Clinical Issues

Proof-of-Principle Trial of Communication to Patients Receiving Predictive Genetic Risk Assessment

PI: Clayton T. Cowl, M.D.
Co-PI: Barbara Koenig, Ph.D.
Co-Investigator and Project Director: Kristina Tiedje, Ph.D.
Co-Investigators: Jon Tilburt, M.D.; Victor Montori, M.D.; Pamela Sinicrope, Ph.D.; Carrie Zabel, G.C.
Mayo Clinic examines the impact of direct-to-consumer, predictive genetic testing provided by Navigenics, Inc., a private company using predictive personal genetic testing for common diseases or conditions. The primary objectives are to:

1. Identify how patients perceive the utility of genetic screening in modifying behaviors that may reduce future health risks,
2. Assess how this information affects the physician/patient encounter, and
3. Determine the most effective way to deliver this information.

Mayo Clinic has developed a proof-of-principle clinical trial to study how patients and physicians understand and utilize predictive genetic risk assessment. Study objectives are to:

1. Identify patients’ hopes, expectations, and concerns about the significance of predictive genetic risk assessment for four common diseases
2. Assess whether genetic risk data supplements, conflicts with, or has no impact on information provided by a detailed family history
3. Compare three strategies (direct-to-consumer, DTC with genetic counselor follow up, and information provided direct to physician) of delivering predictive genetic risk assessment for common diseases
4. Assess physician expectations of the clinical utility and clinical validity of predictive genetic risk assessment
5. Document the impact of predictive genetic risk assessment technology on the clinician/patient outpatient encounter

Funding for this clinical trial is provided jointly by Navigenics and Mayo Clinic Center for Individualized Medicine.

After-Death Interviews to Assess Quality of Dying and Death Care at Mayo Clinic

Mayo Clinic (PI: Elise Carey)
This survey project on the experience of dying and death at Mayo Clinic will focus on three broad categories: end-of-life care (including, but not limited to, palliative care); post-mortem procedures; and care for bereaved loved ones immediately after the patient’s death and in the intervening time until the survey. We will achieve the following aims with this research:

1. Assess areas of potential improvement in Mayo’s care at the end-of-life across recognized measures, for both patients and their loved ones;
2. Produce a needs assessment for establishing an Office of Decedent Affairs; and
3. Discover the need for/effectiveness of bereavement care from healthcare providers involved in the decedent’s care.