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Completed

NCT Number: NCT02895997

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.

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Key information

Conditions

Mental Fatigue Behavior Behavioral Symptoms Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Travel Telehealth Delivery

Other

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 outcomes

  1. Change in Salivary Cortisol Levels

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.

Secondary outcomes

  1. Change in Stanford Sleepiness Scale Score

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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

  2. Change in the Trail Making Test A Score

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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.

  3. Change in the Trail Making Test B Score

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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.

  4. Change in Physical Activity assessed by Multi-Scale Entropy

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Multi-scale entropy will be measured using a Jawbone wristband device provided to participants upon enrollment.

  5. Change in Physical Activity assessed by Multi-Scale Complexity

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Multi-scale complexity will be measured using a Jawbone wristband device provided to participants upon enrollment.

  6. Change in Heart Rate Variability assessed by Deceleration Capacity

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Deceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.

  7. Change in Heart Rate Variability assessed by Acceleration Capacity

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Acceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.

  8. Frequency of Arrhythmias

    Time frame: Duration of Study (Up to 31 Days)

    The frequency of arrhythmias will be collected using a Jawbone wristband device provided to participants upon enrollment.

  9. Change in Sleep Latency

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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.

  10. Number of Awakenings per Hour

    Time frame: Duration of Study (Up to 31 Days)

    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.

  11. Change in Percent of Non Rapid Eye Movement (REM) Sleep

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    Change is the difference between the percentage of non REM sleep taken during performance phases.

  12. Change in Mood Symptom Questionnaire Score

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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.

  13. Change in Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: Baseline, Post Intervention (Up to 8 weeks)

    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.

  14. Change in Number of Camera Sessions

    Time frame: Day 1, Day 31

    Difference in the number of camera sessions completed during performance phases.

  15. Change in Duration of Camera Sessions

    Time frame: Day 1, Day 31

    Difference in the duration of camera sessions during performance phases measured in minutes.

  16. Change in Urgency of Clinical Contacts

    Time frame: Day 1, Day 31

    Difference in priority levels assigned to each clinical contact (levels: preventative; informative/procedural; urgent; life-threatening)

  17. Change in Number if Clinical Record Entries

    Time frame: Day 1, Day 31

    Difference in the number of clinical record entries made by physicians only during the performance phases.

  18. Change in Duration of Service

    Time frame: Day 1, Day 31

    Difference in the duration of physician services during each performance phase measured in hours.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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