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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients received standard after visit procedure based on the provider | |
| Standardized After Visit Instructions Only | Experimental | The standardized after visit instructions (AVI) only group included patients receiving typed standardized AVI which included a text template that providers used to write customized AVI for the patient. |
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| Standardized After Visit Instructions & Teach Back | Active Comparator | The standardized AVI & teach back (TB) group included standardized written AVI with the patient repeating to the provider which changes and future management had been agreed upon during the visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized After Visit Instructions Only | Behavioral | The intervention took a standardized approach to after visit instructions which included a customizable template that would review patients conditions, changes in any medications, and any future labs, imaging, or referrals. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comprehension Survey | This is a telephone survey that will assess patients comprehension of disease over three main categories: disease state, medication changes, and referral/imaging/lab requests. Each category will be measure concordance of the patients understanding with what was written in the note in the form of a percentage from 0% to 100%. A higher percentage means a better understanding of ones disease. | 1-2 weeks after initial visit |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey | Patient satisfaction will be assessed through a in person or email survey that will assess multiple elements of satisfaction. A higher score indicates a higher level of satisfaction. | Will receive in email or in person immediately after initial visit |
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Inclusion Criteria:
- Patients seen in the Rush University Medical Center Rheumatology Clinic
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sobia Hassan, MD | Rush University Medical Center Associate Professor Rheumatology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center Division of Rheumatology | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2022 | Aug 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2022 | Aug 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064871 | Teach-Back Communication |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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| Standardized After Visit Instructions & Teach Back | Behavioral | This intervention included the Standardized After Visit Instructions and included teach back, a process by which patients restate in their own words their understanding of their condition, what was discussed in the visit, and what potential changes were made |
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