Medical Decisions in the Hospital Setting- M-Safety

Not Applicable

Completed

• Conditions: Diagnostic Errors

• Registration Number: NCT03757884
• Lead Sponsor: University of Michigan

Brief Summary

This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote focused thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.

Detailed Description

This project will introduce and evaluate an intervention designed to improve diagnostic decision making. The intervention will attempt to increase clinician mindfulness and reduce environmental distractions to promote system 2 thinking. A meta-cognitive intervention using a structured checklist will be evaluated to identify improvement in diagnostic and therapeutic decision-making and examine the role of mindfulness and architectural design in enhancing patient safety.

This a pretest-posttest design study that will be conducted with hospitalist physicians working at Michigan Medicine and/or the VA Ann Arbor Healthcare System. The proposed intervention will provide the participants with tools to help promote mindfulness and focus to assist with the diagnostic process. To reduce distraction, headphones to block out surrounding noise and table screens to limit distractions will be offered. To assist with diagnosis, a diagnostic checklist and use of a IPad to use an online diagnosis application will be provided.

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Status Verified: 2019-09
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Hospital Medicine Physicians

Exclusion Criteria

• Physicians other than Hopitalists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Number of Patient Differential Diagnosis	8 months	Differential Diagnosis
Change in the Use of Diagnostic Checklist	8 months	Diagnostic Checklist

Secondary Outcome Measures

Name	Time	Method
Change in Mindfulness Behaviors Score	8 months	This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never
Change in Number of Patient Diagnostic Testing	8 months	Diagnostic Testing includes Laboratory and Imaging
Change in Time Participants are Measured as Calm	8 months	Time Measured in Minutes, Using the Spire Monitor
Change in Time Participants are Measured as Focused	8 months	Time Measured in Minutes, Using the Spire Monitor
Change in Time Participants are Measured as Tense	8 months	Time Measured in Minutes, Using the Spire Monitor

Trial Locations

Locations (2)

Ann Arbor VA Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States