Formal Pre-Operative Education

Not Applicable

Terminated

• Conditions: Upper Extremity Orthopedic Surgery Patients
• Interventions: Behavioral: Formal pre-operative education

• Registration Number: NCT04401891
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Primary Completion: 2023-08-02
• Study Completion: 2023-08-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formal Pre-operative education/therapy prior to surgery	Formal pre-operative education	-

Primary Outcome Measures

Name	Time	Method
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative	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
PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed	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	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	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	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	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) post operative	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	prior to surgery and 2 weeks post surgery	0 to 10 likert scale. 0 being no pain and 10 being worst pain possible

Trial Locations

Locations (1)

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States