Investigating the Impact of a Shared Decision-Making Tool on Patient Attitudes and Behaviors Regarding Treatment for Knee Osteoarthritis
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 4/27/2022
CLINICAL STUDY PROTOCOL
Observational Study of Individual or Group Template
Investigating the Impact of a Shared 
Decision-Making Tool on Patient Attitudes 
and Behaviors Regarding Treatment for 
Knee Osteoarthritis
 
2000032637
 
Protocol Version
February 18, 2022
 Version 1
Confidentiality Statement:
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Synopsis
Purpose
The purpose of this study is to determine the impact of a Shared Decision-Making Tool 
(SDMT), which provides information about osteoarthritis disease progression, on a patient’s 
decision to pursue treatment for knee osteoarthritis.
Primary Objective
The primary objective of this study is to assess the impact of the shared decision-making 
tool on a patient’s decision to seek treatment for knee osteoarthritis.
Secondary Objective
Our secondary objectives include investigating the impact of the SDMT on patient 
understanding of disease progression as well as patient understanding of the impact of 
treatment on disease progression. Additional secondary objectives include evaluating the 
impact of the SDMT on patient behaviors and engagement with treatment modalities.
Study Design
This is a randomized control trial in which participants will be assigned to one of two arms. Patients 
in the control arm of the study will watch a short video and then receive standard of care counseling 
with an orthopaedic surgeon. Patients in the treatment arm of the study will watch a short video and 
then receive standard of care counseling with an orthopaedic surgeon that includes discussion of 
the SDMT. All patients will complete pre- and post-visit surveys designed to measure the severity of 
their knee osteoarthritis and their willingness to proceed with different treatment modalities.
All patients who are receiving care for knee osteoarthritis with one of the participating orthopaedic 
surgeons, and are greater than age 18 and speak English, will be eligible for inclusion in the study. 
The study will be conducted at Yale-affiliated clinics. 
Study Date Range and Duration
Patient responses for this study will be collected between May 23rd, 2022– August 08th, 2022.  
Number of Study Sites 
-
Yale Ortho – New Haven Office 
Yale Physician Building 800 Howard Ave 1st Fl New Haven, CT 06519
-
Yale Ortho – Milford 
48 Wellington Rd Milford, CT 06461
-
Yale Medicine Multispecialty
800 Boston Post Rd Guilford, CT 06437
Primary Outcome Variables
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The variables used to measure the primary outcome will include patient willingness to 
proceed with specific treatment modalities as measured by the pre- and post-visit surveys.
Secondary and Exploratory Outcome Variables (if applicable)
The variables used to measure the secondary outcomes will include patient 
understanding of disease progression, patient understanding of the impact of treatment 
modalities on disease progression, patient-reported pain and functional status, and patient 
engagement in treatment modalities as measured by the pre- and post-visit surveys.
Study Population
The target population for this study will be persons aged 45-65, who have mild to moderate 
knee pain, and are seeking care from an orthopaedic surgeon specializing in total knee 
arthroplasty.
Number of Participants
We are seeking 200 participants. The attrition rate is assumed to be 10-20%. It may be 
lower due to the short follow-up period of one month, or higher given the targeted patient 
demographic.  We anticipate enrolling 200-250 patients to account for loss to follow-up.
Study Schedule
We anticipate at least an initial patient visit that would take 30-50 minutes including an 
explanation of the study and obtaining consent, pre-study survey, PROMIS survey, clinical 
exam, Shared Decision-Making Tool discussion, and any additional questions the patient 
may have. 
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Protocol Revision History
Version 
Date
Summary of Substantial Changes
Include the IRB approved protocol version number and date for each revision of the protocol. All 
version history should remain in the table and never be deleted. The oldest IRB approved version of 
the protocol should be listed on the top row. The most recent IRB approved version should be listed 
on the bottom row.
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Statement of Compliance 
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to the Common Rule at 45CFR46 (human 
subjects) and other applicable government regulations and Institutional research policies and 
procedures.
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Abbreviations
Abbreviation 
Explanation
OA
Osteoarthritis
PI
Principal Investigator 
SDMT
Shared Decision-Making Tool 
UPIRSO
Unanticipated Problems Involving Risks to 
Subjects or Others 
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Glossary of Terms
Glossary
Explanation
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Table of Contents
Preface....................................................................................................................................2
Synopsis ..................................................................................................................................3
Purpose................................................................................................................................3
Primary Objective.................................................................................................................3
Secondary Objective ............................................................................................................3
Study Design........................................................................................................................3
Study Date Range and Duration ..........................................................................................4
Number of Study Sites .........................................................................................................4
Primary Outcome Variables .................................................................................................4
Secondary and Exploratory Outcome Variables (if applicable)............................................4
Number of Participants.........................................................................................................5
Study Schedule ....................................................................................................................5
Protocol Revision History.....................................................................................................6
Statement of Compliance.........................................................................................................7
Abbreviations ...........................................................................................................................8
Glossary of Terms....................................................................................................................9
1
Background/Literature Review........................................................................................13
1.1
Background .............................................................................................................13
1.2
Prior Experience (if applicable)................................................................................13
2
Rationale/Significance ....................................................................................................14
2.1
Rationale and Study Significance............................................................................14
2.2
Purpose of Study/Potential Impact ..........................................................................14
2.3
Potential Risks and Benefits....................................................................................14
2.3.1
Potential Risks..................................................................................................14
2.3.2
Potential Benefits .............................................................................................15
3
Study Purpose and Objectives .......................................................................................15
3.1
Hypothesis...............................................................................................................15
3.2
Primary Objective ....................................................................................................15
3.3
Secondary Objective (if applicable).........................................................................15
4
Study Design ..................................................................................................................16
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4.1.1
General Design Description .............................................................................16
4.1.2
Study Date Range and Duration ......................................................................16
4.1.3
Number of Study Sites .....................................................................................16
4.2
Outcome Variables..................................................................................................16
4.2.1
Primary Outcome Variables .............................................................................16
4.2.2
Secondary and Exploratory Outcome Variables (if applicable)........................16
4.3
Study Population .....................................................................................................16
4.3.1
Number of Participants.....................................................................................17
4.3.2
Eligibility Criteria/Vulnerable Populations.........................................................17
5
Study Methods/Procedures .........................................................................................18
5.1
Study Procedures....................................................................................................18
5.1.1
Data Collection.................................................................................................18
5.1.2
Adverse Events Definition and Reporting.........................................................18
5.2
Study Schedule .......................................................................................................18
5.3
Informed Consent....................................................................................................19
5.3.1
Screening (if applicable)...................................................................................19
5.3.2
Recruitment, Enrollment and Retention (if applicable).....................................19
5.3.3
Study Visits (is applicable) ...............................................................................19
5.4
Statistical Method ....................................................................................................20
5.4.1
Statistical Design..............................................................................................20
5.4.2
Sample Size Considerations ............................................................................20
5.4.3
Planned Analyses.............................................................................................20
5.4.4
Analysis of Subject Characteristics (if applicable)............................................20
5.4.5
Interim Analysis (if applicable)..........................................................................20
5.4.6
Handling of Missing Data .................................................................................20
6
Trial Administration.........................................................................................................20
6.1
Ethical Considerations: Informed Consent/Assent and HIPAA Authorization .........21
6.2
 Institutional Review Board (IRB) Review................................................................22
6.3
Subject Confidentiality.............................................................................................22
6.4
Deviations/Unanticipated Problems.........................................................................23
6.5
Data Quality Assurance...........................................................................................25
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6.6
Study Records.........................................................................................................25
6.7
Access to Source.....................................................................................................25
6.8
Data or Specimen Storage/Security ........................................................................25
6.9
Retention of Records...............................................................................................25
6.10
Study Monitoring......................................................................................................26
6.11
Study Modification ...................................................................................................26
6.12
Study Completion ....................................................................................................26
6.13
Funding Source .......................................................................................................26
6.14
Conflict of Interest Policy.........................................................................................26
6.15
Publication Plan.......................................................................................................27
Appendices ............................................................................................................................28
List of Tables..........................................................................................................................29
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1 Background/Literature Review
1.1
Background
Knee osteoarthritis (OA) is the most commonly diagnosed type of arthritis, with approximately 
thirteen percent of women and ten percent of men over age sixty suffering from symptomatic 
knee osteoarthritis. While the character and intensity of osteoarthritis (OA) symptoms is 
different for each patient, OA is generally a progressive disease that can result in disability, 
loss of function, and ultimate loss of quality of life for patients (Hsu & Siwiec, 2021). While OA 
has no cure, management of this condition centers around severity of symptoms and current 
disease progression, with common treatment modalities including exercise, weight loss, and 
patient education, with additional interventions such as non-steroidal anti-inflammatory drugs 
and intraarticular injections (Katz et al., 2021). Pursuing these non-operative interventions can 
lengthen the time a patient with osteoarthritis (OA) has before surgery, such as total joint 
replacement, becomes the primary option. 
Utilizing shared decision-making (SDM) can facilitate conversations that can benefit patients 
before OA becomes a major health concern. SDM in the clinic relies on three principles: 1) 
having the clinician provide unbiased and accurate medical advice on all treatment 
alternatives, including the possibility of not receiving treatment; 2) having the clinician 
communicate these options to the patient; and 3) having the clinician respect and prioritize the 
patient’s values and preferences based on the discussed information, goals of treatment, and 
future concerns and possible treatment burdens (Johnson, 2021). Therefore, building 
provider-patient communication tools that resonate with all stakeholders is necessary to inform 
patients as they work to make health decisions reflective of their individual beliefs.  
Previous attempts to address these clinical concerns resulted in the development of the 
Shared Decision-Making Tool (SDMT), which was designed to provide a personalized, patient-
centered framework for clinical discussions regarding treatment options for knee OA. The tool 
functions through patient input of information such as pain severity and current symptoms, 
alongside other demographic information such as age, race, and comorbidities, to offer a 
series of outcomes to better illustrate how the patient’s specific disease presentation will 
progress (Johnson, 2021). Ultimately, using the SDMT may impact patient behavior if patients 
change their treatment preferences after utilizing the tool. This can empower them to seek 
additional support over time and maintain communication with their orthopedist to ensure they 
are on a healthier path.
In addition to the patient’s efforts, the SDMT can address provider influences. Bias likely 
influences patients; experiences with clinicians, and the SDMT can serve to deter implicit bias 
by focusing on the disease of patients, thus avoiding the development of healthcare disparities 
(Marcelin et al., 2019). Encouraging individuals who have historically not taken advantage of 
preventive care or healthy lifestyles to induce change is paramount to making the medical 
experience in America more equal for all its citizens and reducing total societal costs. 
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This study seeks to determine if providing an overview of future disease progression through 
the SDMT helps patients, with a focus on the following concerns: i) whether it assists the 
patient with readiness for treatment; ii) whether the patient finds the overview and information 
helpful immediately and/or one month after the discussion; and iii) whether patients consider 
the mid- to long-term consequences of treatment options. 
To address these concerns, we have designed a prospective study to observe the use of a 
SDMT and its impact on a patient’s decision to pursue treatment options recommended by 
their provider.
Hsu H, Siwiec RM. Knee Osteoarthritis. [Updated 2021 Jul 25]. In: StatPearls [Internet]. 
Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK507884/
Johnson C. B. (2021). A Personalized Shared Decision-Making Tool for Osteoarthritis 
Management of the Knee. Orthopedic nursing, 40(2), 64–70. 
https://doi.org/10.1097/NOR.0000000000000739
Katz, J. N., Arant, K. R., & Loeser, R. F. (2021). Diagnosis and Treatment of Hip and Knee 
Osteoarthritis: A Review. JAMA, 325(6), 568–578. https://doi.org/10.1001/jama.2020.22171
Marcelin J., Siraj D., Victor R., Kotadia S., Maldonado Y. (2019). The impact of unconscious 
bias in healthcare: How to recognize and mitigate it. The Journal of Infectious 
Diseases, 222(220 Suppl. 2), S62–S73. 10.1093/infdis/jiz214
1.2
Prior Experience (if applicable) 
2 Rationale/Significance
2.1
Rationale and Study Significance 
Research on the Shared Decision-Making (SDMT) is instrumental to determine if it is effective 
at motivating patients to pursue treatment options that can subsequently improve mobility and 
their quality of life. 
2.2
Purpose of Study/Potential Impact 
The main purpose of this study is to determine the impact of the SDMT on patient decision-
making regarding various treatment modalities for knee OA. If the SDMT is found to be 
beneficial, it can be implemented to help engage patients in their care and support more 
efficient implementation of treatment suggestions. This subsequently will improve patient’s 
quality of life. Getting patients who have not taken advantage of preventive care or healthy 
lifestyles to change is paramount to making the medical experience in America more equal for 
all its citizens and reducing total societal costs. Building provider-patient communication tools 
that resonate with all stakeholders should inform patients as they work to make health 
decisions that reflect their individual beliefs.  
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To determine whether this information helps patients, we have designed a prospective, 
randomized controlled implementation study outlined here. 
2.3
Potential Risks and Benefits
2.3.1
Potential Risks 
Participation in this research involves the potential risk of breach in confidentiality to the 
patient’s stored health information. 
2.3.2
Potential Benefits
The study provides patients with additional information about knee pain and osteoarthritis. The 
knowledge gained will help target helpful information for patients. The study can support 
providing an information tool used by patients to better understand the role of lifestyle and 
treatment on their prognosis.
3 Study Purpose and Objectives
3.1
Hypothesis
We hypothesize that patients who are exposed to the SDMT will have an increased willingness 
to pursue treatment modalities for OA.
3.2
Primary Objective 
The primary objective of this study is to assess the impact of the shared decision-making tool 
on a patient’s decision to seek treatment for knee osteoarthritis.
3.3
Secondary Objective (if applicable)
Our secondary objectives include investigating the impact of the SDMT on patient 
understanding of disease progression and patient understanding of the impact of treatment 
on disease progression. Additional secondary objectives include evaluating the impact of the 
SDMT on patient behaviors and engagement with treatment modalities.
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4 Study Design
4.1.1
General Design Description
This is a randomized control trial in which participants will be assigned to one of two arms. Patients in 
the control arm of the study will watch a short video and then receive standard of care counseling with 
an orthopaedic surgeon. Patients in the treatment arm of the study will watch a short video and then 
receive standard of care counseling with an orthopaedic surgeon that includes discussion of the SDMT. 
All patients will complete pre- and post-visit surveys designed to measure the severity of their knee 
osteoarthritis and their willingness to proceed with different treatment modalities.
All patients who are receiving care for knee osteoarthritis with one of the participating orthopaedic 
surgeons, and are greater than age 18 and speak English, will be eligible for inclusion in the study. The 
study will be conducted at Yale-affiliated clinics. 
4.1.2
Study Date Range and Duration
Patient responses for this study will be collected between May 23rd, 2022 – August 8th 2022. 
4.1.3
Number of Study Sites
(1) New Haven Office  - Yale Physician Bldg 800 Howard Ave 1st Fl New Haven, CT 06519
(2) Yale Milford  - 48 Wellington Rd Milford, CT 06461
(3) Yale Medicine Multispecialty - 800 Boston Post Rd Guilford, CT 06437
4.2
Outcome Variables
4.2.1
Primary Outcome Variables
The variables used to measure the primary outcome will include patient willingness to proceed 
with specific treatment modalities as measured by the pre- and post-surveys.
4.2.2
Secondary and Exploratory Outcome Variables (if applicable)
The variables used to measure the secondary outcomes will include patient understanding of 
disease progression, patient understanding of the impact of treatment modalities on disease 
progression, patient reported pain and functional status, and patient engagement in treatment 
modalities as measured by the pre- and post-surveys.
4.3
Study Population
The target population for this study will be persons aged 45-65, who have mild to moderate 
knee pain seeking care from an orthopaedic surgeon specializing in total knee arthroplasty. 
4.3.1
Number of Participants
The goal is to screen and accept 200-250 study participants
4.3.2
Eligibility Criteria/Vulnerable Populations
To be included in this study, an individual must be age 45-64 with mild to moderate knee pain 
consistent with a diagnosis of osteoarthritis. Exclusion criteria includes known inflammatory 
disease diagnosis (ex. Lupus, Sjogren, or rheumatoid arthritis, prior knee replacement, acute 
knee trauma), and BMI over 45. This study will not include persons from vulnerable 
populations.
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5 Study Methods/Procedures 
5.1
Study Procedures
Potential subjects will be identified by the PI and participating orthopaedic surgeons. The PI 
and Sub-I will recruit potential subjects for this study.
Subjects will be consented in a private room by a designated member of the study team. Each 
subject will be consented in the language appropriate and presented with a consent form, 
written in that language. All aspects of the study will be discussed with the potential subject 
including the reason the subject is being asked to participate, the schedule of visits, the study 
activities that will occur, and the risks and benefits of participation.  The subject will then have 
an opportunity to ask any questions they have. Once all questions have been answered and 
the subject feels that he/she would like to participate, the designated member of the research 
team will obtain verbal consent for the study. 
A subject’s capacity to provide consent will be evaluated by a member of the consenting staff 
based on the questions the subject asks about his/her involvement in the study as well as by 
asking the subject questions pertaining to aspects of the study.
Eligible patients who agree to participate and provide verbal informed consent, will be 
randomized to participate in either the Control Group or Intervention Group. Both groups will 
complete the PROMIS Computer Adaptive Test and pre-survey as well as watch a short video 
providing general information about knee OA. The intervention for the intervention group will 
be the surgeon utilizing the SDMT during the visit. Both the control and intervention group will 
complete the post-event survey immediately after completing the control or intervention and 
then 1 month later.
 
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5.1.1
Data Collection 
Written survey responses will be collected from patients and electronic responses captured 
via iPad collection. Each patient will be assigned a random alphanumeric code that will be 
associated with their survey information. No specific patient identifiers will be recorded along 
with the survey data. Identifying patient information and research data will be de-identified at 
the earliest reasonable time after it is received or collected, and a unique study identifier code 
will be used which does not directly identify the participant. All computers will be password 
protected and all data will be kept in locked cabinets only accessible by members of the 
research team. Collaborators will be provided access to data after obtaining permission from 
the principal investigator. 
5.1.2
Adverse Events Definition and Reporting
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving 
Risks to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the 
unlikely event that such events occur, Reportable Events (which are events that are serious 
or life-threatening and unanticipated (or anticipated but occurring with a greater frequency 
than expected) and possibly, probably, or definitely related) or Unanticipated Problems 
Involving Risks to Subjects or Others that may require a temporary or permanent interruption 
of study activities will be reported immediately (if possible), followed by a written report within 
5 calendar days of the Principal Investigator becoming aware of the event to the IRB (using 
the appropriate forms from the website) and any appropriate funding and regulatory agencies. 
The investigator will apprise fellow investigators and study personnel of all UPIRSOs and 
adverse events that occur during the conduct of this research project via email as they are 
reviewed by the principal investigator. The protocol’s research monitor(s) and regulatory and 
decision-making bodies will be informed of adverse events within 5 days of the event 
becoming known to the principal investigator. 
Yale will minimize this risk of breach in confidentiality by (a) removing direct identifiers from 
stored participant information (e.g., names, medical record number); (b) securing any 
identifiable data in a separate location and limiting access to only those members of the 
research team listed on the protocol; (c) limiting access to stored information to only those 
members of the research team listed on the protocol.
5.2
Study Schedule
For this study patients will not need to schedule visits outside of normally requested 
appointments for care or follow-up. Participation in the study will lengthen the time of a normal 
visit and is expected to be a 45–50-minute appointment. 
5.3
Informed Consent
A waiver of documentation of consent is requested due to the only record linking the subject 
and the research would be the informed consent form and the principal risk would be potential 
harm resulting from a breach of confidentiality. Each subject (or legally authorized 
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representative) will be asked whether the subject wants documentation linking the subject with 
the research, and the subject's wishes will govern.
5.3.1
Screening (if applicable) 
Not applicable
5.3.2
Recruitment, Enrollment and Retention (if applicable)
Potential subjects will be identified by the PI and participating orthopaedic surgeons. PI and 
Sub-I will recruit potential subjects for this study.
Subject will be consented in a private room by a designated member of the study team listed 
above. Each subject will be consented in the language appropriate and presented with a 
consent form, written in that language. All aspects of the study will be discussed with the 
potential subject including the reason the subject is being asked to participate, the schedule 
of visits, the study activities that will occur, and the risks and benefits of participation.  The 
subject will then have an opportunity to ask any questions they have. Once all questions have 
been answered and the subject feels that he/she would like to participate, the designated 
member of the research team will ask the subject to provide verbal consent. 
A subject’s capacity to provide consent will be evaluated by a member of the consenting staff 
based on the questions the subject asks about his/her involvement in the study as well as by 
asking the subject questions pertaining to aspects of the study.
5.3.3
Study Visits (is applicable)
The only study visit will be the scheduled appointment with the orthopaedic surgery and 
subsequent meeting with the researcher.
5.4
Statistical Method
5.4.1
Statistical Design
Power Analysis
Statistical Power is determined by the estimated mean and standard deviation of one primary 
endpoint or composite endpoint to determine ending sample size in each group (test and 
control).  The study power varies with Standard Deviation and Expected Difference in 
Performance between control and investigational groups. The power is the probability the 
study will detect a statistical difference between the two groups based on the expected 
standard deviation and mean difference between the two groups. 
This study for which a power of 0.8 is sufficient and we expect a difference in score between 
the test group and control group to be at least 20% and a standard deviation of 10 points or 
less.  Even if the difference between groups drops to 10% with a standard deviation of 10 
points our target sample size of 200 patients is sufficiently powered.
5.4.2
Sample Size Considerations
We are collecting socioeconomic data, education level, insurance type, pain and activity data 
at the outset with the thought that these may be related to patient experience or confound the 
impact of the shared decision-making tool. 
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PROMIS is. standardized, validated tools with defined scoring methods.  The three study 
specific tools (1. SDM Survey; 2. Post-Survey (immediately provided); 3. Post-Survey (One 
Month Follow-up Survey) would be scored independently using a 5 point scale for each line 
item. The score of 5 would apply to the most positive score and the score of 1 would apply to 
the least positive score.  
Instrument
Scoring
Comment
Survey (Pre-
appointment) 
(Baseline)
Yes / no or in buckets
Set initial 
understanding of 
patient sentiment prior 
to starting the study
PROMIS
Defined
Knee pain and activity 
scale
1. SDM Tool
1 to 5 point scale
Primary study outcome
2.  Post-appointment 
Survey Follow-up
1 to 5 point scale
Same as Pre-survey 
and used to gauge 
changes in patient 
sentiment post-study
3. One Month Post-
appointment Survey 
1 to 5 point scale
Secondary study 
outcome
Table 2. Items 1 through 3 are the study outcome surveys.
5.4.3
Planned Analyses
We plan to perform univariate and multivariate regression analyses to assess 
associations between the SDMT and the patient willingness to proceed with specific 
treatment modalities. Additional univariate and multivariate regression analyses will 
be performed to assess our secondary study outcomes. 
5.4.4
Analysis of Subject Characteristics (if applicable)
Not applicable
5.4.5
Interim Analysis (if applicable)
Not Applicable
5.4.6
Handling of Missing Data
Patients who have missing data will be excluded from the analysis. 
6 Trial Administration 
6.1
Ethical Considerations: Informed Consent/Assent and HIPAA Authorization
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Each patient will be assigned a random alphanumeric code that will be associated with their 
survey information. No specific patient identifiers will be recorded along with the survey data. 
Identifying patient information and research data will be de-identified at the earliest reasonable 
time after it is received or collected, and a unique study identifier code will be used which does 
not directly identify the participant. All computers will be password protected and all data will 
be kept in locked cabinets only accessible by members of the research team. The principal 
investigator, study monitors, and student researchers will have access to the data. Identifiable 
data will be destroyed after 1 year and de-identified data will be destroyed after 5 years
Yale will minimize this risk of breach in confidentiality by (a) removing direct identifiers from 
stored participant information (e.g. names, medical record number); (b) securing any 
identifiable data in a separate location and limiting access to only those members of the 
research team listed on the protocol; (c) limiting access to stored information to only those 
members of the research team listed on the protocol.
Subject will be consented in a private room by a designated member of the study team listed 
above. Each subject will be consented in the language appropriate and presented with a 
consent form, written in that language. All aspects of the study will be discussed with the 
potential subject including the reason the subject is being asked to participate, the schedule 
of visits, the study activities that will occur, and the risks and benefits of participation.  The 
subject will then have an opportunity to ask any questions they have. Once all questions have 
been answered and the subject feels that he/she would like to participate, the designated 
member of the research team will ask the subject to provide verbal consent. Participants will 
have time between the explanation of the project and the commencement of the appointment 
to consider and provide consent to participate. A subject’s capacity to provide consent will be 
evaluated by a member of the consenting staff based on the questions the subject asks about 
his/her involvement in the study as well as by asking the subject questions pertaining to 
aspects of the study.
Additional text if applicable:
A verbal explanation will be provided in terms suited to the participant’s comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research 
participants.
6.2
 Institutional Review Board (IRB) Review
If this study is approved by the IRB protocol modifications, study team updates, reportable 
events, and unanticipated problems will be reported immediately, if possible, or within 5 days. 
The study is a prospective study conducted via survey data collection from patients. 
6.3
Subject Confidentiality
Data will be collected via handwritten surveys entered the computer, paper files, and via 
electronic devices like an iPad. The physical files will be stored in locked filing cabinets while 
electronic data will be stored via laptop computer using encrypted software. The principal 
investigator, study monitors, and student researchers will have access to the data. Yale will 
minimize this risk of breach in confidentiality by (a) removing direct identifiers from stored 
participant information (e.g., names, medical record number); (b) securing any identifiable 
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data in a separate location and limiting access to only those members of the research team 
listed on the protocol; (c) limiting access to stored information to only those members of the 
research team listed on the protocol.
6.4
Deviations/Unanticipated Problems
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving 
Risks to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the 
unlikely event that such events occur, Reportable Events (which are events that are serious 
or life-threatening and unanticipated (or anticipated but occurring with a greater frequency 
than expected) and possibly, probably, or definitely related) or Unanticipated Problems 
Involving Risks to Subjects or Others that may require a temporary or permanent interruption 
of study activities will be reported immediately (if possible), followed by a written report within 
5 calendar days of the Principal Investigator becoming aware of the event to the IRB (using 
the appropriate forms from the website) and any appropriate funding and regulatory agencies. 
The investigator will apprise fellow investigators and study personnel of all UPIRSOs and 
adverse events that occur during the conduct of this research project via email as they are 
reviewed by the principal investigator. The protocol’s research monitor(s) and regulatory and 
decision-making bodies will be informed of adverse events within 5 days of the event 
becoming known to the principal investigator. 
6.5
Data Quality Assurance
To ensure good clinical practices are followed, researchers will follow-up with the principal 
investigator to communicate weekly experiences and are expected to communicate any 
concerns, protocol deviation, or questions immediately. The principal investigator is 
responsible for monitoring the data, assuring protocol compliance, and conducting the safety 
reviews on a monthly basis.
6.6
Study Records
Study records include study surveys, consent forms, and subject medical records.
6.7
Access to Source
Each patient will be assigned a random alphanumeric code that will be associated with their 
survey information. No specific patient identifiers will be recorded along with the survey data. 
Identifying patient information and research data will be de-identified at the earliest reasonable 
time after it is received or collected, and a unique study identifier code will be used which does 
not directly identify the participant. All computers will be password protected and all data will 
be kept in locked cabinets only accessible by members of the research team. Collaborators 
will be provided access to data after obtaining permission from the principal investigator. 
6.8
Data or Specimen Storage/Security
Data will be collected via handwritten surveys entered into the computer, paper files, and via 
electronic devices like an iPad. The physical files will be stored in locked filing cabinets while 
electronic data will be stored via laptop computer using encrypted software.
6.9
Retention of Records
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Identified data will be retained for 1 year and deidentified data will be retained for 5 years. If 
permission is needed to remove or destroy data, the principal investigator will be to be 
contacted. 
6.10 Study Monitoring
The principal investigator is responsible for monitoring the data, assuring protocol compliance, 
and conducting the safety reviews on a monthly basis.  During the review process the principal 
investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to further enrollment.
6.11 Study Modification
The principal investigator, the Institutional Review Board (IRB), or study monitor have the 
authority to stop or suspend the study or require modifications.
6.12 Study Completion
This study’s anticipated completion date for data collection is May 23rd, 2022 – August 08th, 
2022, IRB will be contacted via email to provide written confirmation of the study completion. 
6.13 Funding Source
There is currently no funding request or support for this study.
6.14 Conflict of Interest Policy
There are no conflicts of interest to report.
6.15 Publication Plan
Once the research is complete, there is a plan to submit to peer-reviewed journals for 
publication along with submission to specialty-related conferences for presentation. 
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Appendices
Appendix #
Title
Section
Topic
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List of Tables
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