Fatigue
Conditions
Keywords
Shift work, Fatigue, Sleepiness, Injury
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?
Interventions
BEHAVIORALText-message assessments only
Text message assessments only. No intervention for high level fatigue.
BEHAVIORALText-message interventions for high level fatigue
Intervention messages to promote alertness while on duty at work including activities. Additionally at the end of the shift, participants were queried on their adoption of the suggested activities and perception of the activities' effectiveness.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Fatigue at End of Shift Work | At the end of scheduled work shifts during a 90 day study period | Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool | end of study at 90 day follow up | Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work. |
| Normative Beliefs Scale One Subscale of the SFAB | end of study at 90 day follow up | Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued. |
| Normative Beliefs Scale Two Subscale of the SFAB | end of study at 90 day follow up | Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued. |
| Self Efficacy Subscale of the SFAB | end of study at 90 day follow up | Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work. |
| Knowledge-one Subscale of SFAB | end of study at 90 day follow up | Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education. |
| Knowledge-two Subscale of the SFAB | end of study at 90 day follow up | Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education. |
| Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool | Assessed at the end of 90-day study period | Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work. |
| Environmental Constraints One Subscale of the SFAB | end of study at 90 day follow up | Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work. |
| Environmental Constraints Two Subscale of the SFAB | end of study at 90 day follow up | Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work. |
| Environmental Constraints Three Subscale of the SFAB | end of study at 90 day follow up | Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work |
| Habits Subscale of the SFAB | end of study at the 90 day follow up | Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness. |
| Intentions Subscale of the SFAB | end of study at 90 day follow up | An individual's intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree). |
| Importance Subscale of SFAB | end of study at 90 day follow up | Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work. | 52 |
| Intervention Group The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.
Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness. | 48 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 4 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 10.2 | 35.0 years STANDARD_DEVIATION 9.7 | 35.6 years STANDARD_DEVIATION 10 |
| Certification/License EMT-Basic | 4 participants | 5 participants | 9 participants |
| Certification/License Nurse | 7 participants | 10 participants | 17 participants |
| Certification/License Paramedic | 34 participants | 31 participants | 65 participants |
| Certification/License Physician/Other | 7 participants | 2 participants | 9 participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 29 Participants |
| Sex: Female, Male Male | 41 Participants | 30 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 48 |
| serious Total, serious adverse events | 0 / 52 | 0 / 48 |
Outcome results
Primary
Self-Reported Fatigue at End of Shift Work
Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).
Time frame: At the end of scheduled work shifts during a 90 day study period
Population: Analysis using intention to treat.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Self-Reported Fatigue at End of Shift Work | 2.17 units on a scale | Standard Error 0.1746 |
| Intervention Group | Self-Reported Fatigue at End of Shift Work | 1.78 units on a scale | Standard Error 0.1782 |
p-value: 0.08395% CI: [-0.8272, 0.0508]Mixed Models Analysis
Secondary
Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool
Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.
Time frame: Assessed at the end of 90-day study period
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool | 61.9 units on a scale | Standard Deviation 19.9 |
| Intervention Group | Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool | 69.3 units on a scale | Standard Deviation 17.1 |
p-value: 0.0114ANCOVA
Secondary
Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool
Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool | 27.8 units on a scale | Standard Deviation 21.1 |
| Intervention Group | Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool | 30.3 units on a scale | Standard Deviation 22.8 |
p-value: 0.99ANCOVA
Secondary
Environmental Constraints One Subscale of the SFAB
Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Environmental Constraints One Subscale of the SFAB | 64.5 units on a scale | Standard Deviation 27.5 |
| Intervention Group | Environmental Constraints One Subscale of the SFAB | 64.4 units on a scale | Standard Deviation 29.6 |
p-value: 0.51ANCOVA
Secondary
Environmental Constraints Three Subscale of the SFAB
Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Environmental Constraints Three Subscale of the SFAB | 49.4 units on a scale | Standard Deviation 24.4 |
| Intervention Group | Environmental Constraints Three Subscale of the SFAB | 44.5 units on a scale | Standard Deviation 23 |
p-value: 0.093ANCOVA
Secondary
Environmental Constraints Two Subscale of the SFAB
Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Environmental Constraints Two Subscale of the SFAB | 38.3 units on a scale | Standard Deviation 31.1 |
| Intervention Group | Environmental Constraints Two Subscale of the SFAB | 45.5 units on a scale | Standard Deviation 33.4 |
p-value: 0.28ANCOVA
Secondary
Habits Subscale of the SFAB
Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.
Time frame: end of study at the 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Habits Subscale of the SFAB | 39.3 units on a scale | Standard Deviation 21.6 |
| Intervention Group | Habits Subscale of the SFAB | 48.5 units on a scale | Standard Deviation 26.8 |
p-value: 0.56ANCOVA
Secondary
Importance Subscale of SFAB
Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Importance Subscale of SFAB | 62.0 units on a scale | Standard Deviation 16.5 |
| Intervention Group | Importance Subscale of SFAB | 68.8 units on a scale | Standard Deviation 18.6 |
p-value: 0.21ANCOVA
Secondary
Intentions Subscale of the SFAB
An individual's intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Intentions Subscale of the SFAB | 72.3 units on a scale | Standard Deviation 14.7 |
| Intervention Group | Intentions Subscale of the SFAB | 77.4 units on a scale | Standard Deviation 17 |
p-value: 0.2ANCOVA
Secondary
Knowledge-one Subscale of SFAB
Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knowledge-one Subscale of SFAB | 76.5 units on a scale | Standard Deviation 22.5 |
| Intervention Group | Knowledge-one Subscale of SFAB | 81.4 units on a scale | Standard Deviation 19.5 |
p-value: 0.65ANCOVA
Secondary
Knowledge-two Subscale of the SFAB
Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Knowledge-two Subscale of the SFAB | 77.1 units on a scale | Standard Deviation 17.8 |
| Intervention Group | Knowledge-two Subscale of the SFAB | 76.8 units on a scale | Standard Deviation 18.3 |
p-value: 0.95ANCOVA
Secondary
Normative Beliefs Scale One Subscale of the SFAB
Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Normative Beliefs Scale One Subscale of the SFAB | 48.9 units on a scale | Standard Deviation 18.8 |
| Intervention Group | Normative Beliefs Scale One Subscale of the SFAB | 59.7 units on a scale | Standard Deviation 18.8 |
p-value: 0.0927ANCOVA
Secondary
Normative Beliefs Scale Two Subscale of the SFAB
Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Normative Beliefs Scale Two Subscale of the SFAB | 47.2 units on a scale | Standard Deviation 19.8 |
| Intervention Group | Normative Beliefs Scale Two Subscale of the SFAB | 58.8 units on a scale | Standard Deviation 25.6 |
p-value: 0.0578ANCOVA
Secondary
Self Efficacy Subscale of the SFAB
Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.
Time frame: end of study at 90 day follow up
Population: Intention to treat among participants with 90 day data (completers)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Self Efficacy Subscale of the SFAB | 57.9 units on a scale | Standard Deviation 24.9 |
| Intervention Group | Self Efficacy Subscale of the SFAB | 58.9 units on a scale | Standard Deviation 26.8 |
p-value: 0.69ANCOVA