NCT02895997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

September 1, 2016

Last Update Submit

November 18, 2018

Conditions

Keywords

mental fatiguecritical care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Change in Stanford Sleepiness Scale Score

    Baseline, Post Intervention (Up to 8 weeks)

  • Change in the Trail Making Test A Score

    Baseline, Post Intervention (Up to 8 weeks)

  • Change in the Trail Making Test B Score

    Baseline, Post Intervention (Up to 8 weeks)

  • Change in Physical Activity assessed by Multi-Scale Entropy

    Baseline, Post Intervention (Up to 8 weeks)

  • Change in Physical Activity assessed by Multi-Scale Complexity

    Baseline, Post Intervention (Up to 8 weeks)

  • +13 more secondary outcomes

Study Arms (1)

Clinical Operations Room Staff

EXPERIMENTAL

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

Interventions

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.

Clinical Operations Room Staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicians working in the clinical operations room at Emory University Hospital who volunteer participation in the study

You may not qualify if:

  • Declining to participate after the first phase of data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Timothy Buchman, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 12, 2016

Study Start

July 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Data will be shared with future researchers.

Locations