Case Studies Archives - Vibrent https://www.vibrenthealth.com/category/case-studies/ Wed, 22 Nov 2023 17:45:48 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.2 https://www.vibrenthealth.com/wp-content/uploads/2021/07/favicon.png Case Studies Archives - Vibrent https://www.vibrenthealth.com/category/case-studies/ 32 32 Building a genomics cohort study through patient engagement https://www.vibrenthealth.com/building-genomics-cohort-study-patient-engagement/ Mon, 03 Jul 2023 18:38:37 +0000 https://www.vibrenthealth.com/?p=8299 How Baylor College of Medicine is Engaging Patients to Build a Biorepository for Genomics Research Background Baylor College of Medicine is both a medical school […]

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How Baylor College of Medicine is Engaging Patients to Build a Biorepository for Genomics Research

Background

Baylor College of Medicine is both a medical school and research center located in Houston, Texas, and is affiliated with the world’s largest medical center, Texas Medical Center. In its creation of an Institute for Genomic Medicine, Baylor College of Medicine is building a repository of biospecimen and clinical data. A cohort of 100,000 participants over 18 will consent to provide biospecimens, EHR data, and optional research survey responses.

The institution is no stranger to genomics, with its Human Genome Sequencing Center being one of 20 global institutions involved in the Human Genome Project. This project was a 15-year effort that pioneered the DNA sequencing of an entire human genome. To-date, it has been the largest collaborative biological project and has paved the way for advances in medicine and biotechnology. 

In terms of funding from the National Institutes of Health (NIH), Baylor College of Medicine receives the most grant money out of any medical school in Texas. Additionally, its Department of Molecular and Human Genetics receives the most funding out of any medical school department in the United States, and it has eight over departments in the top 30 departments nationwide who receive the most NIH funding.  

Scientific Aims

The goal for Institute for Genomic Medicine cohort study is to build a research database with genotypic and phenotypic information that can be used to fuel future research studies across its many disciplines.  

The initial collection of genotypic data via biospecimens (primarily blood) will take place over the course of three years. Corresponding phenotypic data will be collected both via active data collection throughout the research and passively through participant medical records. Participants will consent for return of results, which will serve as the basis for future clinical utility studies. The consent process will also allow for the mining of de-identified patient data for other further research. 

Cohort

The Institute for Genomic Medicine cohort research team will recruit 100,000 participants over the course of 12 months from study launch. The study will use following the eligibility criteria: 

  • Ages 18 and older  
  • Received services within the Baylor College of Medicine system 
  • Able to provide a blood sample 

Baylor's Study by the Numbers

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Participants to be enrolled
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Methods for Assessment and Data Collection

The Institute for Genomic Medicine cohort study team determined to collaborate with Vibrent Health to develop a study infrastructure that would accelerate eConsent and data collection for participants. As part of this collaboration, Vibrent implemented a highly secure and privacy preserving participant portal and eConsent experience built on Vibrent’s Participant Experience Manager and Research Cloud products. 

The study uses the following methods of data collection:  

Informed eConsent

The eConsent process in the participant portal is created with the highest security and privacy standards. And it has several features that help increase participant comprehension over traditional paper and basic eConsent processes.  

Baylor College of Medicine has a single-tier electronic consent that includes a video to review the study activities, as well as a knowledge check where participants answer basic questions to indicate they understand the consent content. Research Cloud enforces a baseline level of informedness for consent, as participants must answer at least 3 out of 5 consent questions correctly to demonstrate study understanding before signing. If after 3 attempts a participant cannot demonstrate study understanding, the participant is not allowed to self-consent and a member from the study will contact them to review and sign consent. 

For Baylor College of Medicine, there is also a Certified Spanish translation of eConsent documents to ensure optimal comprehension of Spanish-speaking populations in the catchment areas that Baylor College of Medicine serves. 

Participants have access to their signed consent documents and can withdraw consent at any time via the secure participant portal. The status of the participant’s consent in the study is kept up to date in Baylor College of Medicine’s EMR system. 

Epic EHR MRN Verification

Baylor College of Medicine requires that participants who sign up for the study remotely to confirm they are patients in Baylor’s EHR system. To do this, the patient enters information such as name, date of birth, and other personally identifiable information in the secure portal, and this information is then matched with the patient’s corresponding medical record number (MRN) to verify their status as a patient. The study system also verifies that the patient has not signed up for the study before to avoid duplicated data.  

Participant Survey

Participants are invited to complete one optional survey, with the possibility of more surveys in the future. This survey is taken from Vibrent’s library of validated instruments to ensure quality and consistency. A request to complete the survey in the participant portal is sent to participants via email or SMS, depending on their specified communication preferences. They can review their survey responses before submission.  

Participants who choose to do this can also create an account on the participant portal, where they can perform future surveys, and receive additional information from the study team. 

Biospecimen Sample Collection

Biological specimens are obtained from consented participants using:  

  • Blood sample discards collected from pathology and research labs, emergency room visits, as well as in-clinic visits.  
  • Sample draws in-clinic or from ER, pathology labs, and research labs.  

Recruitment and Engagement

Baylor College of Medicine will recruit for their Institute for Genomic Medicine cohort study by research staff, encouraging word of mouth from other participants, and with the help of collaborating clinicians.  

Study Website

For all methods of recruitment, interested individuals are directed to the study website, built through Vibrent Research Cloud. The website includes introductory information about the study, FAQs, and links to the participant portal where study recruits can fill out the consent form and an optional survey for data collection. 

Email and MyChart Recruitment

Study staff can recruit potential participants by messaging them through Epic’s MyChart application. 

In-clinic Enrollment

Baylor College of Medicine and their affiliate sites will tell their patients about the study, give potential participants time to ask questions, as well as a copy of the consent form pending interest. Potential participants are told that their participation is voluntary and that their choice whether to participate will not impact their usual care.

Patients who are enrolled onsite can use their blood draw discards or go to a pathology lab to provide their biospecimen following consenting to participate in the study. Consent is obtained using a kiosk or tablet in-clinic.

Participant Engagement

Participants can be engaged on an ongoing basis by receiving communications via email or SMS messaging, including notices of completion of activities (e.g. consent, specimen collection), reminders that action is needed or availability of new surveys, and when errors or problems occur (e.g. locked out of account, forgot password). 

Participant Portal

Participants can configure their communication preferences to receive updates via SMS or email. Communications may include when their return of results is ready, and if they need to complete additional surveys. They can also change their contact details to ensure that they receive these communications.  

Research Impact

Baylor College of Medicine is a world-renowned leader in clinical care and genetics and serves as the hub of the largest medical center in the world. Moreover, Baylor College of Medicine is a tertiary referral center for many common and rare disorders and sees a high volume of patients across ancestries given the uniquely diverse makeup of Houston and the surrounding areas. This is critical as there is a substantial underrepresentation of individuals from non-European ancestries in genomic and biological research leading to healthcare inequities. 

In choosing a broad goal of trying to understand the fundamental biological basis for disease, Baylor College of Medicine has plans for the study to have interdisciplinary aspects and to create further research studies as a result. The college also plans to integrate the use of genomics and genetics in routine clinical practice for the advancement of precision medicine at their institution. 

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]]> How Virginia Commonwealth University Accelerated Data Collection from Twins for Long-COVID Study https://www.vibrenthealth.com/how-virginia-commonwealth-university-accelerated-data-collection-from-twins-for-long-covid-study/ Tue, 02 May 2023 12:48:00 +0000 https://www.vibrenthealth.com/?p=8530 How Virginia Commonwealth University Accelerated Data Collection from Twins for Long-COVID Study Background There is increasing evidence that some individuals suffer long term symptoms after

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How Virginia Commonwealth University Accelerated Data Collection from Twins for Long-COVID Study

Background

There is increasing evidence that some individuals suffer long term symptoms after recovering from Coronavirus Disease 2019 (COVID-19) infection. The term ‘long COVID’ was coined to refer to a variety of symptoms affecting different organs reported by people following a COVID-19 infection.

Twin360 is a research effort by scientists at Virginia Commonwealth University (VCU) who wanted to get the full picture of the impact of COVID-19 on the health of twin families. Twin360 analyzed long-term symptoms of COVID-19 that have been reported ranging across depression, exercise intolerance, weakness, and neurologic symptoms.

Studying twins who had the virus, as well as those who did not, is a powerful way to understand the impacts of COVID-19 and improve our ability to support those impacted. 

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Cohort

The Twin360 project needed to recruit a large number of participants quickly, and the study primarily used the Mid-Atlantic Twin Registry of Virginia Commonwealth University (MATR). MATR was established in the 1970s as a resource for scientists to better understand the genetic and environmental influences impacting human health and disease—through conducting research with twins.

Twin360’s research cohort recruited twins identified as having electronic health record information in the VCU health system. The study compared responses to surveys from participants with data from their electronic health record, if they agreed to provide access to that information through informed consent.

Twin360 By the Numbers

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Approach and Methods for Assessment and Data Collection

The Twin360 study aimed to examine the role of genetics vs. environment on acute and long-haul symptoms of COVID. This was done by comparing acute and long-haul symptoms between monozygotic or identical twins, who share 100% of their genes to dizygotic or fraternal twins, who only share 50% of their genes.
With the focus on COVID-19, a rapidly spreading infectious disease, it was important for the study team to recruit a large, diverse participant base very quickly. To achieve this, the Twin360 team decided to collaborate with Vibrent Health to develop a study infrastructure to speed up recruitment, eConsent and data collection. As part of this collaboration, Vibrent launched a participant portal for Twin360 , built on Vibrent’s Participant Experience Manager.
The study used the following methods of data collection:

Participant Portal

Twins wishing to participate could create an account on the participant portal for the Twin360 study. This portal, available as a web or mobile application, runs on Participant Experience Manager, and provides participants access to informed consent, data collection, their user account details, genomic results, and more information. The study used the participant portal as one of the primary means for data collection.

Informed eConsent

Through a series of text screens and videos hosted on the participant portal, the Twin360 study educated participants about participating. Agreement to participate was documented with digital signatures. The eConsent software automatically emailed participants a copy of the IRB-approved PDF consent form with their added signatures, and participants could withdraw their consent at any time. 

Participant-Generated Data & Surveys

The study obtained extensive health information from participants through surveys, also ran through the participant portal, including:

Electronic Health Record Data

The Twin360 study also collected participant electronic health record data (EHR) and linked them to survey and biospecimen data for use in a broad range of research. EConsent for this data collection was processed through the participant portal, running on Vibrent’s Participant Experience Manager.

Recruitment and Engagement

The Twin360 study team selected 5,588 adult twins who had already consented to re-contact from the MATR for outreach. The study staff used multi-modal communication to drive the twins to the Twin360 study platform, run on Vibrent Health’s Participant Experience Manager platform.

Email and SMS recruitment

Twins from the registry were sent recruitment emails and text messages.

Multi-modal communication

A pilot subset of 309 twins were selected for phone calls and, in addition to emails/texts, they received:
Within a 6-month period, the MATR recruited over 1,300 twins to enroll in the Twin360 study and over 400 pairs of twins completed the Twin360 survey. At study completion, there were over 1400 participants, 90.4% of whom completed the survey.

Research Impact

Studying twins who had the virus, as well as those who did not, is a powerful way to expand our knowledge of COVID-19 and ideally improve our ability to support those impacted. The Twin360 project provided a pathway for twins to take part in this innovative and important research, and the research team selected Vibrent’s Research Cloud and Participant Experience Manager products to power the study.
“The virtual nature of digital research, utilizing mobile devices or computers from anywhere, allows us to engage twins for decentralized studies around the globe,”
Dr. Judy Silberg, VCU Scientific Director of Mid-Atlantic Twin Registry
Twin360 utilized the Mid Atlantic Twin Registry (MATR), a registry of over 55,000 twins, to survey twins on COVID infection across twins and development of long-term symptoms. This assisted in understanding why some of those infected with the virus experience long-term or recurring symptoms or sometimes develop brand new symptoms months later. 
Twins were studied using the following methods:

More to read

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]]> How the SuperAgers Family Study Uses Multi-Modal Engagement to eConsent and Engage the Largest Cohort of Centenarians https://www.vibrenthealth.com/how-the-superagers-family-study-uses-multi-modal-engagement-to-econsent-and-engage-the-largest-cohort-of-centenarians/ Tue, 02 May 2023 12:47:00 +0000 https://www.vibrenthealth.com/?p=8470 How the SuperAgers Family Study Uses Multi-Modal Engagement to eConsent and Engage the Largest Cohort of Centenarians Background Researching what leads some individuals to age

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How the SuperAgers Family Study Uses Multi-Modal Engagement to eConsent and Engage the Largest Cohort of Centenarians

Background

Researching what leads some individuals to age more slowly than the rest of the population could enable novel strategies for the treatment or prevention of aging-related chronic disease. Some genetic determinants have already been discovered in centenarians, and learning more about these factors could lead to therapies and treatments that improve quality and quantity of life. However, exceptional longevity, generally defined as survival to 85 years or older, is uncommon. Thus, there is the need to improve sample sizes to ensure scientific rigor. The Centenarian Family Research Study and Biorepository to Identify Determinants of Healthy Aging and Exceptional Longevity study formed to use multi-modal engagement to develop the world’s largest centenarian family registry and biorepository for systematic investigation of healthspan and exceptional longevity in humans.

This initiative is spearheaded by the American Federation for Aging Research and the Albert Einstein College of Medicine, and is known as the SuperAgers Family Study.

Scientific Aims

The overarching goals of this coalition are to amass the world’s largest cohort of centenarians as well as their offspring who possess protective phenotypes related to aging compared to spouse controls. The scientific aims include:

Cohort

The project is an observational cohort study that includes two phases. In the pilot feasibility phase, the study aims to enroll 250 centenarians and 500 offspring of centenarians and offspring’s spouses. In the scale up phase, 10,000 centenarians, as well as their offspring and offspring spouses if available, will be recruited according to the inclusion criteria:

SuperAgers Family Study by the Numbers

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Centenarians to be recruited
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Surveys for phenotypic data collection
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Larger than any other cohort of centenarians

Approach and Methods for Assessment and Data Collection

The SuperAgers Family Study is a remote study, using a HIPAA compliant direct-to-participant (DTP) using the Vibrent Health Participant Experience Manager and Research Cloud products. These solutions enable eConsent, enrollment, and acquisition of self-reported clinical, lifestyle, social and other data.

The SuperAgers Family Study uses the following methods of data collection: 

Informed eConsent

The study team uses direct-to-participant (DTP) eConsent forms delivered through Participant Experience Manager. In addition to eConsent, individuals who are not able to provide consent using the eConsent application due to limitations in abilities to use technology, can request a hard copy consent form to be mailed to them along with a self-stamped return envelope.

Participants using eConsent can manage their participation in the program through Participant Experience Manager, which includes the ability to download their consent and related information, and withdraw consent at any time.

Consent to recontact research participants is also an important element of the research initiative’s eConsent process. The study team contacts participants with periodic updates and opportunities to participate in studies of healthy aging and longevity and drug development activities.

Computer Assisted Telephone Interviews (CATI)

Because of the unique needs of the centenarian population, the SuperAgers Family Study uses CATI features, part of Vibrent’s digital health research platform, to engage participants in contributing data when necessary. This approach helps to increase the eConsent and survey completion volume for such participants.  

CATI is a structured system of data collection by telephone that allows trained program staff to verify participant identity and verbal authorization to proceed, then complete the collection of participant data. Once a CATI session is completed, the participant has access to information submitted within their account.  

Family Relationship Link

With a focus on creating a family registry and biorepository for the centenarian population, the SuperAgers Family Study also collects the family link among offspring and their related centenarian.

The study team uses Data Explorer to visualize links between the centenarians and the offspring through data collected during enrollment in the study.

Electronic Health Records (EHR)

Research participants can eConsent to share their EHR data through HL7 FHIR subject EHR exchange.

Participant-Generated Data & Surveys

Using Participant Experience Manager, the SuperAgers Family Study uses multi-modal engagement (website, SMS, and phone) to collect self-reported clinical, lifestyle, social and other data from optional surveys. The data collection in these surveys includes:

Biospecimen Sample Collection

The SuperAgers Family Study aims to perform genome and exome-wide sequencing of samples and to perform association analyses of all genotypes across the genome (genome-wide) with all clinical phenotypes from survey and EHR data (phenome-wide).

Following enrollment and acquisition of phenotypic data, participants submit a biospecimen. Through Participant Experience Manager’s integration with DNA Genotek, participants automatically receive a collection kit so that they can collect the biospecimen at home by doing a simple cheek swab procedure or providing a saliva sample that requires no assistance or presence of outside providers.

This automated process makes the protocol non-invasive and user-friendly for this older population.

Participant Portal

This portal runs on Vibrent Participant Experience Manager, and provides participants access to capabilities that include:

Multi-Modal Recruitment and Engagement

The study recruits research participants from the Centenarian Family Registry established at the American Federation for Aging Research (AFAR).  The program builds gerontology community awareness about the study using multi-modal engagement methods.

Researchers also use email outreach to invite enrollees in the AFAR Centenarian Family Registry, who agree to receive information about research or other initiatives to participate in the research study.

The study team also targets the offspring of centenarians, which is a population familiar with mobile and computer technologies and motivated to reach out to their centenarian parent and to participate in research themselves.

Email and SMS engagement

The study team uses Research Cloud to send participants periodic engagement communications via email, mobile phone push notifications or SMS messaging. The participant can choose the method of messaging they prefer through the Participant Portal, which runs on Participant Experience Manager.

The study team sends messages that include:

Multi-Modal Appointment Management

The study team uses Research Cloud to manage inbound appointment requests, appointment scheduling, and the fulfillment of the appointments, which include consent and survey assistance, as well as video-based age verification.
Participants can schedule appointments through Participant Experience Manager for video age verification, or call to schedule appointments of the other types over the phone.

Return of Results

As a benefit of participation in the research study, participants can choose whether or not to receive information about their ancestry. Participants can access this data within the Participant Experience Manager portal.

Research Participant Data Access for Researchers

Each researcher and supporting staff have a unique login to Research Cloud and access to participant datasets, adhering to the principle of least privilege.
The Vibrent platform supports multi-modal engagement centrally, where research team members can use push notifications, email, SMS messaging, website content, and computer assisted telephone interviews for data collection.

All study tools that run on the Vibrent platform adhere to the Federal Information Security Management act of 2002 (FISMA), the Federal Risk and Authorization Management Program (FedRAMP), and Defense Information Systems Agency (DISA) guidelines.

Research Impact

The older an individual becomes, the more extreme is the longevity phenotype. Age 85 years is beyond the average life expectancy, but age 90 years is closer to the 90th percentile. Age 100 years is beyond the 99th percentile for contemporary birth cohorts. While not immune to age-related conditions, studying these individuals offers the promise of discovering genetic factors that impact the speed at which humans age.

A deeper understanding of biological and social determinants of healthy aging and exceptional longevity determinants could lead to novel strategies to delay aging and the chronic diseases associated with aging. This would:

More to read

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]]> How Dana-Farber Cancer Institute Created a Digital Cancer Registry to Improve Cancer Research and Maximize Patient Engagement https://www.vibrenthealth.com/how-dana-farber-cancer-institute-created-a-digital-cancer-registry-to-improve-cancer-research-and-maximize-patient-engagement/ Tue, 02 May 2023 12:47:00 +0000 https://www.vibrenthealth.com/?p=8567 How Dana-Farber Cancer Institute Created a Digital Cancer Registry to Improve Cancer Research and Maximize Patient Engagement Study Overview and Scientific Aims Lynch Syndrome affects

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How Dana-Farber Cancer Institute Created a Digital Cancer Registry to Improve Cancer Research and Maximize Patient Engagement

Study Overview and Scientific Aims

Lynch Syndrome affects about 1 in 300 people, and greatly increases one’s risk for a variety of cancers, including colon, rectal, uterine, ovarian, urinary tract, and other malignancies. It is the leading cause of hereditary colorectal (colon) cancer, and a common cause of endometrial cancer. The Dana-Farber Cancer Institute (DFCI) aimed to establish a comprehensive system and cancer registry to learn about new and ongoing options for individuals affected by Lynch syndrome.

 

To achieve this aim, DFCI chose to partner with Vibrent Health and the University of Pennsylvania. The primary goal of this study is to help researchers develop strategies that can improve prevention, early detection, and treatment of cancer by collecting clinical information and various biological samples from individuals with Lynch syndrome.

Cohort

The eligibility criteria includes participants who are aged 18 or older, and who have one of the following:

The Lynch Registry by the Numbers

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People are estimated to be affected by Lynch syndrome
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Types of wearable data collected from Apple Health
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Surveys questions for phenotypic data collection

Approach and Methods for Assessment and Data Collection

The Lynch syndrome study team collaborated with Vibrent Health to provide a study infrastructure that would accelerate eConsent and data collection for participants in the cancer registry. As part of this collaboration, Vibrent implemented a highly secure and privacy-preserving participant portal and eConsent experience built on Vibrent’s Participant Experience Manager product.

The study uses the following methods of data collection: 

Participant Portal

All participants can create an account for themselves on the participant portal for the Lynch Syndrome registry. This portal, available as a web or mobile application, provides participants with access to surveys, other data collection methods, their user account details, and more information about the study.

Informed eConsent

Vibrent provides a secure, privacy-protecting eConsent platform for the Lynch Syndrome study through its website features. Participants watch an educational study video to better understand what they must do as part of the study, then complete the steps of consent.

Participant-Generated Health Surveys

The study obtains information from participants through surveys. Surveys can be sent via email or SMS to participants on initial registration and subsequent annual follow-ups. Surveys can also be delivered through postal mail, completed on paper, then entered by research staff into the Vibrent research database. The data collection in these surveys includes: 

Electronic Health Record Data (EHR)

The Lynch Syndrome registry also collects participant electronic health record data (EHR). For participants who do not receive care from the Dana-Farber Cancer Institute, the study team will request medical records after obtaining signed release of information.

Vibrent helps DFCI to perform data collection, upon participant consent, automatically from EHR systems, including Epic and Cerner. Data collected from the EHR include: 

Patient-Generated Data from Wearables (Apple Health)

In addition to EHR, participants using Apple Health can connect and share data from their wearable device with the study team, from within the cancer registry participant portal.

Biospecimen Sample Collection

Biological specimens are obtained from consented participants, in order for the study team to incorporate genomic data into the research study dataset. Specimens are collected as part of participant’s routine clinical care.

Options for biospecimen collection include time of consent, pre-paid mailed kit, external lab, or separate appointment at DFCI. Specimens collected include:

Cancer Registry Recruitment and Engagement

Because of the specific focus of the cancer registry, the cohort only includes participants with known or suspected Lynch syndrome. To identify these potential participants, the Lynch Syndrome study team uses Vibrent Research Cloud to perform outreach using digital methods like email and SMS.

The team also distributes its IRB-approved study materials through study coordinators, DFCI physicians and staff, during in-person interactions, social media, brochures, flyer, and mail.

Using Vibrent Health’s Participant Experience Manager, recruitment for interested individuals can be automated through the participant-facing tools, and study eConsent forms.

Email and SMS engagement

The study team uses Research Cloud to send participants periodic engagement communications via email, mobile phone push notifications or SMS messaging. The participant can choose the method of messaging they prefer through the Participant Portal, which runs on Participant Experience Manager.

The study team sends messages that include:

Return of Results

As a benefit of participation in the research study, participants can choose whether or not to receive information from the study. During the consent process, participants can clarify what, if any, individual results they wish to receive should any become available that are deemed appropriate for return.

Research Impact

The Dana-Farber Cancer Institute, by creating an efficient and secure collection and storage of clinical data and specimens by those that are affected by Lynch Syndrome over the course of time will result in improvement of care, and potential prevention.

Registration in the cancer registry will be ongoing, and any clinical significance of results is unknown. In order to expand participation, partnering with Vibrent Health provides DFCI an infrastructure that accelerates eConsent, data collection, while providing security and privacy.

More to read

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]]> How My Healthy Maryland Uses Vibrent Health to Power eConsent, Recruitment, Data Collection, and Participant Engagement for Its 250,000 Participant Precision Health Study https://www.vibrenthealth.com/how-my-healthy-maryland-uses-vibrent-health-to-power-econsent-recruitment-data-collection-and-participant-engagement-for-its-250000-participant-precision-health-study/ Tue, 02 May 2023 12:46:00 +0000 https://www.vibrenthealth.com/?p=8768 How My Healthy Maryland Uses Vibrent Health to Power eConsent, Recruitment, Data Collection, and Participant Engagement for Its 250,000 Participant Precision Health Study Background Precision

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How My Healthy Maryland Uses Vibrent Health to Power eConsent, Recruitment, Data Collection, and Participant Engagement for Its 250,000 Participant Precision Health Study

Background

Precision Health is a medical model that takes into account a patient’s genes, clinical and biomarker information, environment and lifestyle to individualize medical decisions, treatments, and practices. Unfortunately, for Precision Health studies to validate utility requires the collection of data from very large numbers of research participants. In genetics, new technologies like high-throughput genotyping, DNA sequencing, and exome sequencing have shown promise and, in some cases, become the standard of care for rare conditions. 

Most genetic studies and discoveries, however, have been made in predominantly Caucasian populations of European origin. This presents a critical gap in our knowledge and understanding of the genetic architecture of health and disease in more diverse populations, and the My Healthy Maryland Precision Medicine Health Initiative aims to help bridge the diversity gap to narrow health care disparities in Maryland and beyond. 

Scientific Aims

The primary aim of the My Healthy Maryland Precision Health Initiative is to recruit a large diverse longitudinal cohort of research participants across Maryland for health-related basic, clinical and translational research, and the implementation of evidence-based precision health into the health care systems of the State of Maryland. 

Cohort

Large numbers of participants are necessary in order to achieve the research aims of Precision Health studies like My Healthy Maryland. The My Healthy Maryland team initiated the study with a feasibility phase in which they aim to recruit 5,000-10,000 participants, which will be followed by a scale-up phase to as many as 250,000 participants over the next 5-10 years, according to the eligibility criteria: 

  • Ages 18 and older 
  • All races 
  • Maryland resident at the time of enrollment 

With a focus on Maryland residents, My Healthy Maryland aims to establish a remarkably diverse dataset, particularly because of the ethnic and racial diversity of the state: 

  • 51.1% Non-Hispanic White 
  • 30.9% Non-Hispanic Black 
  • 10.6% Hispanic 
  • 7.1% Non-Hispanic Asian or Pacific Islander 
  • 0.3% Non-Hispanic American Indian 

My Healthy Maryland Precision Health Initiative

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Participants to be enrolled
Health systems’ EHR to integrate
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eConsent completion rate

Approach and Methods for Assessment and Data Collection:

The My Health Maryland team determined to collaborate with Vibrent Health to develop a study infrastructure that would accelerate eConsent and data collection for participants. As part of this collaboration, Vibrent implemented and maintains the My Healthy Maryland Participant Portal and Application, built on Vibrent’s Participant Experience Manager.

The study uses the following methods of data collection: 

Participant Portal

All interested participants can create an account for themselves on the participant portal for My Healthy Maryland Precision Health Initiative. This portal, available as a web or mobile application, runs on Vibrent’s Participant Experience Manager, and provides participants access to informed consent, data collection, their user account details, genomic results, and more information. The portal is one of the primary means for the My Healthy Maryland study to collect data. 

Informed eConsent

The digital informed consent process, as a part of the participant portal, incorporates a series of text screens and videos to educate participants about participating. Agreement to participate is documented with digital signatures and participants are emailed a copy of the IRB approved pdf consent form with their added signatures.  

Electronic Health Record Data

The Initiative collects participant electronic health record data (EHR) and links them to survey and biospecimen data for use in a broad range of research. EConsent for this data collection is also acquired through the participant portal, running on Vibrent’s Participant Experience Manager. Data types collected from the EHR include: 

  • Demographics 
  • Clinical encounters 
  • Diagnoses 
  • Medications 
  • Laboratory tests 
  • Anthropometrics 
  • Procedures 
  • Vital signs 

Participant-Generated Data & Surveys

The study obtains extensive health information from participants through surveys, also run through the participant portal, including: 

    Electronic Health Record Data

    • Basics 
    • Overall Health 
    • Personal Medical History 
    • Family Medical History 
    • Lifestyle  
    • Demographics 
    • Clinical encounters 
    • Diagnoses 
    • Medications 
    • Laboratory tests 
    • Anthropometrics 
    • Procedures 
    • Vital signs 

    Biospecimen Sample Collection

    Biological specimens are obtained from consented participants using: 

      • Buccal swabs, delivered by mail. These are requested through Participant Experience Manager and mailed with instructions for use at home along with return postage. Up to four swabs are collected from each participant. 
      • Biospecimens collected from participants under other IRB-approved studies including blood samples, saliva samples, buccal swab samples or extracted DNA  
      • Residual samples from clinical blood collection 

        Recruitment and Engagement

        To achieve the broad recruitment goals for this study, the My Healthy Maryland study team performs outreach to potential participants using a variety of advertising and communication methods including targeted recruitment, web advertisements, social media, community events and press coverage.  

        To accelerate recruitment, the My Healthy Maryland Precision Medicine Health Initiative established numerous outreach methods using Vibrent’s Research Cloud. These outreach methods include:

        Biospecimen Sample Collection

        For all methods of recruitment, interested individuals are directed to the study website, built through Vibrent Research Cloud. The website includes introductory information about the study, FAQs, and links to the study consent form.  

        Targeted recruitment

        Study staff can contact participants who are enrolled in other UM IRB-approved protocols and have agreed to re-contact by email/letter to offer participation.  

        Email and SMS recruitment

        Study staff reach potential participants through personalized email and SMS messages to existing lists of contacts. Potential participants can select their preferred method of communication.  

        Community events

        During community outreach events or other locations, study staff use enrollment and interest forms through Research Cloud to capture information about an interested potential participant. Interested individuals can also download the mobile app or navigate to the web application on their own mobile device or use an on-site kiosk or tablet on which they can review the audiovisual content and provide e-consent.  

        Participant engagement

        Participants are engaged on an ongoing basis by receiving communications via email, push notifications or SMS messaging, including notices of completion of activities (e,g. consent, specimen collection), reminders that action is needed or availability of new surveys, and when errors or problems occur (e.g. locked out of account, forgot password).  

        Participant portal

        In addition to outbound messages, participants are engaged through the participant portal, run on Vibrent’s Participant Experience Manager. Participants can access the portal through the web or mobile application, and gain access to information about their participation, including: 

        • Genomics results 
        • Personalized educational content 
        • Quick polls, which allow participants to answer a question to see how their responses compare to aggregated responses from the cohort 
        • Notifications of actions needed, or new updates 
        • Personal account details 
        “Using Vibrent’s digital health research tools, we can support a mutually beneficial partnership between participants and researchers, which promotes participant engagement. Through communication tools embedded in the digital research platform, we can keep in touch with participants and share results and updates with them through the lifecycle of the study.”

        study principal investigator Stephen Davis, MBBS, FRCP, FACE, MACP, Theodore E. Woodward Professor and Chair of the Department of Medicine at UMSOM, and Director, Institute for Clinical and Translational Research and Vice President of Clinical Translational Science at the University of Maryland, Baltimore.

        Research Impact:

        The large-scale recruitment of the My Healthy Maryland Precision Health Initiative participants 

        and their engagement for longitudinal follow up will provide an unprecedented opportunity for researchers to better understand the human genomic variation and its relationship to disease and treatment.  

        The data collected will be representative of the diversity of Maryland’s population integrating clinical phenomic, genomic and other -omic sciences with state-of-the art big data analytics, informatics, and artificial intelligence to advance basic discovery, epidemiologic, translational, and clinical and implementation research in precision health, to improve the health of Marylanders and the value of healthcare in Maryland and beyond. 

        The Initiative will serve not only as a substrate to implement evidence-based precision health into our health care system, but to study its implications in terms of health outcomes, quality of life, impact on society, ethics and the law, and economic value.

        Participants can configure their communication preferences to receive updates via SMS or email. Communications may include when their return of results is ready, and if they need to complete additional surveys. They can also change their contact details to ensure that they receive these communications.  

        More to read

        The post How My Healthy Maryland Uses Vibrent Health to Power eConsent, Recruitment, Data Collection, and Participant Engagement for Its 250,000 Participant Precision Health Study appeared first on Vibrent.

        ]]>                 How the National Institutes of Health’s All of Us Research Program Uses eConsent, Surveys, EHR Data, and Wearables to Build Its Million-Person Dataset https://www.vibrenthealth.com/how-the-national-institutes-of-healths-all-of-us-research-program-uses-econsent-surveys-ehr-data-and-wearables-to-build-its-million-person-dataset/ Tue, 02 May 2023 12:41:00 +0000 https://www.vibrenthealth.com/?p=8599 How the National Institutes of Health’s All of Us Research Program Uses eConsent, Surveys, EHR Data, and Wearables to Build Its Million-Person Dataset Background Precision

        The post How the National Institutes of Health’s All of Us Research Program Uses eConsent, Surveys, EHR Data, and Wearables to Build Its Million-Person Dataset appeared first on Vibrent.

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        How the National Institutes of Health’s All of Us Research Program Uses eConsent, Surveys, EHR Data, and Wearables to Build Its Million-Person Dataset

        Background

        Precision medicine is emerging as a more effective way to prevent, diagnose, and treat disease. The success of this approach is in the incorporation of an individual’s unique genetic and phenotypic information, and how those factors can impact the nature of disease.  

        However, as is the case with much of health care today, the benefits of precision medicine have not been equitably accessible across racial, geographic, socioeconomic, and other measures. Not only does this impact marginalized groups, but the promise of precision medicine can only be achieved with input from a broad population that reflects the true diversity and life experiences of the populace. 

        All of Us Research Program Logo

        The All of Us Research Program aims to deliberately build a cohort of one million participants, with unprecedented diversity, in order to enable research for a wide range of diseases, both common and rare. The magnitude of this cohort has the statistical power to detect associations between genetic and environmental exposures and a wide variety of health outcomes.  

        The All of Us Research Program also aims to engage participants in line with the evolving culture of health care in the United States. Besides collecting genomic and phenotypic data, the program seeks to actively engage participants in all aspects of the program, including governance, oversight, design, conduct, dissemination, and evaluation.  

        Scientific Aims

        The primary aim of the All of Us Research Program is to build a robust research resource composed of participant-provided information (PPI), environmental, physiologic, genetic, and health data, plus biospecimens from one million or more research participants reflecting the diversity of the United States. This resource will facilitate the exploration of biological, social, and environmental determinants of health and disease. 

        The All of Us Research Program aims to have the scale and scope to enable research for a wide range of diseases, both common and rare, as well as increase our understanding of healthy states. 

        Cohort

        The All of Us Research Program aims to recruit 1,000,000 or more individuals willing and able to answer questionnaires (PPI), provide biospecimens and physical measurements, share their EHR data, and authorize re-contact. The inclusion criteria for this cohort is: 

        Participants are enrolled via two modes, whichever is most convenient for the participant: through HPOs or DV sites, using the Participant Technology Services Center, which runs on Vibrent’s platform.

        The All of Us Research Program By the Numbers

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        eConsented participants
        0 %
        Racial and ethnic minority
        0 %
        Underrepresented in biomedical research
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        Electronic health records (EHR)
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        Biosamples
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        Funded partner organizations

        Approach and Methods for Assessment and Data Collection

        The All of Us Research Program chose to award Vibrent Health to develop and run the foundational technologies needed for such large-scale enrollment. Vibrent’s platform powers the Participant Technology Systems Center, which includes a participant-facing portal and participant management tools for more than 100 nationwide program partners.

        The study uses the following methods of data collection: 

        Informed eConsent

        Vibrent’s platform provides a flexible, modular, and secure eConsenting process for the All of Us Research Program through its website features. Each module includes the eConsent screens, a formative evaluation, and a form requiring a signature, and these modules cover these processes: 

        • Primary consent – overview of all program activities, and approval to take part in the PPI, data linkage, physical measurements, biospecimen collection, biobanking, biomarker assays, genomic testing, and sensor/wearable technology activities if invited. 
        • HIPAA Authorization for Research EHR/Part 2 Supplement – gives details about allowing the research program access to a participant’s EHR. 
        • Consent for genetic return of results – explains the potential risks and benefits from receiving genetic/genomic results from the program. 

        Vibrent also supports the All of Us Research Program by managing state-specific requirements for eConsent in these modular forms. 

        Additionally, the All of Us Research Program manages two eConsent “refresher loop” eConsent screen sets: 

        • Physical Measurement and Biospecimen Refresher eConsent screens – reminds participants of the scope, limits, risks, and benefits of these procedures. 
        • Sensor and Wearable Technology eConsent screens – these present a more detailed look at sensor/wearable technology participation, including scope, limits, baseline privacy, and more. 
        All of Us Research Program data collection surveys

        Participant Portal

        The All of Us Research Program provides program updates and messages to participants through its participant portal, built on Vibrent’s platform. Through either the participant-facing website or the mobile app, participants are able to access their individual-level information, like responses to PPI questionnaires, values from their physical measurements, their responses to snap surveys, notifications that they have provided EHR data, and information about the wearables they have chosen to integrate. 

        Participant-Generated Health Surveys

        Individuals who join the All of Us Research Program by completing the informed consent process  are eligible to start contributing information to the program through the participant portal. 

        The data collection in these surveys includes: 

        • Basics (sociodemographic information)  
        • Overall Health  
        • Lifestyle (personal habits)  
        • Personal and Family Health History  
        • Health Care Access and Utilization  
        • COVID-19 Participant Experience (COPE)  
        • Social Determinants of Health  
        • Medications 
        • Mental Health 

        Vibrent provides a secure, privacy-protecting eConsent platform for the Lynch Syndrome study through its website features. Participants watch an educational study video to better understand what they must do as part of the study, then complete the steps of consent.

        All of Us Research Program data collection

        Participant Wearables and Fitness Tracker Data

        Participants in the All of Us Research Program can connect an array of sensor technologies using the participant portal, which runs on Vibrent’s digital platform. Connecting wearables and sensors enables the longitudinal collection of physiologic and environmental data. 

        The program collects data from sensors and wearables including: 

        • Smartphone data  
        • Hardware-based sensors in smartphone handsets (such as gyroscopes, accelerometers, barometric pressure meters, touchscreen features, cameras, microphones, and Global Positioning System) 
        • Software-based sensors resulting from in-phone features provided by other participant-authorized software  
        • External device data  
        • Physical devices that transmit to the participant’s smartphone, using Bluetooth or other similar wired or wireless networking technologies 
        • Fitbit 
        • Withings 
        • Phillips 
        • Apple HealthKit 
        • Samsung Health 
        • Garmin 
        • Medical-grade technologies like telemetry and continuous glucose monitoring  
        • Devices that transmit data from a participant-authorized server (including Facebook, Maps, FourSquare, Weather Data, Location Service GIS data, data provided from IoT [Internet of Things] devices, and environmental technologies like home automation tools).

        Computer-Assisted Telephone Interviews (CATI)

        The All of Us Research Program uses CATI features, part of Vibrent’s digital health research platform, to engage participants in contributing data, particularly those with a range of disabilities of varying degrees and severity (e.g., stamina, communication, cognitive, physical) or who have barriers to accessing technology. This approach helps to increase the survey completion volume for such participants.  

        CATI is a structured system of data collection by telephone that allows trained program staff to verify participant identity and verbal authorization to proceed, then complete the collection of participant data. Once a CATI session is completed, the participant has access to information submitted within their account.  

        Biospecimen Sample Collection

        Biological specimens are obtained from consented participants for genomic sequencing, including: 

        • Blood samples 
        • Urine specimens 
        • Saliva samples 

        Electronic Health Record Data

        Data collection involving electronic health record data (EHR) is a key contribution of the All of Us Research Program to health informatics research efforts nationwide. Vibrent’s platform manages the eConsent for the program’s acquisition of this data, and integrates with EHR systems to automatically collect participant data for the All of Us Research Program. These datatypes include all parts of the EHR, such as:  

          • Demographics 
          • Visits 
          • Diagnoses 
          • Procedures 
          • Medications 
          • Laboratory tests 
          • Vital signs  
          • Health care provider notes 
          • Radiology 
          • Messaging 
          • Reports 
          • Other testing (e.g., electrocardiograms) 
          All of Us Research Program - EHR data

          Recruitment and Engagement

          The consortium of the All of Us Research Program members use a suite of software tools and services to facilitate participant engagement and retention, built on Vibrent Health’s platform.

          These tools and services include resources for scheduling; communications and case management; individual engagement; cohort, sub-cohort, and individual analytics; participant account support; and more.  

          Study Website

          Web-based materials are an important part of the recruitment process in order to educate the large numbers of prospective participants needed to meet the enrollment goal of one million or more participants. The All of Us Research Program hosts IRB-approved materials targeted to the general public on the research program’s website, which is managed on Vibrent’s digital platform. The website includes: 

          Computer-Assisted Telephone Interviews (CATI)

          The All of Us Research Program uses CATI features, part of Vibrent’s digital health research platform, to engage participants in contributing data, particularly those with a range of disabilities of varying degrees and severity (e.g., stamina, communication, cognitive, physical) or who have barriers to accessing technology. This approach helps to increase the survey completion volume for such participants.  

          • Videos about the research program in English and Spanish, and with subtitles 
          • Frequently asked questions  
          • Messages from program leadership  
          • Testimonials from participants 

          Email and SMS recruitment

          Study staff reach potential participants through personalized email and SMS messages to existing lists of contacts, including those who have opted in to receive updates and information about the research program. Potential participants can select their preferred method of communication.  

          Participant incentives

          The All of Us Research Program offers participants who travel to an enrollment site for physical measurements and/or biospecimen collection a payment incentive intended as reimbursement for their time and resources spent traveling. 

          Health care provider organization (HPO) enrollment

          The All of Us Research Program enrolls people who are members of an HPO’s health plan and their affiliates or have received care the HPO – directly through that organization. However, any eligible individual who wishes to enroll at an HPO may do so, even if they do not have a prior connection with that HPO. HPOs use Vibrent’s participant management tools to enroll these participants.

          Participant engagement

          The All of Us Research Program values participants as research partners and employs digital engagement strategies using Vibrent’s platform. The Web and mobile application have been designed to be user-friendly and engaging, with a responsive and intuitive user interface. The program also uses Vibrent’s tools to engage participants through: 

          • Sending communications and information via email, push notifications or SMS messaging 
          • Posting snap questions and quick polls along with related facts 
          • Returning participant information through digital tools 

          Participant portal

          In addition to outbound messages, participants are engaged through the participant portal, run on Vibrent’s platform. Participants can access the portal through the web or mobile application, and gain access to individual-level information about their participation, including: 

          • Responses to PPI questionnaires 
          • Personalized educational content 
          • Values from their physical measurements 
          • Responses to snap surveys and quick polls, which allow participants to answer a question to see how their responses compare to aggregated responses from the cohort 
          • Notifications that they have provided EHR data 
          • Information about the wearables they’ve connected 

          Return of results

          Participants do not have to receive information such as genetic sequencing data and wearable sensor data, but are able to do so if they choose. Participants are empowered to decide if and when to access their individual-level data, and can provide consent using the program’s eConsent framework, which runs on Vibrent’s secure platform.

          Participants who elect to receive their information can access it through the participant portal, also running on Vibrent’s platform.  

          Research Impact

          The All of Us Research Program’s dataset is poised to help researchers unlock answers related to long COVID, social determinants of health, health disparities, and more. Health data from nearly 20,000 people who have had SARS-CoV-2 is now available to researchers across the U.S., opening new opportunities to study COVID-19 disease prevention, progression, and recovery. These records are part of the National Institutes of Health’s All of Us Research Program’s expanded dataset encompassing clinical, genomic, and participant-reported information. 

          In addition to the COVID-19 data, the program has added more than 57,600 initial responses from its new social determinants of health (SDOH) survey to drive novel insights into how lived experiences affect health.

          More to read

          The post How the National Institutes of Health’s All of Us Research Program Uses eConsent, Surveys, EHR Data, and Wearables to Build Its Million-Person Dataset appeared first on Vibrent.

          ]]>                     How Mount Sinai Delivers eConsent and Phenotypic and EHR Data Collection for Its Million Person Genomics Research Program https://www.vibrenthealth.com/how-mount-sinai-delivers-econsent-and-phenotypic-and-ehr-data-collection-for-its-million-person-genomics-research-program/ Tue, 02 May 2023 10:42:00 +0000 https://www.vibrenthealth.com/?p=8661 How Mount Sinai Delivers eConsent and Phenotypic and EHR Data Collection for Its Million Person Genomics Research Program Background Genomic data has emerged as a

          The post How Mount Sinai Delivers eConsent and Phenotypic and EHR Data Collection for Its Million Person Genomics Research Program appeared first on Vibrent.

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          How Mount Sinai Delivers eConsent and Phenotypic and EHR Data Collection for Its Million Person Genomics Research Program

          Background

          Genomic data has emerged as a promising way to enable researchers to make novel discoveries about human disease, and methods of treatment. However, large amounts of diverse data sets are necessary to ensure scientific rigor.  

          In addition to the need for large cohorts, there is the need for research to immediately remedy the lack of participant diversity in racial, ethnic, and other markers of demography.  

           
          The Mount Sinai Million study is the first million-person genomics-led longitudinal program in close collaboration between a health system, pharma and a digital health company. The initiative aims to gather and build a repository of molecular and clinical data (as well as a repository of biospecimens) from one million racially and ethnically diverse Mount Sinai Health System patients.

          By building these data and biospecimen biorepositories, the study will promote a new wave of biomedical research, one which will have the capability to accelerate discoveries into the nature and treatment of human disease. 

          Scientific Aims

          The primary aim of the Mount Sinai Million program is to establish a data repository that links genotypic and phenotypic data on one million individuals, over the course of six years. 

          The data and biospecimens in these repositories will be used by multiple researchers for multiple purposes, enhancing the utility of the data and biospecimens. Ultimately, Mount Sinai Million will spearhead a new approach to large-scale population genetic research with the potential to affect the medical care of millions of individuals.  

          Cohort

          This Mount Sinai research team will recruit 1,000,000 participants over the next 6 years, according to the eligibility criteria: 

          • Ages 18 and older 
          • Received services within the Mount Sinai Health System 
          • Able to provide a blood biospecimen 

          Participants will be recruited at any Mount Sinai Health System site including Mount Sinai Hospital,   Mount Sinai West, Mount Sinai Morningside, Mount Sinai Beth Israel, New York Eye and Ear Infirmary of Mount Sinai, Mount Sinai Queens, and Mount Sinai Brooklyn. 

          Mount Sinai Million By the Numbers

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          Participants to be enrolled
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          Hospital sites
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          Years enrollment period

          Approach and Methods for Assessment and Data Collection

          The Mount Sinai Million study team determined to collaborate with Vibrent Health to develop a study infrastructure that would accelerate eConsent and data collection for participants. As part of this collaboration, Vibrent implemented a highly secure and privacy preserving participant portal and eConsent experience built on Vibrent’s Participant Experience Manager and Research Cloud products.

          The study uses the following methods of data collection: 

          Participant Portal

          All participants can create an account for themselves on the participant portal for the Mount Sinai Million initiative. This portal, available as a web or mobile application, runs on the Participant Experience Manager, and provides participants access to surveys, data collection, their user account details, return of results and more information.  

          Informed eConsent

           Vibrent Research Cloud provides a secure, decentralized eConsenting platform for the Mount Sinai Million program through its website features. Participants watch an educational study video on the Vibrent’s platform, then review the consent. Research Cloud also enforces a baseline level of informedness for consent, as participants must answer at least 3 out of 5 consent questions correctly to demonstrate study understanding before signing. If after 3 attempts a participant cannot demonstrate study understanding, the participant is not allowed to self-consent and a member from the study will contact them to review and sign consent. 

          Data and EHR Verification

          Verification that the participant is a Mount Sinai Health System patient takes place on the secure Participant Experience Manager platform. Participants provide a few specific details about themselves and this information is matched against Mount Sinai Health System records automatically. 

           

          EHR Data Collection

          The Mount Sinai Million program collects participant electronic health record data (EHR) and combines it with phenotypic data for the study, including survey data for use in a broad range of research. EConsent for this data collection is also acquired through the participant portal, running on Vibrent’s Participant Experience Manager. Data types collected from the EHR include: 

          • Demographics 
          • Vital sign dates, components, and values 
          • Visit diagnoses and dates 
          • Logical observation identifiers names and codes 
          • Single-entry laboratory values and measures 
          • Medical history 
          • Medications 
          • Procedure orders and procedure results 
          • Social history 
          • Survey and PRO data 
          • Raw imaging data 
          • Image derived phenotypes 
          • Clinical notes 
          • Pathology, radiology, catheterizations, and echocardiogram reports 
          • Brief op notes 

          Participant-Generated Data & Surveys

          The study obtains information from participants through optional surveys, also run through Participant Experience Manager. Surveys are sent electronically to participants multiple times per year until they withdraw participation or the study ends. The data collection in these surveys includes: 

          • Baseline  
          • Participant’s health 
          • Healthcare 
          • Participant’s family’s health 
          • Lifestyle 

          Biospecimen Sample Collection

          Biological specimens are obtained from consented participants using: 

          • Clinical discards. Clinical discards are leftover biospecimens obtained from routine clinical purposes. For this study, such biospecimens will not be discarded but will instead be set aside to be used for research upon obtaining participant consent. 
          • Research blood draw. Participants who visit Mount Sinai Health System may provide an additional biospecimen for the study if their clinical blood is not being processed by Mount Sinai’s pathology laboratory or if a suitable blood sample does not exist.

          Recruitment and Engagement

          The Mount Sinai research study team performs outreach to potential participants through study coordinators, MSHS clinicians and staff, and IRB-approved educational study materials disseminated through different platforms and technologies – in-person, phone, brochures, pamphlets, flyers, advertisements, social media, emails, mail, QR codes, and MyChart notifications and messages. 

          To identify patients who have already consented, previously refused to participate, or withdrew to ensure that they are not approached again for consent, the study team uses EPIC, as well as Vibrent Health’s Research Cloud. Potential participants may be contacted using one of the following features of Research Cloud: 

          Study Website

          For all methods of recruitment, interested individuals are directed to the study website, built through Vibrent Research Cloud. The website includes introductory information about the study, FAQs, and links to the study consent form.  

          CATI is a structured system of data collection by telephone that allows trained program staff to verify participant identity and verbal authorization to proceed, then complete the collection of participant data. Once a CATI session is completed, the participant has access to information submitted within their account.  

          Email and SMS recruitment

          Study staff reach potential participants through personalized email and SMS messages to existing lists of contacts, including those within the Mount Sinai Health System patient data repository. Potential participants can select their preferred method of communication.  

          In-clinic enrollment

          All adult patients seen within Mount Sinai Health System who meet the eligibility criteria will be asked to participate. Study team members and clinicians pre-check for eligibility and prior consent using Research Cloud, and then can enroll and assist with eConsent using forms within Research Cloud. Interested individuals can also download the mobile app or navigate to the web application on their own mobile device on which they can review the audiovisual content and provide eConsent.  

          Participant engagement

          Participants can be engaged on an ongoing basis by receiving communications via email, push notifications or SMS messaging, including notices of completion of activities (e.,g. consent, specimen collection), reminders that action is needed or availability of new surveys, and when errors or problems occur (e.g. locked out of account, forgot password).  

          Participant portal

          In addition to outbound messages, participants are engaged through the participant portal, run on Vibrent’s Participant Experience Manager. Participants can access the portal through the web or mobile application, and gain access to information about their participation, including: 

          • Genomics results 
          • Personalized educational content 
          • Quick polls, which allow participants to answer a question to see how their responses compare to aggregated responses from the cohort 
          • Notifications of actions needed, or new updates 
          • Personal account details 

          Research Impact

          The Mount Sinai Million study team aims to enable a wide range of critical discoveries with this ambitious research program. Potential outcomes could include novel therapeutics to treat, cure, and ultimately prevent disease. 

          The study also aims to promote a newfound understanding of what health itself means at the genetic level. The ethnic and racial diversity of Mount Sinai’s patients is a large contributing factor to the scientific value of this research, and Mount Sinai Million aims to dramatically expand the knowledge of the biological basis of all common diseases that affect people across the globe.  

          The Mount Sinai Million program marks the first time a health system of this size and diversity has integrated genomic analysis into routine clinical decision-making to understand the impact of genetic variations on human health and disease.

          More to read

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