Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting
Primary Purpose
Flexor Tendon Rupture, Thumb Osteoarthritis, Distal Radius Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Occupational Therapy Pre-operative Consult
Typical Pre-Operative Education
Sponsored by
About this trial
This is an interventional treatment trial for Flexor Tendon Rupture focused on measuring Occupational Therapy, Pre-operative Education, Upper Extremity
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Typical Pre-operative Experience
Occupational Therapy Consult Experience
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patient appointment attendance
Patient adherence to scheduled occupational therapy visits
Upper Extremity Functional Index
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Upper Extremity Functional Index
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Upper Extremity Functional Index
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05095415
First Posted
September 21, 2021
Last Updated
October 14, 2021
Sponsor
Methodist University, North Carolina
Collaborators
Cape Fear Orthopedics & Sports Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05095415
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Methodist University, North Carolina
Collaborators
Cape Fear Orthopedics & Sports Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Rupture, Thumb Osteoarthritis, Distal Radius Fracture
Keywords
Occupational Therapy, Pre-operative Education, Upper Extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants will be masked to the knowledge of if they are receiving the typical pre-operative care or an additional individualized occupational therapy consult.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Typical Pre-operative Experience
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Occupational Therapy Consult Experience
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy Pre-operative Consult
Intervention Description
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
Intervention Name(s)
Typical Pre-Operative Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient appointment attendance
Description
Patient adherence to scheduled occupational therapy visits
Time Frame
Through completion of therapy, up to one year.
Title
Upper Extremity Functional Index
Description
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Time Frame
Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Title
Upper Extremity Functional Index
Description
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Time Frame
Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation
Title
Upper Extremity Functional Index
Description
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Time Frame
Upon discharge from therapeutic services, up to one year
Secondary Outcome Measure Information:
Title
QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)
Description
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.
Time Frame
Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelby G Behnke, BA
Phone
(910)710-5051
Email
sgray18@student.methodist.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting
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