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NCT03107533 Clinical Trial

Scoliosis Shared Decision Making

Scoliosis Clinical Trial

Official title:
Scoliosis Shared Decision Making

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03107533
Other study ID # 17-002245
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2017
Est. completion date March 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact Angela M Severson
Phone (507) 538-3560
Email severson.angela2@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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, Minnesota 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who understand disease treatment as determined by analysis of video recording Video will be recorded then be sent to the shared decision making group at Mayo Clinic, Rochester, Minnesota to run analysis of the data (Shared Decision Making National Resource Center, Knowledge and Evaluation Research Unit, Mayo Clinic). Baseline
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