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Transitional Palliative Care in End-stage Heart Failure

Primary Purpose

End Stage Heart Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transitional Care Model
Usual care
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Heart Disease focused on measuring Transitional care, Supportive and palliative care

Eligibility Criteria

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

Inclusion Criteria:

  • Ability to speak Cantonese
  • Living within the hospital service area
  • Ability to be contacted by phone
  • Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below:

    (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy

Exclusion Criteria:

  • Discharged to nursing home or other institution
  • Inability to communicate
  • Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder

Sites / Locations

  • Grantham Hospital
  • Haven Of Hope Hospital
  • United Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual Care + Transitional Care Model

Usual Care

Arm Description

Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership

Usual care

Outcomes

Primary Outcome Measures

Healthcare utilization
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data

Secondary Outcome Measures

Quality of Life
Change from baseline in quality of life on the palliative specific McGill Quality of Life Questionnaire Hong Kong version (MQOL-HK) at 1 month; change from baseline in MQOL-HK at 3 months; change from baseline in MQOL-HK at 6 months; change from baseline in MQOL-HK at 12 months
Quality of Life
Change from baseline in quality of life on the heart failure specific Chronic Heart Failure Questionnaire-Chinese version (CHQ) at 1 month; change from baseline in CHQ score at 3 months; change from baseline in CHQ score at 6 months; change from baseline in CHQ score at 12 months
Functional status
Change from baseline in functional status on the Palliative Performance Scale (PPS) at 1 month; change from baseline in PPS at 3 months; change from baseline in PPS at 6 months; change from baseline in PPS at 12 months
Symptom intensity
Change from baseline in symptom intensity on the Edmonton Symptom Assessment System (ESAS) at 1 month; change from baseline in ESAS score at 3 month; change from baseline in ESAS score at 6 month; change from baseline in ESAS score at 12 month.
Satisfaction with care
Change from 1 month in satisfaction with care on the 15-item questionnaire developed by the principal investigator which validity confirmed by an expert panel and reported test-retest reliability of .87 (Sat-care) at 3 month; change from 1 month in Sat-care score at 6 months; change from 1 month in Sat-care score at 12 months
Caregiver burden
Change from baseline in caregiver burden on the Zarit Caregiver Burden Scale (ZCBS) at 1 month; change from baseline in ZCBS score at 3 months; change from baseline in ZCBS score at 6 months; change from baseline in ZCBS score at 12 months

Full Information

First Posted
March 7, 2014
Last Updated
August 21, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02086305
Brief Title
Transitional Palliative Care in End-stage Heart Failure
Official Title
Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Palliative care for end-stage organ failure patients has been included as one of the key programs to be implemented in 2011-2012 in the Hospital Authority, Hong Kong. Among all the disease groups, end-stage heart failure patients have the highest mortality rate. Patients at the end stage of heart failure have health concerns shared by other end-stage patients including cancer patients. Many guidelines, local and world-wide, have advocated a palliative approach of care for those heart failure patients who are at end stage. Studies have shown that end-stage heart failure patients tend to have frequent emergency room visits and repeated hospital admissions. Also, these patients suffer from a number of health problems that adversely affect their Quality Of Life. There is scarcity of experimental studies informing practitioners which models work best for palliative patients in Hong Kong. There were randomized controlled trials conducted outside Hong Kong which suggest multidisciplinary approach of palliative care is possible to reduce readmissions but evidence is not present for other outcomes such as symptom control and carer burden. In an attempt to fill knowledge gap and inform practice using evidence, this study is launched to compare the effects of a customary hospital-based palliative heart failure care and an interventional Home-based Palliative heart failure Program. Hypothesis there is no difference in health care utilization for end-stage heart failure patients between the customary hospital-based group and the Home based palliative heart failure program group there is no difference in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary hospital-based group and the Home based palliative heart failure program group there is no difference in perceived health outcomes (quality of life, caregiver burden) between the customary hospital-based group and the Home based palliative heart failure program group there is no difference in cost effectiveness between the customary hospital-based group and the Home based palliative heart failure program group there is no difference In patients' lived experiences between the customary hospital-based group and the Home based palliative heart failure program group
Detailed Description
As described

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Heart Disease, Heart Failure
Keywords
Transitional care, Supportive and palliative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care + Transitional Care Model
Arm Type
Experimental
Arm Description
Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Transitional Care Model
Intervention Description
Symptom assessment and management, care goal setting, post-discharge support
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care is the routine practice in the hospital
Primary Outcome Measure Information:
Title
Healthcare utilization
Description
The time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Change from baseline in quality of life on the palliative specific McGill Quality of Life Questionnaire Hong Kong version (MQOL-HK) at 1 month; change from baseline in MQOL-HK at 3 months; change from baseline in MQOL-HK at 6 months; change from baseline in MQOL-HK at 12 months
Time Frame
baseline, 1 month, 3 months, 6 months, 12 month
Title
Quality of Life
Description
Change from baseline in quality of life on the heart failure specific Chronic Heart Failure Questionnaire-Chinese version (CHQ) at 1 month; change from baseline in CHQ score at 3 months; change from baseline in CHQ score at 6 months; change from baseline in CHQ score at 12 months
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Functional status
Description
Change from baseline in functional status on the Palliative Performance Scale (PPS) at 1 month; change from baseline in PPS at 3 months; change from baseline in PPS at 6 months; change from baseline in PPS at 12 months
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months
Title
Symptom intensity
Description
Change from baseline in symptom intensity on the Edmonton Symptom Assessment System (ESAS) at 1 month; change from baseline in ESAS score at 3 month; change from baseline in ESAS score at 6 month; change from baseline in ESAS score at 12 month.
Time Frame
Baseline, 1 month, 3 month, 6 month, 12 month
Title
Satisfaction with care
Description
Change from 1 month in satisfaction with care on the 15-item questionnaire developed by the principal investigator which validity confirmed by an expert panel and reported test-retest reliability of .87 (Sat-care) at 3 month; change from 1 month in Sat-care score at 6 months; change from 1 month in Sat-care score at 12 months
Time Frame
1 month, 3 months, 6 months, 12 months
Title
Caregiver burden
Description
Change from baseline in caregiver burden on the Zarit Caregiver Burden Scale (ZCBS) at 1 month; change from baseline in ZCBS score at 3 months; change from baseline in ZCBS score at 6 months; change from baseline in ZCBS score at 12 months
Time Frame
Baseline, 1 month, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to speak Cantonese Living within the hospital service area Ability to be contacted by phone Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below: (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy Exclusion Criteria: Discharged to nursing home or other institution Inability to communicate Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances KY Wong
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Haven Of Hope Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
28434275
Citation
Wong FKY, So C, Ng AYM, Lam PT, Ng JSC, Ng NHY, Chau J, Sham MMK. Cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure. Palliat Med. 2018 Feb;32(2):476-484. doi: 10.1177/0269216317706450. Epub 2017 Apr 24.
Results Reference
derived
PubMed Identifier
27037096
Citation
Ng AY, Wong FK, Lee PH. Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:173. doi: 10.1186/s13063-016-1303-7.
Results Reference
derived

Learn more about this trial

Transitional Palliative Care in End-stage Heart Failure

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