Clinical trial NCT05095415: Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexor Tendon Rupture
Thumb Osteoarthritis
Distal Radius Fracture
Keywords: Occupational Therapy
Pre-operative Education
Upper Extremity
Lead sponsor: Methodist University, North Carolina
Sponsor class: OTHER
Collaborators: name: Cape Fear Orthopedics & Sports Medicine
First posted: 2021-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the experimental or control group in accordance with their diagnosis specific block. This will be continued until there is at least 5 participants in each diagnosis block.
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Patient appointment attendance
timeFrame: Through completion of therapy, up to one year.
measure: Upper Extremity Functional Index
timeFrame: Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
measure: Upper Extremity Functional Index
timeFrame: Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation
measure: Upper Extremity Functional Index
timeFrame: Upon discharge from therapeutic services, up to one year
Secondary outcomes:
measure: QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)
timeFrame: Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Other outcomes:
Locations:
Study officials:
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