Formal Pre-Operative Education

Upper Extremity Orthopedic Surgery Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04401891
• Other study ID #: 201911175
• Status: Terminated
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: August 2, 2023

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Upper Extremity Orthopedic Surgery Patients

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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