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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
ISRCTN84179821 |
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Date of registration:
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14/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Implementation effectiveness of supporting ICUs
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Scientific title:
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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 |
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Date of first enrolment:
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01/10/2014 |
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Target sample size:
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1560 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84179821 |
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Study type:
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Interventional |
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Study design:
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Cluster randomised controlled trial (Other)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Lilian
Vloet |
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Address:
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HAN University of Applied Sciences
Research department Emergency and Critical Care
Postbus 6960
6503 GL
Nijmegen
Netherlands |
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Telephone:
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+31 653981819 |
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Email:
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lilian.vloet@han.nl |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Nurses:
No experience with End-of-life care.
Family:
Family of patients who were organ donors.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nursing guidelines
Not Applicable
Nursing guidelines
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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2013-15-16p
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Source(s) of Monetary Support
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Foundation Innovation Alliance, Regional Attention and Action for Knowledge circulation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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