Scoliosis Shared Decision Making

NCT ID: NCT03107533

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-30

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Video recording of clinical visit

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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A. Noelle Larson, MD

Associate Professor of Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noelle Larson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela M Severson

Role: CONTACT

(507) 538-3560

Facility Contacts

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Vickie Treder

Role: primary

507-538-3561

Related Links

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Other Identifiers

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17-002245

Identifier Type: -

Identifier Source: org_study_id

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