N/A N=213 Randomized Health Services Research

A Pilot Project Exploring the Impact of Whole Genome Sequencing in Healthcare

Healthy Adults (Full Study and Extension Phase) · Hypertrophic Cardiomyopathy or Dilated Cardiomyopathy

Bottom Line

View on ClinicalTrials.gov: NCT01736566 ↗

Enrolled (actual)

213

Serious AEs

1.9%

Results posted

Nov 2018

Primary outcome: Primary: Change in Attitudes and Trust — 0.0; 0.7; 3.5; 1.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Family History + Whole Genome Sequencing (Other); Family History Only (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Attitudes and Trust	0.0; 0.7; 3.5; 1.8; 1.0	—
PRIMARY Change in Self Efficacy	0.3; 0.5; 3.1	—
PRIMARY Change in Preferences for WGS Information	-.1; 0.2; 0; .4; 0.0	—
PRIMARY Change in Perceived Health	-0.1; 0; 0; -0.2; 0.3; -0.1	—
PRIMARY Change in Shared Decision Making	0.1; 0; 0.2; 0.1; -0.2	—
PRIMARY Change in Intolerance of Uncertainty	-0.5; 0.3; -1.3; 0; 4.9	—
PRIMARY Change in General Anxiety and Depression	0.1; -.2; -.4; -.3; -0.5; -1.4	—
PRIMARY Change in Health Behaviors	24; 16; 17; 15; 4; 20	—
PRIMARY Information Sharing	43; 39; 42; 30; 6; 41	—
PRIMARY Changes in Genomic Literacy	-.4; -.5; -.6; -.2; 0.0	—
PRIMARY Changes in Health Care Utilization	3.9; 2.3; 1.7; 1.7; 0.6; 1.4	—
PRIMARY Change in Perceived Utility	-.6; -.9; -1.0	—
SECONDARY Psychological Impact	13.2; 15.1; 14.2; 14.5; 11.4; 14.9	—
SECONDARY Decisional Regret	8.9; 12.9; 6.2; 15.8; 6.1; 9.8	—
SECONDARY Understanding	4.2; 4.5; 4.0; 4.2; 3.9; 4.2	—
SECONDARY Expectations	40; 36; 41; 42; 8; 43	—

Summary

The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's whole genome sequence into the practice of clinical medicine. In the extension phase of MedSeq we are attempting increase our participant diversity by increasing targeted enrollment of African/African American patient participants.

Eligibility Criteria

Note for Age Eligibility:

Cardiology patients 18 Years to 90 Years OR
Primary Care Patients 40 Years to 65 Years (Adult, Senior)

Inclusion Criteria

Primary Care

Generally healthy (as defined by the primary care provider) adult patients at Brigham and Women's Hospital ages 40-65. All patients must be fluent in English.

Cardiology

Patients in the Partners Healthcare System who are 18 years or older with a diagnosis of hypertrophic cardiomyopathy (HCM) or dilated cardiomyopathy (DCM) and a family history of HCM or DCM who previously had or who are candidates for targeted HCM or DCM genetic testing through routine clinical practice within Partners. All patients must be fluent in English.

Exclusion Criteria

Primary Care

Patients who do not meet the above criteria. Patients with cardiac disease or a progressive debilitating illness. Patients who are pregnant or patients whose spouses/significant others are pregnant. Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score > 11 administered at the baseline study visit.)

Cardiology

Patients who do not meet the above criteria. Patients with a progressive debilitating illness. Patients who are pregnant or patients whose spouses/significant others are pregnant. Patients with untreated clinical anxiety or depression (as measured by a Hospital Anxiety and Depression Scale (HADS) score > 11 administered at the baseline study visit.)

Extension Phase - Additional Inclusion Criteria

Part 1:

Above inclusion and exclusion criteria PLUS:
Inclusion: Self-identify as African or African American.

Part 2:

Inclusion Criteria

MedSeq participants determined to have a monogenic finding

Exclusion Criteria

Participants not previously enrolled in MedSeq Project
Participants not identified to have a monogenic finding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01736566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.