Condition category
Not Applicable
Date applied
26/08/2010
Date assigned
01/11/2010
Last edited
13/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicolette de Keizer

ORCID ID

Contact details

Academic Medical Centre
Department of Medical Informatics (J1B-115)
PO Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 5205
n.f.keizer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of a national quality improvement program to overcome barriers to using performance data in intensive care medicine: A cluster randomised controlled trial

Acronym

InFoQI (Information Feedback on Quality Indicators)

Study hypothesis

Giving intensive care units (ICUs) more detailed information on their performance, supporting them with interpretation of these performance data and supporting them with formulating quality improvement actions will lead to higher quality of intensive care compared to only sending ICUs a standard feedback report containing less detailed information on their performance

Ethics approval

We sought advice from the Medical Ethics Board of the Academic Medical Center (Amsterdam, the Netherlands) and were told that approval was not necessary as the study does not interfere with the conventional care process.

Study design

Clustered randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Quality improvement in intensive care medicine

Intervention

Intensive care units participating in InFoQI establish a local multidisciplinary quality improvement team, consisting of at least one intensivist and one ICU nurse. The team's main tasks are to formulate a quality improvement action plan based on their baseline performance indicator data and to monitor their performance using monthly and quarterly feedback reports. The team is supported in these tasks by facilitators during two educational outreach visits - and by phone and e-mail. The facilitators promote the use of the PDSA cycle to guide organisational changes.
Participating ICUs were followed during one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Clinical:
ICU length of stay
2. Non-clinical:
Proportion of shifts with a bed occupancy of 100% or more

Secondary outcome measures

1. Clinical:
1.1. Hospital mortality of ICU patients
1.2. Respiration duration
2. Non-clinical:
Proportion of shifts with a nurse-to-patient ratio below 0.5

Overall trial start date

01/01/2009

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Intensive Care Units that are able to provide their performance data to the national comparative quality registry on intensive care medicine in the Netherlands (NICE registry) and have at least one intensivist and one ICU nurse available for a minimum of four hours per month each. Informed consent was signed by the ICU management before randomisation.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

30 ICUs

Participant exclusion criteria

Intensive Care Units that did not meet the inclusion criteria

Recruitment start date

01/01/2009

Recruitment end date

01/02/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Medical Informatics
PO Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 5269
kik@amc.nl

Sponsor type

Hospital/treatment centre

Website

Organisation

University of Tilburg

Sponsor details

Scientific Center for Transformation in Care and Welfare
Warandelaan 2
Tilburg
5000LE
Netherlands

Sponsor type

University/education

Website

Organisation

NICE Foundation

Sponsor details

PO Box 23640
Amsterdam
1100 EC
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (Netherlands) - Department of Medical Informatics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Tilburg (Netherlands) - Scientific Centre for Transformation in Care and Welfare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NICE Foundation, Amsterdam (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22024188
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26152568

Publication citations

  1. Protocol

    van der Veer SN, de Vos ML, Jager KJ, van der Voort PH, Peek N, Westert GP, Graafmans WC, de Keizer NF, Evaluating the effectiveness of a tailored multifaceted performance feedback intervention to improve the quality of care: protocol for a cluster randomized trial in intensive care., Implement Sci, 2011, 6, 119, doi: 10.1186/1748-5908-6-119.

  2. Results

    MLG de Vos, SN van der Veer, B Wouterse, WC Graafmans, N Peek, NF de Keizer, KJ Jager, GP Westert, PHJ van der Voort, A multifaceted feedback strategy alone does not improve the adherence to organizational guideline-based standards: a cluster randomized trial in intensive care, Implementation Science, 2015, 10, 95, doi: 10.1186/s13012-015-0285-2.

Additional files

Editorial Notes