Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)
CEASE-HF
A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Sep 2012
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 22, 2016
December 1, 2016
1.6 years
June 21, 2013
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient self care
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
3 months
Secondary Outcomes (9)
Death
3 months
Heart failure readmission
3 months
Emergency room heart failure visits
3 months
Perceived caregiver burden
3 months
Heart failure knowledge acquisition
3 months
- +4 more secondary outcomes
Study Arms (4)
Enhanced Caregiver Support with Caregiver
EXPERIMENTAL* 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
OTHER* Usual care
Enhanced Support without Caregiver
EXPERIMENTAL* 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
OTHER* Usual Care
Interventions
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.
Eligibility Criteria
You may qualify if:
- Primary diagnosis of Heart Failure (with preserved or impaired left ventricular systolic dysfunction) confirmed with the Boston Criteria \>= 5 points
- years of age or older
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8N3Z5, Canada
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Demers, MD, MSc, FRCPC
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 21, 2013
First Posted
June 26, 2013
Study Start
September 1, 2012
Primary Completion
April 1, 2014
Study Completion
December 1, 2016
Last Updated
December 22, 2016
Record last verified: 2016-12