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Clinical Trial Summary

This will be a prospective randomized control trial with a blocking method to determine the effect of an occupational therapy focused pre-operative education on 3 pre-determined diagnosis: Carpometacarpal (CMC) Arthroplasty, Distal radius fracture requiring open reduction internal fixation (ORIF) and tendon repairs of the hand. Possible participants will be recruited through Cape Fear Orthopedics & Sports Medicine and receiving care from an orthopedic surgeon & hand specialist. Researchers hypothesize that those who receive the occupational therapy consult will demonstrate improved adherence with occupational therapy appointments, improved patient perceived function, and overall improved experiences with the pre-operative patient experience.


Clinical Trial Description

Participants will be identified by orthopedic surgeon. Once informed consent is obtained participants will subsequently be randomly assigned to the control or experimental block associated with their diagnosis. Patients will be randomly assigned within their diagnosis block through random number generation in Microsoft Excel. Participants randomly assigned to the control group will receive the current & typical educational information provided by their orthopedic surgeon. Participants randomly assigned to the experimental group will receive an additional occupational therapy (OT) focused pre-operation education consultation provided by a third year occupational therapy student under the supervision of an orthopedic surgeon & Occupational Therapist & Certified Hand Therapist. The additional OT pre-operative consult will be included during participants scheduled pre-operative appointment. Specific pre-op appointments are only conducted when patients have not been seen by a provider within 4-weeks of their surgical date. If surgery is scheduled within 4-weeks of the patients last encounter with a provider an additional pre-op visit is not required. Since two of the three pre-determined diagnosis of interest are typically associated with trauma, participants may receive their OT consult at their first encounter with the orthopedic surgeon which is also considered their pre-op visit. The OT consult provided to the individuals assigned to the experimental group will consist of a one-on-one interaction with a third year occupational therapy doctorate (OTD) student providing diagnosis specific educational materials inclusive of what to expect after surgery, the importance of attending therapy as recommended by the orthopedic surgeon and how to accurately complete the Upper Extremity Functional Index (UEFI). Outcomes of this research will include UEFI scores at therapeutic evaluation, after 10 visits and upon discharge, completion of a post operative survey via question pro utilizing a Visual Analog Scale (VAS) at the initial therapeutic encounter, and patient compliance with attending therapy as documented by therapy visit attendance. A semi-structured interview will be completed at patient discharge from therapy to determine areas of possible improvement and further research. Individuals randomly assigned to the control group will participate in the typical pre-operative experience provided by the orthopedic surgeon. Control group participants will not be made aware of experimental group participants experiences. Participants in the control group will be informed that researchers are interested in the pre-operative patient experiences at Cape Fear Orthopedics & Sports Medicine and their participation in the study and honest responses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05095415
Study type Interventional
Source Methodist University, North Carolina
Contact Shelby G Behnke, BA
Phone (910)710-5051
Email sgray18@student.methodist.edu
Status Not yet recruiting
Phase N/A
Start date October 2021
Completion date October 2022

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