Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting

Sponsor
Methodist University, North Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05095415
Collaborator
Cape Fear Orthopedics & Sports Medicine (Other)
30
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Occupational Therapy Pre-operative Consult
  • Other: Typical Pre-Operative Education
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Single (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.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Patient appointment attendance [Through completion of therapy, up to one year.]

    Patient adherence to scheduled occupational therapy visits

  2. Upper Extremity Functional Index [Date of first attended postoperative therapeutic appointment, up to 15 days following surgery]

    Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

  3. Upper Extremity Functional Index [Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation]

    Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

  4. Upper Extremity Functional Index [Upon discharge from therapeutic services, up to one year]

    Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

Secondary Outcome Measures

  1. QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS) [Date of first attended postoperative therapeutic appointment, up to 15 days following surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Methodist University, North Carolina
  • Cape Fear Orthopedics & Sports Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist University, North Carolina
ClinicalTrials.gov Identifier:
NCT05095415
Other Study ID Numbers:
  • MethodistUNC
First Posted:
Oct 27, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Methodist University, North Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2021