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Patient-Outreach Recruitment

MUSC as an Opt-Out Institution

As an opt-out institution, we can reach more people about research and ensure that discoveries made lead to the best possible outcomes for our unique population. Every member of the community should have the opportunity to learn how to be a part of the research process, to experience any benefits that might come from that participation, and to contribute to the overall health and well-being of the greater community. We believe that our obligation, as a leading academic medical center, is to offer the very best care to our patients; this includes increasing research awareness and opportunities for the lives we touch.

MUSC patients can receive additional information about research participation and our opt-out policy at Clinical Trials & Research at MUSC.

Patient-Outreach Recruitment as a Potential Recruitment Strategy

MUSC defines patient-outreach recruitment (POR), also known as cold-contact recruitment, as when an individual is contacted by someone they do not know and the contact is unexpected. Applied to clinical research, MUSC considers POR to be when a patient is contacted by a study team and neither the Principal Investigator (PI) nor the Co-Investigator (Co-I) is a member of the patient’s clinical care team, regardless of the method of communication.

A PI or Co-I of a research study (or their delegated study team members) contacting his/her own clinical patients about participating in a research study is NOT considered POR. It is important to note that POR may not be an appropriate recruitment strategy for all studies. The local IRB will determine the allowability of POR as a recruitment method on a study-by-study basis. As with any other recruitment method, the IRB must approve POR as a recruitment method, as well as any language/scripts used in the various methods of contact. In addition to IRB approval, any studies utilizing POR must follow all MUSC POR guidelines and processes. For more information about potential strategies for research recruitment, please see the MUSC Institutional Review Board's (IRB) Recruitment of Research Participants policy (HRPP Section 7.8). Please note: If you have difficulty opening the policy, close your web browser and try again.

POR Consultation

A consultation with the Research Preferences Manager is available to discuss the potential use of POR and can be requested by submitting a "Learning About Patient-Outreach Recruitment Consultation" in SPARCRequest. The required steps for utilizing POR are outlined below.

Visit SPARCRequest
South Carolina Clinical and Translational Research Institute SPARC Request CTA

POR Process

Learn more and find the guidance you need to navigate each step of the POR process.

IRB approval for POR is required prior to submitting a request for a POR report. Please review the documents below to submit a proposal to use POR as a recruitment method in your IRB application. The IRB tip sheets outlined below address ONLY the application sections that apply to POR. Other selections/information that would need to be made/included in your application that are not addressed here would still apply.

View the following PDFs on SCTR’s internal POR webpage (login required).

  • POR IRB Tip Sheet for Expedited, Full Board, & External Studies
  • POR IRB Tip Sheet for Exempt Studies
  • POR Phone Script Requirements
  • POR Written Materials Requirements

To utilize POR, your study must have a recruitment report created by an MUSC honest broker that lists potentially eligible patients who have not opted out of research contact. The following steps outline the process of requesting a recruitment report for your study once you have received IRB approval.

  1. Submit a “Patient-Outreach Recruitment Query Building Consultation” in SPARCRequest.
  2. The POR Team will reach out via email and request your availability for the consultation and for you to complete a brief POR Intake REDCap survey.
  3. During your POR Query Building Consultation, the POR Team will guide you through identifying your desired patient population and completing a Research Data Request form.

*Please note, this data request cannot be fulfilled until IRB approval for POR has been obtained.

The POR Team will submit the Research Data Request form to the Data Request Committee (DRC). The DRC will look at the data request form to ensure that what is being queried and returned as a recruitment report is in alignment with what you’ve described in your IRB application. A POR Team member or DRC Reviewer might reach out to you if it is determined that any modifications are needed.

Once the DRC approves your request, an honest broker will generate your recruitment report. When the report is ready, the POR Team will contact you and ask that you submit a “Patient-Outreach Recruitment Report Access Training” request in SPARCRequest to schedule the required training. Any study team member who will use the recruitment report must complete this training before being granted access. PIs and Co-Is who need to use the report are also required to complete training.

All study team members who need access must be listed on the IRB application and added as authorized users in SPARC. If the recruitment report will be delivered in Epic, team members must also complete the “Epic – Research Fundamentals Training” in OurDay.

When access is granted, the study team will receive detailed written instructions on using recruitment reports and documenting patient contact.

Documentation of patient contact is an imperative aspect of MUSC’s POR process. Any study team using the POR process is required to document in the manner outlined in trainings and instructional documents the following four circumstances:

  • The date of first contact to the patient
  • If a patient expresses a desire to opt out of future POR contact
  • Notification of the death of a patient
  • If a patient enrolls in the study

Regular monitoring of study team documentation and activities in the report will occur, and any study teams that fail to accurately document patient contact will be prevented from receiving any additional recruitment reports.

Detailed written instructions on report utilization and POR documentation are available as PDFs on SCTR’s internal POR webpage (login required).

  • POR Epic Documentation Instructions
  • POR REDCap Documentation Instructions

As personnel changes occur, the POR Team will need to be alerted to add new staff members or remove old ones. You will need to submit a new “Patient-Outreach Recruitment Report Access Training” in SPARCRequest to add new study team members to the report.

When recruitment has ended, please notify the POR Team so that the recruitment report can be archived. The report will not be deleted, but study staff will be removed as users. The POR Team will still be able to access the report if necessary.

Education and Training

The Research Preferences Manager is available to assist study teams with any aspect of the patient-outreach recruitment process. To schedule a meeting, please submit a "Learning About Patient-Outreach Recruitment Consultation" through SPARCRequest.

Questions

Sarah Bourne, MPH

POR Coordinator
bourne@musc.edu | 843-985-5195