Skip to main content
Clinical Trials/NCT04401891
NCT04401891
Terminated
N/A

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

Washington University School of Medicine1 site in 1 country26 target enrollmentFebruary 5, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Upper Extremity Orthopedic Surgery Patients
Sponsor
Washington University School of Medicine
Enrollment
26
Locations
1
Primary Endpoint
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2020
End Date
August 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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) 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

Study Sites (1)

Loading locations...

Similar Trials