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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
Methodist University, North Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 21, 2021
    Last Updated
    October 14, 2021
    Sponsor
    Methodist University, North Carolina
    Collaborators
    Cape Fear Orthopedics & Sports Medicine
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    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

    Learn more about this trial

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