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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01890239
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 7, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Older Patients Dying in Acute Geriatric Hospital Wards Other: Care Programme for the Last Days of Life

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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 Start Date : September 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Care Programme for the Last Days of Life
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.
Other: Care Programme for the Last Days of Life
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.
No Intervention: Usual care
Care will be provided as usual, also for patients who have entered the dying phase.


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890239


Locations
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, Belgium
Sponsors and Collaborators
End-of-Life Research Group
Agentschap voor Innovatie door Wetenschap en Technologie
Katholieke Universiteit Leuven
VU University Medical Center
University Ghent
Vrije Universiteit Brussel
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: rebecca verhofstede, Doctoral reseracher, End-of-Life Research Group
ClinicalTrials.gov Identifier: NCT01890239     History of Changes
Other Study ID Numbers: B143201213985
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016