Back to resultsEffects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure (ESRF)
Primary Purpose
Palliative Care, Renal Failure, End-stage
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transitional community based palliative care
Sponsored by
About this trial
This is an interventional supportive care trial for Palliative Care focused on measuring transitional palliative care, end stage renal failure
Eligibility Criteria
Inclusion Criteria:
- Patient with chronic kidney disease and diabetic mellitus with Creatinine ≥350 milli mole (uM) or those without diabetic mellitus with Creatinine ≥450 milli mole (uM) who refused renal replacement therapy (RRT);
- Patient not suitable for long term renal replacement therapy (RRT) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support)
- Identified as ESRF patient eligible for palliative care without prior renal replacement therapy
- Ability to speak Cantonese
- Living within the hospital service area
- Ability to be contacted by phone
Exclusion Criteria:
- Discharged to nursing home or other institution
- Inability to communicate
- Cognitive impairment, mini mental stage examination (MMSE) < 20
- Diagnosed with severe psychiatric disorders such as schizophrenia and bipolar disorder
Sites / Locations
- Queen Elizabeth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transitional Palliative Care
Customary care
Arm Description
Transitional palliative care include:- telephone follow up for early identification of signs and symptoms home visit for spiritual support
Customary care receive care :- hospital based medical follow up general nursing assessment and advice
Outcomes
Primary Outcome Measures
Healthcare utilization composite - The dates of re-hospitalizations, length of stay, and number of other hospital services used, including clinics and emergency room visits, will be extracted from the hospital administrative systems.
Secondary Outcome Measures
Evaluated health outcomes composite (functional status, symptom intensity) - The functional status will be measured by the Palliative Performance Scale (PPS )(appendix 6).
The PPS is a clinical tool commonly used in the local settings. The level of physical performance is rated on a scale of 100 (normal) to 0 (death), measured in 10 % decrement levels. The scale has been validated and the inter-rater reliability between doctors and nurses maintained at .85 with strong kappa values of .97 (Myers J, Gardiner K, Harris K et al., 2010).
Full Information
NCT ID
NCT02139917
First Posted
May 5, 2014
Last Updated
March 20, 2019
Sponsor
The Hong Kong Polytechnic University
Collaborators
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02139917
Brief Title
Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure
Acronym
ESRF
Official Title
Effects of a Transitional Palliative Care Model on Patients With ESRF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Hospital Authority, Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary aim:
To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients
To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients
Secondary aim:
To explore the lived experiences of patients with ESRF. Hypothesis The transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.
Detailed Description
Objectives
Related to the primary aim:
Are there differences in healthcare utilization between the ESRF patients in the customary care group and those in the HBPRP group; in the HBPRP group and HBPP group?
Are there differences in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary care group and the HBPRP group ; in the HBPRP group and HBPP group?
Are there differences in perceived health outcomes (quality of life, caregiver burden) between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?
Related to the secondary aim:
How are the lived experiences compared and contrasted between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care, Renal Failure, End-stage
Keywords
transitional palliative care, end stage renal failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transitional Palliative Care
Arm Type
Experimental
Arm Description
Transitional palliative care include:-
telephone follow up for early identification of signs and symptoms
home visit for spiritual support
Arm Title
Customary care
Arm Type
No Intervention
Arm Description
Customary care receive care :-
hospital based medical follow up
general nursing assessment and advice
Intervention Type
Behavioral
Intervention Name(s)
Transitional community based palliative care
Other Intervention Name(s)
Transitional palliative care
Intervention Description
transitional palliative care include:-
telephone follow up for early identification of signs and symptoms
relief of signs and symptoms encountered
home visit with spiritual support
Primary Outcome Measure Information:
Title
Healthcare utilization composite - The dates of re-hospitalizations, length of stay, and number of other hospital services used, including clinics and emergency room visits, will be extracted from the hospital administrative systems.
Time Frame
for 12 months
Secondary Outcome Measure Information:
Title
Evaluated health outcomes composite (functional status, symptom intensity) - The functional status will be measured by the Palliative Performance Scale (PPS )(appendix 6).
Description
The PPS is a clinical tool commonly used in the local settings. The level of physical performance is rated on a scale of 100 (normal) to 0 (death), measured in 10 % decrement levels. The scale has been validated and the inter-rater reliability between doctors and nurses maintained at .85 with strong kappa values of .97 (Myers J, Gardiner K, Harris K et al., 2010).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Perceived outcomes composite (quality of life, caregiver burden, satisfaction with care)
Description
Quality of life will be measured by an ESRF-specific quality of life measure. The caregiver burden will be measured by the Zarit Caregiver Burden Scale (ZCBS). Satisfaction with care will be measured by the 15-item questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with chronic kidney disease and diabetic mellitus with Creatinine ≥350 milli mole (uM) or those without diabetic mellitus with Creatinine ≥450 milli mole (uM) who refused renal replacement therapy (RRT);
Patient not suitable for long term renal replacement therapy (RRT) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support)
Identified as ESRF patient eligible for palliative care without prior renal replacement therapy
Ability to speak Cantonese
Living within the hospital service area
Ability to be contacted by phone
Exclusion Criteria:
Discharged to nursing home or other institution
Inability to communicate
Cognitive impairment, mini mental stage examination (MMSE) < 20
Diagnosed with severe psychiatric disorders such as schizophrenia and bipolar disorder
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
State/Province
Hong Kong SAR
ZIP/Postal Code
852
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure
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