Medical Decisions in the Hospital Setting- M-Safety

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03757884
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 59
• Locations: 2
• Arm: 1
• Actual Duration (Months): 12.2
• Patients Per Site: 29.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Errors	Behavioral: Mindfulness breathing exercise; Behavioral: Diagnostic Checklist; Behavioral: Noise cancelling headphones; Behavioral: Privacy tablescreen; Behavioral: Diagnostic assistance application	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pre-posttest study designPre-posttest study design
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Medical-Decision Through Cognition, Technology and Communication, Phase 2
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Sep 17, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Number of Patient Differential Diagnosis [8 months]

   Differential Diagnosis

2. Change in the Use of Diagnostic Checklist [8 months]

   Diagnostic Checklist

Secondary Outcome Measures

1. Change in Mindfulness Behaviors Score [8 months]

   This 4 Question Survey Measures Characteristics of Mindfulness, Range- 1=Always, 6=Never

2. Change in Number of Patient Diagnostic Testing [8 months]

   Diagnostic Testing includes Laboratory and Imaging

3. Change in Time Participants are Measured as Calm [8 months]

   Time Measured in Minutes, Using the Spire Monitor

4. Change in Time Participants are Measured as Focused [8 months]

   Time Measured in Minutes, Using the Spire Monitor

5. Change in Time Participants are Measured as Tense [8 months]

   Time Measured in Minutes, Using the Spire Monitor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Hospital Medicine Physicians

Exclusion Criteria:

• Physicians other than Hopitalists

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ann Arbor VA Healthcare System	Ann Arbor	Michigan	United States	48105
2	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Vineet I Chopra, MD, University of Michigan

Study Documents (Full-Text)

• Informed Consent Form - Jun 18, 2019

More Information

Additional Information:

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

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.

• Responsible Party: Vineet Chopra, Chief, Division of Hospital Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT03757884
• Other Study ID Numbers: HUM00145793
• First Posted: Nov 29, 2018
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vineet Chopra, Chief, Division of Hospital Medicine, University of Michigan: Diagnostic Errors; Hospital Medicine

Study Results

No Results Posted as of Sep 20, 2019