What

Subject recruitment and retention is a challenge often faced in clinical research. To address this challenge, it is important that recruitment and retention is considered early on during budget development and negotiation. Successful subject recruitment also involves developing and implementing a recruitment plan that utilizes multiple recruitment strategies.

When

Recruitment and Retention strategies should be considered during budget development. To avoid delays, it is recommended that recruitment or informational material is submitted to the IRB for review during the initial protocol submission.

Required Approvals

All recruitment strategies and materials, including informational material must be approved by the study sponsor and the IRB of record prior to advertising and distributing recruitment material.

How

Find Your Patient Population

Epic

Epic is the main electronic health record system (EHR) used at MSHS.

Slicer Dicer is an Epic-based self-service cohort query tool that allows users to have quick views into patient populations.

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Mount Sinai Data Warehouse (MSDW)

The Mount Sinai Data Warehouse (MSDW) collects clinical, operational, and financial data for use in clinical and translational research, as well as quality and improvement initiatives.

The following tools can be used to find your patient population in MSDW:

  • Custom Queries - Work with MSDW analysts to compose custom SQL queries for research.
  • Cohort Query Tool (CQT) - Web-based self-service tool that can be used to query de-identified or identified data in the MSDW.
  • i2b2 - Software application supported by ConduITS, the ISMMS CTSA and the NIH. i2b2 allows investigators to quickly perform self-service queries of de-identified data in the MSDW.

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Mount Sinai Imaging Research Warehouse (MS-IRW)

The Mount Sinai Imaging Research Warehouse (MS-IRW), developed by the BioMedical Engineering and Imaging Institute (BMEII) provides de-identified imaging data along with corresponding health records for over 1 million Mount Sinai patients. The images form the IRW can be linked to de-identified data from the MSDW or visa versa.

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Clinical Trial Recruitment Alerts (CTAs) in Epic

What

This is an Epic-based tool that is set up to notify clinicians with an alert when patients match research criteria for a particular research study. A patient can match clinical data related to age, diagnosis, and lab results, for example.

Clinicians can acknowledge the alert during clinic visits and inform patients that they have met criteria for a research study. This clinical decision tool is helpful for research teams to identify potential patients that wish to be contacted about participating in research. When the alert is acknowledged by a clinician, a secure message can be sent to the research team for review.

Who

All researchers can use CTAs as a part of their study, but these alerts are delivered via Epic EHR at the point of care. The situation for which CTAs are most appropriate is when patients are seen by a provider that is part of the inclusion group that will see the alert soon after alert is created.

How

Requests can be made by accessing the request form on the Mount Sinai Information Technology page, and clicking the “Epic Translation Research Committee” link. The completed Epic Recruitment Feasibility Form should be emailed to the IT Help Desk.

The Epic Applications Team will respond via email in approximately 48 hours after receiving the request from the IT support desk. A meeting/call will be scheduled to discuss the project with the study team and a clinical informatics representative at the earliest convenience for all, generally within two weeks. Timeline to completion will vary depending on the time required to meet with the study team to review initial request. Generally, Clinical Trial Alerts are implemented approximately 3-4 weeks from the time of the approval meeting.

IRB approval will be required for clinical trial recruitment alerts.

CTA Submission Template Language
This study will use Epic Clinical Trial Alerts (CTAs) to accrue patients for clinical trials. Alerts will be presented to providers at the point of care in the EpicCare EHR (Electronic Health Record) for patients matching screening criteria for a clinical trial. Before accepting requests for CTAs, all trials are assessed for feasibility as well as the potential for alert fatigue. At the point of care the provider will see an alert informing him/her that this patient might be a candidate for <title of study>. The provider can then discuss with the patient and choose, “yes, interested” in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent. If the patient says “no,” a message via Epic inbox will also be sent to the designated research personnel.

Our trial will reconcile all messages received as a result of CTAs with other means of accruement such as reports and phone calls. This will ensure that no patient is asked twice. We will supply the Epic team with an end date for our study.

When

Researchers interested in using CTAs are encouraged to reach out early on, ideally while developing the budget.

Cost

The Epic Application Team build fees are $160/hour. The cost of an alert typically runs about $1000, depending on the complexity of the study.

Questions

Contact IT Help Desk, Joseph Kannry, MD.

Center for Community and Academic Research Partnerships (CCARP)

The Centers for Community and Academic Research Partnerships (CCARP) aims to improve health and healthcare by building strong relationships between researchers and stakeholders (patients, front-line clinicians, community representatives, organizational leaders, policy-makers). CCARP offers services to assist research teams with any research-related question, from data collection to best practices in community-engaged study recruitment and retention.

To learn more click here. To request a service email Crispin Goytia.

ResearchMatch

ResearchMatch.Org is a national web-based recruitment registry that matches researchers with volunteers who wish to participate in clinical research studies. ResearchMatch recently launched a Spanish version of website, allowing researchers to connect with Spanish speaking volunteers. This free tool was developed by the Clinical Translation Science Award (CTSA) consortium and is available to all researchers at the Mount Sinai Health System. ResearchMatch can be utilized for:

1)  Feasibility Access

  • Assess the availability of volunteers that meet study eligibility requirements
  • Results are provided in aggregate, without identifying information
  • IRB approval is not required for feasibility access

2)  Recruitment Access

  • Researchers can directly reach out to volunteers who meet study eligibility requirements
  • Recruitment access requires IRB approval to use ResearchMatch and an IRB approved recruitment message

Access - To get started, register using your institutional "mssm.edu" or "mountsinai.org" email address.  Once you are registered, you will be granted feasibility access.

Recruitment Access - To gain recruitment access, you will be required to register your study and upload a copy of your IRB approved recruitment message in ResearchMatch.org. Once your information is verified by the ISMMS ResearchMatch Liaison, you will be granted recruitment access.  For specific details regarding the recruitment message template and IRB submission requirements, click here.

Who Can Recruit
Study coordinators and other research personnel who are authorized to recruit for a study can register as proxy researchers in addition or in lieu of the study's principal investigator. Multiple members of a research team can register for access. The principal investigator will receive an email from ResearchMatch requesting approval to grant the proxy researchers access. Requests for recruitment access will be routed to the principal investigator for approval prior to review by the ISMMS ResearchMatch Liaison.

Questions  - Complete the ORS Research 411 Portal form and select “ResearchMatch.org assistance”.

Research Subject Recruitment and Retention Consulting

The Office of Research Services (ORS) provides free recruitment and retention consultation services. Consultations can be requested through the ORS Research 411 Portal.

Posting Studies to MSHS Clinical Research Pages

The Office of Research Services (ORS) maintains the Clinical Research Portal for the Icahn School of Medicine at Mount Sinai. To list, update, or close a clinical research study which is not registered with ClinicalTrials.gov on the Clinical Research Portal, please use the ORS Research 411 Portal.

Academic Update

The Academic Update is a weekly newsletter that is disseminated to the MSHS community via email. Free study postings can be made in this newsletter by emailing the IRB approval letter and the IRB approved ad to AcademicUpdate1@mssm.edu.

Note - Ideally, study postings should be between 100-150 words.  For additional tips, click here.

Digital Media Center

The Digital Media Center provides creative solutions and services that can assist with developing recruitment material (websites, flyers, brochures). Their services include:

  • Poster Printing
  • Photography
  • Fine Art Printing
  • Website Design
  • Digital Media Services
    • Poster design
    • Photo-quality color printing
    • Black/white, and color photocopies
    • Flyer and brochure design and printing
    • Scanning, including film and transparencies
    • Equipment rental, including Polycom and web camera/microphone

To learn more, click here.

Recruitment Material – Translation Requirements for Non-English Speakers

Based on the demographics of the surrounding geographic area of the Institution, it is expected that some of the adults that are eligible for enrollment in MSHS research studies will not be fluent in English. To ensure that the principle of justice enunciated in the Belmont Report is adhered to, the IRB may require efforts to recruit individuals who are not fluent in English in research studies that offer the potential for therapeutic benefit.

Recruitment materials such as flyers must be translated in order to accommodate Expected Non-English Speaking Subjects (i.e., a significant number of subjects who are not fluent in English). All translations of recruitment materials must be certified by an Acceptable Translator and approved by the IRB prior to their use. For more information, refer to the PPHS Policy on Enrollment of Non-English Speaking Subjects in Research and view “translation and interpretation services”.

More information - Translation and Interpretation Services for Research

Recruitment Material – External Resources

Trial Innovation Network (TIN)

The Trial Innovation Network (TIN) provides free recruitment and retention resources:

Clinical Trials Transformation Initiative (CTTI)

National Cancer Institute - Accrual Net