Medical Decisions in the Hospital Setting- M-Safety

Diagnostic Errors Clinical Trial

— M-Safety  

Official title:

Improving Medical-Decision Through Cognition, Technology and Communication, Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757884
• Other study ID #: HUM00145793
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Hospital Medicine Physicians

Exclusion Criteria:

• Physicians other than Hopitalists

Related Conditions & MeSH terms

• Diagnostic Errors

Intervention

Behavioral:
• Mindfulness breathing exercise
Spire monitor instructed mindfulness breathing
• Diagnostic Checklist
Checklist reminder for diagnosis
• Noise cancelling headphones
Noise cancelling headphones
• Privacy tablescreen
Privacy Tablescreen
• Diagnostic assistance application
Diagnostic assistance application

Locations

Country	Name	City	State
United States	Ann Arbor VA Healthcare System	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chopra V, Harrod M, Winter S, Forman J, Quinn M, Krein S, Fowler KE, Singh H, Saint S. Focused Ethnography of Diagnosis in Academic Medical Centers. J Hosp Med. 2018 Oct 1;13(10):668-672. doi: 10.12788/jhm.2966. Epub 2018 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Patient Differential Diagnosis	Differential Diagnosis	8 months
Primary	Change in the Use of Diagnostic Checklist	Diagnostic Checklist	8 months
Secondary	Change in Mindfulness Behaviors Score	This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never	8 months
Secondary	Change in Number of Patient Diagnostic Testing	Diagnostic Testing includes Laboratory and Imaging	8 months
Secondary	Change in Time Participants are Measured as Calm	Time Measured in Minutes, Using the Spire Monitor	8 months
Secondary	Change in Time Participants are Measured as Focused	Time Measured in Minutes, Using the Spire Monitor	8 months
Secondary	Change in Time Participants are Measured as Tense	Time Measured in Minutes, Using the Spire Monitor	8 months

External Links

•   Patient Safety & Enhancement Program at the University of Michigan and the Ann Arbor VA Heathcare System