Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05616312

Conditions

Education After Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Educational Teach Back

Study Details

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.

Conditions

Education After Trauma

Study ID

NCT05616312

Start date

Oct 13, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Postoperative teach-back educational program

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.

Interventions

Educational Teach Back

Patients will receive teach-back education while they fill out questionnaires.

Primary outcome measure

  • Number of correct answers to the recall-assessing items on the follow-up questionnaire. [ Time Frame: Up to 45 minutes ]
  • Adherence rate to postoperative weightbearing instructions as measured by patient report. [ Time Frame: 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 ]
  • Mean satisfaction as measured by follow-up questionnaire. [ Time Frame: Up to 180 days post op ]

Central Contacts and Locations

Central contacts

Kallie J Chen, MD

920-912-6244kallie.chen@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kallie J Chen, MD

920-912-6244kallie.chen@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-01-12.