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

This study has been completed.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Dr. Edward Etchells, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00469924
First received: May 3, 2007
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Critical Laboratory Values
Drug Laboratory Interactions
Drug Drug Interactions
Procedure: Real Time Clinical Alerting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of an Automated Paging System on Response to Critical Laboratory Values

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures will be: length of stay, mortality, time to resolution and frequency of recurrence. [ Time Frame: During acute care hospitalization ] [ Designated as safety issue: No ]

Enrollment: 271
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alerting system ON
Alerting system is ON
Procedure: Real Time Clinical Alerting
No Intervention: Alerting system OFF
Alerting system is OFF

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469924

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Investigators
Principal Investigator: Edward E Etchells, MD MSc Sunnybrook Health Sciences Centre
  More Information

Responsible Party: Dr. Edward Etchells, Associate Professor, Staff Physician, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00469924     History of Changes
Other Study ID Numbers: Etchells1 
Study First Received: May 3, 2007
Last Updated: May 16, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Informatics
Clinical Laboratory Information Systems
Hospital Communication Systems
Laboratory Techniques and Procedures
Point-of-Care Systems
Therapy, Computer-Assisted

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ClinicalTrials.gov processed this record on December 09, 2016