Overcoming Barriers to Accessing Genetic Medicine

Investigations of Barriers and Methods to Overcome Barriers to Access Genetic Medicine

To learn about patient barriers to accessing genetic medicine, we will analyze anonymous posts from a membership-based online community [Inspire.com], and investigate how these barriers differ for various populations. We will then test whether these barriers can be addressed by providing online access to a genetic counselor to answer patient questions for one group of patients (virtual advisory board group) and compare to that of a control group who does not have access to a genetic counselor (virtual peer-to-peer board group).

Study Overview

• Status: Active, not recruiting
• Conditions: Genetic Disease; Genetic Predisposition
• Intervention / Treatment: Other: Access to Genetic Counselor for answering questions

Detailed Description

Genomic medicine has the potential to advance diagnoses, predict risk, support prevention efforts, and inform treatment decision-making. Though technologies for measuring genetic variants have improved and become more cost-effective, clinical integration of genomic medicine has been surprisingly slow. For genomic medicine to be successfully implemented across specialties and across demographics, the systemic barriers that patients experience need to be identified and addressed.

Online health support is becoming an increasingly important part of healthcare as more patients use digital health networks. In the first part of this study, an analysis of online communication in a membership-based online support community [Inspire.com] will identify systemic, structural and individual barriers to accessing genomic medicine. A genetic counselor will be informed to these results and will be part of the intervention arm of the study.

To assess the extent to which online health networks can directly help genomic medicine implementation, participants will join one of two Virtual Discussion Boards (a Virtual Advisory Board and a Virtual Peer-to-Peer Discussion Board). In the intervention arm, the Virtual Advisory Board will have a genetic counselor answer patient questions online about genomic medicine once every week for a period of three months. In the control arm, participants will answer and comment on each others' questions in the Virtual Peer-to-Peer Discussion Board. We hypothesize that after six months, patients who participate in the Virtual Advisory Board are more likely to self-report receiving genomic medicine than those in the control arm. After completion of the study, participants in the Peer-to-Peer Discussion Board, we will give online access to the genetic counselor to answer any questions

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine A Brownstein, PhD; Phone Number: 6173554764; Email: catherine.brownstein@childrens.harvard.edu
• Study Contact Backup: Name: Pankaj B Agrawal, MD; Phone Number: 6173555861; Email: pankaj.agrawal@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Member of Inspire.com Genetic disease Genetic predisposition to disease -

Exclusion Criteria:

Not member of Inspire.com No genetic disease No genetic predisposition to disease

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Advisory Board; Participants have access to a genetic counselor to answer their questions on accessing genetic medicine.	Other: Access to Genetic Counselor for answering questions; A genetic counselor answers questions posed by participants in the intervention arm on how to access genetic medicine. At the end of the study, the number of participants who were able to access genetic medicine will be assessed
No Intervention: Virtual Peer-to-Peer Discussion Board; Participants answer each others' questions on the topic of accessing genetic medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative self-report of referrals for clinical genetic services	Percentage of participants with self-report of referrals for clinical genetic services	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative self-report of specific barriers to the participant accessing genomic medicine	The ability for a participant to articulate the barriers to them accessing genetic medicine	6 months
Self-report of specific behaviors to overcome barriers to accessing genetic medicine	Qualitative assessment of ability for a participant to self-report performing behaviors to overcome barriers to accessing genetic medicine.	6 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Human Genome Research Institute (NHGRI)

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Diseases, Inborn; Genetic Predisposition to Disease
• Other Study ID Numbers: P00039779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will share aggregated and de-identified data as requested in accordance with our IRB protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No