Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Comparison of Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273463
• Other study ID #: 21-002443
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Sailesh Tummala, MD
• Phone: 4803426800
• Email: Tummala.sailesh[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients of Senior Attending orthopedic sports medicine surgeons at Mayo Clinic Arizona
• Patients with a proficiency in English in order to participate without need for translator.
• Patients with a diagnosis of a primary ACL injury in need of surgical reconstruction utilizing any surgical technique for ACL reconstruction.

Exclusion Criteria:

• Patients with a diagnosis of ACL injury in need of a surgical revision.
• Patients who have any multi-ligamentous injuries to the knee requiring modified postoperative unloading.
• Patients who have history of previous anterior cruciate ligament reconstructions in either leg.
• Patients who have either auditory or visual impairments.
• Patients who are medical professionals with work-related knowledge of ACL reconstruction.
• Patients with an inability or unwillingness of individual or legal guardian to give written informed consent.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Video-Based Intervention
15-minute video about what to expect before, during, and after your surgery
• Classroom-Based Intervention
Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Measured using the Leiden Perioperative Patient Satisfaction Questionnaire. Self-reported questionnaire that rates the subjects satisfaction with information provision, discomfort and needs during perioperative care.	24 months
Secondary	Anxiety	Measured using the PROMIS Emotional Distress - Anxiety Short Form 8a. Self-reported 8-item questionnaire that rates the subjects emotional distress in the past 7 days on a scale of 1=Never to 5=Always. Higher total scores indicate higher anxiety severity.	24 months
Secondary	Self-Efficacy	Measured using the PROMIS Self-Efficacy - Manage Symptoms Short Form 8a. Self-reported 8-item questionnaire that rates the subjects current level of confidence to statements about managing symptoms using a scale of 1="I am not at all confident to 5="I am very confident". Higher total score indicate higher confidence in managing symptoms.	24 months
Secondary	Kinesiophobia	Measured using the Tampa Scale for Kinesiophobia. Self-reported 17-item questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance using a scale of 1=Strongly Disagree to 4=Strongly Agree. Total score range from 17-68 and higher scores indicate severe kinesiophobia.	24 months
Secondary	Physical Function	Measured using the PROMIS Physical Function Short Form 10b. Self-reported 10-item questionnaire that rates the subjects ability to perform an activity using a scale of 5="Without any difficulty" to 1="Unable to do". Higher total scores indicate higher physical function.	24 months
Secondary	Knowledge Retention	Measured using the ACL Reconstruction Perioperative Education Quiz	24 months
Secondary	Pain Interference	Measured using the PROMIS Pain Interference Short Form 6a. Self-reported 6-item questionnaire that rates the subjects pain interference with activities in the past 7 days using a scale of 1="Not at all" to 5="Very much". Higher total scores indicate higher pain interference with activities experienced.	24 months
Secondary	History of Falls	Measured using the History of Falls Questionnaire. Self-reported 5-item questionnaire asking subjects about falls experienced in the past month and seriousness.	24 months
Secondary	Lysholm Knee Score	Measured using the Lysholm Knee Scoring Scale. Self-reported questionnaire that asks subjects to indicate which statement best describes their condition in regards to common complaints frequently experience with knee problems. Total scoring out of 100 and higher score less knee-specific symptoms.	24 months
Secondary	Activity Level	Measured using the Tegner Activity Scale. Self-reported level of activity prior to injury and post injury. Total of 10 levels and higher levels indicate greater activity level.	24 months
Secondary	Confidence in Returning to Sport	Measured using the ACL Return to Sport Index. Self-reported 6-item questionnaire to measure the readiness to return to sports after ACL injury or reconstruction. Using a scale from 0 points (extremely negative psychological responses) to 100 points (no negative psychological responses).	24 months
Secondary	Resilience	Measured using the Brief Resilience Scale. Self-reported 6-item questionnaire to measure perceived ability to recover from stress. Total score range 1-5 with higher scores indicating higher resilience.	24 months