Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting

Distal Radius Fracture Clinical Trial

Official title:

The Effect of an Occupational Therapy Pre-operative Education Consult on Patient Outcomes in the Orthopedic Hand Setting: A Prospective Randomized Block Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05095415
• Other study ID #: MethodistUNC
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: October 2022

Study information

• Verified date: October 2021
• Source: Methodist University, North Carolina
• Contact: Shelby G Behnke, BA
• Phone: (910)710-5051
• Email: sgray18[@]student.methodist.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Exclusion Criteria:

• Less than 18 years old

• Previously sustained one of the inclusion criteria diagnoses

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Flexor Tendon Rupture
• Radius Fractures
• Rupture
• Thumb Osteoarthritis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Methodist University, North Carolina	Cape Fear Orthopedics & Sports Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient appointment attendance	Patient adherence to scheduled occupational therapy visits	Through completion of therapy, up to one year.
Primary	Upper Extremity Functional Index	Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction	Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Primary	Upper Extremity Functional Index	Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction	Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation
Primary	Upper Extremity Functional Index	Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction	Upon discharge from therapeutic services, up to one year
Secondary	QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)	Patient reported outcome analyzing patient pre-operative experiences. VAS is linear scale where participants visually mark the line corresponding to their preoperative experience. Patients are blinded to the numerical value associated to their answer to decrease biases. VAS is ten point linear scale where 1 represents the negative anchor and 10 represents the positive, preferred response. Questions address anxiety, understanding, and overall preoperative experience.	Date of first attended postoperative therapeutic appointment, up to 15 days following surgery