Older Patients Dying in Acute Geriatric Hospital Wards Clinical Trial
— PLaDaysOfficial 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
| NCT number | NCT01890239 |
| Other study ID # | B143201213985 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2012 |
| Est. completion date | May 2015 |
| Verified date | February 2019 |
| Source | End-of-Life Research Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | St Jan Brugge | Brugge | |
| Belgium | St Lucas Brugge | Brugge | |
| Belgium | AZ Sint Blasius | Dendermonde | |
| Belgium | Jessa Ziekenhuis Hasselt | Hasselt | |
| Belgium | Sint Jozefskliniek Izegem | Izegem | |
| Belgium | AZ Lokeren | Lokeren | |
| Belgium | H. Hartziekenhuis Menen | Menen | |
| Belgium | Sin Rembertziekenhuis Torhout | Torhout | |
| Belgium | Sint Augustinuskliniek Veurne | Veurne |
| Lead Sponsor | Collaborator |
|---|---|
| End-of-Life Research Group | Agentschap voor Innovatie door Wetenschap en Technologie, KU Leuven, University Ghent, Vrije Universiteit Brussel, VU University Medical Center |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | within 3 months after a patient's death | |
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | The communication among clinical staff, i.e. informing the family physician about the impending death | within 3 months after a patient's death | ||
| Secondary | 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 | ||
| Secondary | 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 |