Clinical trial NCT02063737: SleepTrackTXT Feasibility and Pilot Study
Official title: The Sleep Track Text Pilot Trial in Emergency Care Clinicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fatigue
Keywords: Shift work
Fatigue
Sleepiness
Injury
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts an emergency medicine clinician's Attitudes, Perceived Norms, Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that can improve alertness during shift work.

Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in real-time at the start and during shift work reduces worker perceived sleepiness and fatigue at the end of shift work.

Detailed description: More than half (55%) of Emergency Medical Services (EMS) shift workers report severe mental and physical fatigue while at work,(Patterson et al, 2012) 36% report excessive daytime sleepiness,(Pirrallo et al; 2012) and 60% poor sleep quality.(Patterson et al; 2012) Sleepiness or fatigue while on duty can result in injuries to EMS workers and medical errors for patients.(Patterson et al; 2012) The investigators' recent research shows that odds of injury among fatigued EMS workers are 1.9 times higher than non-fatigued workers.(Patterson et al; 2012) Additional data show that other emergency workers (e.g., emergency physicians and nurses) are vulnerable to sleepiness and fatigue while at work.(Fisman et al; 2007; Machi et al; 2012; Thomas et al; 2006; Geiger-Brown et al; 2012).

There are a number of individual and system factors that influence sleepiness and fatigue during shift work for emergency workers. Individual factors include sleep hygiene, medical conditions like obstructive sleep apnea, and other factors.(Schaefer et al; 2012; Simon et al; 2012) System factors include shift length, patient care intensity, and workload. Many factors are modifiable, yet some are more difficult than others to change or control. Reducing shift length and customary patterns of shift work, such as 12-hr and 24-hr shifts, is not feasible for many employers and shift workers in the emergency medicine care setting. In some locations, \>80% of EMS workers hold multiple jobs, 40% work more than 16 shifts per month, and many accumulate unsafe amounts of overtime in order to make a livable wage.(Patterson et al, 2010; Patterson et al, 2012; Bauder 2012) Other shift workers in emergency care settings face the same or similar obstacles as do EMS shift workers.

An objective of this research study is to pilot test real-time assessment of emergency care worker sleepiness and fatigue. The investigators seek to determine if text-messaging fatigue-reduction strategies to emergency care workers that report a high-level of sleepiness or fatigue at the start or during their shift reduces perceived sleepiness or fatigue at the end of shift. A long term goal of this research is to determine if this innovative text-messaging tool can be used to reduce the likelihood of fatigue-related injury among emergency care shift workers.

Aim 1: To determine if real-time assessments of perceived sleepiness and fatigue using text-messaging impacts a worker's Attitudes, Perceived Norms, Self-Efficacy, Alertness Habits, Perceived Importance of Fatigue, Knowledge of Sleepiness/Fatigue, and Perceptions of Environmental Constraints regarding behaviors that can improve alertness during shift work.

Rationale: The investigators recognize that emergency care shift workers hold different beliefs and attitudes about the risk of sleepiness and fatigue on duty and are at different stages of adopting risk-reduction behaviors. Behavioral research shows that modifying one or more of these factors can impact future behavior and potentially reduce risk over the long term. Approach: The investigators have developed a list of candidate items that operationalize the Integrative Model of Behavioral Prediction. The investigators will administer these candidate items at baseline and again at the end of the study period to assess impact.

Aim 2: To determine if text-messaging emergency care workers fatigue-reduction strategies in real-time at the start and during shift work reduces worker perceived sleepiness and fatigue at the end of shift work.

Approach: At baseline, the investigators will randomly assign 100 emergency care workers to one of two groups (the control group or intervention group). The control group (n=50 / 50%) will receive standard text-message questions of sleepiness and fatigue at the beginning, during, and end of shift. The other 50% (n=50) will be assigned to our intervention group and receive the same text-message questions as the control group, as well as additional text-messages that include strategies that the investigators hypothesize will lead to a reduction in perceived sleepiness or fatigue at the end of shift work. With 100 EMS workers (50% intervention / 50% control), the investigators have 80% power to detect a difference (effect size of 0.78) in the self-reported fatigue levels reported at the end of shift by the control and intervention groups. The investigators will collect data over a 90-day study period.

Eligibility Criteria include:

1. The study subject must be 18 years of age or older;
2. The study subject must currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
3. The study subject must work shifts as part of your employment in the emergency medicine setting;
4. The study subject must have a cell-phone / smartphone that can receive and send text-messages;
5. The study subject must be willing to take part in a research study where he/she is required to send and receive multiple text-messages at the start, during, and end of scheduled shift work?

Eligibility criteria: Inclusion Criteria:

1. Are 18 years of age or older;
2. Currently work in the emergency medicine setting as an emergency physician, emergency nurse, or emergency medical technician (EMT) / paramedic worker;
3. Currently working shifts as part of your employment in the emergency medicine setting;
4. Have a cell-phone / smartphone that can receive and send text-messages;
5. Willing to take part in a research study where you are required to send and receive multiple text-messages at the start, during, and end of your shift work?

Exclusion Criteria:

1: Those that do not meet inclusion criteria.

Primary outcomes:
measure: Self-Reported Fatigue at End of Shift Work
timeFrame: At the end of scheduled work shifts during a 90 day study period
Secondary outcomes:
measure: Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool
timeFrame: Assessed at the end of 90-day study period
measure: Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool
timeFrame: end of study at 90 day follow up
measure: Normative Beliefs Scale One Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Normative Beliefs Scale Two Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Self Efficacy Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Knowledge-one Subscale of SFAB
timeFrame: end of study at 90 day follow up
measure: Knowledge-two Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Importance Subscale of SFAB
timeFrame: end of study at 90 day follow up
measure: Environmental Constraints One Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Environmental Constraints Two Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Environmental Constraints Three Subscale of the SFAB
timeFrame: end of study at 90 day follow up
measure: Habits Subscale of the SFAB
timeFrame: end of study at the 90 day follow up
measure: Intentions Subscale of the SFAB
timeFrame: end of study at 90 day follow up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Emergency Medicine School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Department of Emergency Medicine School of Medicine
name: Daniel Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson PD, Moore CG, Weaver MD, Buysse DJ, Suffoletto BP, Callaway CW, Yealy DM. Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial. Trials. 2014 Jun 21;15:244. doi: 10.1186/1745-6215-15-244.
citation: Patterson PD, Buysse DJ, Weaver MD, Callaway CW, Yealy DM. Recovery between Work Shifts among Emergency Medical Services Clinicians. Prehosp Emerg Care. 2015 Jul-Sep;19(3):365-75. doi: 10.3109/10903127.2014.995847. Epub 2015 Feb 6.
citation: Patterson PD, Klapec SE, Weaver MD, Guyette FX, Platt TE, Buysse DJ. Differences in Paramedic Fatigue before and after Changing from a 24-hour to an 8-hour Shift Schedule: A Case Report. Prehosp Emerg Care. 2016;20(1):132-6. doi: 10.3109/10903127.2015.1025158. Epub 2015 May 15.
citation: Patterson PD, Buysse DJ, Weaver MD, Doman JM, Moore CG, Suffoletto BP, McManigle KL, Callaway CW, Yealy DM. Real-time fatigue reduction in emergency care clinicians: The SleepTrackTXT randomized trial. Am J Ind Med. 2015 Oct;58(10):1098-113. doi: 10.1002/ajim.22503. Epub 2015 Aug 25.
citation: Patterson PD, Moore CG, Guyette FX, Doman JM, Sequeira D, Werman HA, Swanson D, Hostler D, Lynch J, Russo L, Hines L, Swecker K, Runyon MS, Buysse DJ. Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):254. doi: 10.1186/s13063-017-1999-z.