Utilization and Utility of Patient After-Visit Instructions at a University Rheumatology Outpatient Clinic: Status and Randomized Prospective Pilot Intervention Study
Phase: NA
Conditions: After Visit Instructions, Patient Education, Teach-Back Communication, Patient Comprehension
Sponsor: Rush University Medical Center

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Study Protocol w/ Statistical Analysis Plan 
Last Updated 10/17/2022 
 
 

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1) Protocol Title 
Optimizing After Visit Instructions in an Outpatient Academic Rheumatology Clinic: A 
Prospective Randomized Open Label Trial 
2) Objectives 
The aim of this study is to assess the quality of standardized after visit instructions (AVI) and 
patient teach back in an outpatient academic rheumatology clinic by measuring patient 
retention of disease management and overall patient satisfaction. We propose a prospective 
randomized open label trial to determine if the presence of optimized and standardized 
discharge processes lead to better comprehension and retention of a patient’s management 
plan.  
Primary outcome will be level of retention based on the Follow-up Telephone Protocol. 
Secondary outcomes assessed will include level of patient satisfaction based on our Post 
visit Survey and after visit instructions meeting patients’ health literacy levels measured from 
the REALM-A. 
3) Background 
Patient education is an essential aspect of administering high quality care. How well 
patients understand their diagnoses and implement their plan of care is based on a 
multitude of factors that can drastically impact disease outcomes.1,2 One of the key social 
determinants that affects a patients ability to comprehend and act on their medical 
conditions is health literacy (HL). The Center for Disease Control (CDC) defines two 
different types of HL in their updated Healthy People 2030 initiative. Personal HL is “the 
degree to which individuals have the ability to find, understand, and use information and 
services to inform health-related decisions and actions for themselves and others”. 
Organizational HL is “the degree to which organizations equitably enable individuals to find, 
understand, and use information and services to inform health-related decisions and action 
for themselves and others”. These new definitions of HL now acknowledge that 
organizations have a responsibility, from a public health perspective, to address HL and 
optimize their approach to varying levels of personal HL.3   
In 2003 the National Assessment of Adult Literacy (NAAL) preformed a large-scale survey 
of both literacy and HL. It showed that 36% of adults had basic or below basic HL skills. Of 
the patients that had the lowest health literacy they tended to be older than 65 years old, 
hispanic or black, male, less than a high school education, and at or below the poverty line.4 
Low HL has been linked to poor health outcomes including in rheumatic diseases such as 
rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).5,6 Various studies have 
been performed assessing literacy rates in rheumatology clinics utilizing the tool, the Rapid 
Estimate of Adult Literacy in Medicine (REALM).  These studies have shown that a range of 
10.3% to 19% of patients, within rheumatology clinics, have less than a 9th grade reading 
level.7-9 Various strategies have been implemented to address the need for improving 
patients understanding of their medical conditions and management. The American Medical 
Association and the National Institute of Health have recommended that medical information 
be written at a 6th grade level. 10 However a recent study looking at the medical information 
sheets for common rheumatologic drugs from prominent rheumatology organizations in 
Canada, the UK, and Australia, consistently showed readability scores higher than the 9th 

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grade level.11 The “teach-back” (TB) method, where patients repeat in their own words, 
instructions from the provider is a strategy used to bridge gaps in health literacy. In the 
emergency room setting TB has been shown to lead to less revisits and better retention of 
instructions.12 Teach back communication in rheumatology clinics has been shown to 
improve overall medication compliance.13 In the emergency room setting studies have 
shown that simplified and standardized after visit instructions can help increase patients 
overall understanding of their ER visit.14 
An initial retrospective study showed us that written AVI were an underutilized resource in 
the Rush University Medical Center Rheumatology Clinic (RUMCRC). This retrospective 
assessment also showed that patients with more medications, higher comorbidity, and 
learning preferences that favor written AVI, did not receive more AVI. 
For this study we seek to implement various strategies in an academic outpatient 
rheumatology setting that will address gaps in health literacy. These will include simple, 
standardized discharge instruction and patient teach back. With these strategies 
implemented, we will assess patients’ retention of knowledge and comprehension of 
medical instructions. We will also determine the feasibility of implementing these strategies 
in a rheumatology clinic in terms of time. Long-term studies will analyze how these 
interventions may have impacted various health related outcomes and patient reported 
outcomes.  
4) Inclusion/Exclusion Criteria  
Inclusion Criteria  
- 
Age > 18 yo 
- 
Patients seen in the RUMCRC  
Exclusion Criteria  
- 
Tele-medicine visits  
- 
English is not the primary language. This is due to inability of all providers to provide 
custom AVI due to language limitations  
 
5) Procedures Involved 
There will be three cohorts in total: the control group, the standardized AVI only group, and 
the standardized AVI with teach back group. The control group will involve patients 
receiving the current standard discharge process at the RUMCRC. The standardized AVI 
only group will involve patients receiving written standardized AVI that the patients will take 
home. The standardized AVI with teach back group will include standardized written AVI 
with the patient repeating to the provider which changes, and future management had been 
agreed upon during the visit. The standardized AVI will include a text template that 
providers will use to write customized after visit instructions for the patient that will be in 
addition to the after-visit summary.  
Providers will be taught the standardized discharge approach through in-person education 
modules and handouts. This education will encompass a 30 minute didactic going over the 
tenants of the standardized AVI, accessing standardized AVI templates on EMR, and how 

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to preform appropriate teach back with patients. No providers that are implementing the 
intervention will be a part of the research team.  
Patients will be randomized before the office visit. Patients will not be told which group they 
are in unless they explicitly ask. Providers will be told which intervention group a patient is a 
part of. If a patient is in the control group the providers will not be informed as to not impact 
behavior. Because of the randomization we believe confounding variables will be distributed 
equally throughout the groups. 
All patients included in the prospective study will complete an arthritis adapted REALM 
(REALM-A) form at the observed visit to evaluate their health literacy level. All patients 
included in the prospective study will also complete an immediate post appointment 
questionnaire (Post Visit Satisfaction Survey) that will allow them to provide feedback, rate 
visit satisfaction, and evaluate how after visit instructions were implemented during the visit. 
Within 1-2 weeks after the patient’s initial visit, a standardized phone call will be performed 
where patients will be asked specific questions pertaining to their visit in terms of diagnosis, 
medications, plan, and follow-up appointments. We will score whether their understanding of 
their disease and management corresponds with what was discussed at the prior visit. This 
will be performed for all groups. This score will be assessed as our primary outcome.  
Baseline data points will be collected for patients in both cohorts including: Basic 
demographics, new patients versus follow-up visit, MD-HAQ scores, REALM-A score, 
rheumatologic diagnosis, medications, Charleson co-morbidity scores, barriers to learning, 
and patient preferences for learning.  
After the study, AVI provided will be assessed using Flesch-Kincaid Readability Scores and 
Grade levels to see how they correspond to patients baseline literacy.  
6) Data Management  
Summary tables (descriptive statistics and/or frequency tables) will be provided for all 
variables. Continuous variables will be summarized with descriptive statistics (n, mean, 
standard deviation, range, and median). Ninety-five (95) percent confidence intervals may 
also be presented, as appropriate.  
 
Frequency counts and average will be provided for categorical data. 
 
Data will be coded when stored for analysis. Data that is obtained for this study will be 
coded when stored for analysis. This data will be held under password locked computers 
that can only be accessed by persons who have approval for access via the IRB. Those that 
have access to the coded data will require a key to interpret the data. All data will be deleted 
at the completion of the study. 
7) Risks/Benefits 
Given the nature of intervention there is little to no risk in terms of patient outcomes. This 
study will collect private, identifiable information about human subjects. The main risk is to 

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subjects’ confidentiality should an individual outside of the study team access the study 
data.  
 
Benefits of this study, particularly in the intervention cohort, would be the potential for 
improved patient comprehension and retention of various aspects of their health.  
 
8) Resources Available 
REDCAP will be utilized to store and analyze data. SPSS will be utilized to perform 
statistical analysis.  
Joshlean Faire a clinical research coordinator at the RUMC Division of Rheumatology will 
assist with the consent process and recruitment process. 
9) Confidentiality  
Data will be stored under password protection with coded data on laptops owned by Dijo 
Joseph  
Data will only be accessible by those that are directly involved with obtaining data 
10) Consent Process 
Patients will be contacted with permission from their primary providers prior to their 
scheduled visit to discuss their voluntary participation in the study. If they agree to 
participate informed consent will be completed over the telephone and documents will be 
reviewed and signed electronically. If this is not feasible, they will be instructed to arrive 30 
minutes early to their appointment to perform an in person consent. During this period they 
will sign a corresponding consent form outlining the risks/benefits and procedures of this 
study. 
 
 
 
 
 
 
 
 
 
 
 
 

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References 
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adults: relation between literacy and health status among persons with low literacy 
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Habermann, E. B., Jenkins, D. H., Heller, S. F., Schiller, H. J., & Zielinski, M. D. (2019). 
Enhanced readability of discharge summaries decreases provider telephone calls and 

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