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Clinical Trials/NCT01890239
NCT01890239
Completed
Not Applicable

Improving End-of-life Care in Acute Geriatric Hospital Wards Using the Care Programme for the Last Days of Life: a Cluster Randomized Controlled Trial

End-of-Life Research Group9 sites in 1 country600 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Older Patients Dying in Acute Geriatric Hospital Wards
Sponsor
End-of-Life Research Group
Enrollment
600
Locations
9
Primary Endpoint
The effect of implementation of the Care Programme for the Last Days of Life on the quality of dying in acute geriatric hospital wards: the patient's symptom frequency and symptom burden evaluated by the SM-EOLD and CAD-EOLD
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

BACKGROUND Demographic trends coupled with a rise in chronic diseases mean that the population of patients requiring palliative and end-of-life care is ageing. Due to the ageing population palliative care for older people has been identified as one of the worldwide public health priorities. A majority of elderly patients die in hospital. Studies from the United Kingdom and other countries have shown that many older persons dying in hospital experience suboptimal care. The Care Programme for the Last Days of Life has been developed to improve the quality of end-of-life care in acute geriatric hospital wards. The programme is based on existing end-of-life care programmes but modeled to the acute geriatric care setting. There is a lack of evidence of the effectiveness of end-of-life care programmes and the effects that may be achieved in patients dying in an acute geriatric hospital setting are unknown. The aim of this study is to evaluate the effectiveness of the Care Programme for the Last Days of Life in improving the quality of care and quality of life during the last 48 hours of life of patients dying in acute geriatric hospital wards in Flanders as compared to usual care.

METHODS In order to contribute substantially to the increase of evidence for the effect of the Care Programme for the Last Days of Life in patients dying in acute geriatric hospital wards, a cluster randomized controlled trial will be conducted. Ten hospitals with one or more acute geriatric wards will conduct a one-year baseline assessment during which care will be provided as usual. For each patient dying in the ward, a questionnaire will be filled in by a nurse, a physician and a family carer. At the end of the baseline assessment hospitals will be randomized to receive intervention (implementation of the Care Programme) or no intervention. Subsequently, the Care Programme will be implemented in the intervention hospitals over a six-month period. A one-year post-intervention assessment will be performed immediately after the baseline assessment in the control hospitals and after the implementation period in the intervention hospitals. Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life.

DISCUSSION This will be the first cluster randomized controlled trial to evaluate the effect of the Care Programme for the Last Days of Life for the acute geriatric hospital setting. The results will enable us to evaluate whether implementation of the Care Programme has positive effects on end-of-life care during the last days of life in this patient population and which components of the Care Programme contribute to improving the quality of end-of-life care.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
May 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
End-of-Life Research Group
Responsible Party
Principal Investigator
Principal Investigator

Tinne Smets

Doctoral reseracher

End-of-Life Research Group

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The effect of implementation of the Care Programme for the Last Days of Life on the quality of dying in acute geriatric hospital wards: the patient's symptom frequency and symptom burden evaluated by the SM-EOLD and CAD-EOLD

Time Frame: within 3 months after a patient's death

Using a cluster randomized controlled trail with randomized assignment to the intervention or control group, the effect of the Care Programme on the quality of dying is evaluated with the SM-EOLD and CAD-EOLD

Secondary Outcomes

  • The quality of care during the last 48 hours of life as perceived by family carers, i.e. satisfaction with the care provided to the patient during the last 48 hours of life measured using the EOLD-SWC(within 3 months after a patient's death)
  • The quality of care during the last three days of life as perceived by nurses, i.e. physical symptoms, emotional, psychological and spiritual/existential needs and provision of information and support measured using the POS(within 3 months after a patient's death)
  • The content of care during the last 48 hours of life, i.e. the goal of treatment, medical and nursing interventions, medication policy(within 3 months after a patient's death)
  • The communication between clinical staff and patients and/or family carers, i.e. the perception of communication with the physician during the dying phase by family carers measured using the FPPFC(within 3 months after a patient's death)
  • The level of bereavement of family carers after the death of the patient measured using the PGD scale(within 3 months after a patient's death)
  • The communication among clinical staff, i.e. informing the family physician about the impending death(within 3 months after a patient's death)

Study Sites (9)

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