Older Patients Dying in Acute Geriatric Hospital WardsPLaDaysNCT01890239
The Effectiveness of the Care Programme for the Last Days of Life
A study testing Care Programme for the Last Days of Life in people with Older Patients Dying in Acute Geriatric Hospital Wards, run by End-of-Life Research Group at 9 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Older Patients Dying in Acute Geriatric Hospital Wards
- What is being tested?
- Care Programme for the Last Days of Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 9 sitesBelgium
- Study dates
- Sep 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
Belgium9 sites
St Jan Brugge
Bruges
St Lucas Brugge
Bruges
AZ Sint Blasius
Dendermonde
Jessa Ziekenhuis Hasselt
Hasselt
Sint Jozefskliniek Izegem
Izegem
AZ Lokeren
Lokeren
H. Hartziekenhuis Menen
Menen
Sin Rembertziekenhuis Torhout
Torhout
Sint Augustinuskliniek Veurne
Veurne
About this study
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
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.
- Being tested
- Care Programme for the Last Days of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Programme for the Last Days of LifeOther
The Care Programme essentially aims to raise awareness among geriatric health care staff of the importance for improving end-of-life care and to prepare them for a change in end-of-life care, to train staff in delivering good end-of-life care with the support of a multi-professional document called the Care Guide for the Last Days of Life, to support dying geriatric patients with the Care Guide for the Last days of Life, to regularly evaluate the delivered end-of-life care and support and to further educate the staff in delivering optimal end-of-life care. The Care Programme consists of the following documents: (1) the Care Guide for the Last Days of Life, (2) supportive documentation and (3) an implementation guide.
| Study group | Role | What they receive |
|---|---|---|
| Care Programme for the Last Days of Life | Experimental | 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. Receives: Other: Care Programme for the Last Days of Life |
| Usual care | No intervention | Care will be provided as usual, also for patients who have entered the dying phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 3 months after a patient's death
Secondary outcomes (6)
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
Measured: within 3 months after a patient's death
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
Measured: 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
Measured: within 3 months after a patient's death
The communication among clinical staff, i.e. informing the family physician about the impending death
Measured: 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
Measured: 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
Measured: within 3 months after a patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older Patients Dying in Acute Geriatric Hospital WardsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- End-of-Life Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, KU Leuven, Amsterdam UMC, location VUmc, University Ghent, Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Tinne Smets, End-of-Life Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890239
- Sponsor's protocol ID
- B143201213985
- Acronym
- PLaDays
- Status last verified
- Feb 2019
- First submitted
- 24 Jun 2013
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28526493Verhofstede 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.
PubMed 25887959
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01890239
- Acronym / sponsor ID
- PLaDays / B143201213985
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- End-of-Life Research GroupUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, KU Leuven, Amsterdam UMC, location VUmc, University Ghent, Vrije Universiteit Brussel
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Programme for the Last Days of Life | Experimental | Other: Care Programme for the Last Days of LifeThe 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. |
| Usual care | No intervention | –Care will be provided as usual, also for patients who have entered the dying phase. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Programme for the Last Days of LifeThe Care Programme essentially aims to raise awareness among geriatric health care staff of the importance for improving end-of-life care and to prepare them for a change in end-of-life care, to train staff in delivering good end-of-life care with the support of a multi-professional document called the Care Guide for the Last Days of Life, to support dying geriatric patients with the Care Guide for the Last days of Life, to regularly evaluate the delivered end-of-life care and support and to further educate the staff in delivering optimal end-of-life care. The Care Programme consists of the following documents: (1) the Care Guide for the Last Days of Life, (2) supportive documentation and (3) an implementation guide. | Other | Care Programme for the Last Days of Life |
Primary outcome
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
6 secondary outcomes
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
Time frame: within 3 months after a patient's death
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
Time frame: 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
Time frame: within 3 months after a patient's death
The communication among clinical staff, i.e. informing the family physician about the impending death
Time frame: 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
Time frame: 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
Time frame: within 3 months after a patient's death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 28526493Beernaert 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.
- Derived from this study: PubMed 25887959Verhofstede 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Programme for the Last Days of Life in people with Older Patients Dying in Acute Geriatric Hospital Wards, run by End-of-Life Research Group at 9 sites in Belgium.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: within 3 months after a patient's death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.