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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02730221
Other study ID # 2015.564
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date January 1, 2020

Study information

Verified date April 2019
Source VU University Medical Center
Contact Jantine G Röttgering, Bsc
Phone +31204443697
Email j.rottgering@vumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

In recent years, regulatory authorities request a growing number of protocols and checklists to improve healthcare. Though the intention is to prevent medical mistakes and to improve patient care, these demands might result in an increased administrative workload for physicians and nurses. Recent studies show that administrative tasks and documentation occupy more than thirty percent of the workload of physicians, of which one-third is unrelated to care. This time spent on administration could lower the amount of time spent with the patient and the patient's family. In the Intensive Care Unit and the Medium Care Unit, most of the administrative tasks are executed within the patient data management system. The way an electronic patient data management system is set up could impact the administrative workload for physicians and nurses. A prospective observational study at the department of Intensive and Medium Care of the University medical centre will be performed with the aim to quantify the time spent on direct patient care versus administrative work. Two different patient data management systems will be compared at different points in time. The Nursing Activity Score and other patient characteristics will be registered for all the admitted patients during the two study periods.

The administrative workload of physicians and nurses will be measured before and after the implementation of a new patient data management system, using the following methods:

- Login time in the electronic patient data management system during fourteen consecutive days in the Intensive Care Unit and the Medium Care Unit

- Timing of activities of physicians and nurses with a work sampling method during five consecutive day shifts in the Intensive Care Unit


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 1, 2020
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands VUMedicalCentre Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Pelletier D, Duffield C. Work sampling: valuable methodology to define nursing practice patterns. Nurs Health Sci. 2003 Mar;5(1):31-8. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Amount of time spent on direct patient care per shift for nurses The amount of time spent on direct care during dayshifts measured with a work sampling methode 9 hours a day
Secondary Amount of time spent on direct patient care per shift for doctors The amount of time spent on direct care during dayshifts measured with a work sampling methode 9 hours a day
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