Cancer, Cardiovascular Diseases, Genetic Condition, Prenatal Condition, Reproductive Condition
Conditions
Keywords
genetic counseling, cancer, heart disease, reproductive, prenatal, genetic
Brief summary
The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.
Interventions
OTHERGenetic counseling months 4-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 4 to month 15.
OTHERGenetic counseling months 6-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 6 to month 15.
OTHERGenetic counseling months 8-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 8 to month 15.
OTHERGenetic counseling at months 10-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 10 to month 15.
OTHERGenetic counseling at months 12-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 12 to month 15.
OTHERGenetic counseling at months 14-15
all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 14 to month 15.
Sponsors
University of Minnesota
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Stepped wedge randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 years or older * individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site * understand and be able to provide information for study forms and surveys in English.
Exclusion criteria
* Unable to provide informed consent * For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effectiveness of a genetic counseling skills training intervention | 1 month | The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient perception of overall GC quality | 1 month | Overall perception of quality of the genetic counseling session |
| patient-centered communication | 1 month | An assessment of the patient's experience with their healthcare provider |
| patient empowerment | 1 month | A process through which patients gain control over decisions and actions affecting their health |
| patient activation | 1 month | A patient's ability to manage their own health and take an active role in their care |
| patient information needs met / information overload | 1 month | Assessment of how much information the patient desired and was provided |
| patients' perceived trust in GC | 1 month | Measure of patients' trust in their provider |
| working alliance | 1 month | Relationship between patient and provider |
| GC verbal dominance | 1 month | Measurement of the amount of time the patient, genetic counselor, and other individuals spend talking in the session |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather Zierhut
University of Minnesota
Outcome results
None listed