NCT02922101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

September 26, 2016

Last Update Submit

January 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change from proportion of patient shifts during which pain was measured at least once

    9 months

  • Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed

    9 months

  • Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured

    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

    9 months

Study Arms (2)

Audit and Feedback with toolbox

EXPERIMENTAL

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 FeedbackBehavioral: Toolbox

Audit and Feedback without toolbox

ACTIVE COMPARATOR

Same intervention, but without access to the quality improvement toolbox.

Behavioral: Audit and Feedback

Interventions

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.

Also known as: A&F, Feedback
Audit and Feedback with toolboxAudit and Feedback without toolbox
ToolboxBEHAVIORAL

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).

Also known as: Quality Improvement Toolbox
Audit and Feedback with toolbox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Intensive Care Evaluation foundation

Amsterdam, North Holland, 1100 EC, Netherlands

Location

Related Publications (4)

  • Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Peek N, de Keizer NF. Facilitating action planning within audit and feedback interventions: a mixed-methods process evaluation of an action implementation toolbox in intensive care. Implement Sci. 2019 Sep 18;14(1):90. doi: 10.1186/s13012-019-0937-8.

  • Roos-Blom MJ, Gude WT, de Jonge E, Spijkstra JJ, van der Veer SN, Peek N, Dongelmans DA, de Keizer NF. Impact of audit and feedback with action implementation toolbox on improving ICU pain management: cluster-randomised controlled trial. BMJ Qual Saf. 2019 Dec;28(12):1007-1015. doi: 10.1136/bmjqs-2019-009588. Epub 2019 Jul 1.

  • Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Francis JJ, Peek N, de Keizer NF. Health professionals' perceptions about their clinical performance and the influence of audit and feedback on their intentions to improve practice: a theory-based study in Dutch intensive care units. Implement Sci. 2018 Feb 17;13(1):33. doi: 10.1186/s13012-018-0727-8.

  • Gude WT, Roos-Blom MJ, van der Veer SN, de Jonge E, Peek N, Dongelmans DA, de Keizer NF. Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial. Implement Sci. 2017 May 25;12(1):68. doi: 10.1186/s13012-017-0594-8.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolette F de Keizer, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor of Medical Informatics

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

The National Intensive Care Evaluation (NICE) foundation has a policy for sharing data among its participating ICUs.

Locations