Randomized Trial of Text vs. Video Patient Educational Materials in Cirrhosis
Phase: NA
Conditions: Cirrhosis
Sponsor: University of Michigan

 
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Human Research Protocol 
 
Title: Randomized Trial of Text vs. Video Patient Educational Materials in Cirrhosis 
PI: Patricia P Bloom MD 
 
Version 0.5 
Version Date: 10/7/2021 
 
Background and Significance 
Cirrhosis is a complex chronic disease, with several associated complications, numerous 
symptoms, and patients often require many medications. Cirrhosis is unfortunately linked to 
frequent hospitalizations and re-hospitalizations. Lack of medication compliance leads to 
hospitalizations, and increased disease understanding can improve medication compliance. 
Improved health literacy can prevent hospitalizations in other ways (preventing ED visits for 
ascites or HE). Based on internal QI data, we know that many patients with cirrhosis at U-M do 
not understand their medications and other aspects of their disease. Our essential purpose in this 
study is to compare the efficacy and patient satisfaction associated with traditional text cirrhosis 
education vs. recently-created educational videos on the same topics. 
 
Specific Aims: 
Aim 1: Do educational materials improve patients' understanding of disease? 
 
Assess change in score for pre- and post-evaluations.  
 
Aim 2: Is one mode of patient education more effective than the other? 
Compare efficacy of educational materials when presented as text (Cirrhosis Toolkit) or 
video.  
 
Aim 3: Do patients prefer one mode of education over the other? 
Compare patients’ preference for educational materials presented as text (Cirrhosis 
Toolkit) or video.  
 
Aim 4: How can these educational materials be improved? 
 
Collect feedback from patients on educational materials.   
 
Research Design and Methods 
Overview 
We plan to enroll adult outpatients with cirrhosis who are evaluated at the University of 
Michigan Hepatology Clinic. We aim to enroll a maximum of 320 subjects with cirrhosis, into 
two main study arms. Arm 1 will include 160 responses from subjects who are newly diagnosed 
with cirrhosis, and Arm 2 will include 160 responses from subjects with history of cirrhosis.  
 
After screening, and before being invited to respond to the study survey, participants will be 
randomized into one of 4 subgroups per each study arm, for a total of 8 possible subgroup 
assignments: 
 
 

 
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Subgroups 1and 2 will involve the presentation of educational materials in text-and-graphic 
format (Cirrhosis Toolkit), with each subgroup focusing on a single subject or section of the 
material. Subgroups 3 and 4 will be presented with similar material in video format, also 
focusing on a single subject per subgroup. Recruitment for this study will conclude once 40 
subject-experiments have been completed for each subgroup.  
 
Subjects will be given the option to be randomized into an additional study subgroup (For 
example: if they were randomized into subgroup 1A.1 in the first round, they would be 
randomized into 1A.2 or 1B.4 for their second round of participation) and participate in the study 
a second time. Enrollment will conclude once 160 subject-experiments have been completed for 
each study arm.   
  
 
Inclusion Criteria 
1. Age 18 years or older 
2. Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation 
3. Available email address  
4. Arm 1: New patient visit for cirrhosis (and diagnosis within the last 6 months) 
5. Arm 2: Previous cirrhosis diagnosis (>6 months) 
 
Screening 
For Arm 1, patients with a new diagnosis of cirrhosis will be identified by reviewing the 
University of Michigan Hepatology Clinic outpatient schedule and related notes in the Electronic 
Medical Record.  
 
For Arm 2, Patients with >6 months history of cirrhosis diagnosis will be identified via 
Datadirect, previously established patient lists, and the University of Michigan Hepatology 
Clinic outpatient schedule.   
 
Patients who meet the inclusion criteria will be randomized into one of the above subgroups and 
sent an email invitation to participate in the study. Potential participants will not be called or 
approached in person. The study invitation message will include contact information for study 
staff members in case these patients have any questions or would like to discuss the study in 
more detail before proceeding. 
 
Procedures 
The study will be conducted completely online, via REDCap. The initial study invitation email 
will include a link to the REDCap database, where participants will complete study 
questionnaires and activities. Informed consent for this study will be conducted online via 
REDCap.  
Arm 1: New Diagnosis 
Arm 2: Previous Diagnosis 
1A: Cirrhosis Toolkit 
1B: Cirrhosis Videos 
2A: Cirrhosis Toolkit 
2B: Cirrhosis Video 
1A.1: General 
Cirrhosis Info 
1B.3: General 
Cirrhosis Info 
2A.1: General 
Cirrhosis Info 
2B.3: General 
Cirrhosis Info 
1A.2: Ascites Info 
1B.4: Ascites Info 
2A.2: Ascites Info 
2B.4: Ascites Info 

 
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Demographics Survey 
Participants will be asked to report their age, sex, cause of cirrhosis, and any history of ascites, 
variceal bleeding, or HE.  
 
Pre-Evaluation 
Based on their randomly assigned subgroup, participants will complete a Pre-Evaluation, 
consisting of 5-6 content-specific questions, to determine each participants’ baseline level of 
content knowledge. Pre-Evaluation scores will be recorded, but not presented to participants.  
 
Educational Intervention  
Participants will be prompted to review the educational material associated with their assigned 
subgroup. This will involve reading a specific section of the Cirrhosis Toolkit or watching 
videos. Participants will be given unlimited time to review and interact with educational 
materials and will be prompted to complete the Post-Evaluation when ready.  
 
Post-Evaluation 
Participants will be directed to respond to a set of content-specific questions identical to the Pre-
Evaluation they completed earlier in the study, but in a randomized order. Post-Evaluation scores 
will be presented to participants after they complete the optional feedback survey (below).  
 
The change in score between pre-and-post-evaluations for each participant will inform the results 
of aims 1 and 2. For questions with multiple correct answers, no partial credit will be awarded.  
 
Debrief 
Participants will be informed that all mandatory study activity has been completed and thanked 
for their time.  
The study debrief will present participants with multiple optional study activities:  
 
1) Complete the Feedback Survey 
 
2) Contact study staff for further questions 
 
3) Review their Post-Evaluation Score and complete a brief survey response 
 
4) Re-enroll in the study to ‘learn more’  
 
1) The Feedback Survey will consist of questions related to aims 3 and 4.  
Questions:  
-Did you find this material helpful? (Likert scale) 
-Would you recommend this material to others? (yes/no) 
-Would you prefer further educational materials in text or video format? 
-Do you have any suggestions for improving these educational materials? (text box) 
 
2) Participants will be given contact information for study staff members if they have any further 
questions.  
 

 
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3) Participants will have the option to review their post-evaluation scores only after all other 
activities have been completed, such as the feedback survey. Scores will be reported as [# 
correct]/[# of questions] Participants will be asked to reflect on their score:  
 
-Are you satisfied with your score? (visual analog scale or Likert) 
            -What are your next steps for further education? (select all that apply: Nothing, talk to 
Hepatologist, talk to Nurse, talk to nutritionist, talk to other medical professional, internet search, 
talk to family and friends, other (please explain)) 
 
 
4) Participants will be given the option to ‘learn more’ and re-enroll in the study. If participants 
elect to re-enroll, they will be randomized into a different subgroup of the same study arm.  
 
Statistical Analysis  
Aim 1: Matched pair Wilcoxon comparing pre-test and post-test scores in the whole study 
population. 
 
Aim 2: Matched pair Wilcoxon comparing score change (from pre to post) between video group 
and text group. 
 
Aim 3: Descriptive statistics of Likert scale results. 
 
Aim 4: Will report key themes from patient open-ended responses. 
 
Foreseeable Risks and Discomforts 
The risks of this study are primarily psychological. Subjects may become frustrated if 
performing poorly on the pre-or-post-evaluations. Patients may have privacy concerns about 
study communication via email or conducting study activities online or on their personal device.   
 
Expected Benefits 
A potential direct benefit for participants is the opportunity to learn something new about 
cirrhosis.  
 
Privacy and Confidentiality 
Redcap, a secure and HIPAA-compliant electronic program, will be used for all data collection 
and study activities. Once randomized, participants will be identified only by a study ID number. 
Results of the testing and any other information provided by the subject are available for analysis 
under the heading of this number only, not by name or other personally identifiable information. 
No names or personally identifiable information will be collected or used in any publications.  
 
We will keep a separate password protected screening log on the University shared drive in a 
secured location. Only study personnel will have access to the electronic screening log that maps 
the Subject ID number and Screening ID number (if applicable) to the participant’s email 
address. Only limited identifiable data will be collected for screening purposes. 
 
Data and Safety Monitoring 

 
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There are no safety concerns in this study. We will store data on a secure U-M server. Study staff 
will proofread data weekly to verify accuracy. PI will complete a comprehensive review of all 
data prior to analysis.