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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02922101
Other study ID # METC_W16_271
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date October 2018

Study information

Verified date January 2019
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the addition of a quality improvement toolbox to an online audit and feedback intervention in Dutch intensive care units. The toolbox comprises for each quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift). Half of the participating intensive care units will only receive online feedback, while the other half will additionally gain access to the integrated toolbox to facilitate planning and executing actions.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ICUs treating adult (18 years and above) patients

- ICUs willing and able to submit data monthly

- ICUs with a local quality improvement team of at least 1 intensivist and 1 nurse

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Audit and Feedback
An online dashboard that provides insight into clinical performance on pain management quality indicators. It also incorporates an empty action plan, in which participating intensive care units can define potential bottlenecks in the care process and what actions they intend to undertake to improve.
Toolbox
A quality improvement toolbox, incorporated within the action plan, that comprises for each pain management quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift).

Locations

Country Name City State
Netherlands National Intensive Care Evaluation foundation Amsterdam Noord-Holland

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) National Intensive Care Evaluation Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from proportion of patient shifts during which pain has been adequately managed "Adequately managed" is defined: pain measured AND (acceptable pain score OR (unacceptable pain score AND normalized within 1 hour)). The primary outcome measure is a composite score of four quality indicators (= secondary outcome measures).The measure is limited to only patients' first 12 shifts to prevent bias from patients with a long stay. There are 3 shifts in 1 day. 9 months
Secondary Change from proportion of patient shifts during which pain was measured at least once 9 months
Secondary Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed 9 months
Secondary Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured 9 months
Secondary Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured indicating that the pain score was normalized 9 months
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