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

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.

Study Overview

• Status: Completed
• Conditions: Mental Fatigue
• Intervention / Treatment: Other: Travel Telehealth Delivery

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clinical Operations Room Staff; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in Number of Camera Sessions	Difference in the number of camera sessions completed during performance phases.	Day 1, Day 31
Change in Duration of Camera Sessions	Difference in the duration of camera sessions during performance phases measured in minutes.	Day 1, Day 31
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
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
Change in Duration of Service	Difference in the duration of physician services during each performance phase measured in hours.	Day 1, Day 31

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Timothy Buchman, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: critical care; mental fatigue
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: IRB00088367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with future researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No