Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community

Mental Fatigue Clinical Trial

Official title:

Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895997
• Other study ID #: IRB00088367
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: November 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Mental Fatigue

Intervention

Other:
• Travel Telehealth Delivery
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Salivary Cortisol Levels	Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	Change in Heart Rate Variability assessed by Deceleration Capacity	Deceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	Change in Heart Rate Variability assessed by Acceleration Capacity	Acceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	Frequency of Arrhythmias	The frequency of arrhythmias will be collected using a Jawbone wristband device provided to participants upon enrollment.	Duration of Study (Up to 31 Days)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Duration of Study (Up to 31 Days)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	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.	Baseline, Post Intervention (Up to 8 weeks)
Secondary	Change in Number of Camera Sessions	Difference in the number of camera sessions completed during performance phases.	Day 1, Day 31
Secondary	Change in Duration of Camera Sessions	Difference in the duration of camera sessions during performance phases measured in minutes.	Day 1, Day 31
Secondary	Change in Urgency of Clinical Contacts	Difference in priority levels assigned to each clinical contact (levels: preventative; informative/procedural; urgent; life-threatening)	Day 1, Day 31
Secondary	Change in Number if Clinical Record Entries	Difference in the number of clinical record entries made by physicians only during the performance phases.	Day 1, Day 31
Secondary	Change in Duration of Service	Difference in the duration of physician services during each performance phase measured in hours.	Day 1, Day 31