Formal Pre-Operative Education

Overview

The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.

Full Title of Study: “The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 5, 2022

Interventions

  • Behavioral: Formal pre-operative education
    • One group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office.

Arms, Groups and Cohorts

  • No Intervention: Routine Pre-Operative Education in MD office prior to surgery
  • Experimental: Formal Pre-operative education/therapy prior to surgery

Clinical Trial Outcome Measures

Primary Measures

  • PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest — change is being assessed
    • Time Frame: prior to surgery and two weeks post surgery
    • Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
  • PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest — change is being assessed
    • Time Frame: prior to surgery and two weeks post surgery
    • Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety
  • PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest — change is being assessed
    • Time Frame: prior to surgery and two weeks post surgery
    • Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.
  • PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest — change is being assessed
    • Time Frame: prior to surgery and two weeks post surgery
    • Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain
  • PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest — change is being assessed
    • Time Frame: prior to surgery and two weeks post surgery
    • Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
  • MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
    • Time Frame: prior to surgery
    • 1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
  • MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative
    • Time Frame: 2 weeks post surgery
    • 1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
  • Pain Scale
    • Time Frame: prior to surgery and 2 weeks post surgery
    • 0 to 10 likert scale. 0 being no pain and 10 being worst pain possible

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years or older,
  • English as Primary language,
  • scheduled to have orthopedic upper extremity surgery.

Exclusion Criteria

  • less than 18 years
  • Conservative management or non operative management of orthopedic upper extremity surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathryn McQueen, OTD, Principal Investigator, Washington University in Saint Louis
  • Overall Contact(s)
    • Kathryn McQueen, OTD, 314-286-1669, kmcqueen@wustl.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.