Medical Decisions in the Hospital Setting- M-Safety | NCT03757884

Studies
Medical Decisions in the Hospital Setting- M-Safety

NCT03757884

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Sep 20, 2019Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Diagnostic Errors

Interventions

Mindfulness breathing exercise
Diagnostic Checklist
Noise cancelling headphones
Privacy tablescreen
Diagnostic assistance application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2018Actual

Primary Completion Date

Sep 17, 2019Actual

Completion Date

Sep 17, 2019Actual

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Nov 27, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vineet Chopra, Chief, Division of Hospital Medicine, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual Pod	Experimental	Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application	Behavioral: Mindfulness breathing exercise Behavioral: Diagnostic Checklist Behavioral: Noise cancelling headphones Behavioral: Privacy tablescreen Behavioral: Diagnostic assistance application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness breathing exercise	Behavioral	Spire monitor instructed mindfulness breathing	Virtual Pod

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospital Medicine Physicians

Exclusion Criteria:

Physicians other than Hopitalists

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vineet I Chopra, MD	University of Michigan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ann Arbor VA Healthcare System		Ann Arbor	Michigan	48105	United States
University of Michigan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29694450	Background	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.