Implementation effectiveness of supporting ICUs
| ISRCTN | ISRCTN84179821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84179821 |
| Secondary identifying numbers | 2013-15-16p |
- Submission date
- 08/11/2016
- Registration date
- 14/11/2016
- Last edited
- 10/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Contact information
Public
HAN University of Applied Sciences
Research department Emergency and Critical Care
Postbus 6960
Nijmegen
6503 GL
Netherlands
| Phone | +31 653981819 |
|---|---|
| lilian.vloet@han.nl |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet in Dutch |
| 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 |
| Study hypothesis | Supporting ICUs leads to better adherence of the guidelines for end-of-life care. |
| Ethics approval(s) | CMO Radboudumc Nijmegen, 19/02/20195, ref: 2014-1363 |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2014 |
| Overall study end date | 01/12/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 11 clusters, 1500 ICU nurses, 60 family members |
| 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 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
Study participating centres
Kapittelweg 33
Nijmegen
6525 EN
Netherlands
Nijmegen
6525 GA
Netherlands
Enschede
7512 KZ
Netherlands
Doetinchem
7009 BL
Netherlands
Netherlands
Hoogeveen
7909 AA
Netherlands
Drachten
9202 NN
Netherlands
Sneek
8601 ZK
Netherlands
Hoorn
1624 NP
Netherlands
Amsterdam
1066 CX
Netherlands
Amersfoort
3813 TZ
Netherlands
Leiderdorp
2353 GA
Netherlands
Dordrecht
3318 AT
Netherlands
Breda
4819 EV
Netherlands
Sponsor information
University/education
Research Department Emergency and Critical Care
Nijmegen
6503 GL
Netherlands
| Website | www.laiz.nl |
|---|---|
"ROR" |
https://ror.org/0500gea42 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
