NCT02086305

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3.1 years

First QC Date

March 7, 2014

Last Update Submit

August 21, 2017

Conditions

End Stage Heart DiseaseHeart Failure

Keywords

Transitional careSupportive and palliative care

Outcome Measures

Primary Outcomes (1)

  • Healthcare utilization

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

    up to 12 months

Secondary Outcomes (6)

  • Quality of Life

    baseline, 1 month, 3 months, 6 months, 12 month

  • Quality of Life

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Functional status

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Symptom intensity

    Baseline, 1 month, 3 month, 6 month, 12 month

  • Satisfaction with care

    1 month, 3 months, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Usual Care + Transitional Care Model

EXPERIMENTAL

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

Behavioral: Transitional Care ModelBehavioral: Usual care

Usual Care

ACTIVE COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Transitional Care ModelBEHAVIORAL

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

Usual Care + Transitional Care Model
Usual careBEHAVIORAL

Usual care is the routine practice in the hospital

Usual CareUsual Care + Transitional Care Model

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Grantham Hospital

Hong Kong, Hong Kong

Location

Haven Of Hope Hospital

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 28434275DERIVED

  • 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.

    PMID: 27037096DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Frances KY Wong

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 13, 2014

Study Start

January 1, 2013

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

HK(3)