Genetics Navigator: a digital platform to guide people through genetic testing
The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services
This randomized trial will test whether the Genetics Navigator digital platform helps adults and parents of children referred for clinical genetic testing have less distress and a smoother testing process compared with usual genetics appointments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT06455384 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling adults and parents of pediatric patients referred for clinical genetic testing at three Toronto hospitals. Participants are randomized to use the Genetics Navigator, an end-to-end e-health platform that provides education, a decision aid, family/history collection, and results delivery, or to standard care with genetics professionals. The study measures patient distress, decision quality, patient experience, and service efficiency. Results will determine whether the platform can substitute for or augment traditional genetics appointments.
Who should consider this trial
Good fit: Adults referred for clinical genetic testing and parents or legal guardians of pediatric patients referred to participating clinicians at Mount Sinai Hospital, SickKids, or Sunnybrook in Toronto who are fluent in English and eligible for testing are ideal candidates.
Not a fit: Patients who need urgent or prenatal genetic testing, those not eligible for clinical genetic testing in Ontario, or those not fluent in English are unlikely to benefit from this platform-based pathway.
Why it matters
Potential benefit: If successful, the Genetics Navigator could reduce waiting-related distress, improve patient understanding and decision making, and streamline delivery of genetic testing services.
How similar studies have performed: The team previously tested a related decision support tool (Genetics ADvISER) with promising results, but the Genetics Navigator is a broader end-to-end platform being tested in a randomized trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Adult patients (18 years of age or older) who are referred to participating clinicians at Mount Sinai Hospital for clinical genetic testing. * Parents/legal guardians (18 years of age or older) of pediatric patients who are referred to participating clinicians at SickKids for clinical genetic testing. Exclusion: * Known not to be eligible for clinical genetic testing in Ontario * Requires urgent clinical genetic testing or prenatal genetic testing * Not fluent in English (speaking and reading)
Where this trial is running
Toronto, Ontario and 2 other locations
- Mount Sinai Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Hospital — Toronto, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Yvonne Bombard, PhD — St. Michael's Hospital and University of Toronto
- Study coordinator: Marc Clausen, MA
- Email: Marc.Clausen@unityhealth.to
- Phone: 416-864-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.