Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
Primary Purpose
Mental Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Travel Telehealth Delivery
Sponsored by
About this trial
This is an interventional health services research trial for Mental Fatigue focused on measuring mental fatigue, critical care
Eligibility Criteria
Inclusion Criteria:
- Clinicians working in the clinical operations room at Emory University Hospital who volunteer participation in the study
Exclusion Criteria:
- Declining to participate after the first phase of data collection
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clinical Operations Room Staff
Arm Description
Clinicians and critical care nurse volunteers from the clinical operations room (COR) staff at Emory University Hospital will travel to Sydney Australia to deliver telemedicine.
Outcomes
Primary Outcome Measures
Change in Salivary Cortisol Levels
Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.
Secondary Outcome Measures
Change in Stanford Sleepiness Scale Score
The Stanford Sleepiness Scale is a seven point scale that asks participants to assess how alert they are feeling throughout the day. A result of 4 or below may indicate that a participant could be suffering from a lack of sleep
Change in the Trail Making Test A Score
During the Trail Making Test A, participants will be asked to draw lines to connect circled numbers in a numerical sequence (i.e., 1-2-3, etc.) as rapidly in possible. A shorter time indicates better cognition.
Change in the Trail Making Test B Score
During the Trail Making Test B, participants will be asked to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly as possible. A shorter time indicates better cognition.
Change in Physical Activity assessed by Multi-Scale Entropy
Multi-scale entropy will be measured using a Jawbone wristband device provided to participants upon enrollment.
Change in Physical Activity assessed by Multi-Scale Complexity
Multi-scale complexity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Change in Heart Rate Variability assessed by Deceleration Capacity
Deceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Change in Heart Rate Variability assessed by Acceleration Capacity
Acceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Frequency of Arrhythmias
The frequency of arrhythmias will be collected using a Jawbone wristband device provided to participants upon enrollment.
Change in Sleep Latency
Sleep latency is the length of time it takes to accomplish the transition from full wakefulness to sleep. This will be measured in minutes using a Jawbone wristband device provided to participants upon enrollment.
Number of Awakenings per Hour
The number of times a participants awakes during sleep will be monitored at every hour using a Jawbone wristband device provided to participants upon enrollment.
Change in Percent of Non Rapid Eye Movement (REM) Sleep
Change is the difference between the percentage of non REM sleep taken during performance phases.
Change in Mood Symptom Questionnaire Score
The Mood Symptom Questionnaire was originally designed to diagnose bipolar disorder. The questionnaire takes about five minutes to complete, and can provide important insights into diagnosis and treatment.If the patient answers "Yes" to seven or more of the 13 items in question number 1 AND "Yes" to question number 2 AND "Moderate" or "Serious" to question number 3, there is a positive screen.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a multi-purpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. A score of 5-9 represents signs of minimal depression symptoms. A score of 10-14 represents symptoms of minor depression. A score of 15-19 represents symptoms of major depression, moderately severe. A score of greater than 20 represents symptoms of major depression, severe.
Change in Number of Camera Sessions
Difference in the number of camera sessions completed during performance phases.
Change in Duration of Camera Sessions
Difference in the duration of camera sessions during performance phases measured in minutes.
Change in Urgency of Clinical Contacts
Difference in priority levels assigned to each clinical contact (levels: preventative; informative/procedural; urgent; life-threatening)
Change in Number if Clinical Record Entries
Difference in the number of clinical record entries made by physicians only during the performance phases.
Change in Duration of Service
Difference in the duration of physician services during each performance phase measured in hours.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02895997
Brief Title
Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
Official Title
Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney, Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
Detailed Description
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
As part of this pilot, each participant will undergo a series of evaluations before leaving, while in Australia, and after returning. The evaluations will include questionnaires related to well-being, task assessment (such as completing a paper maze or performing arithmetic), physiology assessment (such as continuous measure of heart rate by a wristwatch type device), and stress assessment (by sampling saliva and measuring cortisol and interleukin-1 Beta).
The researchers would like to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves subjective and objective well-being. Additionally, investigators seek to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves alertness and focus, and determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves job performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue
Keywords
mental fatigue, critical care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Operations Room Staff
Arm Type
Experimental
Arm Description
Clinicians and critical care nurse volunteers from the clinical operations room (COR) staff at Emory University Hospital will travel to Sydney Australia to deliver telemedicine.
Intervention Type
Other
Intervention Name(s)
Travel Telehealth Delivery
Intervention Description
Clinical Operations Room (COR) staff will travel to Sydney Australia to deliver telehealth to patients in Georgia United States. Upon arrival, participants will have eight nights and seven days free of clinical responsibilities. Thereafter, each participant will work four consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. The following week, participants will work three consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. Upon return to the USA, participants will have a week free of clinical responsibilities.
Primary Outcome Measure Information:
Title
Change in Salivary Cortisol Levels
Description
Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Secondary Outcome Measure Information:
Title
Change in Stanford Sleepiness Scale Score
Description
The Stanford Sleepiness Scale is a seven point scale that asks participants to assess how alert they are feeling throughout the day. A result of 4 or below may indicate that a participant could be suffering from a lack of sleep
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in the Trail Making Test A Score
Description
During the Trail Making Test A, participants will be asked to draw lines to connect circled numbers in a numerical sequence (i.e., 1-2-3, etc.) as rapidly in possible. A shorter time indicates better cognition.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in the Trail Making Test B Score
Description
During the Trail Making Test B, participants will be asked to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly as possible. A shorter time indicates better cognition.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Physical Activity assessed by Multi-Scale Entropy
Description
Multi-scale entropy will be measured using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Physical Activity assessed by Multi-Scale Complexity
Description
Multi-scale complexity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Heart Rate Variability assessed by Deceleration Capacity
Description
Deceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Heart Rate Variability assessed by Acceleration Capacity
Description
Acceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Frequency of Arrhythmias
Description
The frequency of arrhythmias will be collected using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Duration of Study (Up to 31 Days)
Title
Change in Sleep Latency
Description
Sleep latency is the length of time it takes to accomplish the transition from full wakefulness to sleep. This will be measured in minutes using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Number of Awakenings per Hour
Description
The number of times a participants awakes during sleep will be monitored at every hour using a Jawbone wristband device provided to participants upon enrollment.
Time Frame
Duration of Study (Up to 31 Days)
Title
Change in Percent of Non Rapid Eye Movement (REM) Sleep
Description
Change is the difference between the percentage of non REM sleep taken during performance phases.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Mood Symptom Questionnaire Score
Description
The Mood Symptom Questionnaire was originally designed to diagnose bipolar disorder. The questionnaire takes about five minutes to complete, and can provide important insights into diagnosis and treatment.If the patient answers "Yes" to seven or more of the 13 items in question number 1 AND "Yes" to question number 2 AND "Moderate" or "Serious" to question number 3, there is a positive screen.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Description
The PHQ-9 is a multi-purpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. A score of 5-9 represents signs of minimal depression symptoms. A score of 10-14 represents symptoms of minor depression. A score of 15-19 represents symptoms of major depression, moderately severe. A score of greater than 20 represents symptoms of major depression, severe.
Time Frame
Baseline, Post Intervention (Up to 8 weeks)
Title
Change in Number of Camera Sessions
Description
Difference in the number of camera sessions completed during performance phases.
Time Frame
Day 1, Day 31
Title
Change in Duration of Camera Sessions
Description
Difference in the duration of camera sessions during performance phases measured in minutes.
Time Frame
Day 1, Day 31
Title
Change in Urgency of Clinical Contacts
Description
Difference in priority levels assigned to each clinical contact (levels: preventative; informative/procedural; urgent; life-threatening)
Time Frame
Day 1, Day 31
Title
Change in Number if Clinical Record Entries
Description
Difference in the number of clinical record entries made by physicians only during the performance phases.
Time Frame
Day 1, Day 31
Title
Change in Duration of Service
Description
Difference in the duration of physician services during each performance phase measured in hours.
Time Frame
Day 1, Day 31
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinicians working in the clinical operations room at Emory University Hospital who volunteer participation in the study
Exclusion Criteria:
Declining to participate after the first phase of data collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Buchman, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with future researchers.
Learn more about this trial
Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
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