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

Palliative Care Clinical Trial

— ESRF  

Official title:

Effects of a Transitional Palliative Care Model on Patients With ESRF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139917
• Other study ID #: 23 January 2014
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary aim:

1. To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients

2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients

Secondary aim:

3. 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.

Description:

Objectives

Related to the primary aim:

1. 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?

2. 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?

3. 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:

4. How are the lived experiences compared and contrasted between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Palliative Care
• Renal Failure, End-stage
• Renal Insufficiency

Intervention

Behavioral:
• Transitional community based palliative care
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

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Hong Kong	Hong Kong SAR

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived outcomes composite (quality of life, caregiver burden, satisfaction with care)	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	12 months
Primary	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.		for 12 months
Secondary	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).	12 months