NCT02730221

Brief Summary

A prospective observational study in the Intensive Care Unit and the Medium Care Unit in a university hospital in Amsterdam. Recent studies show that administrative tasks occupy more than 30% of the workload. One-third of these administrative tasks is unrelated to care. The administrative workload of physicians and nurses will be observed and quantified using two different methods. The amount of time physicians and nurses are logged on into the patient data management system (PDMS) will be measured and the time spent on different work tasks will be monitored with a work sampling method. Two different patient data management systems will be compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

March 31, 2016

Last Update Submit

April 25, 2019

Conditions

Keywords

Administrative workloadPatient data management systemIntensive Care UnitWork sampling methodNursing Activity Score

Outcome Measures

Primary Outcomes (4)

  • Login time in the PDMS per hour for nurses

    The amount of time being logged on to the PDMS per hour will be calculated for different shifts

    24 hours a day

  • Login time in the PDMS per hour for doctors

    The amount of time being logged on to the PDMS per hour will be calculated for different shifts

    24 hours a day

  • Amount of time spent on administrative work and documentation per shift for nurses

    The amount of time spent on administrative tasks and documentation during dayshifts measured with a work sampling methode

    9 hours a day

  • Amount of time spent on administrative work and documentation per shift for doctors

    The amount of time spent on administrative tasks and documentation during dayshifts measured with a work sampling methode

    9 hours a day

Secondary Outcomes (2)

  • Amount of time spent on direct patient care per shift for nurses

    9 hours a day

  • Amount of time spent on direct patient care per shift for doctors

    9 hours a day

Study Arms (2)

Patients admitted during measurement 1

All patients admitted to the Intensive Care and Medium Care Unit during a two-week study period before the implementation of a new electronic patient data management system

Patients admitted during measurement 2

All patients admitted to the Intensive Care and Medium Care Unit during a two-week study period after the implementation of a new electronic patient data management system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted to the Intensive Care Unit during one of the two study periods

You may qualify if:

  • Admission to the Intensive Care Unit during one of the two study periods

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VUMedicalCentre

Amsterdam, North Holland, 1007 MB, Netherlands

RECRUITING

Related Publications (6)

  • Li L, Hains I, Hordern T, Milliss D, Raper R, Westbrook J. What do ICU doctors do? A multisite time and motion study of the clinical work patterns of registrars. Crit Care Resusc. 2015 Sep;17(3):159-66.

    PMID: 26282253BACKGROUND
  • Armstrong E, de Waard MC, de Grooth HJ, Heymans MW, Reis Miranda D, Girbes AR, Spijkstra JJ. Using Nursing Activities Score to Assess Nursing Workload on a Medium Care Unit. Anesth Analg. 2015 Nov;121(5):1274-80. doi: 10.1213/ANE.0000000000000968.

    PMID: 26484461BACKGROUND
  • Bosman RJ. Impact of computerized information systems on workload in operating room and intensive care unit. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):15-26. doi: 10.1016/j.bpa.2008.10.001.

    PMID: 19449613BACKGROUND
  • Urden LD, Roode JI. Work sampling. A decision-making tool for determining resources and work redesign. J Nurs Adm. 1997 Sep;27(9):34-41. doi: 10.1097/00005110-199709000-00009.

    PMID: 9300013BACKGROUND
  • Pelletier D, Duffield C. Work sampling: valuable methodology to define nursing practice patterns. Nurs Health Sci. 2003 Mar;5(1):31-8. doi: 10.1046/j.1442-2018.2003.00132.x.

    PMID: 12603719BACKGROUND
  • Marasovic C, Kenney C, Elliott D, Sindhusake D. A comparison of nursing activities associated with manual and automated documentation in an Australian intensive care unit. Comput Nurs. 1997 Jul-Aug;15(4):205-11.

    PMID: 9260381BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Angelique ME Spoelstra - de Man, MD PhD

    Amsterdam UMC, location VUmc

    STUDY DIRECTOR

Central Study Contacts

Jantine G Röttgering, Bsc

CONTACT

Angelique ME Spoelstra - de Man, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. A.M.E. Spoelstra--de Man

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

January 1, 2020

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations