A Prospective Study Showing the Effect of Video Interactive Education on Medical Decision Making in Patients on Opiate Replacement Therapy (ORT) With a History of Hepatitis C
Phase: NA
Conditions: Hepatitis C
Sponsor: State University of New York at Buffalo

 
 
Official Title: 
Hepatitis C-Video vs. Brochure Education Delivery 
NCT number: 
NCT04204447 
Document Type:  
Study Protocol  
Date of the Document: 
June 30, 2018 
 
 
 

PROTOCOL TITLE:  A prospective study showing the effect of video interactive education 
on medical decision making in patients on opiate replacement therapy (ORT) with a history of 
Hepatitis C. 
Objectives 
The purpose of this study is to assess the effect of education as a determinant for hepatitis-C related 
literacy rate and improvement in decision-making capacity in patients with current or past history 
of hepatitis C who are currently on opiate replacement therapy. 
 
Hypothesis  
We anticipate better outcomes in literacy and decision-making capacity with more interactive 
intervention i.e. video educational session as compared to education delivered via a brochure. 
 
Scientific Endpoints 
Response: 
As a result of participation in the interactive educational sessions, we aim to demonstrate  
1. Improved health literacy in Opioid Agonist Treatment (OAT) patients  
2. Improved decision making among OAT patients  
 
Background 
Hepatitis C virus (HCV) infection infects more than 150 million people worldwide as per the 
World Health Organization.  Acute infection is rarely diagnosed and the majority of patients 
develop chronic infection, which eventually can lead to liver cirrhosis and further complications 
including hepatocellular carcinoma.  People using intravenous drugs have high prevalence of 
hepatitis C virus infection1 and very few receive treatment because of the lack of knowledge 
about HCV infection and its treatment modalities2.The education of the population who is at risk 
for, or have been diagnosed with, chronic hepatitis C infection can improve their participation in 
the disease control and treatment3. To date strategies are not clear for patient education in regard 
to effectiveness.   
We plan to conduct our study to identify the impact of different education delivery modalities on 
overall patient health literacy about hepatitis C and its effect to motive patients on opioid 
replacement therapy to pursue HCV evaluation and treatment. 
Include complete citations or references.  
Response:  
 
1. Page K, Morris MD, Hahn JA, Maher L, Prins M. Injection Drug Use and Hepatitis C Virus Infection in 
Young Adult Injectors: Using Evidence to Inform Comprehensive Prevention. Clinical Infectious Diseases: 
An Official Publication of the Infectious Diseases Society of America. 2013;57(Suppl 2):S32-S38. 
doi:10.1093/cid/cit300.  

2. 
Butt G, McGuinness L, Buller-Taylor T, Mitchell S. Reasons for Nonattendance across the 
Hepatitis C Disease Course. ISRN Nursing. 2013;2013:579529. doi:10.1155/2013/579529.  
3.  
Shah HA, Abu-Amara M. Education provides significant benefits to patients with 
hepatitis B virus or hepatitis C virus infection: a systematic review. Clin Gastroenterol 
Hepatol. 2013;11:922–933. [PubMed] 
 
 
Study Design 
We will start with a retrospective chart review to extract information about patient 
demographics, which will include age, gender, race/ethnicity, educational status, marital status, 
and history of mental health problems, information about substance abuse & status of hepatitis 
C, occupational and employment status. Some of this information will be required to decide 
matching factors between the clinics.  
 
We will employ an observational two-group method design to evaluate the effect of video or 
computer-based education as a determinant of seeking treatment for HCV among patients on 
opioid agonist therapy (OAT). Group A will receive the video class intervention on the 
computer administered by an on-site facilitator, while “group-B” will receive an HCV 
educational brochure. The two groups are matched in 1:1 fashion to make the two groups similar 
with respect to the certain key characteristics, such as race, sex, age etc. The outcome variable 
is the percentage of the individuals in the two groups that retain HCV-knowledge. We expect 
up to 2-3 clinics to participate. 
 
These intervention will occur after pre-test assessment by a designed questionnaire, which will 
include questions from different aspects of hepatitis-C infection disease process. Patients will 
not be notified of their questionnaire score. We will assess the questionnaires reliability and 
accuracy among a patient sample drawn from the clinics where the questionnaires will be 
deployed. We will also convey a committee of experts who will provide input on the design of 
the educational intervention.  The last step before analysis will be post interventional assessment 
with the same questionnaire used for pre-intervention assessment. At the end of the study, we 
plan to utilize the data for analysis and manuscript preparation. 
 
Inclusion and Exclusion Criteria 
Describe the criteria that define who will be included in your final study sample. 
1. Must be at least 18 years of age 
 
2- Currently on suboxone therapy 
 
3. Patients with English as their primary language  
Describe the criteria that define who will be excluded from your final study sample.   
1. Less than 18 years of age 
2. Not treated with suboxone. 
3. Non-English speaking patients 

Indicate whether you will include non-English speaking individuals in your study.  Provide 
justification if you will exclude non-English speaking individuals.  
The intervention in our study involves educational information regarding different aspects of 
hepatitis C including pathogenesis, diagnosis and treatment.  This material will be only presented 
in English, therefore only patients who are able to comprehend English language would be able to 
complete the study pre-and post-test instrument as well as questionnaire to measure the 
effectiveness of the intervention. 
Procedures Involved 
We plan to conduct a study involving 2 groups.  One group consists of the intervention subjects 
and other of the control subjects. The intervention subjects will receive the computer-based video 
education, while the “control group” will receive the brochure-based intervention. The goal is to 
evaluate the effect of education on health literacy in people with hepatitis C and currently on 
opiate replacement therapy.  We also plan to evaluate the willingness for treatment in people 
with active hepatitis C infection. 
We will start with a feasibility survey to assess the patient demographics at all clinic sites where 
this study will be conducted. We will also conduct cognitive testing of the survey instruments to 
be administered to ensure reliability and accuracy. We will also request that patient partners and 
subject matter experts provide guidance on the educational intervention to be delivered. The 
study flyers for advertisement will be distributed at all the clinic sites. Patients will be given 
information about the study. In case of agreement to participate, informed consent will be 
obtained. After enrollment of the population of interest, we will start the retrospective chart 
review in order to extract information about patient demographics, which will include age, 
gender, race/ethnicity, educational status, marital status, and a history of mental health problems, 
information about substance abuse & status of hepatitis C, occupational and employment status. 
After that information is collected, we plan to designate the population in 2 groups i.e. 
Intervention & Control. The next step will be the educational intervention in group A which will 
consist of distribution of HCV educational brochure.  Similarly group B will have the video class 
intervention on the computer administered by an on-site facilitator.  These interventions will 
occur after the pre-test assessment by a designed questionnaire which will include questions on 
different aspects of hepatitis-C infection disease processes. Finally, we will administer a post 
interventional assessment with the same questionnaire used for pre-intervention assessment. For 
patients with history of HCV infection irrespective of treatment, an additional section will be 
added to check their willingness for treatment.  
Study Timelines 
The anticipated time frame review of the records is up to 1-2 months. We estimate it will take 12 
months to complete enrollment in the study.  
Risks to Subjects 
This study involves only minimal risk to study participants. Breach of confidentiality is the 
primary potential risk. However, the data will be kept in secure, encrypted, password-protected 
flash drives made available only to study personnel. All study personnel are well-versed in 

HIPAA compliance and use the electronic medical record on a daily basis. Moreover, study 
personnel are CITI trained in HIPAA compliance.