Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes

Mount Sinai Health System

Status: Completed

Conditions: Information Systems; Ability to Influence Behavior

Treatments: Behavioral: Notification Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01545596

GCO 10-0111

HSM 11-00590

Details and patient eligibility

About

The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) < 75 mmHg, and Bispectral Index (BIS) < 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.

Full description

Data that is routinely collected as part of standard of care intraoperative monitoring including blood pressure, amount of anesthetic administered and a form of processes electroencephalogram called the bispectral index, which is a measure of depth of anesthesia all enter in an electronic record keeper. This project monitors for a combination of a blood pressure below mean of 75mmHg and a BIS of 45. When this is detected, half of the anesthesiologists caring for patients receive a text message on the computer screen and their pagers indicating that a double low situation exists and that they should consider intervening. The other half of practitioners are not provided with the additional messages, although all of the same information is available in the operating room (OR). Most patients undergoing general non-cardiac anesthesia at Mount Sinai are eligible. Documentation of consent was waived. All patients are informed of the ongoing project upon admission and are given a variety of methods of opting out of the project.

The analysis seeks to determine if the messages were effective at influencing clinician behavior and whether that change would make a difference in either length of stay or 90 day mortality.

Enrollment: 20,237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients presenting for general anesthesia and have BIS monitors

Exclusion criteria

• patients who opt out of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,237 participants in 2 patient groups

Notification Group

Experimental group

Description:

Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.

Treatment:

Behavioral: Notification Group

No Notification

No Intervention group

Description:

No additional notification given to anesthesia team apart from the information on their monitors.