Condition category
Not Applicable
Date applied
08/11/2016
Date assigned
14/11/2016
Last edited
10/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Approximately 8% of all intensive care unit (ICU) patients die in the ICU, and 80% of these deaths occur after withholding or withdrawing the life sustaining treatment. The care given before, during and after ending the life sustaining treatment is called end-of-life care. End-of-life care (EOLC) is s complex care pathway, which involves many different professionals. This includes ICU nurses, however it is not yet clear what the role and responsibilities of ICU nurses are during EOLC. Therefore, a Dutch guideline was developed called 'End-of-life care in the ICU, nursing care'. This guideline could help ICU nurses in their care during EOLC. Before this guideline can be followed, it needs to be implemented (put in place). This can be a difficult process, and so a possible way to support the implementation is to train those who are going to use it. The aim of this study is to find out whether supporting the implementation of this guideline can better help nurses to follow it.

Who can participate?
ICU nurses working at participating medical centres who are experienced with EOLC and family members of patients who died 4-5 weeks ago.

What does the study involve?
Participating ICUs are randomly allocated to one of two groups. ICU nurses in the first group take part in a four day training programme in which they are trained to implement the guildeline. This consists of a combination of lectures and workshops. ICUs in the second group are left to implement the guideline by themselves. At the start of the study and then after six and nine months, two ICU nurses from each ICU are interviewed about how well they are able to follow the guideline. In addition, family members of patients who died 4-5 weeks ago are also interviewed and complete a number of questionnaires about their experiences of end of life care in the ICU.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for those participating.

Where is the study run from?
The study is run from HAN University of Applied Sciences and takes place in 13 medical centres (Netherlands)

When is the study starting and how long is it expected to run for?
June 2014 to December 2015

Who is funding the study?
Foundation Innovation Alliance, Regional Attention and Action for Knowledge circulation (Netherlands)

Who is the main contact?
Dr Lilian Vloet
lilian.vloet@han.nl

Trial website

Contact information

Type

Public

Primary contact

Prof Lilian Vloet

ORCID ID

Contact details

HAN University of Applied Sciences
Research department Emergency and Critical Care
Postbus 6960
Nijmegen
6503 GL
Netherlands
+31 653981819
lilian.vloet@han.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013-15-16p

Study information

Scientific title

Effectiveness of supporting intensive care units on implementing the guideline 'End-of-life care in the intensive care unit, nursing care': a cluster randomised controlled trial

Acronym

Study hypothesis

Supporting ICUs leads to better adherence of the guidelines for end-of-life care.

Ethics approval

CMO Radboudumc Nijmegen, 19/02/20195, ref: 2014-1363

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet in Dutch

Condition

Nursing guidelines

Intervention

Participating ICUs are randomly allocated to two groups (manual generated randomization with random allocation concealment), without stratification of ICU size.

Both the intervention and control groups made their own implementation plan and implemented the guideline on their own ICU, with a project team.

Intervention group: ICUs are supported by a training program focusing on implementation processes and strategies and sharing experiences and best practices from other intervention sites. Training takes place over 4 days and consists of a combination of lectures and workshops which cover:
Day 1: Development of specific implementation plan and context analysis
Day 2: Context analysis and Implementation strategies
Day 3: Implementation strategies and Implementation plan
Day 4: Implementation plan and Embedding and monitoring

Control group: ICUs receive no support during the implementation and have to implement the guideline by themselves without supervision from the research group.

Follow up for all ICUs involves interviewing two ICU nurses from each participating ICU after 6 and 9 months and interviewing relatives of patients who have died 4-5 weeks previously at 9 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Adherence to guidelines for end-of-life care is measured by a questionnaire for ICU nurses applying 25 recommendations of the guideline at baseline, and after 6 and 9 months.

Secondary outcome measures

Experiences of ICU nurses and family of deceased patients are measured the Quality of Death and Dying (QDD) and Consumer Quality Index (CQI-R), relatives in the ICU (LAIZ 2016) questionnaires at 9 months.

Overall trial start date

01/06/2014

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Nurses:
1. Working in the ICU
2. Graduated as a ICU nurse
3. Dutch speaking
4. Experience with EOLC in the ICU

Family of deceased ICU patients:
1. Dutch speaking
2. Aged 18 years and over
3. 4-5 weeks after death of the patient
3. Contact person of the deceased patient

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

11 clusters, 1500 ICU nurses, 60 family members

Participant exclusion criteria

Nurses:
No experience with End-of-life care.

Family:
Family of patients who were organ donors.

Recruitment start date

01/10/2014

Recruitment end date

30/11/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

HAN University of Applied Sciences
Research department Emergency and Critical Care Kapittelweg 33
Nijmegen
6525 EN
Netherlands

Trial participating centre

Radboud University Nijmegen Medical Centre
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands

Trial participating centre

Medisch Spectrum Twente
Koningsplein 1
Enschede
7512 KZ
Netherlands

Trial participating centre

Slingeland Ziekenhuis
Kruisbergseweg 25
Doetinchem
7009 BL
Netherlands

Trial participating centre

Ommelander Ziekenhuis Groep
9930 RA
Netherlands

Trial participating centre

Treant Zorggroep
Dr. G.H. Amshoffweg 1
Hoogeveen
7909 AA
Netherlands

Trial participating centre

Nij Smellinghe
Compagnonsplein 1
Drachten
9202 NN
Netherlands

Trial participating centre

Antonius Ziekenhuis
Bolswarderbaan 1
Sneek
8601 ZK
Netherlands

Trial participating centre

Westfriesgasthuis
Maelsonstraat 3
Hoorn
1624 NP
Netherlands

Trial participating centre

Antoni van Leeuwenhoek
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Trial participating centre

Meander MC
Maatweg 3
Amersfoort
3813 TZ
Netherlands

Trial participating centre

Alrijne Ziekenhuis Leiderdorp
Simon Smitweg 1
Leiderdorp
2353 GA
Netherlands

Trial participating centre

Albert Schweitzer Ziekenhuis
Albert Schweitzerplaats 25
Dordrecht
3318 AT
Netherlands

Trial participating centre

Amphia Ziekenhuis
Langendijk 75
Breda
4819 EV
Netherlands

Sponsor information

Organisation

HAN University of Applied Sciences

Sponsor details

Research Department Emergency and Critical Care
Nijmegen
6503 GL
Netherlands

Sponsor type

University/education

Website

www.laiz.nl

Funders

Funder type

Research organisation

Funder name

Foundation Innovation Alliance, Regional Attention and Action for Knowledge circulation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer-reviewed international journal, focusing on nursing sciences (journal of advanced nursing).

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Lilian Vloet (lilian.vloet@han.nl)

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes