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Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care

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ClinicalTrials.gov Identifier: NCT02922101
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
National Intensive Care Evaluation Foundation
Information provided by (Responsible Party):
Prof. dr. Nicolette F. de Keizer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Management Critical Care Quality Improvement Behavioral: Audit and Feedback Behavioral: Toolbox Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Increasing the Effectiveness and Understanding of Audit and Feedback Interventions in Intensive Care: Protocol for a Mixed-methods Study
Study Start Date : September 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Audit and Feedback with toolbox
Access to an online dashboard that provides insight into clinical performance on quality indicators for pain management; including a quality improvement toolbox to facilitate planning and executing actions. Participating ICUs will receive one educational outreach visit and brief monthly telephone calls.
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.
Other Names:
  • A&F
  • Feedback

Behavioral: 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).
Other Name: Quality Improvement Toolbox

Active Comparator: Audit and Feedback without toolbox
Same intervention, but without access to the quality improvement toolbox.
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.
Other Names:
  • A&F
  • Feedback




Primary Outcome Measures :
  1. Change from proportion of patient shifts during which pain has been adequately managed [ Time Frame: 9 months ]
    "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.


Secondary Outcome Measures :
  1. Change from proportion of patient shifts during which pain was measured at least once [ Time Frame: 9 months ]
  2. Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed [ Time Frame: 9 months ]
  3. Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured [ Time Frame: 9 months ]
  4. 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 [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Nil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922101


Locations
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Netherlands
National Intensive Care Evaluation foundation
Amsterdam, Noord-Holland, Netherlands, 1100 EC
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National Intensive Care Evaluation Foundation
Investigators
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Principal Investigator: Nicolette F de Keizer, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. dr. Nicolette F. de Keizer, Full professor of Medical Informatics, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02922101     History of Changes
Other Study ID Numbers: METC_W16_271
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The National Intensive Care Evaluation (NICE) foundation has a policy for sharing data among its participating ICUs.