Clinical trial NCT01890239: The Effectiveness of the Care Programme for the Last Days of Life
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Patients Dying in Acute Geriatric Hospital Wards
Lead sponsor: End-of-Life Research Group
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
name: KU Leuven
name: Amsterdam UMC, location VUmc
name: University Ghent
name: Vrije Universiteit Brussel
First posted: 2013-07-01
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: within 3 months after a patient's death
Secondary outcomes:
measure: 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
timeFrame: within 3 months after a patient's death
measure: 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
timeFrame: within 3 months after a patient's death
measure: The content of care during the last 48 hours of life, i.e. the goal of treatment, medical and nursing interventions, medication policy
timeFrame: within 3 months after a patient's death
measure: The communication among clinical staff, i.e. informing the family physician about the impending death
timeFrame: within 3 months after a patient's death
measure: 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
timeFrame: within 3 months after a patient's death
measure: The level of bereavement of family carers after the death of the patient measured using the PGD scale
timeFrame: within 3 months after a patient's death
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: St Jan Brugge
city: Brugge
country: Belgium
facility: St Lucas Brugge
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
city: Izegem
country: Belgium
facility: Sint Jozefskliniek Izegem
city: Lokeren
country: Belgium
facility: AZ Lokeren
city: Menen
country: Belgium
facility: H. Hartziekenhuis Menen
city: Torhout
country: Belgium
facility: Sin Rembertziekenhuis Torhout
city: Veurne
country: Belgium
facility: Sint Augustinuskliniek Veurne
Study officials:
References:
citation: Beernaert K, Smets T, Cohen J, Verhofstede R, Costantini M, Eecloo K, Van Den Noortgate N, Deliens L. Improving comfort around dying in elderly people: a cluster randomised controlled trial. Lancet. 2017 Jul 8;390(10090):125-134. doi: 10.1016/S0140-6736(17)31265-5. Epub 2017 May 16.
citation: Verhofstede R, Smets T, Cohen J, Costantini M, Van Den Noortgate N, Deliens L. Improving end-of-life care in acute geriatric hospital wards using the Care Programme for the Last Days of Life: study protocol for a phase 3 cluster randomized controlled trial. BMC Geriatr. 2015 Feb 22;15:13. doi: 10.1186/s12877-015-0010-7.