The Effectiveness of the Care Programme for the Last Days of Life

NCT ID: NCT01890239

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Older Patients Dying in Acute Geriatric Hospital Wards

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Care Programme for the Last Days of Life

Intervention Type OTHER

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

End-of-Life Research Group

OTHER

Sponsor Role lead

Responsible Party

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Tinne Smets

Doctoral reseracher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Jan Brugge

Bruges, , Belgium

Site Status

St Lucas Brugge

Bruges, , Belgium

Site Status

AZ Sint Blasius

Dendermonde, , Belgium

Site Status

Jessa Ziekenhuis Hasselt

Hasselt, , Belgium

Site Status

Sint Jozefskliniek Izegem

Izegem, , Belgium

Site Status

AZ Lokeren

Lokeren, , Belgium

Site Status

H. Hartziekenhuis Menen

Menen, , Belgium

Site Status

Sin Rembertziekenhuis Torhout

Torhout, , Belgium

Site Status

Sint Augustinuskliniek Veurne

Veurne, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28526493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25887959 (View on PubMed)

Other Identifiers

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B143201213985

Identifier Type: -

Identifier Source: org_study_id

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