Back to resultsComparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
Primary Purpose
ACL Injury, Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video-Based Intervention
Classroom-Based Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for ACL Injury focused on measuring ACL Reconstruction
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic ArizonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Video-Based Education Group
Virtual Classroom Course Group
Standard of Care Group
Arm Description
Approximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction.
Approximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction.
Participants will receive verbal and written pre-and postoperative instruction as typically received by all ACL reconstruction patients treated by the attending physicians before and after surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Knowledge Retention
Measured using the ACL Reconstruction Perioperative Education Quiz
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.
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.
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.
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05273463
Brief Title
Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
Official Title
Comparison of Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Anterior Cruciate Ligament Injuries
Keywords
ACL Reconstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video-Based Education Group
Arm Type
Experimental
Arm Description
Approximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction.
Arm Title
Virtual Classroom Course Group
Arm Type
Experimental
Arm Description
Approximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Participants will receive verbal and written pre-and postoperative instruction as typically received by all ACL reconstruction patients treated by the attending physicians before and after surgery.
Intervention Type
Behavioral
Intervention Name(s)
Video-Based Intervention
Intervention Description
15-minute video about what to expect before, during, and after your surgery
Intervention Type
Behavioral
Intervention Name(s)
Classroom-Based Intervention
Intervention Description
Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
24 months
Title
Self-Efficacy
Description
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.
Time Frame
24 months
Title
Kinesiophobia
Description
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.
Time Frame
24 months
Title
Physical Function
Description
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.
Time Frame
24 months
Title
Knowledge Retention
Description
Measured using the ACL Reconstruction Perioperative Education Quiz
Time Frame
24 months
Title
Pain Interference
Description
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.
Time Frame
24 months
Title
History of Falls
Description
Measured using the History of Falls Questionnaire. Self-reported 5-item questionnaire asking subjects about falls experienced in the past month and seriousness.
Time Frame
24 months
Title
Lysholm Knee Score
Description
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.
Time Frame
24 months
Title
Activity Level
Description
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.
Time Frame
24 months
Title
Confidence in Returning to Sport
Description
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).
Time Frame
24 months
Title
Resilience
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sailesh Tummala, MD
Phone
4803426800
Email
Tummala.sailesh@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaycee Glattke, PhD
Email
glattke.kaycee@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayley Powell, MSN, RN
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayley Powell, MSN, RN
Phone
480-342-6800
Email
powell.hayley@mayo.edu
First Name & Middle Initial & Last Name & Degree
Kaycee Glattke, PhD
Phone
4803426800
Email
glattke.kaycee@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
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