Clinical trial NCT06021730: Impact of After Visit Instructions on Patient Comprehension
Official title: Utilization and Utility of Patient After-Visit Instructions at a University Rheumatology Outpatient Clinic: Status and Randomized Prospective Pilot Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: After Visit Instructions
Patient Education
Teach-Back Communication
Patient Comprehension
Keywords: After Visit Summary
Readability
REALM
A-REALM
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This prospective study aims to analyze the influence of standardized after visit instructions (AVI) and teach back (TB) method on patients' understanding of health information. The study divided routine clinic patients into three groups: standard care, standardized AVI, and standardized AVI with TB. Patient health literacy, satisfaction, and AVI comprehension were gauged through surveys and post-visit follow-up calls. The investigators hypothesized that there would be an improvement in patient comprehension with the standardized AVI or TB when compared to controls.

Detailed description: This study seeks to investigate the discharge practices of the Rheumatology clinic and analyze whether variations in these practices impact patient satisfaction, enhance their comprehension of their disease, and potentially influence the progression of their condition. Participants agreeing to take part in this study will be engaged for a duration of up to three (3) weeks, encompassing two study visits-one during their regular clinic appointment and another through a telephone study visit.

During the initial in-person visit, participants will complete a health literacy survey before their appointment and a satisfaction survey afterward. Approximately 1-2 weeks following the in-person visit, participants will receive a telephone call to respond to questions regarding their visit. More details of the study are outlined below.

Prior to commencing the study, participants will be asked to provide their consent by signing a form indicating their willingness to take part. The participants will then be randomly allocated to one of three study groups: the Control Group, the After Visit Instructions (AVI) Group, or the AVI with teach back (TB) group.

Throughout the course of the study, participants will engage in various activities. First, they will complete a health literacy form, designed to assess their familiarity with commonly used terms in rheumatology clinics. This will take place prior to the standard clinic visit and is expected to last around 5 minutes.

During the regular clinic visit, participants will follow different protocols based on their assigned group:

* Participants in the Control Group will experience their usual clinic visit.
* Those in the AVI Group will receive a personalized set of After Visit Instructions (AVI) that detail any changes in their care. This additional interaction is anticipated to last approximately 2 minutes.
* Individuals in the AVI with TB Group will be asked to explain, in their own words, the modifications made during their visit. This interaction is expected to take an extra 1 minute.

After the clinic visit, all participants will complete a satisfaction survey, assessing both the provider's performance and their contentment with the discharge process. This survey is estimated to take around 3 minutes to complete.

During the follow-up period, participants will receive a phone call 1-2 weeks after their clinic visit to respond to inquiries regarding their appointment experience and the discharge process. This telephone interview is anticipated to take around 10 minutes and aims to gather valuable insights.

Furthermore, foundational data will be extracted from participants' electronic medical records. This information will encompass details such as gender, date of birth, ethnicity, race, specific disease information, ongoing medications, and data from forms filled out before each visit that provide a comprehensive view of disease activity.

This study incorporates medical data from electronic medical records while ensuring confidentiality. Risks include potential loss of privacy, although safeguards are implemented. The study may extend the clinic visit by a maximum of 15 minutes, with no other anticipated risks.

Potential benefits include enhanced discharge practices, including standardized AVI templates and the "teach back" method, which could improve disease comprehension and management adherence. However, responses to interventions can vary, so outcomes cannot be pre-determined.

Participation in the control group offers no anticipated benefits. This study is not a treatment study, and the only alternative to participation is non-participation.

Eligibility criteria: Inclusion Criteria:

- Patients seen in the Rush University Medical Center Rheumatology Clinic

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

Primary outcomes:
measure: Patient Comprehension Survey
timeFrame: 1-2 weeks after initial visit
Secondary outcomes:
measure: Patient Satisfaction Survey
timeFrame: Will receive in email or in person immediately after initial visit
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center Division of Rheumatology
state: Illinois
Study officials:
affiliation: Rush University Medical Center Associate Professor Rheumatology Department
name: Sobia Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: