Patient Recruitment for a Virtual Clinical Trial on Heart-Related Risk Factors

Introduction:

This case study focuses on efforts to find participants for a virtual, at-home clinical trial aimed at studying heart-related risk factors. The trial recruitment took place over a three-month time period.

Objective:

The primary objective of this case study is to analyze the strategies and outcomes of the patient recruitment campaign, with a particular focus on the metrics provided.

Patient Recruitment Campaign:

Outreach Efforts:

The recruitment campaign began with two separate outreach send dates, where 60,138 total emails were sent, informing our members of this research opportunity.

Engagement Metrics:

• Clicks on ClinicalConnection’s Study Landing Page: Out of the 60,138 email messages that were sent, 6,030 recipients clicked on the study’s landing page, demonstrating initial interest in the study.
• Landing Page Visitors: Among those who visited the landing page, 2,118 individuals expressed interest in the clinical trial by clicking onto our partner’s online screening link.
• Signed Informed Consent Form (ICF): Subsequently, 1,080 participants went on to sign the Informed Consent Form (ICF), indicating their willingness to participate in the study.

Screening Outcomes:

• Passed Screening: 128 participants successfully passed the screening process, indicating their eligibility for the trial.
• Failed Screening: 715 participants failed the screening process. The reasons for their disqualification were as follows:
• 64% were disqualified because they did not have an Epic MyChart online healthcare portal account.
• 33% were disqualified due to self-reported high blood pressure which therefore disqualified them from the trial.
• 18% were disqualified because their arm was too small for the required measurements.

Recruitment Challenges:

• The study criteria were very specific, making the population needed for the study difficult to find.
• The patients needed to have an Epic MyChart account
• The patients could have undiagnosed hypertension
• The study needed a majority of non-white participants

Trial Progress:

• Day-7 Visit: 33 people completed the first of 2 virtual visits required by the trial.
• Unofficial Enrollment: 17 participants completed the necessary steps for unofficial enrollment in the trial.

Discussion:

The recruitment campaign achieved several notable milestones in its efforts to enroll participants for a virtual at-home clinical trial focused on heart-related risk factors. The success can be attributed to a combination of effective outreach strategies to our database of already-interested candidates.

• Outreach Strategy: The campaign's outreach efforts, including two send dates and a total of 60,138 outreach messages, resulted in a substantial number of interested individuals. The number of clicks on the landing page (6,017) demonstrates the effectiveness of the initial messaging.
• Informed Consent: Over 1,000 participants signed the Informed Consent Form (ICF), indicating a strong commitment to participate in the trial. This suggests that the study's objectives and potential benefits resonated with a sizable portion of the initial recipients.
• Screening Process: The screening process, which was completed by our partner who oversaw this study, was critical in ensuring that eligible participants met the study's criteria. The disqualification reasons, such as the absence of Epic MyChart, high blood pressure, or small arm size, reflect the study's specific requirements and the importance of proper screening.
• Trial Results: The trial recruitment exceeded expectations with 33 eligible participants completing the Day -7 Visit and 17 unofficial enrollments. These participants showed commitment and engagement with the study, setting a positive trajectory for its success. ClinicalConnection played a significant role in this study by providing more than the expected number of enrolled participants.

Conclusion:

In summary, ClinicalConnection effectively utilized outreach strategies to successfully enroll participants for a virtual at-home clinical trial. The campaign's results highlight the importance of tailored outreach, clear communication of study requirements, and careful participant selection to ensure the success of clinical trials to contribute to heart-related research.