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Clinical Trials/NCT04401891
NCT04401891TerminatedNot Applicable

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

Washington University School of Medicine2 sites in 1 country26 target enrollmentStarted: February 5, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
26
Locations
2
Primary Endpoint
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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