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

Heart Failure Clinical Trial

— CEASE-HF  

Official title:

A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886534
• Other study ID #: 11-638
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: December 21, 2016
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Standardized Heart Failure Discharge Summary to Primary Care Physicians©
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.

Behavioral:
• Standardized education sessions
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.

Other:
• Heart Failure Diuretic Decision Support Tool for Patient Self Management©
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.
• Digital talking scale
Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.
• Usual care
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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self care	Self-Care Heart Failure Index (SCHFI) for patients and caregivers	3 months	No
Secondary	Death	Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge	3 months	No
Secondary	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	3 months	No
Secondary	Emergency room heart failure visits	Emergency room heart failure visits (< 24 hour hospital stay) during 3 months after hospital discharge	3 months	No
Secondary	Perceived caregiver burden	Modified Oberst Caregiver Burden Scale (CBS)	3 months	No
Secondary	Heart failure knowledge acquisition	Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers	3 months	No
Secondary	Medication adherence	Medication Possession Ratio (MPR)	3 months	No
Secondary	Referral to heart failure clinic or to long-term care		3 months	No
Secondary	Health beliefs	Health Beliefs Questionnaire (HBQ) for patients and caregivers	3 months	No
Secondary	Depression	Geriatric Depression Scale 8 (GDS-8) for the patient	3 months	No