Clinical trial NCT02086305: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Heart Disease
Heart Failure
Keywords: Transitional care
Supportive and palliative care
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Healthcare utilization
timeFrame: up to 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline, 1 month, 3 months, 6 months, 12 month
measure: Quality of Life
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Functional status
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Symptom intensity
timeFrame: Baseline, 1 month, 3 month, 6 month, 12 month
measure: Satisfaction with care
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Caregiver burden
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Haven Of Hope Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Frances KY Wong
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.