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Completed

NCT Number: NCT02139917

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

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.

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Key information

Conditions

Palliative Care Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure, End-stage Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital

Hong Kong, Hong Kong SAR, 852

About this study

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?

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transitional community based palliative care

Behavioral

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

Other names: Transitional palliative care

Primary outcomes

  1. 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 outcomes

  1. Evaluated health outcomes composite (functional status, symptom intensity) - The functional status will be measured by the Palliative Performance Scale (PPS )(appendix 6).

    Time frame: 12 months

    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).

Other outcomes

  1. Perceived outcomes composite (quality of life, caregiver burden, satisfaction with care)

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Official study title

Effects of a Transitional Palliative Care Model on Patients With ESRF

Acronym: ESRF

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 16, 2014
Registry last updated
Mar 22, 2019

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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