Clinical Trial: Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients

Brief Summary:

Current lab reports are designed to communicate results from the laboratory to the provider; they are not designed to be accessible to patients. The investigators believe that a new type of genomic test report, tailored for patient- as well as provider-use, will enable patients to have access to information they can understand allowing them to be more involved in the management of their disorders, better navigate the health care system, and make more informed decisions about their health and health care in conjunction with their providers. This approach has the potential to improve outcomes from both the patient and provider perspectives.

The investigators propose to study the research question, "Can a genomic laboratory report tailored for both providers and families of patients improve interpretation of complex results and facilitate recommended care by enhancing communication and shared decision making?"

Detailed Summary:

The experimental design to be used for this phase of the project is a randomized, single-blinded pre- post-intervention trial with crossover. Figure 2 depicts this phase. As noted below, the subjects for the study are parents of affected children enrolled in the Whole Genome Sequencing (WGS) Clinical Research Pilot Study (study within a study). Parents are the appropriate subjects for this study as they have the primary responsibility for the care and management of their child(ren) affected with these chronic, rare conditions and would be the recipient of communication of test results either from providers (usual care) or through the proposed enhanced report (intervention). Both parents are enrolled in the WGS study for purposes of the interpretation of the genomic results allowing capture of potential differences between fathers and mothers. According to the WGS study protocol all results of the WGS testing will be provided by a geneticist and genetic counselor at an informing session. At this session, results will be returned and explained, recommendations provided and questions answered. Following this session, parents will be consented for participation in the proposed study and consenting parents as couples will be randomized to either the usual care or intervention groups as randomization at the individual level would lead to contamination and spillover if one member of the couple were in the usual care arm and the other in the intervention arm. The initial data collection from the chosen survey instruments will take place at this time. Care from this point forward will be provided by the patient's referring provider although the WGS study team is available for consultation as needed. The PI of this study is staffing most of the informing sessions at present therefore he will be blinded to the randomization.

Because the survey instruments, while chosen based on pati
Sponsor: Geisinger Clinic

Current Primary Outcome: Patient satisfaction and engagement [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Provider satisfaction [ Time Frame: 12 months ]
  Semi-structured interviews will be used to determine provider satisfaction with the enhanced report.
• Patient/Provider Communication [ Time Frame: 12 months ]
  Semi-structured interviews will be used to determine patient and provider communication patterns following use of the enhanced report.

Original Secondary Outcome: Same as current

Information By: Geisinger Clinic

Dates:
Date Received: July 7, 2015
Date Started: August 2015
Date Completion: December 2017
Last Updated: February 17, 2017
Last Verified: February 2017