Andrew Snyder MBA, PMP, FACMPE
One of the most common challenges of conducting clinical trials is related to problems with recruitment. Insufficient or untimely patient recruitment for clinical trials may have serious consequences. The length of the study may be extended, leading to increased costs and staffing concerns. Trials that do not recruit the required number of patients may impact the data integrity. Study teams that cannot recruit patients may not be invited to participate in future studies by industry partners or may have difficulty securing future grants. In some cases, a trial may have to be terminated resulting in unpublishable results, poor financial outcomes, and disappointed stakeholders.
M Health Fairview is a large healthcare system in Minnesota. M Health Fairview is a joint clinical enterprise involving the University of Minnesota and the Fairview Health Services. M Health includes 10 hospitals, 50 clinics, 5,000 providers and 34,000 employees. M Health values medical research throughout the joint clinical enterprise. In support of research programs, M Health instituted a centralized research recruitment department in 2020. The Fairview Research Recruitment Service (FRRS) was designed to support research teams in the M Health Fairview system. FRRS is actively recruiting clinic patients and hospital inpatients for many types of academic and industry sponsored clinical trials.
The Fairview Research Recruitment Services division is excited to work with academic and community Investigators on clinic-based outpatient research projects. FRRS has historically used IRB-approved US postal recruitment letters to reach out to clinic patients. This method of research recruitment has been reliable for decades. Early in 2021, FRRS began working with the Epic medical record team to deploy the Epic MyChart research recruitment module. Epic MyChart has the ability to send IRB approved research recruitment messages to patients with an active MyChart account. Epic MyChart recruiting has the ability to identify highly qualified patients and electronically communicate with them directly using the MyChart patient Inbasket system.
Researchers throughout the M Health system have been excited about the potential for MyChart to enhance recruitment plans. Since deploying the MyChart recruitment module, FRRS has been collecting recruitment data on both US postal letters and MyChart messaging results. The purpose of this article is to share the early data on MyChart messaging recruitment as compared to US postal letters.
FRRS records all MyChart messages and US postal letters sent to patients. Data has been collected in 2021 for 10 clinical trials. The trials may have used US postal letters, MyChart recruitment messaging or both communication modalities. The involved projects were recruiting patients with various medical histories, including cardiac conditions, orthopedic concerns, HIV and diabetes. This brief examination includes 6,305 US postal letters and 14,700 MyChart messages sent to qualified Fairview clinic patients. The following table demonstrates the effectiveness of both US postal letters and MyChart messages.
Table 1: US Postal Letters and EPIC MyChart Message Results – Outpatient Clinic Studies
|Trial Description||US Postal Letters||EPIC MyChart Messages|
|Population||Letters Sent||*Patient Response||Response Rate||MyChart Messages||*Patient Response||Response Rate|
*Patient Response indicates the number of patients that communicated with the study team following receipt of the US postal letter or the MyChart message.
The effectiveness of US Postal letters as compared to MyChart messages is measured by the number of patients that respond to either communication modality. Patients that reach out to the study team as instructed by their recruitment communication represents a positive recruitment endpoint. These patients may result in an enrolled study patient, a study screen failure, a pre-screen termination, a disinterested patient, etc. Regardless, the initial patient response to the study team represents the first step in qualifying, consenting and forming a research relationship with patients.
The studies in Table 1 indicate that the effectiveness of US postal letters and MyChart messages is nearly identical. The study team (or FRRS) received 534 patient responses after mailing 6,305 US postal letters. After sending 14,700 MyChart messages the study team (or FRRS) received a phone call, e-mail or Inbasket reply from 1,277 patients. The results equate to a response rate of 8% and 9% respectively. In the end, both communication modalities adhere to the historical axiom of expecting a patient response rate of 8-10%.
A demographic review of responding patients did not identify any strong correlations. The age difference between respondents is only marginally different, with MyChart responders skewing only slightly younger.
US postal letters and EPIC MyChart messages are effective research recruitment tools. These communication tools provide research teams the ability to identify qualified patients in the Epic medical record system and share IRB approved research recruitment content. Both tools demonstrate a patient response effectiveness rate of 8-9%. Conversations with patients provides further validation of these results. An individual patient may respond to a letter received in the mail, or they may not open their mail for several months. Other patients may open their MyChart message in real-time or delete the message before reading. Neither communication tool is superior.
Research teams are encouraged to consider a joint recruitment strategy that includes both US postal letters and MyChart messages. In order to engage the greatest number of patients a research team can utilize an enhanced laddered strategy that includes both US postal letters and MyChart messaging. Patients may need to hear about a study in several instances before deciding to pursue potential trial participation.
A positive case study example includes an investigational medication trial for patients with type 2 diabetes. This study was initiated with a letter campaign that involved mailing approximately 50 letters each week. The response rate with the US postal letter strategy is 7%. The study team determined that the patient response rate was insufficient to meet their project enrollment goals. FRRS began sending patients the IRB approved MyChart recruitment message 2-3 weeks after their initial letter was mailed. Patients received both a US postal letter and a MyChart message 2-3 weeks apart. The MyChart messages have resulted in an additive response rate of 11%. FRRS conducted a phone prescreen with 58 patients who received a US postal recruitment letter but did not call until having also received the MyChart message. The synergistic effect of utilizing both US postal letters and MyChart messages is resulting in a significantly improved research recruitment, busy coordinators, and a happy Clinical Investigator.