Critical IllnessAWICNCT02730221
Administrative Workload in the Intensive Care Unit
An observational study of Critical Illness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the Intensive Care Unit during one of the two study periods
Who may be able to join
- Admission to the Intensive Care Unit during one of the two study periods
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VUMedicalCentre
Amsterdam, North Holland, 1007 MB
Jantine G Rottgering, Bsc, 0204443331, j.rottgering@vumc.nl
Angelique ME Spoelstra - de Man, PhD Md, 0204443331, am.spoelstra@vumc.nl
About this study
Official title: Administrative Workload in the Intensive Care Unit (AWIC Study)
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.
Read the detailed 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
- Conditions
- Critical Illness
- Keywords
- Administrative workload, Patient data management system, Intensive Care Unit, Work sampling method, Nursing Activity Score
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 hours a day
Secondary outcomes (2)
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
Measured: 9 hours a day
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
Measured: 9 hours a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelique Spoelstra-de Man, Amsterdam UMC, location VUmc
- Investigators
- Angelique ME Spoelstra - de Man, MD PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730221
- Sponsor's protocol ID
- 2015.564
- Acronym
- AWIC
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26282253Armstrong 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.
PubMed 26484461Bosman 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.
PubMed 19449613Urden 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.
PubMed 9300013Pelletier 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.
PubMed 12603719Marasovic 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.
PubMed 9260381
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administrative Workload in the Intensive Care Unit (AWIC Study)
- ClinicalTrials.gov ID
- NCT02730221
- Acronym / sponsor ID
- AWIC / 2015.564
- Conditions
- Critical Illness
- Keywords
- Administrative workload, Patient data management system, Intensive Care Unit, Work sampling method, Nursing Activity Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the Intensive Care Unit during one of the two study periods
Key inclusion criteria (1 listed)
- Admission to the Intensive Care Unit during one of the two study periods
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Login time in the PDMS per hour for nurses
Time frame: 24 hours a day
The amount of time being logged on to the PDMS per hour will be calculated for different shifts
Login time in the PDMS per hour for doctors
Time frame: 24 hours a day
The amount of time being logged on to the PDMS per hour will be calculated for different shifts
Amount of time spent on administrative work and documentation per shift for nurses
Time frame: 9 hours a day
The amount of time spent on administrative tasks and documentation during dayshifts measured with a work sampling methode
Amount of time spent on administrative work and documentation per shift for doctors
Time frame: 9 hours a day
The amount of time spent on administrative tasks and documentation during dayshifts measured with a work sampling methode
2 secondary outcomes
Amount of time spent on direct patient care per shift for nurses
Time frame: 9 hours a day
Amount of time spent on direct patient care per shift for doctors
Time frame: 9 hours a day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 26282253Li 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.
- Background: PubMed 26484461Armstrong 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.
- Background: PubMed 19449613Bosman 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.
- Background: PubMed 9300013Urden 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.
- Background: PubMed 12603719Pelletier 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.
- Background: PubMed 9260381Marasovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique ME Spoelstra - de Man, MD PhD study director
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jantine G Röttgering, Bsc (+31204443697, j.rottgering@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Login time in the PDMS per hour for nurses (time frame: 24 hours a day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730221, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.