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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
Catherine Demers, McMaster University
ClinicalTrials.gov Identifier:
NCT01886534
First received: June 21, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Heart Failure
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Enhanced Caregiver Support Versus Usual Care for Managing Older Heart Failure Patients at Hospital Discharge

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Patient self care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-Care Heart Failure Index (SCHFI) for patients and caregivers


Secondary Outcome Measures:
  • Death [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Deaths (due to cardiac and non-cardiac causes) during 3 months after hospital discharge

  • Heart failure readmission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Emergency room heart failure visits (< 24 hour hospital stay) during 3 months after hospital discharge

  • Perceived caregiver burden [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Modified Oberst Caregiver Burden Scale (CBS)

  • Heart failure knowledge acquisition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Knowledge Acquisition Questionnaire (KAQ) for patients and caregivers

  • Medication adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Medication Possession Ratio (MPR)

  • Referral to heart failure clinic or to long-term care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Health beliefs [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Health Beliefs Questionnaire (HBQ) for patients and caregivers

  • Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Geriatric Depression Scale 8 (GDS-8) for the patient


Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Caregiver Support with Caregiver
  • 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
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.
Other: 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.
Other: 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.
Usual Care with Caregiver
  • Usual care
Other: 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.
Experimental: Enhanced Support without Caregiver
  • 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
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.
Other: 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.
Other: 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.
Usual Care without Caregiver
  • Usual Care
Other: 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886534

Contacts
Contact: Catherine Demers, MD, MSc, FRCPC 905-521-2100 ext 73324 demers@hhsc.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Catherine Demers, MD, MSc, FRCPC    905-521-2100 ext 73324    demers@hhsc.ca   
Principal Investigator: Catherine Demers, MD, MSc, FRCPC         
Sub-Investigator: Norman P Archer, PhD         
Sub-Investigator: Femida Gwandry-Sridhar, BScPhm, MSc, PhD         
Sub-Investigator: Karim Keshavjee, MD, MBA, CCFP, CPHIMS         
Sub-Investigator: Christopher Patterson, MD, FRCPC, FACP, FRCP (Glasg.)         
Sub-Investigator: Robert S McKelvie, MD, PhD, FRCPC         
Sub-Investigator: Maureen Dobbins, BScN, PhD         
Sub-Investigator: Lehana Thabane, PhD         
Sub-Investigator: Patricia Strachan, MScN, PhD         
Sub-Investigator: Jean-Claude Coallier, PhD         
Sub-Investigator: Frederick Spencer, MD, FRCPC         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Catherine Demers, MD, MSc, FRCPC McMaster University
  More Information

No publications provided

Responsible Party: Catherine Demers, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01886534     History of Changes
Other Study ID Numbers: 11-638
Study First Received: June 21, 2013
Last Updated: June 25, 2013
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by McMaster University:
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014