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Reducing Error in ER Settings Through Attention Restoration Theory (RESTART)

Primary Purpose

Attention Fatigue, Attention Restoration

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nature slides
Urban slides
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Fatigue, Attention Restoration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Emergency Medicine Resident of any PGY level. (1-5)

Exclusion Criteria:

  • Anybody under the age of 18
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Nature

    Urban

    Arm Description

    Outcomes

    Primary Outcome Measures

    Working memory
    Working memory will be assessed using the Digit Span test. Participants are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Number of correctly repeated numbers is summed to yield a score ranging from 0 to 28. Higher scores indicated better working memory
    Positive mood
    Positive mood will be assess using the positive affect (PA) scale of the Positive and Negative Affect Schedule (PANAS). The PA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
    Negative mood
    Negative mood will be assess using the negative affect (NA) scale of the PANAS. The NA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2020
    Last Updated
    April 20, 2021
    Sponsor
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04528862
    Brief Title
    Reducing Error in ER Settings Through Attention Restoration Theory
    Acronym
    RESTART
    Official Title
    RESTART Trials: Reducing Error in ER Settings Through Attention Restoration Theory
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to logistical issues the study as designed was determined to not be feasible.
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Commonwealth University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. The other type (involuntary attention) gives directed attention a chance to rest, so people make less mistakes. Certain types of pictures are good at capturing involuntary attention. We think that capturing involuntary attention will help emergency physicians make less mistakes on tests of attention. This study will allow us to learn more about it.
    Detailed Description
    In this study, participants will be asked to do the following things: Before their usual shift in the emergency department, arrive ten minutes early to rate their mood and complete a Digit Span Backwards (DSB) task that tests their memory of different sets of numbers. Five hours into their shift, they will take a ten minute break. During this break, they will be randomly assigned to view either a picture presentation of nature slides or urban slides. After the presentation, they will complete the Digit Span Backwards task again, they will rate their mood again, then return to their shift. Participation in this study will last up to 30 minutes. Approximately fifty individuals will participate in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Fatigue, Attention Restoration

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nature
    Arm Type
    Experimental
    Arm Title
    Urban
    Arm Type
    Sham Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nature slides
    Intervention Description
    participants will view a presentation of nature slides
    Intervention Type
    Behavioral
    Intervention Name(s)
    Urban slides
    Intervention Description
    participants will view a presentation of urban slides
    Primary Outcome Measure Information:
    Title
    Working memory
    Description
    Working memory will be assessed using the Digit Span test. Participants are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Number of correctly repeated numbers is summed to yield a score ranging from 0 to 28. Higher scores indicated better working memory
    Time Frame
    5 hours
    Title
    Positive mood
    Description
    Positive mood will be assess using the positive affect (PA) scale of the Positive and Negative Affect Schedule (PANAS). The PA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
    Time Frame
    5 hours
    Title
    Negative mood
    Description
    Negative mood will be assess using the negative affect (NA) scale of the PANAS. The NA scale consists of 10 adjectives which are rated on a 5 point scale from slightly or not at all to extremely. Items are summed to yield a score ranging from 10 to 50 with higher number indicating higher affect.
    Time Frame
    5 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Emergency Medicine Resident of any PGY level. (1-5) Exclusion Criteria: Anybody under the age of 18 Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen Miller, DO
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Reducing Error in ER Settings Through Attention Restoration Theory

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