Medical Decisions in the Hospital Setting- M-Safety (M-Safety)

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

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Errors
• Intervention / Treatment: Behavioral: Mindfulness breathing exercise; Behavioral: Diagnostic Checklist; Behavioral: Noise cancelling headphones; Behavioral: Privacy tablescreen; Behavioral: Diagnostic assistance application

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Ann Arbor VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospital Medicine Physicians

Exclusion Criteria:

• Physicians other than Hopitalists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Pod; Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application	Behavioral: Mindfulness breathing exercise; Spire monitor instructed mindfulness breathing; Behavioral: Diagnostic Checklist; Checklist reminder for diagnosis; Behavioral: Noise cancelling headphones; Noise cancelling headphones; Behavioral: Privacy tablescreen; Privacy Tablescreen; Behavioral: Diagnostic assistance application; Diagnostic assistance application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Patient Differential Diagnosis	Differential Diagnosis	8 months
Change in the Use of Diagnostic Checklist	Diagnostic Checklist	8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Vineet I Chopra, MD, University of Michigan

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Diagnostic Errors; Hospital Medicine
• Other Study ID Numbers: HUM00145793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data security rules and regulations of the participating facilities (such as the University of Michigan and the Department of Veterans Affairs) will be followed. If data can be shared, all identifiers will be removed from the data. Data will be made available for research to those who request it once analyses has been conducted and findings have been published. Persons interested in using the data will need to submit a request in writing, stating their intended use.
• IPD Sharing Time Frame: Following completion of data analysis and manuscript publication
• IPD Sharing Access Criteria: Persons interested in using the data will need to submit a request in writing, stating their intended use. Requirements for sharing will include proof of IRB approval, acknowledgement in all publications of the funding source and of the study authors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No