The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder
Phase: NA
Conditions: Schizophrenia Disorder, Schizoaffective Disorder, Psychosis
Sponsor: Louisiana State University Health Sciences Center in New Orleans

 
 
 
The Impact of Health Literacy on the Attitudes 
toward Pharmacological Treatment in Patients with 
Schizophrenia Spectrum Disorder 
 
Document type: Study Protocol 
Last modified: July 1, 2025  

The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients 
with Schizophrenia Spectrum Disorder 
Principal Investigator: Jaudé Petrie, M.D.  
Co-Investigator: Rahn K. Bailey, M.D. 
Protocol version July 1, 2025 
Study Sponsor: LSUHSC  
Funding: Janssen Scientific Affairs, LLC 
 
Background  
Problem statement: 
There are racial disparities in relation to the diagnosis and treatment of patients with 
schizophrenia spectrum disorders (SSD). These disparities can be attributed to several factors, 
including cultural incompetence, stigma in regard to mental health disorders, access to care 
barriers, inadequate social support, and poor health literacy. This study aims to investigate 
health equity by increasing health literacy using inpatient educational resources in patients 
diagnosed with SSD.  
 
Introduction: 
Mental health disorders are underdiagnosed, and therefore insuﬃciently treated in 
marginalized communities [1-3]. While the most common disorders are anxiety and 
depression related, a large number of people are greatly aﬀected by psychotic disorders, 
including schizophrenia spectrum disorders (SSD). Worldwide, there are approximately 24 
million people living with schizophrenia [4]. Schizophrenia is a neurocognitive disorder 
involving excess dopamine in the brain [5]. This chemical imbalance leads to a spectrum of 
positive symptoms (hallucinations, delusions, disorganized speech and behavior) and negative 
symptoms (apathy, flat aﬀect, speech poverty, lack of motivation, and social isolation). 
Individuals with schizophrenia can also have concomitant bipolar spectrum disorders (BPSD), 
which can further complicate and delay diagnosis and treatment. Given the progressively 
worsening nature of SSD, symptoms can become severely debilitating. 
 
Research has shown discrepancies in the rate of diagnosis and pharmacological treatment in 
Caucasians compared to ethnically marginalized communities. Even when presenting with the 
same symptoms, African Americans (AA) are 2.4 to 5 times more likely to be diagnosed with 
schizophrenia than White Americans, and White Americans are more likely to be diagnosed 
with Bipolar Spectrum Disorder [6, 7]. When examining the discrepancies in detection and 
treatment between ethnic minorities and White Americans, it is important to consider social   
and cultural influences as potential driving factors for the expansion of the health equity gap. 
In order to make appropriate and eﬀective treatment guidelines for SSD in African Americans 
and other ethnically marginalized communities, several factors must be investigated and 
addressed. 
 
The stigmatization of mental health disorders plays a direct role in delaying diagnosis and 
treatment, as individuals with mental health illnesses are less likely to seek help [8]. In 
addition to this, many ethnic minorities are hesitant to participate in medical studies or even 

seek medical attention for mental and physical illnesses due to a general mistrust of the 
healthcare system [9-11]. The negative beliefs surrounding medical care are a direct result of 
the historically unethical experimentation (HeLa cells, gynecological exploration), intentional 
neglect (Tuskegee Syphilis Study), and mistreatment of ethnic minorities and incarcerated 
populations (unethical sterilization) [12-16]. Dismantling this stigma and mistrust requires 
strategically intentional interventions in such populations and developing culturally 
competent healthcare providers is paramount. 
 
Access to medical care should also be examined, as it plays a large role in healthcare 
outcomes. Burra et al. highlighted how housing status was associated with resources at the 
time of discharge in patients on an inpatient psychiatric unit [17]. In comparison to housed 
individuals, homeless individuals had less resources and support and were less likely to have 
outpatient follow-up, case management, and coverage for prescription medications at time of 
discharge. Access can be influenced by several factors, including health literacy, 
socioeconomic status (SES), access to consistently reliable transportation and medical 
resources, distance to healthcare facilities, healthcare provider-to-patient ratios, access to 
childcare, and financial and social ability to take time away from work in order to receive 
consistent follow up, including psychotherapy and medication management. In areas where 
virtual treatment options are oﬀered, access to reliable resources (equipment, internet access, 
software, etc.) is necessary for adequate patient follow-up. 
 
Given that ethnic minorities often make up the majority of lower SES populations, it can also 
be postulated that their decreased understanding of disease processes, treatment options, and 
handling of adverse side eﬀects is a barrier to seeking and establishing care, as well as 
receiving continuity of care. Several studies have shown an association between low SES and 
higher risk of hospitalization and mortality in patients with schizophrenia when compared to 
individuals with higher SES [18, 19]. Further, poor health literacy regarding mental health is 
associated with lower SES [20]. 
 
Several studies have examined the associations between knowledge, medication adherence, 
and the use of educational programs in patients with schizophrenia [21,22,23]. The 
Knowledge About Schizophrenia Test (KAST) is a validated 18-item, multiple- choice test 
developed to assess knowledge about schizophrenia for research purposes [24]. While this 
test assessed knowledge in lay community members, caregivers of people with schizophrenia, 
police officers, and healthcare professionals, another study by Chan et al. used a modified 
version of the KAST specifically in patients diagnosed with schizophrenia spectrum disorders 
to investigate the association between patient knowledge, insight into illness, and medication 
adherence [25]. This study found that patients with higher KAST scores and more insight 
were more adherent to treatment. Other studies have focused on utilizing educational tools to 
improve quality of life and discovering which medium of educational resources is the most 
promising for enhancing knowledge in patients with schizophrenia [26,27,28]. Although such 
studies are significant in continuing the conversation about the impact of health literacy on 
medication adherence and overall quality of life in patients with mental illness, there is still a 
need for effective, easily accessible educational resources that can be used nationwide to 
assess and improve the healthcare literacy of patients with SSD. Further, most of the studies 
investigating educational interventions are carried out in the outpatient setting on presumably 
well-stabilized individuals. This study will evaluate the effects of providing these 
interventions to patients as they are recovering from acute exacerbations in the inpatient 

setting. Our study aims to develop a multimedia educational approach that involves a 
dedicated space for clinicians to identify and fill health literacy gaps, for the purposes of 
improving attitudes toward treatment and adherence. We plan to carry out a prospective study 
examining the eﬀect of providing culturally sensitive educational resources on the health 
literacy and attitude toward pharmacological treatment in patients with a new or prior 
diagnosis of schizophrenia spectrum disorder at University Medical Center in New Orleans, 
Louisiana. 
 
Health literacy will be assessed using the Knowledge About Schizophrenia Test (KAST). An 
assessment for attitudes toward treatment will be developed specifically for this study, with 
guidance from the Drug Attitude Inventory (DAI) and the Attitudes towards Neuroleptic 
Treatment (ANT), which was found to be useful in the quantitative assessment of attitudes 
before and after initiation of neuroleptic medication [29]. The National Alliance on Mental 
Illness (NAMI) will be used to guide the development of inpatient educational resources. 
 
We hypothesize that health literacy scores and attitude towards treatment will improve following 
educational intervention. A possible limitation of this study is the eﬀect of concomitant 
intellectual disability (ID) on an individual’s ability to comprehend the provided educational 
resources. Therefore, we plan to exclude patients with a documented history of intellectual 
disability and patients suspected to have intellectual disability based on clinical interactions. We 
also plan to follow up with participants monthly, where we will utilize tools such as the 
Medication Adherence Rating Scale (MARS) to provide further insight into adherence to 
treatment plans [30,31]. 
 
We believe the information provided from this study can be of great significance in 
strengthening the patient-provider relationship, building a community, and dissolving the stigma 
around mental health, while simultaneously empowering and encouraging patients to get more 
involved in their care. Due to the contribution of mental health literacy on healthcare outcomes, 
we believe such an intervention can prove to be unequivocal in decreasing the health equity gap 
in mental health disorders and beyond. At the minimum, it will provide necessary insight into the 
needs of this underserved and highly vulnerable population and guidance on navigating their 
treatment. 
 
Study Aims/Objectives 
a. 
Assess health literacy level as it relates to schizophrenia before and after 
provision of educational resources.  
b. 
Assess the attitude toward treatment of each patient before and after 
provision of educational resources. 
c. 
Create and provide inpatient educational resources in the form of 
audiovisual and textual infographics developed by the Louisiana State University 
Health Sciences Center- New Orleans, Department of Psychiatry. 
d. 
Collect and analyze patient- centered data, including age, gender, ethnicities, and 
highest level of education, to identify any trends in healthcare literacy as measured by 
the KAST across these demographics. 
 
Primary endpoints: Post- intervention KAST and ATT scores  
Secondary endpoints: MARS scores, KAST and ATT scores in relation to demographics (age, 

gender, ethnicity, highest level of education) collected   
 
Study Design 
Inclusion Criteria 
i. 
Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient 
behavioral health unit ages 18 and older with a new or previous diagnosis of 
schizophrenia spectrum disorder outside of substance use disorders  
ii. 
Patients must be proficient in English. 
iii. 
Patients must have a government issued social security number (required for 
reimbursement through the university). 
 
Exclusion Criteria 
i. 
Patients at UMCNO that are ages 17 or younger 
ii. 
Patients with SSD and concomitant intellectual disability, as evidenced by prior 
documented history on chart review or patients suspected to have intellectual disability or 
impairment based on clinical interactions  
iii. 
Patients with concomitant substance use and documentation of psychosis being resolved 
after a period of washout and without the use of psychotropic medications  
iv. 
Patients unable to complete health literacy assessments, attitude towards treatment 
assessments, and IQ testing due to severity of symptoms during hospitalization 
v. 
Patients that are not proficient in English 
vi. 
Patients that do not have a government issued social security number 
 
Study Assessments and Outcome Questionnaires 
 
The Knowledge about Schizophrenia Test (KAST): 
The KAST [24] is an 18-item multiple-choice test designed to measure knowledge about 
schizophrenia. The questions focus on knowledge of development, symptoms, treatments, and 
supporting information about schizophrenia.  
 
Attitudes towards Neuroleptic Treatment (ANT): 
The ANT [29] is a 12-item questionnaire assessing attitudes using a visual analogue scale form 
in which participants note their opinions on a scale of 0-100 for each statement. 
 
Drug Attitude Inventory (DAI): 
The Drug Attitude Inventory is a 30-item questionnaire assessing attitudes toward medication 
using a true-false format.  
 
Medication Adherence Rating Scale (MARS):  
The Medication Adherence Rating Scale [30] is a measurement tool for eliciting patients' 
reports of nonadherence. This study will use a 10-item version of the MARS [31].  
 
Study Methods 
 
Phase 1: Development of Educational Intervention Materials 
The LSU- Ochsner Department of Psychiatry, including staff, residents, and trainees will work 
collectively to develop the attitudes toward treatment questionnaire and the interventional 
educational resources that will be provided to the patients during Phase 3. Extensive efforts will 
be made to produce culturally sensitive and appropriate materials. In general, educational 

materials will be developed using language that is inclusive, clear to understand and avoids 
stigmatizing terms. When visual aids are used, they will reflect the diversity of the population 
served, in a respectful manner. Further, the language and visuals utilized in NAMI educational 
videos and online readings will be used as guidance on creating such material. 
 
The attitudes toward treatment (ATT) questionnaire will include approximately 20 items and will 
be developed using guidance from the Drug Attitude Inventory (DAI-10) and the Attitudes 
toward Neuroleptic Treatment (ANT) assessment. The educational video will be approximately 
5- 10 minutes, and the script will be developed using guidance from the National Alliance on 
Mental Illness (NAMI) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth 
Edition (DSM-V). The contents of the video will include the pathophysiology of SSD, as well as 
common symptoms along the spectrum, natural history, available treatment options and 
frequently associated adverse side effects. The educational pamphlet will be produced with 
guidance from NAMI and include similar content, reiterated in written form.   
 
Phase 2: Implementation of Educational Intervention 
Medical charts will be reviewed for patients in the UMCNO inpatient behavioral health unit 
that may qualify based on incoming symptom presentation. Once on the behavioral health 
unit, patients will receive the standard of care, including any necessary testing, medications, 
and therapeutic interventions. This will be provided regardless of insurance status. If patients 
have insurance, their insurance will be utilized to pay for costs associated with their 
hospitalization and they will be responsible for any applicable co-pays. For those patients 
who do not have insurance, case management staff will assist them in applying for insurance 
while in the hospital. If not approved, patients will be sent a bill for the charges associated 
with their hospitalization. It is also the standard of care to provide patients with at least a one-
month supply of their medications prior to discharge. For uninsured patients, there are 
several charity programs staff will utilize to obtain these medications at little to no cost to the 
patients.   
 
Once stabilized on the inpatient unit, patients will be approached for participation in the 
study, and consent will be obtained. Then, the clinician will approach the patient to assess 
participation in the educational portion of the study. If amenable, the clinician will then 
describe the process of the educational intervention phase, which is further described below. 
The patient will also be informed of the follow-up protocol at this time. If the patient is 
amenable, the clinician will take the patient to one of the quiet rooms on the inpatient units so 
that he or she may complete the required components. Participants will be given an 
assessment examining attitude toward treatment, as described in Phase 1. The Knowledge 
about Schizophrenia Test (KAST) will be administered to obtain a baseline health literacy 
score. This will represent Day 1 of the study. On Day 2 of the study, patients will sit with a 
healthcare provider one-on-one, and watch an educational video about SSD, as previously 
described in Phase 1. During this time, the healthcare provider will answer any questions. On 
Day 3, the educational pamphlet will be provided to the patient prior to the second 
psychoeducational meeting. On Day 4, attitude toward treatment and health literacy scores 
will be reassessed using the initial pre-intervention questionnaires. Please see the chart below 
for a schematic representation of the approximate timeline of events.  
 
These days are subject to change given the course of the patient’s hospitalization and any 
patient-specific barriers that prevent the collection of data. If a patient is unavailable or 
experiences an exacerbation or decompensation of their condition, the assessment or 

intervention will be postponed until the patient is able to participate. If a patient experiences 
suicidal ideation or thoughts of self-harm, this will be fully investigated by the healthcare 
provider to determine if intent and plan are present. Every effort will be made to protect 
patients from self-harm while on the unit. Depending on the severity (passive versus active), 
the educational resources or assessments may be postponed until the patient is able to resume 
participation.  
 
Of note, patients will be selected to carry out the KAST and ATT randomly by either of the 
resident physicians using a randomization tool. There will be 4 resident physicians carrying 
out the patient questionnaires and educational sessions. They will be assigned a number 1-4, 
which an excel- integrated tool will use to randomize which physician will administer the 
KAST and ATT questionnaires. The resident that will complete the next task will be the one 
assigned the next chronological number, and so on. For example, resident #2 is randomly 
selected to do the KAST and ATT questionnaires. Then, the resident assigned #3 will carry 
out the first educational session. This is to ensure the patient does not interact with a resident 
physician more than once while on the inpatient unit. Follow up calls will be carried out by 
either resident physician. Patient identities will be concealed from the individuals analyzing 
the data by using numerical identifiers.  
 
Patients will act as their own control, as their initial KAST and ATT questionnaires will 
serve as a baseline for which to compare future KAST and ATT questionnaires. At the end of 
each phase, the clinician will transfer the patient’s answers electronically into the dataset. 
Patients will be paid $50 through Clincards issued by the research team upon discharge from 
the hospital. Assessments and questionnaires will be carried out on paper, while the 
educational resources will be provided electronically via tablet.  
 
Procedures 
Day 1 
Day 2 
Day 3 
Day 4 
Months  
1 -12 
KAST 
X 
 
 
X 
 
ATT (ANT + DAI) 
X 
 
 
X 
 
Video  
 
X 
 
 
 
Psychoeducational  
Meeting 1 
 
X 
 
 
 
Educational Brochure  
 
 
X 
 
 
Psychoeducational  
meeting 2 
 
 
X 
 
 
Monthly follow up phone 
calls with MARS  
 
 
 
 
X  
 
 
Phase 3: Data Extraction  
This project will require approval from both the Louisiana Health Sciences Center-New 
Orleans Institutional Review Board and the University Medical Center- New Orleans Oﬃce 
of Research. A formal data request will be made to UMCNO with the needed information for 
data abstraction. Data metrics will be pulled from the UMCNO electronic medical record 

(EMR). Information that will be extracted from the electronic health record includes race, 
gender, ethnicity, age, mental health diagnosis, number of hospital admissions and 
Emergency room presentations, pharmaceutical agents prescribed, type of insurance, if any, 
housing status, and highest level of education achieved. This will occur once patients have 
been stabilized and consented to participate in the study. 
 
For further clarification on the proposed timeline:  
a. a. Recruitment: This will be an ongoing task from the start of the study, where 
prospective patients will be identified from the Behavioral Health Emergency 
Room (BHER) and BH inpatient units. Consent will be obtained when patients 
are stable. 
b. Administration of questionnaires, completion of educational interventions: Please 
see the proposed timeline table in the protocol. An exact timeline cannot be given, 
as events are contingent upon the patient’s ability to participate and thus will be 
different between individuals.  
c. Data collection will be ongoing and will last until the final follow-up data from 
the last patient is obtained.  
 
Follow up 
Patients will receive monthly follow-up calls that last approximately 5-10 minutes each. During 
these calls, they will be asked questions about medications, symptom control, and follow-up. A 
sample of questions is listed below. In addition, they will also be asked to provide answers to 
the questions listed on a modified version of the Medication Adherence Rating Scale (MARS). 
1. Are you taking any medications to manage your symptoms: yes/ no? 
2. How has that medication affected your symptoms: better/ worse/ no change?   
3. If you are no longer taking your medications, what is the reason: ASE/ unable to pay 
 
   for prescription/ unable to pick up prescription?  
4. If applicable, have you been going to the scheduled follow up visits with your  
 
   behavioral health provider: yes/ no? 
5. If you answered no to the previous question, what is the reason: transportation/ time 
 
   conflict/ forgot? 
6. Have you been admitted to a psychiatric facility since your last follow up call: yes/ 
 
   no?  
7. If so how many times: 1-3/ 3+? 
 

 
 
 Adverse Events  
This study does not anticipate adverse events beyond psychological discomfort as it relates to 
the awareness and processing of a newly diagnosed or established diagnosis of a mental health 
condition. However, all adverse events will be collected and reported in accordance with the 
safety event and quality reporting as outlined by Janssen. This will include adverse events (AE), 
serious adverse events (SAE) including lack of effect of pharmacological intervention, reports 
of drug exposure during pregnancy, and abnormal pregnancy outcomes. Definitions of adverse 
events and contact information are listed below: 
 
Adverse Event (AE) 
Any untoward medical event in a patient administered a pharmaceutical product which does not 
necessarily have to have a causal relationship with the treatment. An adverse event can be any 
unfavourable and unintended sign (including abnormal finding or lack of expected pharmacological 
action), symptom, or disease temporarily associated with the use of a medicinal (investigational or 
non-investigational) product, whether or not related to that (investigational or non-investigational) 
product. 
This includes any occurrence that is new in onset or aggravated in severity from the baseline condition, 
or abnormal results of any diagnostic procedures, including laboratory test abnormalities.  
Adverse Event of Special interest 
Adverse events of special interest are events that the Company is actively monitoring as a result of a 
previously identified signal (even if non-serious). There are no required Adverse events of special 
interest of paliperidone to be reported to the Company.  In case of any amendments to the AESI list, 
Company will notify the Investigator. Investigator will ensure that these changes are updated in the 
protocol as soon as practical.  

Serious Adverse Event (SAE) 
Any adverse event occurring that:  
Results in death  
Is life-threatening  
Requires in-patient hospitalization or prolongation of existing hospitalization  
Results in persistent or significant disability/incapacity  
Is a congenital anomaly/birth defect  
Any suspected transmission of any infectious agent via administration of a medicinal product   
Is considered medically significant* 
 
*Any untoward medical occurrence that is considered medically significant. Medical and scientific 
judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, 
such as important medical events that may not result in death, be life-threatening or require 
hospitalization but may be considered a serious adverse drug experience when, based on appropriate 
medical judgement, that may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the other outcomes listed in the bulleted list above. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an emergency room or 
at home, blood dyscrasias or convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse or malignancy. 
Hospitalization 
For reports of hospitalization, it is the sign, symptom or diagnosis which led to hospitalization that is 
the serious event for which details must be provided. Any event requiring hospitalization or 
prolongation of hospitalization that occurs during a study must be reported as a serious adverse event, 
except hospitalizations for the following: 
Hospitalizations not intended to treat an acute illness or adverse event (e.g., social reasons such as 
pending placement in long-term care facility) 
Surgery or procedure planned before entry into a study. [Note: Hospitalizations that were planned 
before the signing of ICF and where the underlying condition for which the hospitalization was 
planned has not worsened will not be considered serious adverse events. Any adverse event that 
results in a prolongation of the originally planned hospitalization is to be reported as a new serious 
adverse event.] 
Special Situations 
The following special situations must be reported to Company with or without an associated serious 
adverse event (SAE): 
Drug exposure during pregnancy (paternal, maternal) 
Suspected transmission of any infectious agent via administration of a Janssen Product(s) under 
study. 
 
These safety events may not meet the definition of an adverse event; however, the Parties agree that for 
reporting purposes, they are deemed to be adverse events. 
Product Quality Complaints 
A PQC may have an impact on the safety and efficacy of a Company product. Timely, accurate, and 
complete reporting and analysis of PQC information from studies are crucial for the protection of 
patients, investigators, and the Company, and are mandated by regulatory agencies worldwide. The 
Company has established procedures in conformity with regulatory requirements worldwide to ensure 

appropriate reporting of PQC information. The Institution agrees that Lot and/or Batch #s shall be 
collected, when available, for all PQC reports, including reports of failure of expected pharmacological 
action (i.e., lack of effect) of a Janssen Medicinal Product. A sample of the suspected product shall be 
maintained for further investigation if requested by the Company. Any complaint that indicates a 
potential quality issue during manufacturing, packaging, release testing, stability monitoring, dose 
preparation, storage or distribution of the product or delivery system is considered a PQC. Not all 
PQCs involve a patient.  
Examples of PQC include but are not limited to: 
Mislabelling or misbranding   
Information concerning microbial contamination, including a suspected transmission of any 
infectious agent by a product 
Any significant chemical, physical, or other changes that indicate deterioration in the distributed 
product 
Any foreign matter reported to be in the product 
Mixed product, e.g., two drugs are mixed-up in the packaging process 
Incorrect tablet sequence (e.g., oral contraceptive tablets) 
Insecure closure with serious medical consequences, e.g., cytotoxics, child-resistant 
containers, potent drugs 
Suspected counterfeit or tampered product 
Adverse Device Effects including any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, implantation, installation, operation, 
or any malfunction of a medical device or combination product. This also includes any event 
that is a result of a use error or intentional misuse and dosing device malfunctions (e.g., auto-
injector button not working, needle detaching from syringe, etc.) 
Physical defect (e.g., abnormal product odor, broken or crushed tablets, etc.) 
“Extraordinary” correspondence 
Correspondence with a regulatory authority or ethics committee regarding a safety issue that may 
impact the safety or benefit-risk balance of the Janssen Product(s) Under Study, and/or may impact 
patients or public health. Examples include: 
Safety issues relating to a quality defect 
Major safety issues identified with changes in the nature, severity or frequency of known serious 
adverse reactions which are medically significant or the detection of new risk factors for the 
development of a known adverse reaction or a new serious adverse reaction. 
Major safety issues identified in the context of ongoing or newly completed post-marketing studies 
e.g., an unexpected increased rate of fatal or life-threatening adverse events. 
 
Type of report 
Timelines 
How to report 
Serious Adverse Event 
 
Within 15 calendar days of 
becoming aware of the 
event(s)  
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 
Adverse Events of Special 
Interest (AESI) 
Within 15 calendar days of 
becoming aware of the 
event(s)  
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 

Reports of drug exposure 
during pregnancy (maternal 
and paternal), with or 
without SAE. 
Within 15 calendar days of 
becoming aware of the 
event(s)  
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 
Reports of Suspected 
transmission of any 
infectious agent via 
administration of a Janssen 
Product, with or without an 
SAE 
Within 15 calendar days of 
becoming aware of the 
event(s)  
 
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 
Abnormal Pregnancy 
Outcomes (e.g. spontaneous 
abortion, fetal death, 
stillbirth, congenital 
anomaly, ectopic pregnancy) 
Within 15 calendar days of 
becoming aware of the 
event(s)  
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 
Lack of Effect (with or 
without a suspected adverse 
reaction), must be reported 
as an SAE.  
Within 15 calendar days of 
becoming aware of the 
event(s).  
By a secure means, as 
agreed by the Parties, on a 
Serious Adverse Event 
Form. 
Product Quality Complaints 
Within 3 business days of 
becoming aware of the 
event(s)  
 
By a secure means, as 
agreed by the Parties. 
Non-Serious Adverse Event* 
(*Not meeting other listed 3 
business 
day 
reporting 
criteria e.g. AESI) 
Annually and in final study 
report. 
Recorded in CRF and 
reported annually and in 
final study report. 
Follow-up information 
Transmitted 
within 
the 
same timeframes as above 
i.e. if initial report was 
required to be submitted 
within 15 calendar days, 
follow-up information shall 
be submitted within the 
same timeframe.  
Transmitted 
via 
same 
method as above i.e. if 
initial 
method 
of 
transmission was on an 
SAE 
form, 
follow-up 
information 
shall 
be 
transmitted in the same 
manner. 
 
 
Janssen SAE/Pregnancy Notifications 
TO: GMS_AE_Inbo@its.jnj.com 
Please note the underscores (_) in the email name this is 
critical to highlight as if its missing then the SAE will fail 
to transmit. 
CC: Janssen SRS/SRP and Clinical Project Scientist 

Janssen PQC:  
DL-DPYIE-Globalcontacts-NIS@its.jnj.com 
CC: Janssen SRP/CPS  
Janssen Fax: 
1-215-293-9955 
 
 
  Statistical analysis 
A power analysis resulted in the two possible sample sizes as shown below:  
 
An a priori power analysis was performed using g*power to estimate sample size for a 
paired sample t-test. Using a small effect size (d=.2), power of 80% (alpha of .05), the 
desired sample size is 199.  
An a prior power analysis was performed using g*power to estimate sample size for a 
paired sample t-test. Using a medium effect size (d=.5), power of 80% (alpha of .05), the 
desired sample size is 34. 
Per literature review, studies with educational interventions in patients with SSD had sample 
sizes ranging from 20s to several hundreds. None of the studies provided information on power 
analysis calculations or how sample size was obtained. Given that we will not have access to 200 
patients with schizophrenia spectrum disorders at the study site within the time frame of the 
study, we have chosen to use the former power analysis.   
 
 
To assess changes in knowledge and attitudes, a paired samples t-test will be completed on 
pre-intervention and post-intervention scores for the KAST and ATT. Demographic data will 
be analyzed using regression analysis. 
 
 
Data Collection and Storage 
Each study participant will be given an arbitrary study identification number. The study ID 
number will be used on all data collected for the purposes of this study. All assessments and 
questionnaires for this study will be entered using a tablet into the REDCAP system, a secure 
and HIPAA compliant web-based system provided through LSUHSC- New Orleans for data 
collection. Permission to access the project’s Research Electronic Data Capture (REDCAP) 
program must be approved by an investigator or study coordinator. Participants and linking 
study identification numbers will be kept in a database outside of the REDCAP system on the 
LSUHSC-NO secure network drive in a folder that can only be accessed by individuals given 
permission by the primary investigator and study coordinator. This information will also be 
protected by a password only known to the study personnel. Informed consent forms will be 
kept in individual participant files which will be in locked file cabinets in a locked door. 
 
Data extracted from the medical records will also be given an arbitrary study ID. This data will 
be collected using the REDCAP system. To track patient data that has been retrieved, a 
separate database will be kept on the LSUHSC-NO network drive linking the patient’s medical 

requisition number with the arbitrary study ID. This database will also be protected by a 
password only known to study personnel. 
 
After the data has been analyzed and the study closed, data will be destroyed in compliance 
with LSUHSC-NO Institutional Review Board requirements. 
 
Citations 
1. Coleman, K. J., Stewart, C., Waitzfelder, B. E., Zeber, J. E., Morales, L. S., Ahmed, 
A. T., Ahmedani, B. K., Beck, A., Copeland, L. A., Cummings, J. R., Hunkeler, E. 
M., Lindberg, N. M., Lynch, F., Lu, C. Y., Owen-Smith, A. A., Trinacty, C. M., 
Whitebird, R. R., & Simon, G. E. (2016). Racial-Ethnic Diﬀerences in Psychiatric 
Diagnoses and Treatment Across 11 Health Care Systems in the Mental Health 
Research Network. Psychiatric services (Washington, D.C.), 67(7), 749–757. 
https://doi.org/10.1176/appi.ps.201500217 
2. Alegría, M., Chatterji, P., Wells, K., Cao, Z., Chen, C. N., Takeuchi, D., Jackson, J., 
& Meng, X. L. (2008). Disparity in depression treatment among racial and ethnic 
minority populations in the United States. Psychiatric services (Washington, D.C.), 
59(11), 1264–1272. https://doi.org/10.1176/ps.2008.59.11.1264 
3. Zhang, S., Cain, D. S., & Liao, M. (2021). Racial/Ethnic Disparities in the Decision 
Points of Mental Health Service Use and Psychotropic Medication Receipt among 
Depressed Youth. Youth & Society, 53(4), 610–635. 
4. Institute of Health Metrics and Evaluation. Global Health Data Exchange (GHDx), 
(https://vizhub.healthdata.org/gbd-results/, accessed 14 May 2022). 
5. van Hooijdonk, C. F. M., van der Pluijm, M., Bosch, I., van Amelsvoort, T. A. M. 
J., Booij, J., de Haan, L., Selten, J.-P., & Giessen, E. van de. (2023). The substantia 
nigra in the pathology of schizophrenia: A review on post-mortem and molecular 
imaging findings. European Neuropsychopharmacology, 68, 57–77. https://doi-
org.ezproxy.lsuhsc.edu/10.1016/ j.euroneuro.2022.12.008 
6. Schwartz RC, Blankenship DM. Racial disparities in psychotic disorder diagnosis: 
A review of empirical literature. World J Psychiatry. 2014 Dec 22;4(4):133-40. doi: 
10.5498/ wjp.v4.i4.133. PMID: 25540728; PMCID: PMC4274585. 
7. Gara, M. A., Minsky, S., Silverstein, S. M., Miskimen, T., & Strakowski, S. M. 
(2019). A Naturalistic Study of Racial Disparities in Diagnoses at an Outpatient 
Behavioral Health Clinic Psychiatric services (Washington, D.C.), 70(2), 130–134. 
https://doi.org/10.1176/ appi.ps.201800223 
8. Cheng, H.-L., Kwan, K.-L. K., & Sevig, T. (2013). Racial and Ethnic Minority 
College Students’ Stigma Associated with Seeking Psychological Help: Examining 
Psychocultural Correlates. Journal of Counseling Psychology, 60(1), 98–111. 
9. Dean, L. T., & Smith, G. S. (2021). Examining the Role of Family History of Us 
Enslavement in Health Care System Distrust Today. Ethnicity & Disease, 31(3), 
417–424. 
10. Whaley, A. L. (2001). Cultural Mistrust: An Important Psychological Construct for 
Diagnosis and Treatment of African Americans. Professional Psychology: Research 
& Practice, 32(6), 555. https://doi-org.ezproxy.lsuhsc.edu/10.1037/0735-
7028.32.6.555 
11. Hamilton, L. A., Aliyu, M. H., Lyons, P. D., May, R., Swanson, C. L., Jr, Savage, 
R., & Go, R. C. P. (2006). African-American community attitudes and perceptions 
toward schizophrenia and medical research: an exploratory study. Journal of the 

National Medical Association, 98(1), 18–27.  
12. Beskow, L. M. (2016). Lessons from HeLa Cells: The Ethics and Policy of 
Biospecimens. Annual Review of Genomics and Human Genetics, 17, 395–417. 
https://doi- org.ezproxy.lsuhsc.edu/10.1146/annurev-genom-083115-022536 
13. Prunty, M., Bukavina, L., & Hallman, J. C. (2021). Anarcha, Lucy, and Betsey: The 
Mothers of Modern Gynecology. Urology, 157, 1–4. https://doi-
org.ezproxy.lsuhsc.edu/ 10.1016/j.urology.2021.06.048 
14. Freimuth, V. S., Cole, G., Duncan, T., Quinn, S. C., Thomas, S. B., & Zook, E. 
(2001). African Americans’ views on research and the Tuskegee Syphilis study. 
Social Science and Medicine, 52(5), 797–808. https://doi-
org.ezproxy.lsuhsc.edu/10.1016/S0277-9536(00)00178-7 
15. Sharp HC. Vasectomy as a means of preventing procreation in defectives. J Am 
Med Assoc 1909;53(23):1897–902.doi:10.1001/jama.1909.92550230009002e 
pmid:http://www- ncbi-nlm-nih-gov.ezproxy.lsuhsc.edu/pubmed/12334406 
16. Kluchin RM. Fit to be tied: sterilization and reproductive rights in America, 1950-
1980. New Brunswick, N.J: Rutgers University Press, 2009 
17. Burra, T. A., Hwang, S. W., Rourke, S. B., & Stergiopoulos, V. (2012). Homeless 
and Housed Inpatients with Schizophrenia: Disparities in Service Access upon 
Discharge from Hospital. International Journal of Mental Health and Addiction, 
10(5), 778–789. 
18. Goldberg, S., Davidson, M., Weiser, M., Fruchter, E., Reichenberg, A., & Yoﬀe, R. 
(2011). The relationship between risk of hospitalization for schizophrenia, SES, and 
cognitive functioning. Schizophrenia Bulletin, 37(4), 664–670. https://doi-
org.ezproxy.lsuhsc.edu/ 10.1093/schbul/sbr047 
19. Tsai, K.-Y., Chung, T.-C., Lee, C.-C., Chou, Y.-M., Su, C.-Y., Shen, S.-P., Lin, C.-
H., & Chou, F. (2014). Is low individual socioeconomic status (SES) in high-SES 
areas the same as low individual SES in low-SES areas: a 10-year follow-up 
schizophrenia study. Social Psychiatry & Psychiatric Epidemiology, 49(1), 89–96. 
https://doi-org.ezproxy.lsuhsc.edu/ 10.1007/s00127-013-0716-9 
20. von dem Knesebeck, O., Mnich, E., Daubmann, A., Wegscheider, K., Angermeyer, 
M., Lambert, M., Karow, A., Härter, M., & Kofahl, C. (2013). Socioeconomic status 
and beliefs about depression, schizophrenia and eating disorders. Social Psychiatry 
& Psychiatric Epidemiology, 48(5), 775–782. https://doi-
org.ezproxy.lsuhsc.edu/10.1007/s00127-012-0599-1 
21. Ascher-Svanum, H., & Whitesel, J. (1999). A randomized controlled study of two 
styles of group patient education about schizophrenia. Psychiatric Services, 50(7), 
926–930. https://doi.org/10.1176/ps.50.7.926   
22. McIlroy, M. L. (2018). Medication Adherence Among Patients with Schizophrenia 
and Schizoaffective - Bipolar Type Disorder: A Clinical Education Approach to 
Improve Medication Compliance. Medication Adherence Among Patients With 
Schizophrenia & Schizoaffective - Bipolar Type Disorder: A Clinical Education 
Approach To Improve Medication Compliance, 1.   
23. Puspitosari, W. A., & Rahma, V. A. (2024). The effectiveness of psychoeducation 
by health workers at primary health center on medication adherence for people with 
schizophrenia. AIP Conference Proceedings, 3155(1), 1–7. 
https://doi.org/10.1063/5.0218071   
24. Compton, M. T., Quintero, L., & Esterberg, M. L. (2007). Assessing knowledge of 
schizophrenia: Development and psychometric properties of a brief, multiple-choice  
knowledge test for use across various samples. Psychiatry Research, 151(1–2), 87–

95. https:// doi-org.ezproxy.lsuhsc.edu/10.1016/j.psychres.2006.05.019  
25. Chan, K. W. S., Hui, L. M. C., Wong, H. Y. G., Lee, H. M. E., Chang, W. C., & 
Chen, Y. H. E. (2014). Medication adherence, knowledge about psychosis, and 
insight among patients with a schizophrenia-spectrum disorder. Journal of Nervous 
and Mental Disease, 202(1), 25–29. https://doi-
org.ezproxy.lsuhsc.edu/10.1097/NMD.0000000000000068 
26. Laine, A., Välimäki, M., Pekurinen, V., Anttila, M., Löyttyniemi, E., & Marttunen, 
M. (2019). Feasibility, acceptability, and preliminary impacts of web-based patient 
education on patients with schizophrenia spectrum disorder: Quasi-experimental 
cluster study. Journal of Medical Internet Research, 21(10). https://doi-
org.ezproxy.lsuhsc.edu/10.2196/13073 
27. Pitkänen, A., Välimäki, M., Kuosmanen, L., Katajisto, J., Koivunen, M., Hätönen, 
H., Patel, A., & Knapp, M. (2012). Patient education methods to support quality of 
life and functional ability among patients with schizophrenia: a randomised clinical 
trial. Quality of Life Research, 21(2), 247–256. 
28. Mishra, A., Sai Krishna, G., Sravani, A., Kurian, T. D., Kurian, J., Ramesh, M., & 
Kishor, M. (2017). Impact of pharmacist-led collaborative patient education on 
medication adherence and quality of life of schizophrenia patients in a tertiary care 
setting. Bulletin of Faculty of Pharmacy, Cairo University, 55(2), 345–349. 
https://doi.org/10.1016/j.bfopcu.2017.08.001   
29. Kampman, O., Lehtinen, K., Lassila, V., Leinonen, E., Poutanen, O., & Koivisto, 
A.-M. (2000). Attitudes towards neuroleptic treatment: Reliability and validity of 
the Attitudes towards Neuroleptic Treatment (ANT) questionnaire. Schizophrenia 
Research, 45(3), 223–234. https:// doi-org.ezproxy.lsuhsc.edu/10.1016/S0920-
9964(99)00204-2 
30. Chan, A. H. Y., Horne, R., Hankins, M., & Chisari, C. (2020). The Medication 
Adherence Report Scale: A measurement tool for eliciting patients’ reports of 
nonadherence. British Journal of Clinical Pharmacology, 86(7), 1281–1288. 
https://doi.org/10.1111/bcp.1419 
31. Sowunmi, O., & Onifade, P. (2019). Psychometric evaluation of medication 
adherence rating scale (MARS) among Nigerian patients with schizophrenia. 
Nigerian Journal of Clinical Practice, 22(9), 1281–1285. 
https://doi.org/10.4103/njcp.njcp_325_18