Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits
Phase: NA
Conditions: Patient Empowerment
Sponsor: Medical College of Wisconsin

 
 
Mobile Video Education to Improve Patient Clinician Communication During Prenatal 
Clinic Visits 
 
NCT 06323343 
 
Last Modified: 6/28/2024 
 
 
 

1. Background 
a. Value of communication skills 
i. The communication between clinicians and parents is a 
partnership; the family caregivers are equally important, as are their 
behaviors.   
ii. Especially important are parents’ active behaviors, such as asking 
questions, introducing topics for discussion, expressing concerns, 
and sharing opinions. 
iii. Active patients receive more information and support from 
clinicians, are more satisfied with the care, and experience better 
outcomes than passive patients.  
b. Importance in the context of fetal anomalies 
i. Parents who have pregnancies diagnosed with a fetal anomaly are 
often overwhelmed by new medical information while they are in 
the process of grieving a normal pregnancy.  
ii. Often during this stressful time, medical decisions need to be made 
which are preference sensitive. Families and clinicians need to be 
able to work together to achieve a treatment plan that best fits a 
family’s values.   
c. Proposed intervention 
i. We intend to address this problem by creating a short, animated Art 
of Medicine video delivered via text messages. 
ii. The goal of our educational intervention is to improve clinician-
patient communication by equipping families with evidence-based 
skills that they can implement during medical encounters. 
iii. Our research team has developed a smartphone-based text-video 
educational platform with NIH support to prepare pregnant women 
for premature birth. We intend to use this platform to improve 
clinician-patient communication by disseminating concise, 
memorable, and immediately actionable education. 
2. Aim:  
a. Determine the effect of the educational intervention on parents’ 
communication during a fetal concerns appointment.  
3. Study design 
a. The proposed intervention is to be implemented as randomized controlled 
study. 
4. Study population 
a. A pregnant patient referred to Children’s Wisconsin Fetal Concerns Center 
for a prenatal diagnosis.  
b. Own a smartphone 
c. 18 years of age or older 
d. Able to speak and understand English 
i. Currently, the intervention is only available in English.  

e. Exclusion criteria: 
i. Pregnant patient's appointment at Children's Wisconsin Fetal 
Concerns center is not for a fetal anomaly (e.g., screening only, 
past pregnancy with anomaly the only cause of appointment) 
ii. Pregnant patient is considering termination of pregnancy.  
5. Enrollment and consent 
a. Upcoming Children’s Wisconsin FCC appointment schedules will be 
screened by study team.  
b. Eligibility will be discussed with a clinical team member (e.g., medical 
director Dr. Jessica Smith, a nurse care coordinator). Prior to the first 
scheduled visit to the FCC clinic, the patient will be approached with a 
study introduction from the clinical team member through one or more of 
the following: encrypted email, phone call, or MyChart message. This 
introduction will assess patient interest in participation.  
c. If interested, patients will be provided more study information and be 
invited to review an informational letter in REDCap. A waiver of 
documentation of consent is requested.  
d. Participants will be invited to complete an enrollment questionnaire in 
REDCap prior to randomization and intervention delivery.  
6. Randomization 
a. Participants will be randomized 1:1 to receive either the video intervention 
or a control.  
b. Randomization list will be generated by MCW Quantitative Health 
Sciences and will be implemented by study staff via REDCap. 
7. Intervention & control 
 
a. Intervention video development  
i. We will develop the intervention’s video objectives using published 
literature. Topics may include preparing questions for the 
appointment, summarizing using teach back, and participating in 
shared decision making. 
ii. The video will be developed in a collaborative and iterative manner. 
After creating the script to meet the video’s learning objectives, we 
will create the animation and audio using the software Vyond and 
Audacity, respectively. Professional voiceovers will provide 
narration and dialogue.  
iii. The video will run approximately 10 minutes long and feature a 
diverse representation of families.  
iv. This plan for creating and testing videos is similar to the procedure 
followed by Dr. Basir’s team, which successfully generated over 50 
videos through user feedback. 
b. Control education materials 
i. Control education includes links to publicly available webpages 
from Children’s Wisconsin describing the Fetal Concerns Center to 

familiarize them with the clinic and prepare them for the 
appointment.  
c. Education distribution plan: 
i. For participants randomized to the video intervention: After 
enrollment, participants will be registered to the Art of Medicine 
platform and be sent the video link by text message to their 
smartphone.   
ii. For participants randomized to the control: After enrollment, 
participants will be sent links to the Children’s Wisconsin webpages 
by email or text message, depending on participant preference. 
After follow up assessment, control participants will also be sent the 
animated video.  
8. Data collection 
a. Medical record data 
i. After pregnant patients are enrolled, we will gather data from their 
medical records. 
ii. Data includes their date of birth, estimated due date, primary 
diagnosis / reason for referral, and obstetric history.  
b. Website data 
i. Using tracking software already developed and utilized in Dr. 
Basir’s previous project, we will collect information regarding the 
number of video links sent, the number of links clicked, the number 
of complete and partial viewing of the video, and timestamps of 
views. 
c. Questionnaires 
i. Participants will be asked to complete two questionnaires during 
the study, one at enrollment and one the day after their fetal 
concerns appointment. 
ii. The enrollment questionnaire will include a survey collecting 
information regarding sociodemographics, experience with 
healthcare providers, smartphone information, and a health literacy 
assessment (the HL6, see Supporting Documents). 
iii. The follow up assessment will include self-report items of 
participants describing their behavior before and during their 
appointment (see Supporting Documents). 
9. Compensation 
a. For completing the follow up assessment, participants will receive $20 in 
gift cards. 
10. Data management 
a. All data will be stored securely at the Medical College of Wisconsin in 
REDCap. Only study team members will have access to identifiers. 
11. Statistical analysis plan 
a. Missing data 

i. Logistic regression will be used to investigate the missing data 
pattern. In general, we will assume data are missing at random 
(MAR).  
ii. We plan to use random effects models with maximum likelihood 
estimation for repeated measures and multiple imputations for 
items. We may miss obtaining some survey results or observe 
dropout for follow-up and will perform sensitivity analysis allowing 
for different assumptions.  
b. Tracked video viewing data will be analyzed and correlated with study 
assessments and participant characteristics.  
i. To examine relationships between assessment scores, participant 
characteristics, and tracked viewing data, we will use a generalized 
linear model, with link functions such as a negative binomial 
considered. 
c. For patient participants, scoring of the follow up assessment will be 
calculated as percentage of communication behaviors self-reported as 
having occurred.  
i. The primary outcome is a comparison of total follow up assessment 
scores in the video intervention group compared to the control. 
ii. The analysis will include consideration of covariates, e.g., health 
literacy, income. 
iii. Tracked video viewing data will be similarly analyzed.  
12. Risks and benefits 
a. Potential risks 
i. There is a minimal risk of mental distress while reviewing the video 
material or completing the questionnaires as reminders of a 
potentially distressing clinic appointment.  
ii. There is a minimal risk of breach of confidentiality if (1) the security 
of data storage is violated, (2) the data is shared by people other 
than designated researchers and professionals, or (3) the result is 
reported in a manner that could reveal the identity of the 
participants. 
iii. Physical risks or discomfort to the participants are minimal.  No 
physical interventions are being undertaken. 
b. Potential benefits 
i. The potential benefits of the communication education for 
participants outweigh the minimal risks.  
ii. This study will allow us to determine best methods of preparing 
parents to communicate during an appointment with complex 
medical information and shared decision making.