Overview

This trial is active, not recruiting.

Conditions end stage heart disease, heart failure
Treatments transitional care model, usual care
Sponsor The Hong Kong Polytechnic University
Start date January 2013
End date February 2016
Trial size 176 participants
Trial identifier NCT02086305, PolyU5492

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Transitional Care, Evidence-based symptom management, Protocol-driven home visit and telephone follow-up, Trained nurse case manager and volunteer partnership
transitional care model
Symptom assessment and management, care goal setting, post-discharge support
usual care
Usual care is the routine practice in the hospital
(Active Comparator)
Usual care
usual care
Usual care is the routine practice in the hospital

Primary Outcomes

Measure
Healthcare utilization
time frame: up to 12 months

Secondary Outcomes

Measure
Quality of Life
time frame: baseline, 1 month, 3 months, 6 months, 12 month
Quality of Life
time frame: Baseline, 1 month, 3 months, 6 months, 12 months
Functional status
time frame: Baseline, 1 month, 3 months, 6 months, 12 months
Symptom intensity
time frame: Baseline, 1 month, 3 month, 6 month, 12 month
Satisfaction with care
time frame: 1 month, 3 months, 6 months, 12 months
Caregiver burden
time frame: Baseline, 1 month, 3 months, 6 months, 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Effects of a Transitional Palliative Care Model on Patients With End-stage Heart Failure
Principal investigator Frances KY Wong
Description As described
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.