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OpenTrials
Completed

NCT Number: NCT03757884

Medical Decisions in the Hospital Setting- M-Safety

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.

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Key information

Conditions

Diagnostic Errors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann Arbor VA Healthcare System, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospital Medicine Physicians

Exclusion criteria

  • Physicians other than Hopitalists

Treatment and study plan

Mindfulness breathing exercise

Behavioral

Spire monitor instructed mindfulness breathing

Diagnostic Checklist

Behavioral

Checklist reminder for diagnosis

Noise cancelling headphones

Behavioral

Noise cancelling headphones

Privacy tablescreen

Behavioral

Privacy Tablescreen

Diagnostic assistance application

Behavioral

Diagnostic assistance application

Primary outcomes

  1. Change in Number of Patient Differential Diagnosis

    Time frame: 8 months

    Differential Diagnosis

  2. Change in the Use of Diagnostic Checklist

    Time frame: 8 months

    Diagnostic Checklist

Secondary outcomes

  1. Change in Mindfulness Behaviors Score

    Time frame: 8 months

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

  2. Change in Number of Patient Diagnostic Testing

    Time frame: 8 months

    Diagnostic Testing includes Laboratory and Imaging

  3. Change in Time Participants are Measured as Calm

    Time frame: 8 months

    Time Measured in Minutes, Using the Spire Monitor

  4. Change in Time Participants are Measured as Focused

    Time frame: 8 months

    Time Measured in Minutes, Using the Spire Monitor

  5. Change in Time Participants are Measured as Tense

    Time frame: 8 months

    Time Measured in Minutes, Using the Spire Monitor

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: M-Safety

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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