Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting

NCT ID: NCT05095415

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-10-31

Brief 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.

Detailed 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.

Conditions

Flexor Tendon Rupture; Thumb Osteoarthritis; Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Typical Pre-operative Experience

Participants will be be placed in appropriate subgroups based upon their diagnosis and surgical intervention. Subgroups include: CMC Arthroplasty, ORIF of the Distal Radius, and Flexor/Extensor Tendon Repairs.

Group Type: ACTIVE_COMPARATOR

Typical Pre-Operative Education

Intervention Type: OTHER

Participants will receive all preoperative education from their orthopedic surgeon and will not be spoken to directly about the therapeutic process until their first scheduled therapy appointment.

Occupational Therapy Consult Experience

Participants will be be placed in appropriate subgroups based upon their diagnosis and surgical intervention. Subgroups include: CMC Arthroplasty, ORIF of the Distal Radius, and Flexor/Extensor Tendon Repairs.

Group Type: EXPERIMENTAL

Occupational Therapy Pre-operative Consult

Intervention Type: OTHER

Preoperative education will be given by the treating orthopedic surgeon first and will then be followed by a consult with a final semester, occupational therapy student. The pre-operative education will include the importance of attending therapy, what to expect at therapy, typical duration of therapy for their specific diagnosis, and address any questions of ther participant. Participants will be given educational materials and access to education videos to watch if they so choose.

Interventions

Occupational Therapy Pre-operative Consult

Preoperative education will be given by the treating orthopedic surgeon first and will then be followed by a consult with a final semester, occupational therapy student. The pre-operative education will include the importance of attending therapy, what to expect at therapy, typical duration of therapy for their specific diagnosis, and address any questions of ther participant. Participants will be given educational materials and access to education videos to watch if they so choose.

Intervention Type: OTHER

Typical Pre-Operative Education

Participants will receive all preoperative education from their orthopedic surgeon and will not be spoken to directly about the therapeutic process until their first scheduled therapy appointment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Distal Radius Fracture, requiring open reduction internal fixation
• Clinical diagnosis of flexor tendon of the hand laceration
• Clinical diagnosis of CMC arthritis, electing to undergo CMC arthroplasty
• Receiving care from Cape Fear Orthopedics & Sports Medicine
• English Speaking

• Elect not to receive therapeutic services at Cape Fear Orthopedics & Sports Medicine.

Exclusion Criteria

• Less than 18 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cape Fear Orthopedics & Sports Medicine

UNKNOWN

Sponsor Role: collaborator

Methodist University, North Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MethodistUNC

Identifier Type: -

Identifier Source: org_study_id