Back to resultsCoping After Pediatric Scoliosis Surgery (CAPS)
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Intervention
Control
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Pain, Function, Pediatric, Scoliosis, Scoliosis Surgery, Spinal Fusion, Idiopathic Scoliosis, Coping, Coping Skills, Education, Video Intervention, Randomized, Prospective, Satisfaction, Adolescent, Opioid
Eligibility Criteria
Inclusion criteria:
- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach
Exclusion Criteria:
- Non-English speaking
- Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.
- Other comorbidity, including developmental delay.
- Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.
- Unplanned admission within 6 weeks of index operation.
- Active treatment psychotherapy and/or cognitive behavioral therapy for any reason
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Video Intervention
Arm Description
Routine, standard-of-care treatment
Routine, standard-of-care PLUS peri-operative video series
Outcomes
Primary Outcome Measures
Post-Operative Pain
Outcome #1 will evaluate the intervention's impact on post-operative pain via completion of the computer-adaptive NIH PROMIS measures on pain intensity and pain behavior.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Post-Operative Pain
Outcome #2 will evaluate the intervention's impact on a proxy for post-operative pain via completion of a 1-question survey on recent opioid consumption. The question is formatted as a 5-point Likert scale, scored 1-5, with higher scores indicating more frequent opioid consumption.
Secondary Outcome Measures
Patient Reported Outcomes - Global Health
Outcome #3 will measure patient reported outcomes via administration of the computer adaptive NIH PROMIS measures for global health.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores for this measure will be converted to T-scores via the NIH's published guidelines. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Patient Reported Outcomes - Mobility
Outcome #4 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for mobility
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Patient Reported Outcomes - Positive Affect
Outcome #5 will measure patient reported outcomes via completion of the computer-adaptive NIH PROMIS measure for positive affect.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Patient Reported Outcomes - Physical Activity
Outcome #6 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for physical activity.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Patient Reported Outcomes - Strength Impact
Outcome #7 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for strength impact.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Full Information
NCT ID
NCT04063670
First Posted
May 11, 2019
Last Updated
March 21, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04063670
Brief Title
Coping After Pediatric Scoliosis Surgery
Acronym
CAPS
Official Title
Coping After Pediatric Scoliosis Surgery: How Does it Affect Pain and Function?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Pain, Function, Pediatric, Scoliosis, Scoliosis Surgery, Spinal Fusion, Idiopathic Scoliosis, Coping, Coping Skills, Education, Video Intervention, Randomized, Prospective, Satisfaction, Adolescent, Opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized Controlled Clinical Trial
Masking
Care Provider
Masking Description
All clinicians and care providers are blinded to participants randomized group
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Routine, standard-of-care treatment
Arm Title
Video Intervention
Arm Type
Experimental
Arm Description
Routine, standard-of-care PLUS peri-operative video series
Intervention Type
Other
Intervention Name(s)
Video Intervention
Intervention Description
Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Routine, Standard-of-Care
Primary Outcome Measure Information:
Title
Post-Operative Pain
Description
Outcome #1 will evaluate the intervention's impact on post-operative pain via completion of the computer-adaptive NIH PROMIS measures on pain intensity and pain behavior.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Title
Post-Operative Pain
Description
Outcome #2 will evaluate the intervention's impact on a proxy for post-operative pain via completion of a 1-question survey on recent opioid consumption. The question is formatted as a 5-point Likert scale, scored 1-5, with higher scores indicating more frequent opioid consumption.
Time Frame
Up to 6-weeks post-operatively
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes - Global Health
Description
Outcome #3 will measure patient reported outcomes via administration of the computer adaptive NIH PROMIS measures for global health.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores for this measure will be converted to T-scores via the NIH's published guidelines. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Title
Patient Reported Outcomes - Mobility
Description
Outcome #4 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for mobility
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Title
Patient Reported Outcomes - Positive Affect
Description
Outcome #5 will measure patient reported outcomes via completion of the computer-adaptive NIH PROMIS measure for positive affect.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Title
Patient Reported Outcomes - Physical Activity
Description
Outcome #6 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for physical activity.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Title
Patient Reported Outcomes - Strength Impact
Description
Outcome #7 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for strength impact.
For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference.
Time Frame
Up to 6-weeks post-operatively
Other Pre-specified Outcome Measures:
Title
Pain-Related Disability and Post-Operative Functional Status.
Description
Outcome #8 will measure post-operative functional status via a 5-question survey on the following activities: sleeping through the night without awaking for pain medication, walking outside the house, showering and dressing independently, patient return to school and parent return to work. Each of these questions was selected as a proxy for improved functional status. Each question is answered 'Yes' or 'No", and graded '1' or '0', respectively. A higher score represents improved functional status. Each of these questionnaires will be administered on a weekly basis.
Time Frame
Up to 6-weeks post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach
Exclusion Criteria:
Non-English speaking
Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.
Other comorbidity, including developmental delay.
Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.
Unplanned admission within 6 weeks of index operation.
Active treatment psychotherapy and/or cognitive behavioral therapy for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Diab, MD
Organizational Affiliation
UCSF Department of Orthopaedic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Gornitzky, MD
Organizational Affiliation
UCSF Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Coping After Pediatric Scoliosis Surgery
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