After Visit InstructionsNCT06021730
Impact of After Visit Instructions on Patient Comprehension
A study testing Standardized After Visit Instructions Only and Standardized After Visit Instructions & Teach Back in people with After Visit Instructions and Patient Education, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- After Visit Instructions, Patient Education, Teach-Back Communication
- What is being tested?
- Standardized After Visit Instructions Only and Standardized After Visit Instructions & Teach Back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seen in the Rush University Medical Center Rheumatology Clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center Division of Rheumatology
Chicago, Illinois, 60612
About this study
Official title: Utilization and Utility of Patient After-Visit Instructions at a University Rheumatology Outpatient Clinic: Status and Randomized Prospective Pilot Intervention Study
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.
Read the 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.
- Conditions
- After Visit Instructions, Patient Education, Teach-Back Communication, Patient Comprehension
- Being tested
- Standardized After Visit Instructions Only, Standardized After Visit Instructions & Teach Back
- Keywords
- After Visit Summary, Readability, REALM, A-REALM
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized After Visit Instructions OnlyBehavioural
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.
Standardized After Visit Instructions & Teach BackBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standardized After Visit Instructions Only |
| 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. Receives: Behavioral: Standardized After Visit Instructions & Teach Back |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 weeks after initial visit
Secondary outcomes (1)
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.
Measured: Will receive in email or in person immediately after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Dec 2022
- Primary completion28 Apr 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for After Visit InstructionsStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sobia Hassan, MD, Principal investigator, Rush University Medical Center Associate Professor Rheumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021730
- Sponsor's protocol ID
- 22072004
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization and Utility of Patient After-Visit Instructions at a University Rheumatology Outpatient Clinic: Status and Randomized Prospective Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT06021730
- Acronym / sponsor ID
- 22072004
- Conditions
- After Visit Instructions, Patient Education, Teach-Back Communication, Patient Comprehension
- Keywords
- After Visit Summary, Readability, REALM, A-REALM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients received standard after visit procedure based on the provider |
| Standardized After Visit Instructions Only | Experimental | Behavioral: Standardized After Visit Instructions OnlyThe 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. |
| Standardized After Visit Instructions & Teach Back | Active comparator | Behavioral: Standardized After Visit Instructions & Teach BackThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients seen in the Rush University Medical Center Rheumatology Clinic
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized After Visit Instructions OnlyThe 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. | Behavioural | Standardized After Visit Instructions Only |
| Standardized After Visit Instructions & Teach BackThis 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 | Behavioural | Standardized After Visit Instructions & Teach Back |
Primary outcome
Patient Comprehension Survey
Time frame: 1-2 weeks after initial visit
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 secondary outcome
Patient Satisfaction Survey
Time frame: Will receive in email or in person immediately after initial visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sobia Hassan, MD principal investigator
Rush University Medical Center Associate Professor Rheumatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized After Visit Instructions Only and Standardized After Visit Instructions & Teach Back in people with After Visit Instructions and Patient Education, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comprehension Survey (time frame: 1-2 weeks after initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.