The Effectiveness of the Care Programme for the Last Days of Life (PLaDays)

End-of-Life Research Group

Status: Completed

Conditions: Older Patients Dying in Acute Geriatric Hospital Wards

Treatments: Other: Care Programme for the Last Days of Life

Study type: Interventional

Funder types: Other

Identifiers

NCT01890239

B143201213985

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria of the hospitals in the trial are:

• the cluster or hospital has one or more acute geriatric wards
• the medical and nursing head of one or more acute geriatric wards per hospital give consent for participation in the study

The inclusion criteria of patients are:

• those dying in the acute geriatric ward between October 2012 and March 2015
• those that having been hospitalized for more than 48 hours
• those having given informed consent at admission for the use of their personal information from medical or nursing records for the purposes of the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Care Programme for the Last Days of Life

Experimental group

Description:

The Care Programme for the Last Days of Life will be implemented in the acute geriatric hospital wards randomized to the experimental group. Subsequently, older patients hospitalized in one of these experimental wards and for who the multidisciplinary team has decided that he or she has entered the dying phase, will benefit from this Care Programme.

Treatment:

Other: Care Programme for the Last Days of Life

Usual care

No Intervention group

Description:

Care will be provided as usual, also for patients who have entered the dying phase.