Patient Recall After Orthopedic Trauma

• Sponsor: John Sontich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05616312
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.1
• Patients Per Site Per Month: 16.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Education After Trauma	Behavioral: Educational Teach Back	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Validating a "Teach-back" Protocol to Improve Recall in Orthopedic Trauma Patients
• Actual Study Start Date: Oct 13, 2022
• Anticipated Primary Completion Date: Nov 15, 2023
• Anticipated Study Completion Date: Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Postoperative teach-back educational program Patients will receive teach-back education while they fill out questionnaires.	Behavioral: Educational Teach Back; 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.

Outcome Measures

Primary Outcome Measures

1. Number of correct answers to the recall-assessing items on the follow-up questionnaire. [Up to 45 minutes]

2. Adherence rate to postoperative weightbearing instructions as measured by patient report. [Up to 180 days post op]

3. Adherence rate to DVT prophylaxis instructions as measured by patient report. [Up to 180 days post op]

4. Mean satisfaction as measured by follow-up questionnaire. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• John Sontich

Investigators

• Principal Investigator: John Sontich, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Sontich, Physician, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT05616312
• Other Study ID Numbers: STUDY20220951
• First Posted: Nov 15, 2022
• Last Update Posted: Dec 6, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Dec 6, 2022