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临床试验/NCT05095415
NCT05095415撤回不适用

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

Methodist University, North Carolina0 个研究点目标入组 30 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
30
主要终点
Patient appointment attendance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be masked to the knowledge of if they are receiving the typical pre-operative care or an additional individualized occupational therapy consult.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Patient appointment attendance

时间窗: Through completion of therapy, up to one year.

Patient adherence to scheduled occupational therapy visits

Upper Extremity Functional Index

时间窗: 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

次要结局

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

研究者

发起方
Methodist University, North Carolina
申办方类型
Other
责任方
Sponsor

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