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Implementation of the Pain, Agitation and Delirium bundle in the Intensive Care Unit: catches


- candidate number26929
- NTR NumberNTR6472
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2017
- Secondary IDs17-N-38 METC Zuyderland
- Public TitleImplementation of the Pain, Agitation and Delirium bundle in the Intensive Care Unit: catches
- Scientific TitleImplementation of the Pain, Agitation and Delirium bundle in the Intensive Care Unit: catches
- ACRONYM
- hypothesisThe reported incidence of delirium in the intensive care unit varies from 16 to 89%. A delirium is associated with increased mortality, increased hospital length of stay, higher cost of care and cognitive impairment. The Pain, Agitation and Delirium bundle, which has been published in 2013, shows that integrated management of pain, agitation and delirium is of great importance. This is because optimal pain management and light sedation are necessary to evaluate delirium in a patient and the occurrence of pain, agitation and delirium are associated with negative clinical outcomes. In this integrated approach, daily measurement of pain, agitation and delirium plays a central role.
However, recent studies show many Dutch intensive care units do not use validated scores, the factors causing this have yet to be identified. The aim of this study is to identify those factors, that could lead to improved implementation of the PAD bundle and an improvement in the clinical outcomes of ICU patients. In addition, the effect of implementation of the PAD bundle on the use of validated scores by ICU nurses will be evaluated.
- Healt Condition(s) or Problem(s) studiedPain, Sedation, Delirium, Intensive care
- Inclusion criteriaICU nurses working in Dutch Intensive Care Units.
- Exclusion criteriaPoor/no understanding of the Dutch language Under the age of 18 years
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate31-mrt-2018
- Target number of participants250
- InterventionsIn order to be able to implement the PAD-bundle in an Intensive Care Unit, training (either intern or extern) will be organized for each hospital. Questionnaires will be sent to ICU nurses, working in different Dutch Intensive Care Units, before and 6 months after the training. The questionnaire contains questions about the following factors which could prevent the use of validated scores: the amount of scores that have to be filled out, knowledge of the use of different scores, knowledge of the importance of the use of validated scores, registering the performed score and the time necessary to perform a pain score.
- Primary outcomeFactors influencing the use of validated scores.
- Secondary outcomeThe effect of implementation of the Pain, Agitation and Delirium bundle, through training, on the use of validated scores.
- TimepointsThe primary and secondary outcome measures are measured using a questionnaire about the following factors which could prevent the use of validated scores: the amount of scores that have to be filled out, knowledge of the use of different scores, knowledge of the importance of the use of validated scores, registering the performed score and the time necessary to perform a pain score.

For the primary outcome measure the questionnaires were conducted at the end of 2016.
For the secondary outcome measure the questionnaires will be conducted 6 months after the implementation of the PAD bundle.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES M.C.E. van der Woude
- CONTACT for SCIENTIFIC QUERIES M.C.E. van der Woude
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe Pain, Agitation and Delirium (PAD) bundle, which has been published in 2013, shows that integrated management of pain agitation and delirium is of great importance. This is because optimal pain management and light sedation are necessary to evaluate delirium in a patient and the occurrence of pain, agitation and delirium are associated with negative clinical outcomes. In this integrated approach daily measurement of pain, agitation and delirium plays a central role.
However, recent studies show many Dutch intensive care units do not use validated scores, the factors causing this are not yet identified.
The aim of this study is to identify these factors, this could lead to improved implementation of the PAD bundle and an improvement in the clinical outcomes of ICU patients. In addition, the effect of implementation of the PAD bundle on the use of validated scores by ICU nurses will be evaluated.

Recruiting countries: The Netherlands
- Main changes (audit trail)
- RECORD20-mrt-2017 - 5-jul-2017


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