- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616312
Patient Recall After Orthopedic Trauma
January 9, 2026 updated by: John Sontich, University Hospitals Cleveland Medical Center
Validating a "Teach-back" Protocol to Improve Recall in Orthopedic Trauma Patients
The purpose of this study is to evaluate whether receiving education after trauma surgeries affects three things: 1) knowledge about injury and treatment ("recall"), 2) how well patients follow treatment recommendations, and 3) how satisfied patients are with their care.
To do so, some participants in this study will receive education, and some will not.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kallie J Chen, MD
- Phone Number: 920-912-6244
- Email: kallie.chen@uhhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center
-
Contact:
- Kallie J Chen, MD
- Phone Number: 920-912-6244
- Email: kallie.chen@uhhospitals.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Isolated open or closed fracture of the pelvis and/or lower extremity treated surgically
Exclusion Criteria:
- Patient receiving orthopedic care or follow-up at another institution
- Non-English speaking
- Incarcerated (or likely impending incarceration)
- Currently enrolled in a study that does not permit co-enrollment
- Traumatic brain injury, dementia, or other cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postoperative teach-back educational program
Patients will receive teach-back education while they fill out questionnaires.
|
Patients will receive teach-back education while they fill out questionnaires.
|
|
No Intervention: Control
Patients will not receive any teach-back education while filling out questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of correct answers to the recall-assessing items on the follow-up questionnaire.
Time Frame: Up to 45 minutes
|
Up to 45 minutes
|
|
|
Adherence rate to postoperative weightbearing instructions as measured by patient report.
Time Frame: Up to 180 days post op
|
Up to 180 days post op
|
|
|
Adherence rate to DVT prophylaxis instructions as measured by patient report.
Time Frame: Up to 180 days post op
|
Up to 180 days post op
|
|
|
Mean satisfaction as measured by follow-up questionnaire.
Time Frame: Up to 180 days post op
|
Satisfaction will be measured on a Likert scale from 1-5 with 1 being very dissatisfied and 5 being very satisfied with care
|
Up to 180 days post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Sontich, MD, University Hospitals Cleveland Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 15, 2022
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 9, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20220951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.