CClinicalTrials.gg
CompletedNCT00469924Updated May 17, 2016

Effect of an Automated Paging System on Response to Critical Laboratory Values

An interventional study of Real Time Clinical Alerting in Critical Laboratory Values, Drug Laboratory Interactions and Drug Drug Interactions, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
271
Allocation
Randomized
Sex
All
01

Study summary

Patients in hospitals may develop serious problems that are detected by blood tests. It is very important for the physicians to be notified of these abnormal blood tests as soon as possible. Currently, this is done using phone calls from the lab to the nurse. The nurse then pages the doctor and waits for a call back. We are conducting a study using an automated paging system that immediately alerts the physician directly. We will test whether the automated system affects the time for the physician to respond to the abnormality. If the physician's patient has a serious laboratory result, we will automatically send this laboratory result to the physician's PDA. We will also provide guidelines for treating the patient. These guidelines will come from existing hospital policies where available, or from local expert opinion. We will determine whether patients get better and faster care because of the automated alerting system.

Read the 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.

02

Conditions studied

  • Critical Laboratory Values
  • Drug Laboratory Interactions
  • Drug Drug Interactions

Keywords

  • Informatics
  • Clinical Laboratory Information Systems
  • Hospital Communication Systems
  • Laboratory Techniques and Procedures
  • Point-of-Care Systems
  • Therapy, Computer-Assisted
03

In context

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with critical laboratory values or hazardous drug-lab or drug-drug conditions, admitted to inpatient general medicine units

Exclusion criteria

Exclusion Criteria:

  • Values or conditions where no clinical action can be taken
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
271 participants (actual)

Study arms

  • Experimental
    Alerting system ON

    Alerting system is ON

    Procedure: Real Time Clinical Alerting

  • No intervention
    Alerting system OFF

    Alerting system is OFF

Interventions

  • ProcedureReal Time Clinical Alerting
06

What researchers measure

Primary outcomes

  1. (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

Secondary outcomes

  1. Secondary outcome measures will be: length of stay, mortality, time to resolution and frequency of recurrence.

    Time frame: During acute care hospitalization

07

Study locations

1 site
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00469924
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborators
University Health Network, Toronto
Responsible party
Dr. Edward Etchells (Associate Professor, Staff Physician, Sunnybrook Health Sciences Centre) — Principal investigator
First posted
May 7, 2007
Start date
Feb 2006
Primary completion
Jun 2008
Completion
Sep 2008
Last update
May 17, 2016

Study contacts

Edward E Etchells, MD MSc
principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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