Critical IllnessNCT01396044
Daily Checklists and Outcome in the Intensive Care Unit
A study testing Electronic checklist and Verbal prompting in people with Critical Illness, run by Northwestern University at 2 sites in United States.
Trial summary
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Electronic checklist and Verbal prompting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Admission to a medical intensive care unit (MICU) team during the study timeframe
Who cannot join
- Transfer from MICU team to a separate ICU team within 12 hours of admission
- Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern University
Chicago, Illinois, 60611
About this study
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.
The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.
- Conditions
- Critical Illness
- Being tested
- Electronic checklist, Verbal prompting
- Keywords
- Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic checklistOther
Electronic checklist for process of care issues implemented in our institution. Training on a regular basis of the electronic checklist arm to use the electronic checklist. Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
Verbal promptingOther
Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
| Study group | Role | What they receive |
|---|---|---|
| Electronic checklist | Experimental | Electronic checklist Receives: Other: Electronic checklist |
| Verbal prompting | Experimental | Verbal prompting with written checklist Receives: Other: Verbal prompting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empiric Antibiotic Duration
Measured: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Proportion of Empiric Antibiotics
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
Measured: ICU admission
Secondary outcomes (6)
Hospital Mortality
Measured: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Length of Stay
Measured: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Ventilator-free Days
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
Measured: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Proportion of Successful Prompts
Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred
Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed
Measured: During ICU admission, an average of 5 days (although individual patients may vary)
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Proportion of patients-days on which empirical antibiotics were used
Measured: ICU admission
Standardized Mortality Ratio
Measured: Hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Parker B. Francis Fellowship Program
- Responsible party
- Principal investigator, Curtis Weiss, Northwestern University
- Investigators
- Curtis H Weiss, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396044
- Sponsor's protocol ID
- NUIRBSTU00013313
- Status last verified
- Nov 2012
- First submitted
- 13 Jul 2011
- Last updated
- 4 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weiss CH, Moazed F, McEvoy CA, Singer BD, Szleifer I, Amaral LA, Kwasny M, Watts CM, Persell SD, Baker DW, Sznajder JI, Wunderink RG. Prompting physicians to address a daily checklist and process of care and clinical outcomes: a single-site study. Am J Respir Crit Care Med. 2011 Sep 15;184(6):680-6. doi: 10.1164/rccm.201101-0037OC. Epub 2011 May 26.
PubMed 21616996
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Checklists and Outcome in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01396044
- Acronym / sponsor ID
- NUIRBSTU00013313
- Conditions
- Critical Illness
- Keywords
- Quality improvement, Checklist, Critical care, Anti-bacterial agents, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Parker B. Francis Fellowship Program
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 4 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.
The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic checklist | Experimental | Other: Electronic checklistElectronic checklist |
| Verbal prompting | Experimental | Other: Verbal promptingVerbal prompting with written checklist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to a medical intensive care unit (MICU) team during the study timeframe
Key exclusion criteria (2 listed)
- Transfer from MICU team to a separate ICU team within 12 hours of admission
- Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic checklistElectronic checklist for process of care issues implemented in our institution. Training on a regular basis of the electronic checklist arm to use the electronic checklist. Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation. | Other | Electronic checklist |
| Verbal promptingPrompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning. | Other | Verbal prompting |
Primary outcome
Empiric Antibiotic Duration
Time frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
Proportion of Empiric Antibiotics
Time frame: ICU admission
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
6 secondary outcomes
Hospital Mortality
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Length of Stay
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Ventilator-free Days
Time frame: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
Proportion of Successful Prompts
Time frame: During ICU admission, an average of 5 days (although individual patients may vary)
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Time frame: ICU admission
Standardized Mortality Ratio
Time frame: Hospital admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21616996Weiss CH, Moazed F, McEvoy CA, Singer BD, Szleifer I, Amaral LA, Kwasny M, Watts CM, Persell SD, Baker DW, Sznajder JI, Wunderink RG. Prompting physicians to address a daily checklist and process of care and clinical outcomes: a single-site study. Am J Respir Crit Care Med. 2011 Sep 15;184(6):680-6. doi: 10.1164/rccm.201101-0037OC. Epub 2011 May 26.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Curtis H Weiss, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic checklist and Verbal prompting in people with Critical Illness, run by Northwestern University at 2 sites in United States.
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 2 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: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empiric Antibiotic Duration (time frame: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)). The study lists 2 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 NCT01396044, which also lists 1 linked publication.
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 4 Dec 2012.