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

Overview

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.

Full Title of Study: “Increasing the Effectiveness and Understanding of Audit and Feedback Interventions in Intensive Care: Protocol for a Mixed-methods Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2018

Interventions

  • 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.
  • 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).

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Audit and Feedback without toolbox
    • Same intervention, but without access to the quality improvement toolbox.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Collaborator
    • National Intensive Care Evaluation Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. dr. Nicolette F. de Keizer, Full professor of Medical Informatics – Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Overall Official(s)
    • Nicolette F de Keizer, PhD, Principal Investigator, Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)

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