Transitional Palliative Care in End-stage Heart Failure

NCT ID: NCT02086305

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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As described

Conditions

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End Stage Heart Disease Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care + Transitional Care Model

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

Group Type EXPERIMENTAL

Transitional Care Model

Intervention Type BEHAVIORAL

Symptom assessment and management, care goal setting, post-discharge support

Usual care

Intervention Type BEHAVIORAL

Usual care is the routine practice in the hospital

Usual Care

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care is the routine practice in the hospital

Interventions

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Transitional Care Model

Symptom assessment and management, care goal setting, post-discharge support

Intervention Type BEHAVIORAL

Usual care

Usual care is the routine practice in the hospital

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Frances Kam Yuet WONG

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frances KY Wong

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Grantham Hospital

Hong Kong, , Hong Kong

Site Status

Haven Of Hope Hospital

Hong Kong, , Hong Kong

Site Status

United Christian Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 28434275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27037096 (View on PubMed)

Other Identifiers

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PolyU5492

Identifier Type: -

Identifier Source: org_study_id

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