Back to resultsPatient Recall After Orthopedic Trauma
Primary Purpose
Education After Trauma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Teach Back
Sponsored by
About this trial
This is an interventional supportive care trial for Education After Trauma
Eligibility Criteria
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
Sites / Locations
- University Hospitals Cleveland Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Postoperative teach-back educational program
Control
Arm Description
Patients will receive teach-back education while they fill out questionnaires.
Patients will not receive any teach-back education while filling out questionnaires.
Outcomes
Primary Outcome Measures
Number of correct answers to the recall-assessing items on the follow-up questionnaire.
Adherence rate to postoperative weightbearing instructions as measured by patient report.
Adherence rate to DVT prophylaxis instructions as measured by patient report.
Mean satisfaction as measured by follow-up questionnaire.
Satisfaction will be measured on a Likert scale from 1-5 with 1 being very dissatisfied and 5 being very satisfied with care
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05616312
Brief Title
Patient Recall After Orthopedic Trauma
Official Title
Validating a "Teach-back" Protocol to Improve Recall in Orthopedic Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Sontich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education After Trauma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postoperative teach-back educational program
Arm Type
Experimental
Arm Description
Patients will receive teach-back education while they fill out questionnaires.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will not receive any teach-back education while filling out questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Educational Teach Back
Intervention Description
Patients will receive teach-back education while they fill out questionnaires.
Primary Outcome Measure Information:
Title
Number of correct answers to the recall-assessing items on the follow-up questionnaire.
Time Frame
Up to 45 minutes
Title
Adherence rate to postoperative weightbearing instructions as measured by patient report.
Time Frame
Up to 180 days post op
Title
Adherence rate to DVT prophylaxis instructions as measured by patient report.
Time Frame
Up to 180 days post op
Title
Mean satisfaction as measured by follow-up questionnaire.
Description
Satisfaction will be measured on a Likert scale from 1-5 with 1 being very dissatisfied and 5 being very satisfied with care
Time Frame
Up to 180 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kallie J Chen, MD
Phone
920-912-6244
Email
kallie.chen@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sontich, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kallie J Chen, MD
Phone
920-912-6244
Email
kallie.chen@uhhospitals.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Recall After Orthopedic Trauma
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