GeneMatch Referral Manual. Author(s): David Gordon, Trisha Walsh, Hayley Graf Document status: V4
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1 GeneMatch Referral Manual Author(s): David Gordon, Trisha Walsh, Hayley Graf Document status: V4 Release date: February 12, 2018
2 Contents 1. GeneMatch Program Overview Eligibility requirements GeneMatch Kit GeneMatch Recruitment Resources GeneMatch Toolkit Accessing your Toolkit Toolkit Links and Materials Generation Program Referral Process Referral Dashboard Activating Your Dashboard Accessing Your Dashboard Referrals Prescreening referrals Updating Referrals Referral Status Referral Status Guide Contact Log Calendar Scheduling Tool Time Zone Genetic Counselors Scheduling a Genetic Disclosure Session Scheduling a Genetic Counselor for a Non-GeneMatch Referral Study Coordinator Profile Study Site Profile Questions? Contact us at:... 16
3 1. GeneMatch 1.1 Program Overview The goal of GeneMatch is to identify a large group of people interested in participating in research studies based in part on their genetic background. GeneMatch tests for a specific gene called APOE4 using a cheek swab. The result of this test will not be shared with the participant through GeneMatch, however participants may be contacted to join studies that require them to learn their genetic risk Eligibility requirements Are years old inclusive Live in the United States Do not have a diagnosis of cognitive impairment, such as mild cognitive impairment, Alzheimer s disease, or dementia 1.2 GeneMatch Kit All GeneMatch participants receive a kit containing instructions on how to complete their cheek swab, a de-identified bar coded cheek swab in a plastic container, laboratory requisition form, and prepaid shipping envelope. GeneMatch kits can be received by a participant in two different ways: 1. Receive a kit in the mail: Participants who want to receive a kit in the mail can do so by signing up for GeneMatch at Each participant will be asked to confirm their eligibility, watch a short education video and/or read the written educational content, read and electronically sign the informed consent form, and provide basic demographic information. Once this process is completed a kit will be shipped to the participant s address within 2-3 weeks of enrollment. 2. At a study site and community events (Option for GeneMatch partner sites and requires WIRB approval): Each participant will be asked to confirm their eligibility, watch a short education video and/or read the written educational content, read and electronically sign the informed consent form, and provide basic demographic information. Once this process is completed site staff can hand participants a GeneMatch kit to complete at the site or at home. *If your site is interested in having GeneMatch kits onsite, please contact David.Gordon@bannerhealth.com 1.3 GeneMatch Recruitment Resources We are happy to provide your site with the necessary tools to recruit and register participants for GeneMatch. All sites receiving GeneMatch referrals will have access to the following tools: IRB approved content* Sample GeneMatch content to be used in online recruitment campaigns. GeneMatch education video This video can be shown at community events where your site plans to register a large number of people. This video can be provided as a URL or DVD. Registry/GeneMatch Slide Deck* Provides an overview of the GeneMatch program and can be incorporated into community outreach presentations.
4 GeneMatch FAQs* This is a list of IRB approved responses to some of the common questions participants have about GeneMatch. GeneMatch Brochures/Business Cards* GeneMatch brochures and business cards can aid in participant recruitment. Please requests for brochures and business cards to GeneMatch.Request@endALZnow.org. Facebook/Twitter Posts GeneMatch ads for your sites Facebook page that directs people to the GeneMatch webpage. Community Event Postcards and Newspaper ads GeneMatch ads for your site to use for promoting community outreach events. Banner can tailor these ads to meet your site specific needs, including branding with your site name and logo. GeneMatch Postcards Directs people to the GeneMatch website where they can register and receive a kit in the mail. This mailer can be branded with your site name and logo. *These items are available in your GeneMatch toolkit (see section 1.4) 1.4 GeneMatch Toolkit Each Generation Program site will have access to a GeneMatch toolkit that will provide your site the necessary information to recruit and enroll participants into the GeneMatch program. Sites do not have to be GeneMatch partner sites to access and use the majority of the materials in the toolkit Accessing your Toolkit To access your toolkit please navigate to Search for your site and click on your site link to pull up your toolkit. *Sites are listed by state Toolkit Links and Materials The following links and materials can be found in the GeneMatch toolkit: Mailed GeneMatch Kit Link This link is for registering participants for GeneMatch who want to receive a cheek swab kit in the mail. The link is site specific and can be used in communications and participant recruitment materials. Community Event Slide Deck This slide deck contains IRB approved GeneMatch content as well as a link to the GeneMatch educational video to be shown at community events. IRB-Approved Content Sample GeneMatch content to be used in online recruitment campaigns. GeneMatch Brochure Order Link Please use this link to place orders for GeneMatch brochures and other collateral.
5 GeneMatch Manual This link contains the latest version of the GeneMatch manual. This manual will be your guide for the GeneMatch program, including recruitment and referral management. GeneMatch FAQ Document This document contains a list of IRB approved responses to the most common questions received from GeneMatch participants. GeneMatch Informed Consent This document should be used for participant reference only. Please note, consent must be given online during GeneMatch Registration. The following links and materials can be found only in GeneMatch partner site toolkits: On-Site GeneMatch Registration This link contains your site specific URL and should only be used when handing GeneMatch kits directly to participants. GeneMatch Cheek Swab Resupply Form To order more GeneMatch kits, download and fill out this form and submit to the GeneMatch team at GeneMatch.Request@endALZnow.org. 2. Generation Program Referral Process Once a Generation Program site is activated in a particular state, GeneMatch will begin sending invitations to eligible participants in the state. The ability for GeneMatch to send invitations to participants for the Generation Program is dependent on having enough participants in GeneMatch in that region for the referral algorithm to be activated. When a participant is selected to receive an invitation to learn more about the Generation Program, they receive the following Subject Line: You have a study match from GeneMatch! Dear XXX, Based on your Alzheimer s Prevention Registry GeneMatch program profile, you have been matched to a study opportunity. The Generation Program is enrolling people age 60 to 75 who may have a higher risk of developing Alzheimer's later in life. This risk is because of a certain gene (called APOE4) that may or may not be in your DNA. The Generation Program is enrolling participants at sites across North America, Europe and Australia. The Generation Program is inviting selected GeneMatch participants to learn more about the study. This invitation does not mean you have the APOE4 risk factor. People with and without the risk factor are being invited to learn more about the program, which consists of two parts. Part 1 of the Generation Program is open to people with different APOE profiles who, if qualified, will receive genetic counseling to learn their specific APOE results. Part 2 of the Generation Program is only open to people with a specific APOE profile, who, if qualified, may receive study medication and study-related care. The Generation Program is investigating medications that could advance doctors' understanding of how to potentially prevent the onset of Alzheimer s disease. In addition, it will help them understand how to communicate genetic results to adults.
6 To qualify for the Generation Program, you must: Be 60 to 75 years of age Have normal memory and thinking ability If the participant chooses to learn more and accept the study invitation, they are prompted to log in to their GeneMatch account and are directed to Generation invitation landing page which takes them through the following steps: 1. Review study information
7 2. Watch an educational video on the Generation Program and review Frequently Asked Questions 3. Choose a Generation Program site and request their contact information be sent to the selected study site
8 4. Confirm site selection and review the contact information for the study team at the selected study site By clicking submit the participant s contact information is populated on the Referral Dashboard at the selected study site. Once the selection is made, an is sent to the site staff member with access to the GeneMatch Dashboard notifying them of the new referral. Site staff are responsible for contacting the participant within 10 business days to provide additional information on the Generation Program and schedule the Prescreening and Disclosure study visit 1 if the participant is deemed eligible by your site. 3. Referral Dashboard 3.1 Activating Your Dashboard Once your site is activated for the Generation Program, the GeneMatch team will request the contact information (First and Last Name, , Phone Number) for the designated staff member at your site who will manage your GeneMatch referrals. Once we receive this information, a Referral Dashboard account will be activated and the designated site staff member will receive an automated with a link to the login page.
9 3.2 Accessing Your Dashboard To access your Referral Dashboard, you will need to login at Enter your username and password into the designated fields and click Log In. If you cannot access your dashboard please contact When you first login to the Referral Dashboard you will be taken to the Referrals page as shown below: 3.3 Referrals The Study Referral Tool is located on the home page of the Referral Dashboard. All potential participants that have been referred to your site from GeneMatch will be listed here. (Please note that if you contact a participant for the Generation Program and they indicate they would like to change their site selection, you should notify the GeneMatch Team at GeneMatch.Request@endALZnow.org via secure mail). The Study Referral tool will provide you with an easy way to manage your referrals. Referrals can be sorted by multiple fields including name, study, study status, last contacted date.
10 3.3.1 Prescreening referrals GeneMatch invites a predefined ratio of genetically eligible and non-eligible participants to the Generation Program. Each participant who selects to participate in the Generation Program at your site has also self-identified as not having a diagnosis of cognitive impairment at the time of GeneMatch consent. Please note that no further prescreening activities such as collecting history of exclusionary medical conditions, confirming the participant has a study partner, etc., are conducted by the GeneMatch staff. We encourage all sites recruiting from GeneMatch to prescreen each participant before bringing them in for a screening and disclosure study visit. Below, we have provided you with some useful tips/talking points when contacting GeneMatch referrals. Remember: Referrals have consented to the GeneMatch program and provided a genetic sample Referrals have not been told their genotype through GeneMatch Referrals self-identify as meeting inclusion criteria for GeneMatch only After consenting for GeneMatch, referrals are not asked to re-confirm whether or not they have received a diagnosis of cognitive impairment No Generation Program specific prescreening has been completed except for age eligibility Referrals are told to expect a call from site staff within 10 business days When talking with the participant we recommend confirming the following information: Date of birth If this is different than what is listed on the participants referral profile, please contact GeneMatch at GeneMatch.Request@endalznow.org Has the participant had a change in cognitive status? (e.g.: Confirm that the participant has not received a diagnosis of cognitive impairment) Has the participant watched the Generation Program Pre-Disclosure video? Is the participant aware that they will learn their genotype during visit 1? Updating Referrals Referrals need to be updated throughout the pre-screening and screening process. To update a referral s profile, click on their name as shown above. This will take you to that participants Referral Profile.
11 All fields in the Referral Profile are editable by site staff Referral Status As referrals are contacted and scheduled, please update their Referral Status as appropriate. To update the referral status, click the drop down menu (shown above) and select the appropriate status. Once selected, click the update button, circled in red above Referral Status Guide Please reference the table below for referral status definitions. This table will help to ensure the correct status is selected for each of your referrals. Referred All new referrals that are populated on your dashboard will have a status of Referred. Contacted, not yet scheduled Site has contacted/attempted to contact participant but the initial study visit has not been scheduled. Scheduled Participant has been scheduled to come in to the site for Visit 1. Enrolled Participant has signed Informed Consent Form (ICF) at visit 1. Please note, no further update to participant status needs to be made after this point. Not eligible Participant screen fails at any point prior to signing ICF. Not Interested Lost to follow up Participant is not interested in the study. Participant cannot be reached by study coordinator after multiple attempts Contact Log When a referral is contacted, a New Note should be added to that referral s profile page briefly describing the conversation. The contact log can be found below the participant information on the
12 Referral Profile page. When creating a note, fill in the appropriate information and click save. The note will be saved to the Contact Log Calendar When a genetic disclosure session is scheduled for a participant at your site, the appointment details will populate in their Referral profile in the Calendar section. This section can be found below the Contact Log. If you would like to edit the details of this appointment you will need to navigate to the Scheduling tool. 3.4 Scheduling Tool To navigate to your Scheduling Tool click on the Scheduling button in the upper right hand corner of your Referral Dashboard. For sites not using a local Genetic Counselor or Provider, disclosure sessions will be provided using remote genetic counseling services delivered by the University of Pennsylvania (Penn) Telegenetics Program. The Scheduling Tool will be used to schedule genetic disclosure sessions with the Penn Telegenetics Team for participants screening for the Generation Program. A screen shot of the scheduling tool is shown below as well as a description of significant features.
13 Available appointments for genetic disclosure sessions are labeled as Open Slots. Once an appointment is booked it is labeled Genetic Disclosure Session and shaded green, as shown in the screen shot above. Booked Genetic Disclosure Sessions are only visible by the individual that booked that appointment. Open Slots are visible by all users Time Zone The default time zone will be set based on the information provided in your application. If it is not correct, you may change the time zone by clicking on the time zone drop down menu. *All Open Slots and Genetic Disclosure Sessions are automatically adjusted to the time zone you select Genetic Counselors For sites using remote genetic counseling services provided by the Penn Telegenetics Program, available appointment times on the Scheduling Tool are labeled as Open Slots as shown in the screen shot above. Please note that you will not be able to book appointments within 7 days of the current date as counselors need sufficient time to prepare for the session Exceptions may be made for extenuating circumstances. To discuss the possibility of scheduling someone within the 7 day window contact Penn Telegenetics directly at (215) and / or Penn.Telegenetics@uphs.upenn.edu.
14 3.4.3 Scheduling a Genetic Disclosure Session Appointments on the Scheduling Tool are shown either as an Open Slot or a Genetic Disclosure Session and are all scheduled for 1 hour. Open Slots can be scheduled by anyone with access to the Scheduling Tool. A booked slot labeled as a Genetic Disclosure Session is only viewable and/or editable by the individual who booked the appointment. To book an appointment, find an Open Slot" on the calendar that meets your scheduling needs and click the Open Slot button. A green Appointment Details box will appear (shown to the right). 1. Begin typing the participants name and select them from the drop down list. Be sure to select the correct name from the drop down options. You cannot succesfully schedule an appointment simply by typing in a participant s name. 2. Select which Generation Study, 1 or 2, the participant will be screening for. 3. The phone number associated with your account will automatically populate in the Study Site Details. Please enter an additional Alternate phone number that the Genetic Counselor can use to reach you if necessary the day of the appointment. 4. Insert a Name and Phone Number of a backup contact that can be reached in case you are not available is also required for scheduling. 5. Review information for accuracy and click Save Updates. 6. The appointment should now show as booked "Genetic Disclosure Session (shaded green) on the Scheduling Tool calendar and is only viewable and/or editable by you. A confirmation will be sent to you with the following language: A Genetic Disclosure Session has been scheduled as part a screening visit for the Generation Program. Details of the appointment are provided below. Site Name: Study Coordinator Name:
15 Appointment Date: Appointment Start Time: (*** all appointment times will populate in Eastern Time as this is the time zone of the Penn Telegenetics Counselors) Appointment Duration: 60 Minutes Genetic Counselor Name: Meeting Phone Number: Generation Study: If for any reason this appointment needs to be canceled or rescheduled, please follow the procedures outlined in the GeneMatch Referral Manual. Sincerely, The Generation Program Team 7. To delete an appointment, click on the event in the calendar to show the appointment details. Then Click the Delete Button. You will be prompted with a warning Are you sure you want to delete? If you are sure select yes, and the appointment will convert back to an Open Slot that can be booked by other individuals (unless it is within 7 days, which in that case it will no longer be available for scheduling and disapear from the calendar). An confirming that the appointment has been canceled will be sent to you and the Genetic Counselor Scheduling a Genetic Counselor for a Non-GeneMatch Referral For non-genematch referrals who need to be scheduled for a remote genetic disclosure session with the Penn Telegenetics Team, please start typing Non-GeneMatch Referral into the participant name fieldand select Non-GeneMatch Referral from the drop down list (as shown below). Fill in the rest of the required information as described in the section above. Click Save Updates and confirm that the appointment shows as a booked Genetic Disclosure Session (shaded green) on the Scheduling Tool. A confirmation will be sent to you as described in the section above. The Participant Intake Form (included in the Genetic Disclosure Visit Manual) and a valid genetic report will need to be provided to the Penn Telegenetics team at least 3 business prior to the scheduled session.
16 3.5 Study Coordinator Profile To navigate to your Study Coordinator Profile, click on your user name at the top right of the Research Referral Dashboard. Here you can review and edit your personal profile information, as well as change your password. To edit your password, enter your current password and double enter your new password in the spaces provided. Click save to update. Your study site information can also be found on this page. If your site information changes, please contact Below your site information is a list of Your Studies receiving referrals. Click on the study details button to navigate to the Study Information page. 3.6 Study Site Profile To navigate to your study site profile, click on the View/Edit Study Site Profile button at the top right of your Referral Dashboard. The information on this page is not editable by site staff. If any of the information on this page changes or is incorrect please contact GeneMatch.Request@endALZnow.org. Questions? Contact us at: GeneMatch.Request@endALZnow.org STOP-ALZ ( )
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