Usual care

• Registration Number: NCT01886534
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2014-04
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Caregiver Support with Caregiver	Digital talking scale	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Caregiver Support with Caregiver	Usual care	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Caregiver Support with Caregiver	Standardized Heart Failure Discharge Summary to Primary Care Physicians©	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Caregiver Support with Caregiver	Standardized education sessions	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Caregiver Support with Caregiver	Heart Failure Diuretic Decision Support Tool for Patient Self Management©	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Support without Caregiver	Standardized Heart Failure Discharge Summary to Primary Care Physicians©	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Support without Caregiver	Digital talking scale	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Usual Care with Caregiver	Usual care	* Usual care
Enhanced Support without Caregiver	Standardized education sessions	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Enhanced Support without Caregiver	Usual care	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale
Usual Care without Caregiver	Usual care	* Usual Care
Enhanced Support without Caregiver	Heart Failure Diuretic Decision Support Tool for Patient Self Management©	* Standardized Heart Failure Discharge Summary to Primary Care Physicians© * Standardized education sessions * Heart Failure Diuretic Decision Support Tool for Patient Self Management© * Digital talking scale

Primary Outcome Measures

Name	Time	Method
Patient self care	3 months	Self-Care Heart Failure Index (SCHFI) for patients and caregivers

Secondary Outcome Measures

Name	Time	Method
Heart failure readmission	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
Emergency room heart failure visits	3 months	Emergency room heart failure visits (\< 24 hour hospital stay) during 3 months after hospital discharge
Perceived caregiver burden	3 months	Modified Oberst Caregiver Burden Scale (CBS)
Heart failure knowledge acquisition	3 months	Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers
Medication adherence	3 months	Medication Possession Ratio (MPR)
Referral to heart failure clinic or to long-term care	3 months
Health beliefs	3 months	Health Beliefs Questionnaire (HBQ) for patients and caregivers
Depression	3 months	Geriatric Depression Scale 8 (GDS-8) for the patient
Death	3 months	Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada