Using the EHR Recruitment Service requires IRB approval. Below are detailed steps to include this recruitment strategy in your IRB submission. Study teams may include the below descriptions in their IRB application before having an initial PRP consultation but must agree to submit PRP-drafted patient facing materials as a modification after onboarding.

1. IRB Application, "Recruitment" section:

Use the following template language to indicate that you will be using the CTSI Consultation Services:

This study is working with CTSI to use MyChart for recruitment along with cohort identification and direct mail for recruitment of patients who are not enrolled in MyChart. Here’s how it works:

MyChart (Apex) conducts a search for patients based on the study’s inclusion and exclusion criteria. This is a completely computer-aided search, meaning the computer — and not a person — searches patient charts. When a patient is identified as potentially eligible, they receive an email from MyChart that says to log in to MyChart to read about a study that they might be interested in. The email is short and is the same for every recipient—there is no patient-specific, study-specific, or disease information in it.

When the patient logs into MyChart, there is a “Research” page with template information about participating in research and how to opt out of receiving recruitment messages. The patient can click through to learn about a specific study that they may be eligible for. 

Of note:

1. The patient has the option of clicking a link/button to let the study team know that they are interested in learning more about the study. Only if the patient takes this action will the study team receive information about the patient. If the patient clicks “No thanks” or simply does not respond, they will not be contacted by the study team, they will not receive any follow-up emails from MyChart about this study, and their information will not be shared with the study team.

2. The messaging in all recruitment materials—email, MyChart research page, and study description— clearly states that the patient is being contacted about research, not clinical care.

We are collaborating with the CTSI Participant Recruitment Program (PRP), which will provide cohort identification and direct mail for the recruitment of patients who are not enrolled in MyChart in order to address racial and ethnic disparities that exist in MyChart enrollment.

2. IRB Application, "Waiver of Consent/Authorization for Recruitment Purposes" section: Answer all questions and explain what info will be collected prior to obtaining informed consent.

3. Attach the patient-facing materials: After consultation with PRP, we will draft patient-facing materials, such as the direct mail letter and MyChart message, ensuring that they are written at an 8th-grade level or below. Study teams must submit these materials for IRB approval. If EHR recruitment has already been included in your IRB application, a modification submission of these documents will still be required.

Note:

• For detailed instructions on submitting to the IRB, please refer to our MyChart IRB submission guidance. 
• IRB application versions may vary in how information is collected; if you have questions about how to implement this guidance in your specific version please contact [email protected].

Not all patients use MyChart, and activation rates are lower among under-represented populations, patients with limited English proficiency (LEP), and pediatrics. 

% MyChart Active at time of Encounter (8/1/22-8/31/22)

Source: https://dashboards.ucsf.edu/dashboards/mychart-activation-ambulatory

To address the disparity in MyChart activation, PRP provides mechanisms to contact all patients—whether they have MyChart accounts or not. Patients who have MyChart accounts can be contacted via MyChart; those without MyChart accounts can be contacted via paper letters.  To ensure equitable outreach and avoid widening disparities in research participation, studies using the EHR Recruitment Service are required to send paper letters in addition to MyChart messages. To match the approximate overall MyChart activation rate at UCSF (see table above), we recommend studies recruiting adults plan for at least 10% of your overall outreach via the EHR Recruitment service to be by letter. For pediatrics, we recommend you plan 20%-40% of your outreach by letter due to lower activation rates among pediatrics. cost section

We expect all studies to prioritize increasing outreach to patients underrepresented in research and budget for this expense. Please see cost section below for guidance on budgeting for letters. More information about how to send letters is in the EHR Recruitment Letters Information section below. 

Studies wishing to use the EHR Recruitment Service must meet eligibility requirements. 

The study must:

• Have inclusion/exclusion criteria that can be identified in structured data fields in the electronic medical record. Please refer to the APeX (UCSF) Pick List for a comprehensive list of variables that can be used for participant selection.
• Have or request an APeX Study Build (instructions below)
• Have a UCSF IRB number (External IRB approval is acceptable, as long as there is also a UCSF IRB record as well.)
• Send paper letters to non-MyChart users to address disparities in MyChart vs. Non-MyChart user patient populations.

PI and staff must:

• Be UCSF employees (and have a UCSF Employee ID number)
• Have or obtain APeX user accounts (instructions below)

Once recruitment starts, study personnel must agree to:

• Log into APeX at least 3x/week once recruitment period starts:
• Respond to inbasket notifications from potential research participants within 1 week, preferably within 1-2 business days.
• Send recruitment messages to new batches of patients.
• Promptly report any technical problems, patient feedback, or complaints to PRP at: [email protected].

The set-up process for the EHR Recruitment Service can take about eight weeks. This timeline is dependent on 1.) study team's timely completion of set-up tasks; 2.) availability and work queue of programming staff at time of submission; and 3.) IRB approval time. PRP will make every effort to keep the study team apprised of updates related to setup and expected launch dates.

All studies interested in using the EHR recruitment service start with a consultation to discuss the service and determine if it’s a good fit for the study. This meeting is free and there is no further obligation.

For studies that wish to proceed with the service, the following costs will apply: Set-up, Programming, Monthly Maintenance Fee, and Letters for non-MyChart users.  Please review each of these components below carefully to estimate the costs associated with this service. If you have any questions, please contact [email protected].

Set-up

$440 (4 hours at $110/hour*)
Set-up time includes project management, consultation on patient-facing messages, and guidance on submitting for IRB approval.

This will be billed in installments:

• First installment: $220 once patient-facing materials are drafted.
• Second installment: $220 once programming and MyChart setup is complete.

*Quoted rates are for non-industry sponsored trials; for more information on industry rates, see Consultation Services recharge policy.

Programming

$560-$1,120 (4-8 hours at $140/hour)
This service is done in collaboration with Academic Research Systems (ARS) programmers who work with the study team to develop the query for the recruitment reports. Recruitment queries typically take 4-8 hours per project but can increase if the query is complicated. (This range is provided for budgeting and estimation purposes only; project estimates will be provided by ARS for each project before work commences.)

Scholarships may be available to support the cost of data query development work. You will be offered an opportunity to apply for scholarship funds once your project has been triaged to the ARS programming team. 

Monthly Maintenance Fee (starting July 1, 2024)
$110 (1 hour at $110/hr)
The maintenance fee applies only to studies in an “active” status on EHRMa. The fee covers PRP staff efforts for tasks like responding to patient inquiries, processing letters, answering client questions, troubleshooting system issues, and updating recruitment information in APeX.

Letters
We recommend studies recruiting adults plan for at least 10% of your recruitment outreach to be by letter. For pediatrics, we recommend you plan for 20%-40% of your outreach to be by letter because of lower MyChart activation rates. 

Step 1:  Estimate the number of letters

To estimate the number of letters you will need to send, multiply the total number of participants you expect to enroll via the EHR Recruitment Service by 10 (for adult populations) or 20-40 (for pediatric populations).  This will give you the approximate number of letters you can expect to send.

Step 2: Calculate the cost.

Multiply the number of letters by the price per letter.  Letters sent in batches over 200 qualify for non-profit postage rates; if sending fewer than 200 letters at a time, first class postage rates apply. 

• Orders >200 (Non-profit postage): $.58/letter
• Orders <200 (First-class postage): $.97/letter

Note: We encourage studies to send letters in batches of >200 letters. If study eligibility is restrictive and you do not expect to have 200 eligible patients at any given time, please budget using the first-class postage rates.

Examples: Budgeting for letters

Example: a study plans to enroll 100 adults via the EHR Recruitment service.  They estimate they need to send 1,000 letters to meet their letters outreach goal. They plan to send two batches of 500 letters to qualify for the non-profit postage rate.  Their letters budget is $580 (1,000 letters * $.58/letter).

Additional examples:

Study set-up: New APeX Users

1. User Account Request Form:

Study PIs and CRCs will need to have accounts in APeX before the study can be built (see Study set-up: APeX Study Build below).

Concurrent with the training (step 2) you can request APeX user access via the Account Request Form.

Request form: https://accountrequestform.ucsfmedicalcenter.org/

Guide to creating a request: http://myapex.ucsf.edu/system/files/Tip_Sheets/Creating_an_ARF.pdf

You will need to request the following Role / Template:

• Template: Select RESEARCH → UCSF RSH RESEARCH COORDINATOR

Note about PI access: All PIs must create APeX accounts but if they are creating accounts for recruitment purposes solely, they only need to request the UCSF RSH RESEARCH COORDINATOR ​template.

Tips for completing the ARF: You will need to select an approver from your department—this is usually a manager, but not all managers have APeX approval authority. If you cannot find your manager in the system, please work with your manager to find someone in the database who would be appropriate to approve this request. You are also able to suggest an approver from within your department (this will take a bit longer).

2. APeX Training

All new APeX research users who will log into APeX to perform recruitment activities must complete the following eLearning modules on the UC Learning Center. This must be completed before requesting a study build (see APeX Study set-up: APeX Study Build below) but can be done concurrently with the Account Request Form (step 1 above).

APeX View Only access (finding, reviewing patient info, responding to inBasket messages) requires completion of the following trainings. To access, please follow this link.

APeX View Only Access (Outpatient)

• Overview of Hyperspace in an Outpatient Setting [CLNAMB001] (12 mins)
• Clinical Information Review [ED013] (8 mins)

APeX View Only Access (Inpatient)

• Overview of Hyperspace in an Inpatient Setting [CLNINP001] (9 mins)
• Overview of Hyperspace [MD100] (12 mins)
• Finding Patient Information [MD103] (5 mins)

Study set-up: Current APeX Users

Current APeX users who will be conducting MyChart recruitment must:

1. Have the correct research APeX User Template:
For Clinical Research Coordinators or other non-clinician: You must have the APeX User Template "UCSF RSH RESEARCH COORDINATOR" (Updates can be requested via an Account Request Form (ARF); at Step 3, click on the "Role/Template button and select RESEARCH → UCSF RSH RESEARCH COORDINATOR ).
For Clinicians with existing APeX access. You must have the APeX User Subtemplate: UCSF RESEARCH USER SUBTEMPLATE. (Updates can be requested via an Account Request Form (ARF); skip Step 3 (Role/Template) and in the General Comment box type: “Add Template UCSF RESEARCH USER SUBTEMPLATE”)

2. Ensure they are listed as a study coordinator on the APeX study build. (Submit an APeX Maintenance Ticket to add the person to the APeX study build.)

All account details can be confirmed by calling IT Support: 415-514-4100, press 1 for APeX, it is a good idea to check your account details to ensure everything is correct.

All studies using the EHR Recruitment Service must have a valid study record in APeX. Before requesting a new APeX study record, please make sure that you have completed the required APeX trainings and user account requests (see APeX Study Set-up: User accounts above). To request a new APeX study record, please review the following process:

Submitting a New APeX Study Request:

1. Coverage Analysis Determination Form: Before initiating a New APeX Study Request, please complete the Coverage Analysis Determination Form. This form must be submitted to determine the coverage analysis status for your study. If you have questions or need more information, please review the Coverage Analysis section on the Office of Clinical Trial Activation website. 
2. Submit New APeX Study Request: Once the coverage analysis status is determined, submit an APeX Study Request form. 
3. APeX Study Request Form Guidance: 

• Provide Submission ID: Within the APeX Study Request Form, provide the corresponding Submission ID # generated by the Coverage Analysis Determination Form. This step confirms that the coverage analysis process has been completed or initiated. 
• Select the appropriate location: West Bay (San Francisco), Benioff Children's Hospital (East Bay), or both.
• In the study build information section, ensure the Study Name begins with "ZZ or XX" followed by your study name (e.g., "zzSAMPLE Study"). The study title (excluding the "zz") will be patient-facing in the study description. 
• Fill out the Billing Information/Chart of Accounts section. If the study record is exclusively for EHR recruitment, no charges will be billed through APeX.
• Ensure that the person conducting EHR recruitment is listed as a study coordinator on the request form.

Once set-up is complete (see above), here’s an overview of how the EHR Recruitment Service works:

1. Study staff logs into the EHRMa EHR Recruitment Platform selects the number of patients they wish to send recruitment messages to, and clicks a button to send the recruitment messages.
2. Patients receive a brief email saying they have a new message about research. They can log into MyChart and land on a Research page (see image below) where they can read about your study. If they would like to learn more, they can click a button that says “I’m Interested”.
3. For patients that click “I’m Interested” the study team will receive an APeX Inbasket message with that patient’s information. The study team can then respond to that patient per the study’s preferred workflow. (Tip: use a SmartPhrase to quickly reply to patients with information about your study.) Note that study teams never see the PHI of a patient until a patient expresses interest.
4. Studies can send up to 250 MyChart Messages per day. Up to 5,000 letters can be sent in one batch.

An EHRMa tip sheet with detailed instructions is available for your review.

The “Research” page in MyChart:

We require studies to send letters in addition to MyChart messages, and recommend at least 10% of your outreach be by letter.  Read more about equitable recruitment outreach.

Sending Letters

• Check your IRB approved letter and make sure that the information is still current. You can check the current letter we have on file by logging in to EHRMa and checking the "Files" section on the righthand side of the recruitment screen. 
• Does your letter need an update? Submit an IRB modification and upload the new version to your EHRMa account. 
• Once you have IRB approval, upload your new document in the Files section in EHRMa and put in a letter order. 

Cost

• Orders >200 (Non-profit postage): $.58/letter
• Orders <200 (First-class postage): $.97/letter

See the cost section above for more detailed information about the cost of letters and how to budget for it. We strongly encourage studies to 
send letters in batches >200 pieces.

Letters Processing schedule

Letter orders will be processed twice per month; schedule posted below. Generally processing will take place on the first and third Fridays of each month, 
with some exceptions during holidays

To send messages and view recruitment metrics:

·         Log into EHRMa (via MyAccess) 

·         Follow the instructions on the tipsheet to send messages and view metrics

To view patient responses and follow up: 

·         Log into APeX

·         View responses the APeX InBasket messaging system 

Letter orders are processed twice a month on the first and third Fridays of each month. Any exceptions to this schedule will be posted on the EHR Recruitment Letters section of our website. We strongly encourage studies to send letters in batches over 200 pieces.

Recruitment messages are sent to patients in an overnight batch process. You should start to see responses the day after you send the messages. 

Please review the EHRMa Metrics Report Guide for instructions on creating reports in EHRMa.

Yes. We can load multiple versions of the text in different languages into APeX; patients will automatically see the different languages based on their language preferences in MyChart. To add additional languages, please send the translated MyChart patient-facing language to [email protected]. For letters, you can upload the documents directly in EHRMa in the Files section on the right-hand side of the recruitment page.

For small updates related to contact information or description of study procedures, submit the revised document directly to the IRB. If you are making bigger updates with changes to to the format or readability of the patient-facing language, please send to [email protected] before submitting for IRB approval. PRP will do a quick review to make sure it is in line with our formatting and accessibility standards. 

After IRB Approval:

MyChart messages: Email [email protected] with the updated document. Updates are usually complete in about a week.

Letters: You can now upload/update your letter directly in EHRMa in the "Files" section on the right-hand side of the recruitment page.

No, you can only filter your cohort by gender, age, language, race, ethnicity, location (zip code), contact status, and MyChart account status. To learn how to update your query, please check the FAQ below: Link

If you need to adjust your query, please email [email protected] and we will connect you to the programming team. Additional fees will apply.

In your email, please include information about why you are requesting a change.  For example, the query may be too narrow and you aren't getting enough eligible patients, or the query may be too broad and you are getting too many patients that are failing screening.

Congratulations! Email [email protected] to let us know that you have completed recruitment. We will move your study to "completed" status and you will be able to access a PDF summary report of your recruitment data in EHRMa in a few days.

Note that once we update your study as "complete", we cannot reactivate it, so please be sure you are really done before making this update.