Medical Decisions in the Hospital Setting- M-Safety

NCT ID: NCT03757884

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-09-17

Brief Summary

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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

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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.

Conditions

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Diagnostic Errors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-posttest study design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Virtual Pod

Mindfulness breathing, privacy screen, noise cancelling headphones, diagnostic checklist, diagnostic support on-line application

Group Type EXPERIMENTAL

Mindfulness breathing exercise

Intervention Type BEHAVIORAL

Spire monitor instructed mindfulness breathing

Diagnostic Checklist

Intervention Type BEHAVIORAL

Checklist reminder for diagnosis

Noise cancelling headphones

Intervention Type BEHAVIORAL

Noise cancelling headphones

Privacy tablescreen

Intervention Type BEHAVIORAL

Privacy Tablescreen

Diagnostic assistance application

Intervention Type BEHAVIORAL

Diagnostic assistance application

Interventions

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Mindfulness breathing exercise

Spire monitor instructed mindfulness breathing

Intervention Type BEHAVIORAL

Diagnostic Checklist

Checklist reminder for diagnosis

Intervention Type BEHAVIORAL

Noise cancelling headphones

Noise cancelling headphones

Intervention Type BEHAVIORAL

Privacy tablescreen

Privacy Tablescreen

Intervention Type BEHAVIORAL

Diagnostic assistance application

Diagnostic assistance application

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hospital Medicine Physicians

Exclusion Criteria

* Physicians other than Hopitalists
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Vineet Chopra

Chief, Division of Hospital Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vineet I Chopra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Ann Arbor VA Healthcare System

Ann Arbor, Michigan, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29694450 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://psep.med.umich.edu/

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

Other Identifiers

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HUM00145793

Identifier Type: -

Identifier Source: org_study_id

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