NCT06021730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

August 21, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

After Visit SummaryReadabilityREALMA-REALM

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient Satisfaction Survey

    Will receive in email or in person immediately after initial visit

Study Arms (3)

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.

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.

Behavioral: Standardized After Visit Instructions & Teach Back

Interventions

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 Only

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

Standardized After Visit Instructions & Teach Back

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients seen in the Rush University Medical Center Rheumatology Clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center Division of Rheumatology

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Sobia Hassan, MD

    Rush University Medical Center Associate Professor Rheumatology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 1, 2023

Study Start

December 1, 2022

Primary Completion

April 28, 2023

Study Completion

May 12, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations