Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial
Phase: NA
Conditions: Fatigue, Sleep
Sponsor: University of Pittsburgh

 
1 
Real-time intervention to reduce fatigue among Emergency Medical Services 
workers 
 
Study Protocol Document 
 
Short title: The Sleep and Teamwork in EMS Study 
(SaFTiE) 
 
 
Supported by the National Institute for Occupational Safety and Health (NIOSH) 
Grant Number: 1R01OH011502-01 
 
Research study principal investigators:  
P. Daniel Patterson, PhD; Francis X. Guyette, MD 
 
University of Pittsburgh Institutional Review Board (IRB) # STUDY19040354 
Initial IRB approval date: May 31, 2019;  
Last modification approval date: December 21, 2023; 
ClinicalTrials.gov (NCT04456764) registered on June 29, 2020; 
First enrollment on December 8, 2020 
 
 
 
 

 
2 
Table of Contents 
 
 
Background and specific aims 
Page 3 
Overview of methods 
Page 4 
Study site 
Page 5 
Recruitment methods 
Page 6 
Compensation / remuneration offered to participants 
Page 7 
Study design (including power analysis and statistical analyses) 
Page 8 
Consent procedures 
Page 15 
Data safety monitoring 
Page 16 
Protecting privacy 
Page 17 
Termination, withdrawal, or attrition 
Page 18 
 
 
 
 
 
 
 

 
3 
Background and specific aims 
 
Problem: 
More than half of Emergency Medical Services (EMS) workers report work-related 
mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly 
double that of non-fatigued workers. There is a compelling need to reduce fatigue 
among EMS workers, yet few EMS organizations have a formal fatigue management 
program and many may not be cost-effective or evidence-based. This study addresses 
national goals of the National Occupational Research Agenda (NORA) and tests a novel 
approach to fatigue risk management that is easily scalable to large workforces and 
low-cost for employers of shift workers. 
 
Significance: 
This research study addresses fatigued EMS workers, for which there has been no 
standard for fatigue risk management. This proposal logically builds on our pilot trial, 
which demonstrated feasibility, high compliance, and a positive impact on indicators of 
sleep and fatigue. This proposal addresses national goals of the National Occupational 
Research Agenda (NORA) and tests a novel approach to fatigue risk management that 
is easily scalable to large workforces and low-cost for employers of shift workers. 
 
Specific aims: 
Aim 1: Determine the impact of the enhanced intervention on EMS worker fatigue and 
sleep health in a cluster-randomized trial. 
 
Aim 2: Identify worker-level and EMS agency-level conditions linked to a reduction in 
worker fatigue. 
 
Aim 3: Perform exploratory analyses to determine impact of the enhanced intervention 
on the incidence of work-related injury and workplace safety culture. 
 
Hypothesis: 
Our global hypothesis is that dissemination of tailored sleep health information 
combined with tailored alertness promoting strategies in real-time can improve intra-shift 
fatigue, sleep health, and ultimately workplace safety culture.  
 
 
 
 

 
4 
Overview of methods 
 
We will use a parallel, two-arm cluster-randomized trial study design. The design is 
clustered because we will have multiple participants from the same organization 
(agency) participating. Thus, participants are clustered together. 
 
Each participant will be asked to participate for 6 months using our mobile technology, 
the SaFTiE mobile app and text message platforms. These platforms deliver our study 
intervention materials via text and information shared on the mobile app.  
 
 
 
 

 
5 
Study site 
 
The University of Pittsburgh main campus 
 
The Department of Emergency Medicine has the necessary personnel and computer 
equipment, as well as software, to fulfill the study's aims. The Department of Psychiatry 
WPIC Office of Academic Computing is a partner in this project and has demonstrated, 
in numerous studies, to have the personnel, expertise, computer equipment, and 
software needed to fulfill this study as designed. The Department of Health Information 
Management within the School of Health and Rehabilitation Sciences is also a partner 
in this project and has demonstrated, in numerous studies, to have the necessary 
personnel, expertise, and equipment needed to fulfill this study as designed. 
 
 
 
 

 
6 
Recruitment methods 
 
Members of the study team will communicate with EMS agency directors and individual 
EMS clinicians using telephone and email communication and other methods as 
necessary (e.g., in-person communication). 
 
Methods used: 
-Directly approaching potential subjects (in-person) 
-Email/Listserv/Electronic Mailing List 
-Flyers/Posters or Brochures 
-Radio/Television/Video announcements 
-Telephone scripts 
-Website/social media 
 
Details: 
We will use traditional paper-based research study flyers and standardized emails to 
connect with and recruit EMS agency directors to participate. We will also use a video-
based version of our study flyer that can be hosted on our study website 
(www.saftie.pitt.edu) and circulated on social media.  
 
We will communicate directly with EMS agency leaders and with individual EMS 
clinicians who may be interested in participating in this research study. Once an agency 
director or individual clinician reaches out to us, they will be screened.  
 
We will ask agency administrators to set a date for opening enrollment. When that date 
arrives, the agency administration will distribute a paper-based study flyer (a 
standardized recruitment email) and help to distribute a video-based individual EMS 
clinician recruitment flyer (as a complement to the paper version) to their crew members 
via their internal email lists. We will also host the video flyers on our platforms for ease 
of viewing. We will ask the EMS agency administrators to post the paper-based study 
flyer in high traffic areas on the EMS organization and to circulate our video-based 
flyer.  
 
If our communication is with an individual EMS clinician, they will be directed to the 
study website and asked to complete the screening form. If eligible, they will be assisted 
with signing up for the study and instructed to watch the video consent on our study 
website.  
 
We have two recruitment videos. One that shows various aspects of the study and a 
second video that highlights various aspects of the mobile app. 
 
 
 

 
7 
Compensation / remuneration offered to participants 
 
Our remuneration package for study participants will include $25 dollars to sign 
up/enroll, followed by $10 distributed for months 1 to 5, and then $25 at the end of the 
6-month study distributed on the 6th month of participation. In total, a study participant 
who participates for the full 6 months may accumulate a total of $100 in remuneration.  
 
We will also mail directly to participants several popular EMS novelty items. These 
include coffee mugs, glove pouches, EMS shoulder patches, challenge coins, wallet 
sized reference index cards for special patient groups (e.g. burn patients), ball point 
pens, water bottles, keychains, and flashlights. We will mail these items monthly when a 
participant completes a monthly survey.  
 
In addition, we will reimburse participants for smartphone data and text message use 
during participation. We will send active participants $50 at month 3 and $50 at month 
6. We will issue this reimbursement for expenses on the University of Pittsburgh Vincent 
MasterCard.  
 
 
 

 
8 
Study design 
 
Total number of subjects to be enrolled = 2500 
 
Describe and explain the study design: 
We will use a parallel, two-arm cluster-randomized trial study design. The design is 
clustered because we will have multiple participants from the same organization 
(agency) participating. Thus, participants are clustered together.  
 
Each participant will be asked to participate for 6 months using our mobile technology, 
the SaFTiE mobile app and text message platforms. These platforms deliver our study 
intervention materials via text and information shared on the mobile app.  
 
Primary and secondary outcomes: 
Our PRIMARY OUTCOME of interest for Aim 1 is the proportion of workers that self-
report fatigue as measured by the Chalder Fatigue Questionnaire (CFQ). The CFQ 
evaluates both physical and mental fatigue by eliciting a response of (Always, 
Sometimes, Rarely, Never) across 11 items. Item-level responses are recorded as (1, 1, 
0, 0) with Always=1, Sometimes but not always=1, Rarely=0, Never=0. Scores are 
summed to reach a total score ranging from 0 to 11. Scores ≥4 indicate severe mental 
and physical fatigue.  
 
Supporting citations for primary outcome: 
Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 
Jan;65(1):86. doi: 10.1093/occmed/kqu168. PubMed PMID: 25559796. 
 
Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom 
Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11. 
PubMed PMID: 20630259 
 
Our SECONDARY OUTCOMES of interest include sleep quality as measured with the 
reliable Pittsburgh Sleep Quality Index (PSQI), and three additional measures of fatigue 
as measured by the Occupational Fatigue, Exhaustion, Recovery Scale (OFER). 
 
Supporting citations for secondary outcomes: 
Buysse DJ, Reynolds CFr, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep 
Quality Index: a new instrument for psychiatric practice and research. Psychiatr Serv. 
1989;28(2):193-213. 
 
Winwood PC, Winefield AH, Dawson D, Lushington K. Development and validation of a 
scale to measure work-related fatigue and recovery: the Occupational Fatigue 
Exhaustion/Recovery Scale (OFER). J Occup Environ Med. 2005;47(6):594-606. 
 
Timeline: 
Duration of an individual subject’s active participation: Six months. 
 

 
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Inclusion criteria for EMS agencies: 
At the EMS Agency level, eligibility criteria for inclusion include: (1) the agency employs 
a minimum of 20 paid (full-time or part-time) EMS clinician shift workers; (2) employees 
work in shifts; (3) duties of EMS workers include standard tasks such as emergent or 
non-emergent patient care, driving/operating ambulances, and lifting/moving patients 
and EMS equipment; and (4) agency policies and procedures do not limit use of 
personal cell-phone or smartphone, with the exception of restrictions while driving and 
performing standard duties. 
 
Exclusion criteria for EMS agencies: 
At the EMS agency level, we are recruiting and enrolling EMS agencies that employ 
EMS clinicians who work primarily in ground-based EMS operations. We will exclude 
EMS agencies where the primary mission of that agency is to provide only one-type of 
EMS service, specifically only air-medical transport services. Air-Medical agencies that 
provide both air and ground-based services are eligible to participate. We will exclude 
agencies that do not allow their EMS clinician employees to use their personal cellular / 
smartphones during shift work. 
 
Inclusion criteria for individual EMS personnel: 
At the individual EMS clinician level, eligibility for participation will include answering 
YES to the following screening questions: 
 
[1] Are you 18 years of age or older? 
 
[2] Do you live in the United States (Hawaii & Alaska included)? 
 
[3] Are you a licensed / certified EMS professional (e.g., EMT-Basic, Firefighter, 
Paramedic, Flight Nurse, or other type of prehospital clinician)? 
 
[4] Do you currently work in shifts (e.g., 8 hours, 12 hours, 16 hours, 24 hours, or other 
duration)? 
 
[5] Do you work at least one shift per week as an EMS clinician? 
 
[6] When you work shifts, does most of your work involve direct contact with patients 
and delivery of patient care? 
 
[7] Do you currently own a cellular telephone or smartphone that can send and receive 
text messages AND operate mobile apps that can be downloaded from the Apple 
Appstore or GooglePlay? 
 
[8] Are you willing to periodically answer online surveys, and send and receive text 
messages as part of a research study?  
 
 
 

 
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Exclusion criteria for individual EMS personnel: 
At the individual EMS clinician/worker level, we will exclude individuals who primarily 
work administrative jobs/roles at the agency. We will exclude individuals who answer 
NO to any of the screening questions (see screening questions in #5 above). 
 
EMS clinician workers are required to have certification / licensure to provide 
emergency medical services care. These individuals are 18 years or older. Thus no 
children or persons <18 years of age will be eligible or enrolled. 
 
Power analysis: 
Our power calculation was designed to determine the number of agencies and 
individual EMS clinician workers needed to detect an important impact on fatigue and 
sleep quality.  
 
Given our experience, we feel it appropriate and necessary to have a moderate to low 
level of the anticipated number of individual enrollees per cluster (agency). With 60 total 
clusters (30 EMS agencies in the intervention group and 30 in the APC group) and an 
average of 10 individuals enrollees per cluster, we will have 83.7% power to detect: 
 
[A] a 15% reduction in the point-prevalence of fatigue in the intervention assigned 
participants versus the APC assigned participants; and  
 
[B] a clinically meaningful change of >3 points on the Pittsburgh Sleep Quality Index 
from randomization to 3 months and 6 months.  
 
If we enroll a total of 100 EMS agencies (50 EMS agencies in the intervention group 
and 50 in the APC group) with an average of 5 individuals per cluster (agency), we will 
have 85.8% power to detect: 
 
[A] a 15% reduction in the point-prevalence of fatigue in the intervention assigned 
participants versus the APC assigned participants; and  
 
[B] a clinically meaningful change of >3 points on the Pittsburgh Sleep Quality Index 
from randomization to 3 months and 6 months. 
 
A cluster is defined as an EMS agency with at least 2 individual participants enrolled. 
Locations (agencies) with 1 or no enrollments will not be considered as counting 
towards total cluster goal enrollment. 
 
 
Statistical analyses: 
The primary outcome for this agency-randomized trial is EMS worker fatigue related to 
shift work, measured by the CFQ at 3 and 6 months after randomization. To test the 
effect of the intervention on worker fatigue, we will use a generalized linear mixed model 
with logit link (due to the dichotomous nature of outcome: fatigued versus not-fatigued). 
We will use a random agency effect to account for the clustering of EMS workers within 

 
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agencies and a random worker effect to account for the correlation between repeated 
measures within worker. The main effects of time, intervention, and intervention*time 
interaction will be fit as fixed effects with primary focus on the contrast between the 
intervention and APC groups at 6 months post start of treatment period. The mixed 
model using both time points allows us to borrow information from the correlation 
between the time points for those workers with missing data on either time point. We will 
control for agency size since it will be a randomization stratification factor. We will use a 
similar approach to compare sleep quality, measured with the PSQI, between enrolled 
EMS workers at intervention agencies and enrolled workers at APC agencies. This 
analysis will use a linear mixed model (assuming normality of these numeric outcomes) 
controlling for baseline sleep quality and agency size. We will also report the intraclass 
correlation coefficients for fatigue and sleep quality to assess our assumptions for 
sample size analyses. Secondary analyses will adjust for EMS worker characteristics 
that are potentially imbalanced at baseline and have been shown to be associated with 
fatigue and sleep quality. Factors include, but are not limited to, years of experience, 
employment status, shifts per month, number of patients seen during shift, shift length, 
health status and number of medical conditions.  
 
 
Research activities: 
We will begin recruitment of EMS agencies by disseminating the Study Flyers (and the 
video-based study flyer) to various EMS agency contacts (e.g., the National Association 
of State EMS Officials email lists, the National EMS Management Association email 
lists, the National Association of EMS Physicians email lists, and with other 
organizations). 
 
We will screen EMS agencies that respond to the study flyer for eligibility using a 
telephone-based (or via email) screening procedure.  
 
If the initial communication comes from an individual EMS clinician NOT affiliated with 
an agency that reaches out to us, we will still allow this individual to participate in our 
study, yet we will not communicate with the agency director unless he/she wishes to 
communicate with us. In this situation, we may likely have multiple "clusters" with just 
one participant in it. The individual who decided to sign up for this study is participating 
as an individual and consenting to participate as an individual.  
 
Next, we will execute / perform our randomization procedure which will determine if the 
agency (cluster) will be in the Intervention (Sleep/Fatigue) study group/arm or the Active 
Placebo Control (Teamwork) study group/arm. Once we know the agency's group 
assignment, we will ask EMS agency administrators to share study flyers (paper and 
video) with the employees. These study flyers will instruct the individuals within the EMS 
agency to visit the study designated website (www.saftie.pitt.edu) and follow steps for 
screening for eligibility. If the individual is eligible, he/she will be instructed to follow 
steps for enrollment. 
 
All enrollment procedures for individual EMS clinician participants will take place on the 

 
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study designated website. First, persons who screened-in will be taken to the video 
consent webpage. Once there, the video consent will play and the individual will have a 
decision to make regarding participation. He/she will either click on one of two options: 
[1] I have watched the informed consent video and agree to participate (I ACCEPT) or 
[2] I DO NOT ACCEPT and do NOT want to participate in this research study. 
 
Those who ACCEPT are then taken to a webpage where they type in the name of their 
EMS agency, their name, their cellular telephone number, and an email address. Our 
study tool will have a database of enrolled EMS agencies (clusters). When an individual 
types in the agency name, the information is verified in real-time and those who are 
affiliated with an agency in the system will be allowed to proceed. Those who type in an 
agency not verified will receive an error message and be directed to contact the study 
coordinator. The email and cellular telephone number are used to [1] get the individual 
registered in the automated texting platform developed by our research team; and [2] to 
email the individual a paper-based copy of the consent form and his/her temporary 
password for the study website. If an individual EMS clinician who is eligible, wants to 
participate, yet is unaffiliated with an agency in our database - our study coordinator will 
provide him/her with information that will allow them to move past this phase of the 
enrollment procedures. This information will be the name of their agency which will be 
obtained from the individual when he/she expressed interest in participation. We 
capture this information so that if additional individuals from the same agency want to 
enroll, they are then assigned to the same cluster (agency). This is important for 
purposes of analysis of clustered data. 
 
Next, the individual will receive multiple welcome text messages that say: "Welcome to 
SaFTiE, the Sleep and Teamwork in EMS Study. You should receive an email with your 
password and instructions very soon." 
"You can expect 3-11 questions at the start, end and every four hours of your registered 
shifts. You will get 8 questions each day off, as well." 
"If you received this text message in error or ever want to end these messages, text 
"STOP". To get contact and study information text HELP at any time." "REMEMBER: 
DON'T TEXT WHILE DRIVING" "Download the SaFTiE app and use this as your CODE 
NUMBER: ####" 
 
Next, the individual will check his/her email and obtain the temporary password and 
then visit the study website to sign-in (at www.saftie.pitt.edu). The participant will enter 
in a cellular phone number and temporary password. The participant will then follow a 
few steps to set a permanent (self-selected) password. The participant will then login 
again with the new password. 
 
Next, the participant will use the CODE NUMBER sent via text message to download 
the SaFTiE app from the Apple Appstore or the GooglePlay store. The participant will 
enter in the CODE NUMBER - which allows for use of the SaFTiE app. No one can use 
the SaFTiE app without a valid code number. Each code number is created in real-time 
when a participant enrolls and is assigned a study ID# upon enrollment/consent.  
 

 
13 
When the SaFTiE mobile app is successfully downloaded, the participant will enter in a 
mailing address in the My Info section of the app - which is used for sending our 
remuneration. The participant will then be directed to the Surveys component of the 
SaFTiE mobile app to answer survey questions. After the survey questions are 
answered, the participant can view the other components of the app at any time. The 
app will send out reminders to fill out the Weekly Goals component on Saturday or 
Sunday of each week. The SaFTiE mobile app will also send out reminders to complete 
the monthly surveys to earn remuneration. The SaFTiE mobile app will also notify the 
participant when a new video story/interview has been posted / uploaded to the Stories 
component of the app. All participants will be asked to remain in the study using the app 
for a total of 6 months after downloading. 
 
After the SaFTiE mobile app has been downloaded, each participant will be sent a 
variety of text message questions. Participants assigned to the intervention group will 
receive text-message queries for 7 consecutive days, followed by three weeks with no 
text-message queries. This pattern (one week on, three weeks off) is repeated for six 
months - and overlap with the timeline for use of the SaFTiE mobile app. The content of 
the text messages for those in the Intervention group is focused on fatigue and sleep. If 
a participant reports a high level of fatigue, sleepiness, or difficulty with concentration, 
he/she will immediately receive a fatigue-mitigation strategy message via text-message. 
These strategy messages will be pulled from a "bank" of messages based on the 
domains of the Sleep, Fatigue, and Alertness Behavior (SFAB) survey, which is 
administered to participants at baseline, at 3 months, and again at the 6 month follow 
up. 
 
Participants in the active placebo group (Teamwork group) will also receive text-
messages in the same format and timing as the intervention group (one week on, 
followed by three weeks off). The timing of text messages is like the Intervention group. 
The main difference between the two groups is the content of the text-messages. The 
content for the active placebo group is focused on teamwork. If a participant in the 
active placebo group reports a low level of teamwork when queried via text-message, 
the participant will immediately receive a teamwork promoting message pulled from a 
"bank" of messages that our computer platform will select from at random and 
automatically. These messages are NOT informed by any particular response to the 
SFAB survey. This is one key difference between the Intervention and Active Placebo 
groups. 
 
All participants (in both groups) will be asked to answer survey questions via the SaFTiE 
mobile app once each month. Questions will be like those asked at baseline. 
Participants will be remunerated monthly for their participation. 
 
At the end of calendar year 2021 and 2022 and 2023, we will send a letter to each 
agency contact (the agency Chief, Director, or Manager) and request a summary of their 
OSHA300 logs (agency-level injury data) be abstracted into a table. 
 
We will mail a letter to all agency contacts in July/August 2023 notifying the contacts 

 
14 
that the study will be closed to NEW enrollments but remains active for data collection 
from all active participants until their end date has been reached. 
 
 
 
 

 
15 
Consent procedures 
 
Waiver to document written / signed consent form approved. 
 
All potential participants will view a video-based consent made available on the study 
designated website. We will use a video-based consent procedure whereby the 
potential participants watch a video version of the consent form and make a decision to 
[1] I have watched the informed consent video and agree to participate (I ACCEPT) or 
[2] I DO NOT ACCEPT and do NOT want to participate in this research study. We are 
requesting a waiver to document informed consent for all study subjects because it will 
be obtained via video-based methods. Our study is nationwide, which makes it 
extremely difficult to obtain written consent from all participants. We will still obtain 
consent from the subjects to participate via video, which does not increase risk. The 
study involves text messages, a mobile app, and continuing education videos. None of 
these normally require written informed consent. 
 
Minimize coercion and undue influence:  
Potential participants will be allowed to rewind and watch the consent video multiple 
times if needed. They can also email or call the study team prior to selecting the 
ACCEPT or DO NOT ACCEPT options for consent. 
 
Ensure understanding: 
Our consent video will provide a detailed description of the study. Potential participants 
will again be allowed to rewind and watch the consent video multiple times if needed. 
They can also email or call the study team prior to selecting the ACCEPT or DO NOT 
ACCEPT options for consent. 
 
 
 

 
16 
Data safety monitoring 
 
We will regularly report on progress with recruitment, enrollment, data collection, and 
any unexpected issues to the Department of Emergency Medicine's Data Safety 
Monitoring Committee (DSMC). The DSMC will meet at least once per month. 
 
 
 

 
17 
Protecting privacy 
 
Only members of our research team are involved in this study protocol. No research 
findings will be provided to participant family members, insurance companies, 
employers, or any third party without the participant's authorization. 
 
All data that we collect for this research study will be assigned an ID number only when 
received by our computerized data collection system. We will maintain a data file that 
contains the participant's name, mobile telephone number, and email address. This file 
will be located on a computer server and kept separate from the other data. This file will 
be password protected and access to will be restricted to core members of the research 
team. 
 
This research study is also covered by a Certificate of Confidentiality (CoC) from the 
Centers for Disease Control and Prevention (CDC). The researchers with this Certificate 
may not disclose or use information, documents, or data that may identify the participant 
in any federal, state, or local civil, criminal, administrative, legislative, or other action, 
suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, 
unless the participant has consented for this use. Information, documents, or data 
protected by this Certificate cannot be disclosed to anyone else who is not connected 
with the research except, if there is a federal, state, or local law that requires disclosure 
(such as to report child above or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings); if the participant 
has consented to the disclosure, including for his/her medical treatment; or if it is used 
for other scientific research, as allowed by federal regulations protecting research 
subjects. 
 
Upon completion of this research study, we will de-identify all data, expunge all files that 
contain mailing addresses used for remuneration, and add a new randomly generated 
ID number to all records. All previously used ID numbers will be removed, therefore 
creating a new dataset with a new randomly generated ID assignment for each record. 
We will publish the study findings in aggregate in peer-reviewed medical journals. We 
will do everything possible to protect the participant's privacy. 
 
 
 
 
 
 

 
18 
Termination, withdrawal, or attrition 
 
If a participant has not responded to study related text queries, or monthly surveys over 
multiple months, the study team will attempt to contact the participant to determine if 
he/she is still participating. The PI and co-investigators will meet to discuss these cases 
and make a group / consensus decision to classify the participant as withdrawn OR to 
continue attempts to reestablish communication over a specified period of time (e.g., up 
to a one month). If the team's attempts to contact the participant are unsuccessful, the 
team will monitor activity for one additional month, and if at that time there is no 
communication, the participant may be classified as "withdrawn" or "lost to attrition," and 
his/her account on the study website will be suspended. 
 
If a participant withdraws from the study, we will reach out to the participant with a 
standard email. That email will [1] acknowledge the participant's withdrawal; [2] thank 
the participant for his/her time commitment to the study prior to withdrawing; and [3] 
extend an offer to the participant to contact the study team any time with questions. Our 
study does not have a category of partial withdrawal.