NCT00469924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

May 3, 2007

Last Update Submit

May 16, 2016

Conditions

Keywords

InformaticsClinical Laboratory Information SystemsHospital Communication SystemsLaboratory Techniques and ProceduresPoint-of-Care SystemsTherapy, Computer-Assisted

Outcome Measures

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.

    During acute care hospitalization

Secondary Outcomes (1)

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

    During acute care hospitalization

Study Arms (2)

Alerting system ON

EXPERIMENTAL

Alerting system is ON

Procedure: Real Time Clinical Alerting

Alerting system OFF

NO INTERVENTION

Alerting system is OFF

Interventions

Alerting system ON

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Values or conditions where no clinical action can be taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

  • Edward E Etchells, MD MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Staff Physician

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations