- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00469924
Effect of an Automated Paging System on Response to Critical Laboratory Values
Study Overview
Status
Intervention / Treatment
Detailed Description
We will evaluate the effect of real time clinical alerting on the time to response and the quality of the response to critical laboratory values. We define time to response as the time from acceptance of the laboratory value in the laboratory information system to the time that a physician's order is written in response to the laboratory value. In the absence of a timed physician order, we use the time of administration of treatment to estimate the time of response. We define the quality of response as whether the treatment was consistent with existing hospital policies and expert guidelines.
This will be a prospective interrupted time series study.
The setting is secondary-tertiary care inpatient general medicine units at academic teaching hospitals (Sunnybrook and UHN). The physician participants are staff physicians and medical residents in the Division of General Internal Medicine. The patient participants are general internal medicine inpatients with critical laboratory values. The intervention is an automated real time clinical alerting system that includes evidence based decision support and patient specific information about critical laboratory abnormalities. There are two primary outcome measures: (1) time to response, defined as the time from the critical laboratory abnormality to time of resolution of the critical laboratory abnormality, and (2) quality of response, defined as whether the response was concordant with existing evidence based protocols of care. Secondary outcome measures will be: length of stay, mortality, time to resolution of the abnormality, and frequency of recurrence of the abnormality. Other process measures will be: quality of response, time to resolution, and proportion resolved within 24 hours. Time to response is defined as time from the identification of the critical value in the laboratory to time of a physician order in response to the abnormality.
There are two primary outcome measures: (1) time to response, defined as the time from the critical laboratory abnormality to time of a physian order in response to the critical laboratory abnormality, and (2) quality of response, defined as whether the response was concordant with existing evidence based protocols of care. Secondary outcome measures will be: length of stay, mortality, time to resolution and frequency of recurrence. Time to resolution is the time from the initial laboratory abnormality to the time that the abnormality resolves. Frequency of recurrence is the proportion of patients who develop a second episode of the same critical abnormality after resolution.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with critical laboratory values or hazardous drug-lab or drug-drug conditions, admitted to inpatient general medicine units
Exclusion Criteria:
- Values or conditions where no clinical action can be taken
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alerting system ON
Alerting system is ON
|
|
No Intervention: Alerting system OFF
Alerting system is OFF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
(1) time to response, defined as the time to a physician order and (2) quality of response, defined as whether the response was concordant with existing evidence based protocols of care.
Time Frame: During acute care hospitalization
|
During acute care hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcome measures will be: length of stay, mortality, time to resolution and frequency of recurrence.
Time Frame: During acute care hospitalization
|
During acute care hospitalization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Edward E Etchells, MD MSc, SunnyBrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Etchells1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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