Formal Pre-Operative Education

The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Extremity Orthopedic Surgery Patients
• Intervention / Treatment: Behavioral: Formal pre-operative education

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Logan Berlet, OTD; Phone Number: 314-286-1669; Email: lberlet@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University in Saint Louis
      • Contact: Logan Berlet, OTD; Phone Number: 614-202-5333; Email: lberlet@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Pre-Operative Education in MD office prior to surgery
Experimental: Formal Pre-operative education/therapy prior to surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed	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.	prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed	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	prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed	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.	prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed	Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain	prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed	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.	prior to surgery and two weeks post surgery
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative	1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable	prior to surgery
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative	1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable	2 weeks post surgery
Pain Scale	0 to 10 likert scale. 0 being no pain and 10 being worst pain possible	prior to surgery and 2 weeks post surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Logan Berlet, OTD, Washington University in Saint Louis

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Anticipated): February 5, 2024
• Study Completion (Anticipated): February 5, 2025

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 201911175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No