Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06021730 |
Other study ID # |
22072004 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 1, 2022 |
Est. completion date |
May 12, 2023 |
Study information
Verified date |
September 2023 |
Source |
Rush University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.