Enhancing Genomic Laboratory Reports to Enhance Communication and Empower Patients

NCT02504502 | Completed Results

• 1 other identifier: 2013-0594
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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?"

Conditions

Intellectual Disability; Autism; Multiple Congenital Anomalies

Keywords

Whole Genome Sequencing; Laboratory Report; Patient Centered; Communication of Results; Patient Provider Communication

Outcome Measures

Primary Outcomes (1)

• Satisfaction With Genomic Test Report

  3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.

  3 months after receipt of enhanced report

Study Arms (2)

Enhanced genomic report

EXPERIMENTAL

routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study

Other: enhanced genomic report

Control with delayed access

OTHER

routine clinical care for return of results per whole genome sequencing study and no intervention through three months. This arm will crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report

Other: enhanced genomic report

Interventions

enhanced genomic report OTHER

a patient-centered version of a genomic results report delivered to patient through the electronic record portal

Control with delayed access; Enhanced genomic report

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Research participants who are consented to participate in the WGS Study (#2012-0187).
• Providers who have referred participants to the WGS Study (#2012-0187) and who have participated in the WGS genomic medicine workgroup or who have participated in the WGS Program Oversight Committee.

You may not qualify if:

• Participants who are not consented to participate in the WGS Study (#2012-0187)
• Providers who have not referred patients to the WGS Study (#2012-0187).
• Providers who have not had a relationship with the oversight of the WGS study (#2012- 0187).

Sponsors & Collaborators

• Geisinger Clinic: lead
• Patient-Centered Outcomes Research Institute: collaborator

Related Publications (20)

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  BACKGROUND

MeSH Terms

Conditions

Intellectual Disability; Autistic Disorder; Abnormalities, Multiple

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Fewer parents than expected received a causal variant result for their child's condition. Qualitative data indicate that parents without a causal variant did not feel need to open the enhanced report and did not find additional information helpful.

Results Point of Contact

• Title: Alanna Kulchak Rahm, PhD
• Organization: Geisinger Health System

akrahm@geisinger.edu

570-214-5093

Study Officials

• Marc S Williams, MD

  Geisinger Genomic Medicine Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants do not know whether they are in the intervention (enhanced report) or control (routine clinical care with delayed access to the enhanced report) arm
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Genomic Medicine Institute

Model Details: intervention = routine clinical care for return of results per whole genome sequencing study with enhanced genetic test results report developed through phase 1 and 2 of this study. Control with delayed intervention = routine clinical care for return of results per whole genome sequencing study with crossover to receipt of enhanced report upon completion of baseline and 3 month post-baseline followup surveys. Participants in this arm will complete a third survey at 3 months post receipt of enhanced report

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 12, 2018
• Results First Posted: June 15, 2017

Record last verified: 2017-08