A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases
Phase: NA
Conditions: Rheumatic Diseases, Physician-Patient Relations, Contraception
Sponsor: University of Pittsburgh

 
 
 
 
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Official Title: MyVoice Pilot Study : A Pilot Study to Assess Feasibility and Acceptability of 
MyVoice, a Family Planning Decision Aid for Women with Rheumatic Diseases – Protocol for 
Research Staff 
 
Brief Title: MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases 
 
NCT Number: NCT04879745 
 
Protocol ID: STUDY20060240 
 
Document Date: August 23, 2021 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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MyVoice Pilot Study 
 
A Pilot Study to Assess Feasibility and Acceptability of MyVoice, a Family 
Planning Decision Aid for Women with Rheumatic Diseases 
 
 
PittPRO ID: STUDY20060240 
 
 
Full Research Protocol for Study Staff 
Version II – August 23, 2021 
 
 
Principal Investigator: Mehret Birru Talabi, MD, PhD 
University of Pittsburgh 
Department of Rheumatology 
3500 Terrace Street 
Bioscience Tower South, 7th Floor 
Pittsburgh, PA 15261 
Birrums@upmc.edu 
 
 
 
 

 
 
 
 
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Contents 
 
STATEMENT OF COMPLIANCE 
INVESTIGATOR’S SIGNATURE ............................................................................. 6 
A. Study Aim .................................................................................................... 7 
B. Study Flow Chart and Randomization Schema ........................................... 10 
C. Risk/Benefit Assessment ........................................................................... 12 
D. Screening Procedures ................................................................................ 13 
C1. Eligibility Criteria ...................................................................................................................... 13 
C1a.  Inclusion Criteria ....................................................................................................................... 13 
C1b. Exclusion Criteria ....................................................................................................................... 13 
E. Recruitment Plan ....................................................................................... 14 
D1. Recruitment Tracking ............................................................................................................... 14 
D2. Remote Recruitment ............................................................................................................... 15 
D3.  Clinic Recruitment .................................................................................................................. 16 
D4.  Provider Recruitment .............................................................................................................. 17 
D5.  Additional Recruitment Methods ............................................................................................ 17 
D5a. Pitt+Me ...................................................................................................................................... 17 
F. 
Materials List ............................................................................................. 19 
G. Data Collection and Entry .......................................................................... 20 
F1.  REDCap Instructions ................................................................................................................ 20 
Accessing REDCap Database ............................................................................................................. 20 
F1a.  Form Completion Instructions ................................................................................................. 20 
F1b.  Order of Form Completion ....................................................................................................... 20 
F2.  Telemedicine Participants ....................................................................................................... 21 
F3.  Clinic Participants .................................................................................................................... 21 
F4.  Troubleshooting ...................................................................................................................... 21 
F4a.  REDCap Issues ........................................................................................................................... 21 
F4b.  Internet Connection Issues ...................................................................................................... 21 
H. Study Procedures ....................................................................................... 23 
G1.  Randomization ....................................................................................................................... 23 
G2.  Telemedicine Participants ....................................................................................................... 23 
G2a.  Consent .................................................................................................................................... 23 
G2b. T0: Baseline ............................................................................................................................... 24 
G2c.  T1: Intervention ....................................................................................................................... 24 
G2d.  T2: Up to 48 Hours Post-Intervention ..................................................................................... 25 
G2e.  T3: 2 Weeks Post-Recruitment Completion (Providers) ......................................................... 25 
G2f.  T4: 3 Months Post-Intervention ............................................................................................... 26 
G3.  Clinic Participants ................................................................................................................... 27 
G3a.  Consent .................................................................................................................................... 27 
G3b.  T0: Baseline .............................................................................................................................. 27 

 
 
 
 
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G3c.  T1: Intervention ....................................................................................................................... 27 
G3d.  T2: Up to 48 Hours Post-Intervention ..................................................................................... 28 
G3e.  T3: 2 Weeks Post-Recruitment Completion (Providers) ......................................................... 28 
G3f.  T4: 3 Months Post-Intervention ............................................................................................... 29 
G4.  Troubleshooting ..................................................................................................................... 30 
I. 
Payment Protocol ...................................................................................... 31 
H1.  Full Study Completion ............................................................................................................. 31 
H2.  Partial Study Completion ........................................................................................................ 31 
I. 
Communication Protocol ........................................................................... 32 
J.     Protocol for Withdrawal/Lost to Follow Up ............................................... 33 
J1.  Withdrawal .............................................................................................................................. 33 
J2.  Lost to Follow Up ..................................................................................................................... 33 
K.    SAFETY ASSESSMENTS ............................................................................... 34 
L. 
Publication and Data Sharing Policy ........................................................... 37 
M.    Appendix .................................................................................................. 38 
N.      Statistical Analysis Plan………………………………………………………………………… 43 
 
 
 

 
 
 
 
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Statement of Compliance 
The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 
 

 
 
 
 
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INVESTIGATOR’S SIGNATURE 
 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
 
 
Name*:  Mehret Birru Talabi 
 
Title*: Assistant Professor of Medicine 
 
Investigator Contact Information 
Affiliation*: University of Pittsburgh Department of Rheumatology 
Address: 3500 Terrace Street 
Bioscience Tower South, 7th Floor 
Pittsburgh, PA 15261 
Telephone: 412-383-8000 
Email: birrums@upmc.edu 
 
 

 
 
 
 
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A. Study Aim 
 
MyVoice is a web-based patient-centered decision aid developed to help women with 
rheumatic diseases make informed decisions about pregnancy and other family planning 
decisions. This pilot trial is designed to assess the extent to which MyVoice decision aid can be 
feasibly and acceptably implemented into the rheumatology clinical setting and will inform 
operational procedures for a future hybrid effectiveness-implementation trial. Women in the 
intervention arm will receive the MyVoice decision aid (n=38). Women in the control arm 
(n=12) will receive a paper-based version of the American College of Rheumatology pamphlet 
about pregnancy, which, similarly to MyVoice, targets women with a broad range of rheumatic 
diseases. 
 
 

 
 
 
 
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B. Protocol Summary 
 
Title: 
A Pilot Study to Assess Feasibility and Acceptability of MyVoice, a 
Family Planning Decision Aid for Women with Rheumatic Diseases 
 
Grant Number: 
K23 AR075057-01A1 
 
Study Description: 
This protocol describes procedures and goals for the pilot testing of 
MyVoice, a web-based decision aid to help women with autoimmune 
diseases clarify their reproductive goals and learn about if and how their 
autoimmune diseases and medications affect these goals. Primary 
hypothesis: MyVoice will be feasible and acceptable to patients who 
receive rheumatology care. 
 
Objectives*: 
 
Our aim is to conduct a pilot trial to assess feasibility and acceptability 
of MyVoice vs. a patient pamphlet among female patients ages 18-44 
(n=55) who receive rheumatology care. 
 
Endpoints*: 
Feasibility measures: 
-Number of women who express interest in the study vs who are 
contacted 
-Number of women who enroll vs. decline to participate 
-Completion rates for MyVoice 
-Technical feasibility (e.g., software reliability of MyVoice) 
-Number of consented women who complete the study vs. number of 
consented women who partially complete the study or do not open or 
utilize the study materials 
 
Acceptability measures: 
-Completion rates for MyVoice 
-Patients' satisfaction with MyVoice or pamphlet 
-Patients' comprehension of instructions, scales, and surveys 
-Completion rates for instructions, scales, and surveys 
 
Preliminary implementation measures: 
-Surveys of barriers/facilitators of use 
-Survey of physicians’ readiness to adopt the intervention in clinic 
-Technical issues with video visits/Epic 
-Number of patients who no-show for their telemedicine visits 
 
Study Population: 
We will recruit 55 women aged 18-44 who are diagnosed with 
rheumatoid arthritis, myositis, systemic sclerosis, or systemic lupus 
erythematosus who receive care at one of three UPMC rheumatology 
clinics. Participants cannot be pregnant and cannot be sterilized. 
Phase* or Stage: 
Phase II  
 
Description of 
Sites/Facilities Enrolling 
Participants: 
Participants will be recruited from the UPMC Falk Rheumatology 
Clinic, the Lupus Center of Excellence, and the Magee Women’s Health 
Rheumatology Clinic.   
Description of Study 
Intervention/Experimental 
Manipulation: 
Interested individuals will arrive at the clinic one hour prior to their 
scheduled rheumatology appointment. They will be consented and 
randomized to either receive the intervention (the MyVoice decision aid, 
an interactive website) or to receive the control pamphlet. They will 
have approximately 40 minutes to review the tool or pamphlet prior to 
meeting with their rheumatologist. 
 

 
 
 
 
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Study Duration*: 
Nine months 
 
Participant Duration: 
Two hours. 
 
 

 
 
 
 
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C. Study Flow Chart and Randomization Schema 
 
 
 
Below is a detailed description of the data in each survey [Appendix] collected at each time 
point. 
 
T0: Baseline Survey 
• National Survey of Family Growth Family Planning Services Question 
• COLLABORATE shared decision-making scale 
• Self-efficacy (Perceived Efficacy in Patient-Provider Interactions [PEPPI]) 
• Reproductive knowledge (ReproKnow) 
• Desire to avoid pregnancy scale (DAP) 
• Demographic questionnaire 
 

 
 
 
 
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T2: Exit Survey 
• Acceptability and implementation measures for the MyVoice tool 
• Reproductive knowledge (ReproKnow) 
• Self-efficacy (Perceived Efficacy in Patient-Provider Interactions [PEPPI]) 
• Decision Conflict Scale (Low Literacy version) 
• Interpersonal Quality of Family Planning (IQFP) Scale 
 
T3: Provider Survey 
• Providers’ experiences with the study as well as information related to encounters with 
patients enrolled in the study 
 
T4: 3 Month Survey 
• National Survey of Family Growth Family Planning Services Question 
• Self-efficacy (Perceived Efficacy in Patient-Provider Interactions [PEPPI]) 
• Reproductive knowledge (ReproKnow) 
• London Measure of Unintended Pregnancy 
 
 
 
 
 

 
 
 
 
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D. Risk/Benefit Assessment 
 
Known Potential Risks 
 
• Discomfort- Study activities involve information regarding reproductive health; some 
individuals may be uncomfortable discussing this topic.  
• Invasion of Privacy- Participants may feel uncomfortable discussing their reproductive 
health where other individuals may hear them.  
• Breach of Confidentiality- Any possibility that de-identified information could be viewed 
by unauthorized parties.  
 
Known Potential Benefits 
 
• This pilot study will inform the procedures and practices related to a future full-scale 
testing of a patient-facing decision support tool for family planning. Our study team and 
others have demonstrated that women with rheumatic diseases do not receive 
adequate family planning care. We will not directly counsel patients about their 
particular risks, and therefore, patients will not receive a direct benefit from their 
participation. However, they may learn more about their family planning options in the 
context of their diseases. 
 
Assessment of Potential Risks and Benefits 
 
• Discomfort- We will minimize occurrence of discomfort by being clear about the content 
of the study tool and assessment measures during recruitment. All questions in study 
surveys and interviews will be optional, and participants will be told they can skip any 
question they do not wish to answer. 
• Invasion of Privacy- The study will not be discussed with potential or current 
participants in public settings. Conversations about the study will only occur in private 
exam rooms or research spaces or via email or phone conversations. We will minimize 
risk by placing phone calls while in a private room and asking the potential participant 
whether they are in a private location before discussing the study. 
• Multiple steps will be taken to prevent any breaches in confidentiality, including not 
recording patients' names or linking their names to their assessments. All study data 
collected from the participants will be assigned a numerical code in order to de-identify 
it and minimize the risk of a breach of confidentiality. will minimize the severity of the 
potential risks by not asking for highly personal or sensitive information in the 
assessment or demographic survey. 
• Every step will be taken to avoid or minimize the above risks. Because this is a minimal 
risk study, we feel the potential benefits of the study outweigh the outlined risks. We 
will remind participants that they can withdraw from the study at any time. 
 
 
 

 
 
 
 
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E. Screening Procedures 
 
      C1. Eligibility Criteria 
 
      C1a.  Inclusion Criteria 
Participants are eligible to participate if they meet the following criteria: 
• Diagnosed with at least one of four rheumatic diseases diagnosed by a rheumatologist: 
rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, and systemic lupus 
erythematosus (SLE). 
• Enrolled in a disease registry for RA, SSc, myositis, or SLE 
• Female sex assigned at birth 
• Age 18-44 (reproductive age as described by the Centers for Disease Control and 
Prevention) 
• Able to read and speak English 
• Access to a smartphone, personal computer, or tablet 
 
Rheumatology providers are eligible to participate if they meet the following criteria: 
• Rheumatologist who sees patients in the UPMC system 
 
     C1b. Exclusion Criteria 
Participants are ineligible to participate if they meet any of the following criteria: 
• Prior hysterectomy or sterilization 
• Currently pregnant 
• Do not have access to a smartphone, personal computer, or laptop 
• Do not see a rheumatologist in the UPMC system 
 
 
 

 
 
 
 
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F. Recruitment Plan 
 
Due to the current COVID-19 pandemic, we anticipate that some potential participants will be 
completing their medical visits remotely via video with their rheumatologists. To ensure that all 
eligible potential participants are given equal access to our study and to reduce potential bias in 
only recruiting participants who are willing or able to come to the rheumatology clinic in 
person, we will offer both remote (telemedicine) and in-person (clinic) study participation and 
will recruit both remotely and in clinic. 
 
Although enrollment, randomization, and all non-exploratory outcome measures are occurring 
in one day, we anticipate some possibility of attrition. Therefore we will recruit a maximum of 
55 participants with the goal of 50 participants completing the aforementioned activities. This is 
a pilot study; therefore, outcomes are primarily related to feasibility and acceptability. 
Furthermore, we have no sample size calculations in this proposal for which we need to 
account for participant attrition. 
 
     D1. Recruitment Tracking 
 
This section describes the protocol for tracking potential participants through the recruitment 
process. 
 
All recruitment documentation and tracking will take place in the “Recruitment Tracking” 
spreadsheet in SharePoint. After screening for eligibility in the clinic schedules, research 
coordinators will enter all patient information into the “Approaching in Clinic” tab. The 
following information will be documented: 
• Name 
• Appointment Date 
• Appointment Time 
• Provider 
• Age 
• Disease diagnosis 
 
Research coordinators will enter potential registry participants into the “Registry Enrollees” tab 
of the spreadsheet with the same information entered. 
 
Research coordinators will enter potential participants into the recruitment spreadsheet in the 
“Interested” tab immediately upon expressing interest in study participation. The following 
information will be documented in SharePoint: 
• Name 
• Phone Number 
• Email Address 
• Mode of Contact (in person, text, email, phone) 
• Date of Interest 

 
 
 
 
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If any information is missing or not given by a potential participant, research coordinators will 
leave it blank. 
 
This interest can be expressed in person or remotely via phone, email, or text. 
 
All participants will then be assigned a recruitment status which can be updated at any time to 
reflect changes in status. 
 
Explanation and instructions for categorization of Participant Recruitment Status: 
• Interested: patient has expressed interest in participating, screening not yet completed 
o If and when screening is complete, patient will be moved to appropriate 
recruitment status as described below 
• Maximum attempts reached: study staff has reached out to interested patient three 
times without a response 
o Study staff will not contact interested patients again unless contacted my patient 
• Ineligible: patient is ineligible to participate based on screening criteria 
o Study staff will not assign patient an ID in REDCap 
• Enrolled: patient is interested in participating and decides to enroll 
o Study staff will assign patient an ID in REDCap 
 
 
 
     D2. Remote Recruitment 
 
Existing patients who have scheduled video return visits with their rheumatologists:  
Research coordinators will identify registry patients who appear to meet inclusion/exclusion 
criteria and have upcoming telemedicine rheumatology visits within 12 weeks. There are 
currently 303 eligible patients already identified within the existing rheumatology research 
registries (listed below) willing to be contacted for future studies. 
 
Registries: 
 
1. UPMC Lupus Center of Excellence Patient Registry (STUDY19060329) 
2. Rheumatoid Arthritis Comparative Effectiveness Research (RACER) registry 
(STUDY19090282) 
3. Banking of Biological Samples and Collection of Clinical Data for Connective Tissue 
Disease Research (STUDY19090054) 
 
We will start recruitment with these patients. All patients who are able to conduct video visits 
for UPMC are assumed to have access to smartphones or tablets/laptops/PCs. 
 

 
 
 
 
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Patients will be contacted via phone, email, or by mail to inquire if they would be amenable to 
discussing our study with a research coordinator. Patients who are amenable will contact one 
of the research coordinators, Olivia Stransky or Alison Decker, at their office phone numbers 
(voice mail checked daily) or via email. Research coordinators will discuss the study with 
patients prior to their rheumatology visits, and screen for eligibility and interest. The 
coordinator will also provide a link for the written informed consent form, which patients can 
review while she is on the phone call with them or at a later time. They will be asked to sign the 
form electronically if they consent to participation. If they desire more time to think about the 
study and review the consent document before committing, they will be given the research 
coordinator’s information to contact her if they wish to enroll in the study. Verbal consent may 
also be provided to patients based on their preference or ability to electronically sign a consent 
document. Participants will also sign a HIPAA authorization allowing study personnel to access 
their medical records. This form will be discussed over the phone, and an electronic version will 
be sent via DocuSign to the participant’s email. DocuSign will send out automated reminder 
emails to participants to remind them to complete the consent form. Once completed, 
DocuSign automatically uploads the completed document to the DocuSign site and notifies the 
research study staff of form completion. 
 
 
     D3.  Clinic Recruitment 
 
Recruitment will occur among patients who receive care at three UPMC rheumatology clinics 
that are located within a three-mile radius of each other: 
 
UPMC Falk Clinic 
3601 Fifth Ave. 
Suite 2B 
Pittsburgh, PA 15213 
412-647-6700 
 
UPMC Mercy 
1350 Locust St. 
Suite G102 
Pittsburgh, PA 15219 
412-647-6700 
 
Lupus Center of Excellence 
580 South Aiken Ave. 
Suite 430 
Pittsburgh, PA 15232 
412-586-3550 
 
 

 
 
 
 
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Research coordinators will identify registry patients who have upcoming in-person clinic visits 
within 12 weeks, screen for eligibility and interest as above, and ask them to come to their next 
clinic visits one hour early to provide consent and engage in study procedures. They will also 
sign a HIPAA authorization allowing study personnel to access their medical records.  
 
     D4.  Provider Recruitment 
 
Rheumatologists within the UPMC healthcare system will be notified via email when the study 
begins recruitment. Drafted language for recruitment notification sent to rheumatology 
providers (distributed by Dr. Birru-Talabi): 
 
“Dear Colleagues, 
 
I am principal investigator of a research study that is testing the benefit of a web-based family 
planning decision aid for women with rheumatic diseases that will begin soon. The study will be 
recruiting. The purpose of this email is simply informational—no action is required on your part. 
Women enrolled in the study who use the decision aid will get a printout summary sheet 
generated by the decision aid and some patients may wish to share this with you, their care 
providers. Please treat this summary sheet similarly to any other information patients bring to 
their appointments. Please feel free to reach out if any questions or concerns arise.” 
 
Note: Edits to this language should include only site-specific changes to the clinic name. 
 
Rheumatology providers with enrolled patients will be asked to complete a survey at T3 
(described in study procedures section). The registry database indicates the rheumatologist 
that the patient sees, which will be confirmed using Epic Hyperspace. If one or more of their 
patients completed the study, rheumatologists will be encouraged, via email, to complete an 
anonymous REDCap survey about their experiences with the study and related patient 
encounters. This will occur 2 weeks after the final patient participant completes the study. 
Rheumatologists will not be informed by study personnel which of their patients participated in 
the study. 
 
 
     D5.  Additional Recruitment Methods 
 
     D5a. Pitt+Me 
 
We do not anticipate difficulty recruiting 55 women using our remote and in clinic recruitment 
methods. However, if we are not recruiting 2-3 patients per week after 2 months, we will begin 
recruitment with Pitt+Me. 
 
A description of the study will be posted on CTSI’s Pitt+Me research registry website for women 
to self-refer. Pitt+Me also distributes emails that will advertise the study to women who may be 

 
 
 
 
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eligible based upon demographics and/or participant-chosen health areas of interest. Pitt+Me 
advertises over multiple social media avenues such as Twitter and Facebook. 
 
Because our remote and in clinic recruitment stems from a registry of UPMC rheumatology 
patients and EPIC schedules for rheumatology providers within UPMC, we will need to confirm 
that all interested patients referred through Pitt+Me meet the same criteria as those recruited 
remotely or in clinic. Pitt+Me patients must therefore be screened to ensure that they meet the 
following inclusion criteria: 
 
• Under the current care of a UPMC rheumatologist 
• An upcoming scheduled appointment with their UPMC rheumatologist within the next 
3-4 months 
 
To confirm patient answers to the prescreening questions and to confirm eligibility, research 
coordinators will ask for verbal approval to access the patient’s EPIC medical records. Patients 
will be reassured that their medical information will remain confidential and will not be used 
for anything other than to confirm eligibility. If verbal approval is given, coordinators will then 
check the patient’s medical records to confirm the patient’s responses. If the patient is eligible, 
they will be further screened based on inclusion criteria described in the Screening Procedures 
section. If the patient is found to be ineligible after the prescreen, she will be informed that she 
cannot complete the study. 
 
 
 
 

 
 
 
 
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G. Materials List 
 
The following is a list of items that need to be brought to the clinics with research staff for in-
person study visits: 
 
• Paper printouts of baseline and exit surveys 
• Stylus 
• iPad 
• iPad charger 
• iPad keyboard 
• Disinfecting wipes 
• Audio recorder 
• Audio recorder batteries (AAA) 
• Pens 
• Smartphone with voice recording technology (for backup) 
• Vincent payment cards 
• Vincent payment brochures 
• Ear plugs 
• REINA Registry consent forms 
 
All materials will be located in a study kit for easy transport to and from clinic visits. At least two 
study kits will be made available to allow for both research coordinators to complete study 
visits simultaneously, if needed. 
 
 
 

 
 
 
 
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H. Data Collection and Entry 
 
      F1.  REDCap Instructions 
 
Accessing REDCap Database 
 
Pitt Log in Page https://www.ctsiredcap.pitt.edu/redcap/  
 
REDCap Account Request Form (Pitt) 
https://www.ctsiredcap.pitt.edu/redcap/surveys/?s=injPIG 
 
REDCap Introductory/Training Videos – general overview information of how to use REDCap 
• https://projectredcap.org/resources/videos/ 
• https://redcapinfo.ucdenver.edu/redcap-videos.html 
 
 
     F1a.  Form Completion Instructions 
 
To enter participant data: 
• Click “Add/Edit Records” 
• For a participant with an existing ID, choose appropriate participant ID from the drop 
down menu 
• For a new participant without an existing ID, click “Add new record” 
• Choose appropriate form corresponding to the time point of the participant to enter 
data or administer survey 
 
     F1b.  Order of Form Completion 
 
• Time point T0: MyVoice RD Baseline Survey 
• Time point T2: MyVoice RD Exit Survey 
• Time point T3: MyVoice RD Provider Survey 
• Time point T4: MyVoice RD 3 Month Survey 
• Withdrawal Form: MyVoice RD Withdrawal Form 
 
Throughout time points T0-T4 (delineated in “Study Procedures”), participants will be asked to 
complete a series of surveys to gather study information. Clinic patients will complete all 
surveys on an iPad provided by the research team. Telemedicine participants will be required to 
complete all surveys on their own smartphone, personal computer, or tablet. All surveys are 
located in REDCap within the “MyVoice RD Pilot” study page. 
 
 

 
 
 
 
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     F2.  Telemedicine Participants 
 
To access study forms and surveys for telemedicine participants, research coordinators must 
send a REDCap link to participants via email as described in the REDCap Instructions section. 
Study participants will then enter their own data using the REDCap link. During the remote 
study visit, research coordinators will call the participant on the phone to assist with any issues 
or to answer any questions that participants may have and will remain on the phone until study 
activities are completed. 
 
 
     F3.  Clinic Participants 
 
To access study forms and surveys for clinic participants, research coordinators must log in to 
their REDCap account to administer the surveys. During the in-person clinic study visit, research 
coordinators will log in to their REDCap accounts, open the appropriate surveys for each 
specific time point, and administer the survey to participants by allowing participants access to 
the iPad to answer the questions confidentially. Coordinators will be present for the duration of 
the survey completion to assist with any iPad issues or to answer any questions that 
participants may have. 
 
     F4.  Troubleshooting 
 
     F4a.  REDCap Issues 
 
Should there be an unforeseeable issue with REDCap during a telemedicine or clinic study visit 
that prevents REDCap log in, research coordinators will be prepared with paper copies of all 
study forms and surveys located in their study kits.  
 
For telemedicine participants, research coordinators will administer all surveys over the phone 
to participants and record their responses on a paper form. For clinic participants, research 
coordinators will allow participants to complete paper copies of the surveys themselves. Once 
REDCap is accessible again, the coordinator who administered the surveys will then record 
participant responses in REDCap manually and retain all paper copies. 
 
If REDCap experiences issues while participants are logged in and completing surveys, the 
research coordinator will contact the REDCap support administrator at 
Pitt_Biomedical_Informatics_Support@pitt.edu to attempt to restore any survey responses 
already recorded. If REDCap is still experiencing issues, the study will continue with paper form 
protocol as described above.  
 
     F4b.  Internet Connection Issues 
 

 
 
 
 
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Should telemedicine participants experience an issue with their own internet connectivity/WiFi 
that prevents them from logging in to REDCap, the research coordinator will administer the 
surveys over the phone while logged in to REDCap and will enter all responses in real time. 
 
For clinic participants, any issues with internet connectivity/WiFi within the clinics will follow 
paper form protocol by having participants complete the surveys on a paper copy of the 
surveys. Once access to an internet connection/WiFi is regained, the coordinator who 
administered the surveys will then record participant responses in REDCap manually and retain 
all paper copies. 
 
 
 
 
 

 
 
 
 
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I. Study Procedures 
 
After eligible participants are screened and enrolled, participation in the study can begin. While 
it is preferred that participants answer as many questions on the surveys and complete as much 
of the study activities as they can, participants will be reminded that all questions and activities 
throughout the study are completely voluntary, and they do not need to answer any questions 
they do not wish to answer. In this case, there is a “prefer not to answer” response for all 
survey questions. 
 
     G1.  Randomization 
 
Research coordinators will randomize patients using sealed envelope protocol. In this protocol, 
a series of unmarked envelopes will be prepared at the onset of the study. In each envelope, a 
piece of paper will assign the patient to the control arm or to the intervention arm. When a 
patient gives consent, the coordinator will select the next envelope in the pile, open the 
envelope, and assign the patient to the intervention or control arm.  
 
Women in the intervention arm will receive the MyVoice decision aid (n=38). Women in the 
control arm (n=12) will receive a paper-based version of the American College of Rheumatology 
pamphlet about pregnancy [Appendix], which, similarly to MyVoice, targets women with a 
broad range of rheumatic diseases. 
 
 
 
     G2.  Telemedicine Participants 
 
Telemedicine participants will be asked to engage in T0 and T1 study activities between 1 week 
and 1 hour prior to their remote clinic visit. 
 
     G2a.  Consent 
 
Consent will occur prior to performing any of the research interventions/interactions and 
before the participant goes to their clinic appointment. Research coordinators will discuss the 
study with patients prior to their rheumatology visits, and screen for eligibility and interest. The 
coordinator will also provide a link for the written informed consent form, which patients can 
review while she is on the phone call with them or at a later time. They will be asked to sign the 
form electronically if they consent to participation. If they desire more time to think about the 
study and review the consent document before committing, they will be given the research 
coordinator’s information to contact her if they wish to enroll in the study.  
 
Verbal consent may also be provided to patients based on their preference or ability to 
electronically sign a consent document. Participants will also sign a HIPAA authorization 

 
 
 
 
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allowing study personnel to access their medical records. This form will be discussed over the 
phone, and an electronic version will be sent via DocuSign. 
 
If a patient wishes to participate, they will sign the document electronically in DocuSign, which 
creates an encrypted identifiable signature. The electronic consent process will also ask the 
participant to provide their mother's maiden name, the location of their birth, and the name of 
their high school. 
 
 
     G2b. T0: Baseline 
 
For telemedicine participants, T0 forms will be completed prior to their remote clinic visit. 
 
The following forms are to be completed at T0: 
 
• Baseline Survey: This survey collects demographic information and asks participants 
about their medical visits, knowledge on their rheumatic disease as related to pregnancy 
and risk, as well as their experiences with birth control, pregnancy, and healthcare 
services for women. 
 
 
     G2c.  T1: Intervention 
 
For telemedicine participants, T1 will be completed prior to their remote clinic visit. 
 
Participants randomized at enrollment to the intervention arm will access the MyVoice 
intervention tool. Those randomized to the control arm will access the American College of 
Rheumatology online pamphlet. This access will be given prior to their clinic visit. Participants 
randomized to the intervention arm will have approximately 20 minutes to navigate through 
the MyVoice decision tool. 
 
For telemedicine participants, patients who have not completed their forms will receive one 
text (using Google Voice) or email every day to remind them to complete the forms prior to 
their rheumatology appointment. The final reminder will occur 3 hours before their clinic visit. 
If forms are still not completed before their clinic visit patients will be contacted to inform them 
that they are withdrawn from the study. If these patients have an additional rheumatology 
appointment within the recruitment period and are still interested in participating, they will be 
given the option to reschedule their study visit and will not be considered withdrawn. 
 
Patients randomized to the intervention arm will have the option to print out a summary of the 
questions they have asked and decisions they have made using the tool (i.e., the MyVoice 
summary sheet) to bring to their appointment if they have access to a printer. 
 

 
 
 
 
25 
 
     G2d.  T2: Up to 48 Hours Post-Intervention 
 
For telemedicine participants, T2 forms will be completed up to 48 hours post-intervention 
after their rheumatology visit. 
 
The following forms are to be completed at T2: 
 
• Exit Survey: This survey asks participants questions regarding acceptability and 
implementation measures for the MyVoice tool. 
 
After completion of the exit survey, women will also engage the research coordinator in a post-
visit phone interview to discuss their perceptions and reactions to the MyVoice tool and their 
experience using it. This interview will take approximately 20 minutes. 
 
Ideally, the exit survey and interview will be completed immediately after the patient leaves her 
rheumatologist visit. However, if participants are unable to complete the study activities at that 
time, research coordinators will schedule a time to complete them over the phone between 24-
48 hours after the visit. 
 
Research coordinators will collect the following PHI from electronic health records of 
participants within 24 hours of their rheumatology visit, and again 90 days later at T4: 
 
• Orders for pregnancy tests (urine, serum)  
• Orders for emergency contraception  
• Billing code for family planning or contraception counseling  
• Order for non-emergency contraception method  
• Order/Referral for obstetrics-gynecology or maternal-fetal medicine consultation  
• Order/Referral for PCP consultation for family planning indication  
• Prescription for prenatal vitamin  
• Change from fetotoxic/teratogenic disease-modifying anti-rheumatic drug or small 
molecule medication to a pregnancy-compatible anti-rheumatic drug  
• Documentation of pregnancy 
 
 
     G2e.  T3: 2 Weeks Post-Recruitment Completion (Providers) 
 
T3 is a time point only relevant to rheumatology providers. No action is needed from 
participants at T3. 
 
The following forms will be completed at T3: 
 
• Provider Survey: This survey will be given to rheumatology providers with one or more 
patients enrolled in the research study. This survey asks providers about their 

 
 
 
 
26 
 
experience with the study as well as information related to encounters with patients 
enrolled in the study. 
 
Providers will be emailed this survey to complete through a REDCap link. Emails with the 
REDCap link to the survey will be sent out 2 weeks after our final participant completes their T2 
survey. Providers will NOT be informed of which of their patients participated in the study. 
Study personnel will follow up with providers once a week via email to complete the survey a 
maximum of three times. 
 
 
     G2f.  T4: 3 Months Post-Intervention 
 
T4 will begin for participants 3 months post-intervention. 
 
The following forms will be completed at T4: 
 
• 3 Month Survey: This survey asks participants about any potential pregnancies post-
intervention, their current birth control habits, and their knowledge on pregnancy risks 
in the context of rheumatic disease. 
 
Participants will be emailed this survey via a REDCap link (as described in REDCap instructions 
section). Prior to emailing, study personnel will call participants to remind them of their 
upcoming survey. Study personnel will follow up with participants once a week via email to 
complete the survey for a maximum of three times. 
 
Participants will also complete a follow-up interview at the T4 time point. Research 
coordinators will reach out to participants 3 months post-intervention to schedule the 
interview. Coordinators will reach out to schedule interview once a week via email and phone 
to complete the survey for a maximum of three times. 
 
Research coordinators will collect the following PHI from electronic health records at T4: 
 
• Orders for pregnancy tests (urine, serum)  
• Orders for emergency contraception  
• Billing code for family planning or contraception counseling  
• Order for non-emergency contraception method  
• Order/Referral for obstetrics-gynecology or maternal-fetal medicine consultation  
• Order/Referral for PCP consultation for family planning indication  
• Prescription for prenatal vitamin  
• Change from fetotoxic/teratogenic disease-modifying anti-rheumatic drug or small 
molecule medication to a pregnancy-compatible anti-rheumatic drug  
• Documentation of pregnancy 
 

 
 
 
 
27 
 
 
     G3.  Clinic Participants 
 
Clinic participants will be asked to arrive to their rheumatology clinic visits 1 hour early to 
complete required study activities. Research coordinators will meet with participants in an 
available space in the clinic. If space is not available, study activities will be completed outside 
(weather permitting) or in a neutral space inside. 
 
     G3a.  Consent 
 
Consent will occur prior to performing any of the research interventions/interactions and 
before the participant goes to their clinic appointment. At consent, a research coordinator will 
walk through the informed consent document with participants and answer any questions that 
arise. If the participant agrees to participate, both the participant and the research coordinator 
will sign the informed consent document. They will also sign a HIPAA authorization allowing 
study personnel to access their medical records. 
 
     G3b.  T0: Baseline 
 
The following forms are to be completed at T0: 
 
• Baseline Survey: This survey collects demographic information and asks participants 
about their medical visits, knowledge on their diseases as related to pregnancy, as well 
as their experiences with birth control, pregnancy, and healthcare services for women. 
 
 
     G3c.  T1: Intervention 
 
For clinic participants, T1 will be completed prior to their clinic visit. 
 
Participants randomized at enrollment to the intervention arm will be administered MyVoice on 
a computer tablet provided by the research coordinator. Those randomized to the control arm 
will be given a paper version of the American College of Rheumatology online pamphlet. 
Participants randomized to the intervention arm will have approximately 20 minutes to 
navigate through the MyVoice decision tool. 
 
To comply with social distancing in the clinic, the location in which the patients complete the 
survey will be delineated prior to their appointment. We will work with UPMC clinic 
management to see if there is an available room in which the patients can complete the surveys 
and tool or assess if they should be met at their cars and given the study materials. 
 

 
 
 
 
28 
 
Patients randomized to the intervention arm will be given a copy of the summary sheet (printed 
by a research coodinator) with questions they have asked and decisions they have made using 
the tool to bring to their appointment. 
 
     G3d.  T2: Up to 48 Hours Post-Intervention 
 
For clinic participants, T2 forms will be completed up to 48 hours post-intervention after their 
rheumatology visit. Ideally, clinic patients will complete this immediately after their 
rheumatology visit. 
 
The following forms are to be completed at T2: 
 
• Exit Survey: This survey asks participants questions regarding acceptability and 
implementation measures for the MyVoice tool. 
 
After completion of the exit survey, women will also engage the research coordinator in a post-
visit interview to discuss their perceptions and reactions to the MyVoice tool and their 
experience using it. This interview will take approximately 20 minutes and will be completed 
either in person in an open space at the clinic or via phone, depending on the participants’ 
preference. 
 
Ideally, the exit survey and interview will be completed immediately after the patient leaves her 
rheumatologist visit. However, if participants are unable to complete the study activities at that 
time, research coordinators will schedule a time to complete them over the phone between 24-
48 hours after the visit. 
 
Research coordinators will collect the following PHI from electronic health records of 
participants within 24 hours of their rheumatology visit, and again 90 days later at T4: 
 
• Orders for pregnancy tests (urine, serum)  
• Orders for emergency contraception  
• Billing code for family planning or contraception counseling  
• Order for non-emergency contraception method  
• Order/Referral for obstetrics-gynecology or maternal-fetal medicine consultation  
• Order/Referral for PCP consultation for family planning indication  
• Prescription for prenatal vitamin  
• Change from fetotoxic/teratogenic disease-modifying anti-rheumatic drug or small 
molecule medication to a pregnancy-compatible anti-rheumatic drug  
• Documentation of pregnancy 
 
 
     G3e.  T3: 2 Weeks Post-Recruitment Completion (Providers) 
 

 
 
 
 
29 
 
T3 is a time point only relevant to rheumatology providers. No action is needed from 
participants at T3. 
 
The following forms will be completed at T3: 
 
• Provider Survey: This survey will be given to rheumatology providers with one or more 
patients enrolled in the research study. This survey asks providers about their 
experience with the study as well as information related to encounters with patients 
enrolled in the study. 
 
Providers will be emailed this survey to complete through a REDCap link. Emails with the 
REDCap link to the survey will be sent out 2 weeks after our final participant completes their T2 
survey. Providers will NOT be informed of which of their patients participated in the study. 
Study personnel will follow up with providers once a week via email to complete the survey a 
maximum of three times. 
 
 
     G3f.  T4: 3 Months Post-Intervention 
 
T4 will begin for participants 3 months post-intervention. 
 
The following forms will be completed at T4: 
 
• 3 Month Survey: This survey asks participants about any potential pregnancies post-
intervention, their current birth control habits, and their knowledge on pregnancy risks 
in the context of rheumatic disease. 
 
Participants will be emailed this survey via a REDCap link (as described in REDCap instructions 
section). Prior to emailing, study personnel will call participants to remind them of their 
upcoming survey. Study personnel will follow up with participants once a week via email and 
phone to complete the survey for a maximum of three times.  
 
Participants will also complete a follow-up interview at the T4 time point. Research 
coordinators will reach out to participants 3 months post-intervention to schedule the 
interview. Coordinators will reach out to schedule interview once a week via email and phone 
to complete the survey for a maximum of three times. 
 
Research coordinators will collect the following PHI from electronic health records at T4: 
 
• Orders for pregnancy tests (urine, serum)  
• Orders for emergency contraception  
• Billing code for family planning or contraception counseling  
• Order for non-emergency contraception method  

 
 
 
 
30 
 
• Order/Referral for obstetrics-gynecology or maternal-fetal medicine consultation  
• Order/Referral for PCP consultation for family planning indication  
• Prescription for prenatal vitamin  
• Change from fetotoxic/teratogenic disease-modifying anti-rheumatic drug or small 
molecule medication to a pregnancy-compatible anti-rheumatic drug  
• Documentation of pregnancy 
 
 
     G4.  Troubleshooting 
 
For telemedicine and clinic participants, T0 (baseline) is completed before their scheduled 
rheumatology appointments. While participants will be asked to arrive one hour early to their 
appointments to complete study activities, we suspect that everything can be completed in 45 
minutes. If participants arrive more than 20 minutes late to their scheduled study appointment, 
research coordinators will inform them that they cannot complete the first part of the study 
that day. If the participant has another upcoming rheumatology appointment within one 
month, they can be rescheduled. If they do not, they will be withdrawn from participation. 
  
 

 
 
 
 
31 
 
J. Payment Protocol 
 
     H1.  Full Study Completion 
 
Participants who complete all study activities in time points T0-T3 will receive $40 payable by a 
university-issued payment card (Vincent). This payment card will be loaded and issued to the 
participant by the research coordinator and will be reloaded with additional funds if and when 
the participant completes follow up visits. For telemedicine participants, Vincent cards will be 
mailed to them. Participants will be asked to contact the study team upon receipt of their card 
for the study team to activate it. Clinic participants will be given their loaded Vincent cards at 
the time of their study visits. Participants will be instructed to keep their Vincent cards until the 
completion of the study (3 months post-intervention). 
 
Participants who complete the study remotely (telemedicine) will receive an additional $10 on 
their payment card to compensate for data usage and cell phone minutes, regardless of how 
much of the study they complete. Those who complete the study in-person (clinic) will receive a 
parking voucher, worth $8-10. 
 
Participants who complete the interview at T4 (3 months post-intervention) will receive an 
additional $20 on their Vincent cards. 
 
 
     H2.  Partial Study Completion 
 
Because the study is voluntary and participants have the option to withdraw at any time, there 
is potential for partial payment depending on how much of the study is completed. Partial 
payment guidelines are listed below, described as how much a participant would receive if 
withdrawing after completing the listed study activity. 
 
• Consent: $0 
• Baseline survey/Intervention (MyVoice/pamphlet): $5 
 
Telemedicine participants that only complete a portion of the study will still be compensated an 
additional $10 for data usage and cell phone minutes, regardless of how much of the study they 
complete. 
 
 
 
 

 
 
 
 
32 
 
I. Communication Protocol 
 
Participants will be asked how they would prefer to be contacted for study reminders and 
communication (call, email, text, or any combination of these options). 
 
For those who request text message communication or reminders, texts will be sent by the 
study team using Google Voice to remind participants about upcoming appointments. Google 
Voice generates a unique phone number (412-419-1563) and allows research staff to 
communicate with participants via phone and text anonymously without needing to provide 
personal phone numbers to participants. 
 
Phone numbers for texting are also included on recruitment materials. Participants will be able 
to contact the study team via Google Voice texting with study related questions. Messages and 
contact information will not be stored on or downloaded to any devices. Research staff will 
delete text message chains on a regular monthly basis. The content of the messaging is limited 
to appointment reminder and study related information questions.  
 
A study specific email address was created for communication with participants during 
recruitment and for scheduling/appointment reminder purposes. This study email address is: 
myvoice@pitt.edu. 
 
 
 

 
 
 
 
33 
 
     J.     Protocol for Withdrawal/Lost to Follow Up 
 
     J1.  Withdrawal 
 
Participants are able to withdraw from study participation at any time for any reason. To 
withdraw, a participant must either provide verbal or written notification that they want to 
withdraw from the study and discontinue any ongoing study activities. Any information and 
data collected prior to withdrawal will be retained and can be used for research-related 
purposes, unless specified by participant at withdrawal. 
 
At the time of participant withdrawal, research coordinators will load a Vincent card for the 
withdrawn participant with the appropriate payment amount as delineated in the Payment 
Protocol section. Coordinators will then complete the Withdrawal Form in REDCap. 
 
     J2.  Lost to Follow Up 
 
Participants will be deemed lost to follow up if they participate in the intervention but are 
unable to be reached for future study activities (time point T2). To clarify, if participants do not 
complete the exit survey/interview after their rheumatology appointment, research 
coordinators will attempt to schedule study activities 24-48 hours after their visits (described in 
Study Procedures section). If study staff is unable to reach them to schedule and they do not 
hear from the participant to complete the study activities, participants will then be considered 
lost to follow up. Coordinators will then complete a Lost to Follow Up form in REDCap. 
 
Note: Because T4 study activities are supplemental to the main study data, participants that 
cannot be reached to complete the final 3-month survey will not be considered lost to follow 
up.  
 

 
 
 
 
34 
 
    K.    SAFETY ASSESSMENTS 
 
1. Study oversight is being conducted by an internally-appointed Safety Officer, Dr. Elizabeth 
Krans, Assistant Professor in the Department of Obstetrics, Gynecology & Reproductive 
Sciences at the University of Pittsburgh. 
 
2. ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
i. DEFINITION OF ADVERSE EVENTS 
Adverse event: An unfavorable medical occurrence, which may include abnormal signs (for 
example, abnormal physical exam or laboratory finding), symptoms, or disease, temporally 
associated with, but not necessarily considered related to, the subject’s participation in the 
research study.   Not all adverse events meet IRB reporting guidelines. 
 
Possible adverse events for this study include discomfort, invasion of privacy, and breach of 
confidentiality. See the DSM for greater detail. 
 
ii. DEFINITION OF SERIOUS ADVERSE EVENTS 
An adverse event or suspected adverse reaction is considered “serious” if, in the view of either 
the investigator or sponsor, it results in any of the following outcomes: Death, a life threatening 
adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent 
or significant incapacity or substantial disruption of the ability to conduct normal life functions, 
or a congenital anomaly/ birth defect.  Important medical events that may not result in death, 
be life-threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition.  
 
We do not anticipate any serious adverse events for this study. 
 
iii. DEFINITION OF UNANTICIPATED PROBLEM 
Any accident, experience, or outcome that meets all of the following criteria: 
1. Unexpected in terms of nature, severity, or frequency; 
2. Related, or possibly related, to a subject’s participation in the research; 
3. Places subjects or others at a greater risk of harm (including physical, psychological, 
economic, or social harm) than was previously known or recognized. 
 
Possible unanticipated problems might include changes to the clinic structure based on the 
Covid-19 pandemic or a complaint from the subject about content of study materials. 
 
iv. DEFINITION OF PROTOCOL DEVIATION 
Non-compliance: Failure on the part of the investigator or any member of the study team to 
follow the terms of University of Pittsburgh IRB approved protocol or to abide by applicable 

 
 
 
 
35 
 
laws or regulations, or University of Pittsburgh IRB policies. This includes protocol deviations. 
  
Incidents of non-compliance on the part of research participants which do not involve risk need 
not be reported to the IRB. 
 
Possible protocol deviations include: 
• Enrollment of an ineligible participant 
• Failure to obtain consent prior to the start of study activities 
• Participant interview and exit survey conducted outside of follow-up window 
 
3. Reporting 
i. General IRB Reporting Timelines for Adverse Events 
Adverse Events that meet the University IRB’s reporting requirements must be reported to the 
IRB office as follows: 
• 
Adverse Events which are unexpected, fatal or life-threatening, and related or possibly 
Related to the Research Intervention will reported to the IRB within 24 hours of learning 
of the event.  
• 
All other Adverse Events will be reported to the IRB within 10 working days of the 
investigator learning of the event. 
All non-serious adverse events will be reported in aggregate to the Internal S.O. and the NIAMS 
as part of the routine safety report. 
We do not anticipate any Serious Adverse Events such as death during this study; however, all 
Serious Adverse Events will be reported to the Internal S.O. and NIAMS within 48 hours of the 
investigator becoming aware of the event. The Internal S.O.’s feedback will be shared with 
NIAMS once received by the study team.  
ii. Unanticipated Problems Involving Risk to Subjects or Others and Non-
compliance 
Unanticipated problems which meet the following definition of “any accident, experience or 
outcome” that meets all three of the following criteria must be reported: 
• 
unexpected in terms of nature, severity, or frequency; 
• 
related, or possibly related, to a subject’s participation in the research; 
• 
places subjects or others at a greater risk of harm (including physical, psychological, 
economic, or social harm) than was previously known or recognized; 
Incidents of non-compliance, which meet the following must be reported: 

 
 
 
 
36 
 
• 
Failure on the part of the investigator or any member of the study team to follow the 
terms of University of Pittsburgh IRB approved protocol or to abide by applicable laws or 
regulations, or University of Pittsburgh IRB policies that: 
o adversely affect that rights and welfare of human subjects, or 
o significantly compromises the quality of the research data 
 
   3. Incidents of protocol deviations impacting participant safety: 
All incidents of protocol deviation which impact participant safety will be reported to 
NIAMS and the Internal S.O. within 48 hours of the investigator becoming aware of the 
event; all other protocol deviations which do not impact participant safety can be 
reported as part of the routine safety report.  
 
Examples of non-compliance that are not reportable but should be documented in a 
log:    
• 
Obtaining consent using an outdated consent form when there were no 
substantive differences between the consent form that was used and the consent 
form that should have been used (i.e., dates in the footer)   
• 
Protocol deviations that do NOT adversely affect the rights and welfare of human 
subjects or significantly compromise the quality of the research data 
• 
Subject non-compliance that doesn’t involve risk or alter the data 
• 
Performing non-safety related research procedures outside the protocol specified 
window, i.e., involuntarily administering a questionnaire outside of the protocol 
specified window. 
General Reporting Requirements for Unanticipated Problems Involving Risk to Human Subjects 
or Others and Non-Compliance: 
Investigators are to submit all Unanticipated Problems Involving Risks to Human Subjects or 
Others that are Possibly or Definitely Related to the research and incidents of reportable Non-
compliance within 10 working days of the investigator becoming aware of the reportable 
event/reportable new information. 
 
 

 
 
 
 
37 
 
L. Publication and Data Sharing Policy 
 
This study will be conducted in accordance with the following publication and data sharing 
policies and regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access 
to the published results of NIH funded research. It requires scientists to submit final peer-
reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central 
upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information 
Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results 
information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will 
be made to publish results in peer-reviewed journals.  Data from this study may be requested 
from other researchers one year after the completion of the primary endpoint by contacting Dr. 
Mehret Birru Talabi. Only de-identified data will be shared and will not be traceable back to 
individual participants.  
 
 

 
 
 
 
38 
 
M.    Appendix 
 
Screening Script 
  
Hi Ms (_____________________), 
  
Thank you again for participating in the Pitt (disease) registry. We have a new research study 
we wanted to tell you about. This research study is being conducted by University of Pittsburgh 
Division of Rheumatology and is funded by a grant from the National Institutes of Health.   
  
The purpose of the research study is to explore whether a web-based tool called MyVoice or a 
pamphlet from the American College of Rheumatology helps women with autoimmune 
diseases to get the information and support they need to make informed decisions about if and 
when to have a child, and gives them information about birth control, fertility options, and how 
their diseases and medications might affect a pregnancy.  
  
Does this sound like it might be of interest to you?  
  
If No, thank the patient and hang up. 
  
If Yes, continue 
  
Let me tell you a little more about the research study to help you to make up your mind.  
  
This research study will be conducted remotely. You’d need to have access to the Internet to 
complete this study. 
  
Do you have access to Internet? (probe: smart phone, laptop, personal computer, tablet, etc) 
  
If No, thank the patient and hang up. 
  
If Yes, continue 
  
Great. Two weeks before your next appointment with your rheumatologist, we would email or 
text you a link with some surveys to complete, along with either the web-based tool or a link to 
the pamphlet from the American College of Rheumatology. We will send you some email or 
text reminders to complete the study.  
  
Overall, we think the surveys will take about 30 or 40 minutes to complete, and the tool will 
take about 20 minutes or so to navigate through.  
  
Then, you’d have your visit with your rheumatologist. We’d like to interview you within a week 
of the visit to see how the visit with your rheumatologist went, and to give you some additional 

 
 
 
 
39 
 
surveys. This step would probably take an additional 30 minutes or so. We’d need to be able to 
talk with you over the phone. Our research coordinator will also look in your chart immediately 
after the visit, and 90 days after your visit.  
  
We think altogether, you might expect to spend about two hours on the study. We would 
compensate you with $40 for completing the study and $10 to go towards your use of your cell 
phone minutes or data. 
  
I should mention that your rheumatologist will not be told that you are participating in the 
study, and all of your survey and interview content will be kept confidential.  
  
Might you be interested in participating in the research study? If so, I have a consent form that I 
will send you. If you are interested, I can go over this document with you verbally and you can 
consent for the study now over the phone.  
  
If No, thank the patient and hang up. 
  
If Yes, continue with the verbal consent. 
 
 
 
 

 
 
 
 
40 
 
 
Interview Guide 
  
Note: Consent for participation in the study will have previously been obtained. 
  
INTRODUCTION: (OPTIONAL) 
  
Hello.  My name is XXX. I am very appreciative that you are taking the time to talk with me 
today.  The purpose of this research study is to hear about your thoughts and opinions related 
to the MyVoice:RD decision aid as well as your experiences and perspectives regarding 
reproductive health discussions you may have had with your rheumatologist. What we learn 
from talking with women like you will help us improve the tool and this aspect of care for 
women with rheumatic diseases.   
  
I am going to use an audio recorder to tape our conversation.  Our conversation will be entirely 
anonymous, which means that I won’t share this recording with anyone but our study team. We 
will not use your name or the name of anyone else you mention in this interview.   
  
I really want to make sure that you feel comfortable sharing your experiences and opinions 
with me. All questions are voluntary, so you don’t have to answer any that you don’t want to. 
You can stop participating at any time.  If there are any comments or thoughts that you’d like to 
add, I’d love to hear them.     
  
There are no risks or benefits to participating in this interview.  I expect that the interview will 
take around 20-30 minutes to finish.   
  
Do you have any additional questions about the information we just reviewed together? 
  
If any questions do arise, please don’t hesitate to ask.  I’ll also give you my information at the 
end of the interview so you can follow up with me if you wish.    
  
Do you have any questions for me at this point?   
  
I will turn on the recorder now.     
  
I. MyVoice:RD Feedback 
  
• Please tell me your thoughts about MyVoice:RD. 
  
[Prompt] What did you like about it?  What did you dislike? 
  
[Prompt] Did you learn anything about pregnancy, parenthood, or birth control related to 
women with rheumatic diseases from the decision aid? 
  

 
 
 
 
41 
 
[Prompt] Has MyVoice:RD been helpful to you?  Did it help you to have a conversation with 
your rheumatologist related to your reproductive health? Did MyVoice:RD help you make 
decisions related to your reproductive goals (parenthood, pregnancy, or choice of 
contraception)?  If yes, tell me about that. 
  
[Prompt] What can we do to make the tool better? 
  
• Is MyVoice:RD appropriate for women with rheumatic diseases? Is it valuable? 
  
• How usable is MyVoice:RD? 
  
[Prompt] What features were easy to use?  What features were too complex? 
  
[Prompt] Do you need help using MyVoice:RD? 
  
[Prompt] Were the different parts of MyVoice:RD well-integrated?  
  
• What are the barriers to using MyVoice:RD? 
  
[Prompt] Did using MyVoice:RD require an excessive amount of time?   
  
• What are the facilitators to using MyVoice:RD? 
  
[Prompt] Did anything help you to use MyVoice:RD 
  
• Are there any situations where you think MyVoice:RD would be particularly helpful?  
Are there any situations or practices where you think MyVoice:RD would not be helpful? 
  
  
II. Reproductive Health Discussions with your rheumatologist 
  
• Did you discuss your reproductive goals or plans (including parenthood, pregnancy, or 
choice of birth control) with your rheumatologist during your last visit?  If yes, how did 
that discussion go?  If no, why not? 
  
[Prompt] Who initiated the conversation? Who was in the room? 
  
[Prompt] Did you feel heard? Did your provider help you understand your reproductive 
decisions?  
  
[Prompt] Did your provider listen to the things that matter most to you about your 
reproductive decisions? 
  

 
 
 
 
42 
 
[Prompt] How much effort was made to include what matters most to you in choosing what to 
do next?  
  
• Did MyVoice:RD influence your discussions with your rheumatologist?  If yes, how? 
  
• Did you have reproductive health discussions with your rheumatologist before you used 
MyVoice:RD?   
  
[Prompt] Were those conversations different at all after using MyVoice:RD? 
  
• Do you feel confident in your ability to get answers to your reproductive health 
question? Seek out reproductive health care? 
  
[Prompt] Did MyVoice:RD help at all? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
43 
 
 
N. Statistical Analysis Plan  
 
Measures  
 
We collected baseline information about participants’ demographic and personal 
characteristics. Questions about contraception use, reproductive histories, and healthcare 
utilization were adapted from the National Survey of Growth. The Desire to Avoid Pregnancy 
scale was used to assess patients’ preferences around a future pregnancy.  
 
 
Feasibility, usability, and acceptability of MyVoice:Rheum and the control pamphlet 
were assessed using qualitative and quantitative measures. The validated Intervention 
Appropriateness Measure (IAM) and Acceptability of Intervention Measure (AIM) consist of 
Likert scales ranging from 1-5; we assigned a feasibility threshold of ≥ 3.5 of 5 for AIM and 
IAM scores, for which higher scores indicate more positive responses. Usability was assessed via 
summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale 
with scores ranging from 0-100; we set a threshold of scores >80.3 as ‘A’/excellent and 68-80.3 
as ‘B’/very good, consistent with standard rating for the SUS. To assess the perceived value of 
MyVoice:Rheum and the pamphlet, we developed a five-item Likert scale with responses 
ranging from 1-5 (1: strongly disagree, 5: strongly agree).  
 
 
While pilot studies are not designed to test hypotheses, we preliminarily assessed the 
effectiveness of MyVoice:Rheum in prompting family planning discussions by comparing the 
incidence in which these discussions occurred across the study arms. We also evaluated self-
efficacy and knowledge scores within each arm before and after the intervention. Self-reported 
efficacy in communicating with providers was assessed using a modified version of the validated 
five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Rheumatology-
specific reproductive health knowledge was assessed via ReproKnow, a measure developed and 
preliminarily validated by our team that covers domains of contraception safety and efficacy, 
pregnancy management, pre-conception planning, medication safety, fertility; a score of nine 
indicates the highest level of reproductive knowledge. Overall knowledge scores as well as 
scores related to specific domains of reproductive knowledge were calculated across individuals 
in each study arm. Among MyVoice:Rheum users only, knowledge was assessed again three 
months after the intervention.  
 
Analysis 
Quantitative. Quantitative measures of demographics, feasibility, and acceptability were 
assessed via descriptive statistics. Among MyVoice:Rheum users and controls, we conducted 
paired comparisons pre- and post-intervention regarding self-efficacy and reproductive health 
knowledge, using McNemar’s test for proportions and Wilcoxon’s signed rank test for means. 
Calculations were performed using Stata 17.0. 
 
Qualitative.  A deductive approach was used to prepare the preliminary codebook, which 
was organized by the following domains: feasibility and acceptability; family planning discussed 
at rheumatology visit (yes/no), and reasons why or why not; barriers and facilitators to 
discussing family planning at the rheumatology visit; ideal timepoints and contexts to use the 
tool; and suggested modifications. Interview transcripts were entered into NVivo software to 

 
 
 
 
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facilitate coding and thematic analysis. Transcripts were reviewed by two experienced qualitative 
analysts with master’s degrees in public health and sociology, respectively (O.S., L.P.). O.S. and 
L.P. used an open coding approach to identify themes that arose inductively, and subsequently 
refined the codebook based on the most frequent and important codes. G.L., a trained research 
assistant, also independently coded the transcripts. As a form of investigator triangulation, the 
analysts and P.I. (M.B.T.) used a consensus approach to reconcile coding and create new codes. 
Focus coding was used to re-review all transcripts and synthesize themes.  
 
RESULTS 
Sample Characteristics  
Fifty-five patients consented to participate in the study, among whom 46 patients were 
randomized to a study arm. Forty patients completed the study, among whom 31 patients were 
randomized to the MyVoice:Rheum intervention and 9 were randomized to the control arm. The 
most common rheumatic disease diagnoses were SLE, RA, and myositis. Most participants 
identified as heterosexual, and nearly half of all participants were married. More than half of 
participants had at least a college degree. Over 40% of participants identified their 
rheumatologist as their main health provider. Most participants had never been pregnant, and 
approximately 10% had a diagnosis of infertility. Over two-thirds of participants used a method 
of contraception.   
 
Quantitative Outcomes  
MyVoice:Rheum and the control pamphlet were both rated as feasible, acceptable, 
usable, and valuable by study participants. The minimum threshold score of 3.5 for the 
Acceptability of Intervention Measure (AIM) was met or exceeded by 96.8% of 
MyVoice:Rheum users and 88.9% of controls; average AIM scores for MyVoice:Rheum and 
controls were 4.4 (S.D. 0.58) and 3.97 (S.D. 0.65), respectively. The minimum threshold score of 
3.5 for the Intervention Appropriateness Measure (IAM) was met or exceeded by 96.8% of 
MyVoice:Rheum users and 88.% of controls; average IAM scores among MyVoice:Rheum and 
controls were 4.48 (S.D. 0.60) and 4.11 (S.D. 0.85), respectively. System Usability Scale scores 
for MyVoice:Rheum users were rated in the range of “excellent”, whereas scores for pamphlet 
users were rated in the range of “very good” (83.0 vs. 79.3, respectively).  
 
Approximately 55% of MyVoice:Rheum users vs. 44% of control participants discussed 
any family planning issues, plans, or questions with their rheumatologists during their clinic 
visit. Among these participants, 55% of MyVoice:Rheum users indicated that the tool influenced 
their decision to discuss family planning with their rheumatologists as compared to 44% of 
controls. Among MyVoice:Rheum users, self-efficacy scores on the PEPPI scale rose from a pre-
test mean of 3.47 (S.D. 1.19) to a post-test mean 4.07 (S.D. 0.82) (mean difference: 0.59 (S.D. 
0.91)).  
Overall reproductive knowledge scores on ReproKnow rose from a pre-test mean of 5.77 
(S.D. 1.76) to a post-test mean of 7.27 (S.D. 1.17) (mean difference: 1.50 (S.D. 1.93)). 
Reproductive knowledge appeared to increase across the ReproKnow domains of birth outcomes, 
fertility, contraception, pre-pregnancy planning, and pregnancy management. 
 
Qualitative Outcomes. The following themes emerged from interviews with MyVoice:Rheum 
users: 1) MyVoice:Rheum was feasible, informative, usable, and customizable to the user; 2) 

 
 
 
 
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MyVoice:Rheum users felt prepared to initiate and engage in family planning conversations with 
their rheumatologists; 3) MyVoice:Rheum optimally should be provided for patients to review 
immediately prior to the rheumatology encounter, around the time of the initially RMD diagnosis 
and periodically afterwards; 4) Family planning conversations at the rheumatology visit were 
facilitated by respectful and trusting relationships with the rheumatologist, whereas distrustful 
relationships and rushed visits were a barrier to family planning conversations; 5) Suggested 
modifications to MyVoice:Rheum included tools directed towards clinicians to facilitate patient-
centered care, and information modules for partners or family members. Representative 
quotations are presented in. 
 
Three-month outcomes. Most MyVoice:Rheum users engaged in interviews three months 
following the intervention (N=30). Some MyVoice:Rheum users indicated receipt of family 
planning services after the intervention, including: 1) initiation of a new birth control method 
(N=7); 2) counseling about birth control or pregnancy planning from a clinician (N=4); and/or 3) 
a clinic visit or medical test related to birth control or pregnancy planning (N=3). When 
reproductive knowledge was re-evaluated again three months, overall scores remained 
significantly higher than pre-intervention scores (pre-intervention mean 5.77 (SD 1.76) vs. post-
intervention 7.27 (1.17), mean difference 1.50 (1.93)).