NCT03757884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

November 27, 2018

Last Update Submit

September 18, 2019

Conditions

Diagnostic Errors

Keywords

Diagnostic ErrorsHospital Medicine

Outcome Measures

Primary Outcomes (2)

  • Change in Number of Patient Differential Diagnosis

    Differential Diagnosis

    8 months

  • Change in the Use of Diagnostic Checklist

    Diagnostic Checklist

    8 months

Secondary Outcomes (5)

  • Change in Mindfulness Behaviors Score

    8 months

  • Change in Number of Patient Diagnostic Testing

    8 months

  • Change in Time Participants are Measured as Calm

    8 months

  • Change in Time Participants are Measured as Focused

    8 months

  • Change in Time Participants are Measured as Tense

    8 months

Study Arms (1)

Virtual Pod

EXPERIMENTAL

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

Behavioral: Mindfulness breathing exerciseBehavioral: Diagnostic ChecklistBehavioral: Noise cancelling headphonesBehavioral: Privacy tablescreenBehavioral: Diagnostic assistance application

Interventions

Mindfulness breathing exerciseBEHAVIORAL

Spire monitor instructed mindfulness breathing

Virtual Pod
Diagnostic ChecklistBEHAVIORAL

Checklist reminder for diagnosis

Virtual Pod
Noise cancelling headphonesBEHAVIORAL

Noise cancelling headphones

Virtual Pod
Privacy tablescreenBEHAVIORAL

Privacy Tablescreen

Virtual Pod
Diagnostic assistance applicationBEHAVIORAL

Diagnostic assistance application

Virtual Pod

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospital Medicine Physicians

You may not qualify if:

  • Physicians other than Hopitalists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann Arbor VA Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 29694450BACKGROUND

Related Links

Study Officials

  • Vineet I Chopra, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Pre-posttest study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Hospital Medicine

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

September 10, 2018

Primary Completion

September 17, 2019

Study Completion

September 17, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Following completion of data analysis and manuscript publication
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.

Locations

US(2)