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NCT Number: NCT02086305

Transitional Palliative Care in End-stage Heart Failure

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

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Key information

Conditions

End Stage Heart Disease Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grantham Hospital, Hong Kong

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About this study

As described

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transitional Care Model

Behavioral

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

Usual Care

Behavioral

Usual care is the routine practice in the hospital

Primary outcomes

  1. Healthcare utilization

    Time frame: up to 12 months

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

Secondary outcomes

  1. Quality of Life

    Time frame: baseline, 1 month, 3 months, 6 months, 12 month

    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

  2. Quality of Life

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months

    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

  3. Functional status

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months

    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

  4. Symptom intensity

    Time frame: Baseline, 1 month, 3 month, 6 month, 12 month

    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.

  5. Satisfaction with care

    Time frame: 1 month, 3 months, 6 months, 12 months

    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

  6. Caregiver burden

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months

    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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2014
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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