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Transitional Palliative Care in End-stage Heart Failure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086305
Enrollment
84
Registered
2014-03-13
Start date
2013-01-31
Completion date
2016-12-31
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Heart Disease, Heart Failure

Keywords

Transitional care, Supportive and palliative 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

Interventions

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

BEHAVIORALUsual care

Usual care is the routine practice in the hospital

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Healthcare utilizationup to 12 monthsThe time from hospital discharge to hospital readmission using hospital clinical management system to retrieve data

Secondary

MeasureTime frameDescription
Quality of Lifebaseline, 1 month, 3 months, 6 months, 12 monthChange 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
Functional statusBaseline, 1 month, 3 months, 6 months, 12 monthsChange 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 intensityBaseline, 1 month, 3 month, 6 month, 12 monthChange 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 care1 month, 3 months, 6 months, 12 monthsChange 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 burdenBaseline, 1 month, 3 months, 6 months, 12 monthsChange 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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026