Scoliosis Shared Decision Making

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03107533
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Other: Video recording of clinical visit

Detailed Description

For patients and parents who are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options. This video will then be sent to the shared decision making group at Mayo Clinic, Rochester, MN to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). Investigators will follow the patient's electronic medical records for 2 years after their decision of treatment option. No outcome forms will be specifically collected as part of the study, as outcomes forms are currently being collected clinically on all scoliosis patients.

Based off of the initial video recordings, the first visual prototype of the shared decision making tool for scoliosis has been developed. This prototype of the shared decision making tool will be now be used to help test it's efficiency.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Scoliosis Shared Decision Making
• Actual Study Start Date: Mar 30, 2017
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Video recording of clinical visit Investigators will enroll patients from the Department of Orthopedic Surgery for enrollment. The shared decision group will provide staff for data analysis.	Other: Video recording of clinical visit; For patients and parents that are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options.

Outcome Measures

Primary Outcome Measures

1. Number of patients who understand disease treatment as determined by analysis of video recording [Baseline]

   Video will be recorded then be sent to the shared decision making group at Mayo Clinic, Rochester, MN to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Scoliosis curve >40 degrees, < 65 degrees

• Risser score > 2

• Age > 13 years

Exclusion Criteria:

• Risser score of 0 or 1

• Non-ambulatory scoliosis patients

• Ages 12 year and under

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Noelle Larson, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: A. Noelle Larson, Associate Professor of Orthopedics, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03107533
• Other Study ID Numbers: 17-002245
• First Posted: Apr 11, 2017
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Mar 18, 2022