Scoliosis Shared Decision Making

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 13 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03107533
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Noelle Larson, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Vickie Treder

[email protected]

507-538-3561