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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
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
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring 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

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Experimental

Other

Arm Label

Enhanced Caregiver Support with Caregiver

Usual Care with Caregiver

Enhanced Support without Caregiver

Usual Care without Caregiver

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient self care
Self-Care Heart Failure Index (SCHFI) for patients and caregivers

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2013
Last Updated
December 21, 2016
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01886534
Brief Title
Caregiver Enhanced Assistance and Support for the Elderly Heart Failure Patient at Hospital Discharge (CEASE-HF)
Acronym
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Caregiver Support with Caregiver
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care with Caregiver
Arm Type
Other
Arm Description
Usual care
Arm Title
Enhanced Support without Caregiver
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care without Caregiver
Arm Type
Other
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Standardized Heart Failure Discharge Summary to Primary Care Physicians©
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized education sessions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heart Failure Diuretic Decision Support Tool for Patient Self Management©
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Digital talking scale
Intervention Description
Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient self care
Description
Self-Care Heart Failure Index (SCHFI) for patients and caregivers
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Death
Description
Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge
Time Frame
3 months
Title
Heart failure readmission
Description
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
Title
Emergency room heart failure visits
Description
Emergency room heart failure visits (< 24 hour hospital stay) during 3 months after hospital discharge
Time Frame
3 months
Title
Perceived caregiver burden
Description
Modified Oberst Caregiver Burden Scale (CBS)
Time Frame
3 months
Title
Heart failure knowledge acquisition
Description
Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers
Time Frame
3 months
Title
Medication adherence
Description
Medication Possession Ratio (MPR)
Time Frame
3 months
Title
Referral to heart failure clinic or to long-term care
Time Frame
3 months
Title
Health beliefs
Description
Health Beliefs Questionnaire (HBQ) for patients and caregivers
Time Frame
3 months
Title
Depression
Description
Geriatric Depression Scale 8 (GDS-8) for the patient
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Demers, MD, MSc, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

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

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