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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)

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date January 10, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02922101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Change from proportion of patient shifts during which pain was measured at least once [ Time Frame: 9 months ]
  • Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed [ Time Frame: 9 months ]
  • Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured [ Time Frame: 9 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care
Official Title  ICMJE Increasing the Effectiveness and Understanding of Audit and Feedback Interventions in Intensive Care: Protocol for a Mixed-methods Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Pain Management
  • Critical Care
  • Quality Improvement
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Audit and Feedback
    • Behavioral: Toolbox
  • Active Comparator: Audit and Feedback without toolbox
    Same intervention, but without access to the quality improvement toolbox.
    Intervention: Behavioral: Audit and Feedback
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
30
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02922101
Other Study ID Numbers  ICMJE METC_W16_271
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The National Intensive Care Evaluation (NICE) foundation has a policy for sharing data among its participating ICUs.
Responsible Party Prof. dr. Nicolette F. de Keizer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE National Intensive Care Evaluation Foundation
Investigators  ICMJE
Principal Investigator: Nicolette F de Keizer, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP