The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

Study Overview
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Brief Summary
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The overarching goal of this proposal is to address the MedEvac foundation priority of educational techniques and technologies and improve Helicopter Emergency Medical Services (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS clinicians can be improved with real-time assessment and intervention. Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS clinician fatigue reported in real-time during and at the end of shift work. Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality and sleep health indicators including hours of sleep and recovery between shift work.

Detailed Description
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The investigators will examine short term impact by examining self-reported fatigue captured at the start, during, and end of scheduled shifts. The investigators will determine longer-term impact on sleep quality by comparing scores on the Pittsburgh Sleep Quality Index (PSQI) taken at baseline and then again at 4 months.

Official Title
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Real-time Fatigue Mitigation With Air-medical Personnel: The SleepTrackTXT2 Randomized Trial

Conditions
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Poor Quality Sleep, Fatigue

Intervention / Treatment
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* Behavioral: SleepTrackTXT2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older working clinically at a study site currently working in shifts has a smart phone and willing to take part in a research study that requires the sending and receiving of multiple text messages daily over 4-months Exclusion Criteria: does not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SleepTrackTXT2<br>Participants will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days. | Behavioral: SleepTrackTXT2<br>* Participants that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness during shift work. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.<br>|
| No Intervention: Text-Message Assessments Only<br>Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Measured by the Pittsburgh Sleep Quality Index (PSQI); Scores range from 0 to 21. Higher scores indicate poorer sleep quality. Scores >6 indicate poor sleep quality. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue During Shiftwork | Single item measure of fatigue taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much); higher scores indicate more fatigue. | Every 4 hours up to 12 hours within work shifts | 
| Sleepiness During Shiftwork | Single item measure of sleepiness taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more sleepiness. | Every 4 hours up to 12 hours within a work shift | 
| Difficulty With Concentration During Shiftwork | Single item measure of difficulty with concentration taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more difficulty with concentration. | Every 4 hours up to 12 hours at end of work shift | 
| Inter-Shift Recovery | The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery. | 4 months |