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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.

Verhofstede R, Smets T, Cohen J, Costantini M, Van Den Noortgate N, Deliens L - BMC Geriatr (2015)

Bottom Line: 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.Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life.

View Article: PubMed Central - PubMed

Affiliation: End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium. rebecca.verhofstede@vub.ac.be.

ABSTRACT

Background: 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 paper is to describe the research protocol of a cluster randomized controlled trial to evaluate the effects of the Care Programme for the Last Days of Life.

Methods and design: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT01890239. Registered June 24th, 2013.

No MeSH data available.


Flowchart of the cluster randomized controlled trial.
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Fig2: Flowchart of the cluster randomized controlled trial.

Mentions: While a classic randomized clinical trial is known as the most appropriate method to study the effect of an intervention, it is impossible to randomize a complex intervention within a hospital without contamination of the control arm [24]. For this reason, a multicentre two arm cluster randomized controlled trial will be performed. To prevent possible bias at the level of the hospital, a clustering will take place on the hospital level. Consequently, randomization will be carried out at the level of the hospital. The flow diagram of the study protocol is outlined in FigureĀ 2. The CONSORT guidelines have been followed to design this study [25]. The trial is registered in ClinicalTrials.gov, identifier NCT01890239.Figure 2


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.

Verhofstede R, Smets T, Cohen J, Costantini M, Van Den Noortgate N, Deliens L - BMC Geriatr (2015)

Flowchart of the cluster randomized controlled trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4340777&req=5

Fig2: Flowchart of the cluster randomized controlled trial.
Mentions: While a classic randomized clinical trial is known as the most appropriate method to study the effect of an intervention, it is impossible to randomize a complex intervention within a hospital without contamination of the control arm [24]. For this reason, a multicentre two arm cluster randomized controlled trial will be performed. To prevent possible bias at the level of the hospital, a clustering will take place on the hospital level. Consequently, randomization will be carried out at the level of the hospital. The flow diagram of the study protocol is outlined in FigureĀ 2. The CONSORT guidelines have been followed to design this study [25]. The trial is registered in ClinicalTrials.gov, identifier NCT01890239.Figure 2

Bottom Line: 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.Primary outcomes are symptom frequency and symptom burden of patients in the last 48 hours of life.

View Article: PubMed Central - PubMed

Affiliation: End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium. rebecca.verhofstede@vub.ac.be.

ABSTRACT

Background: 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 paper is to describe the research protocol of a cluster randomized controlled trial to evaluate the effects of the Care Programme for the Last Days of Life.

Methods and design: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT01890239. Registered June 24th, 2013.

No MeSH data available.