Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in...

Area of Science:

• Clinical Trials
• Public Health
• Epidemiology

Background:

• The COVID-19 pandemic significantly disrupted non-COVID-19 clinical trials in 2020, impacting participant recruitment and trial continuity.
• The Should I Take Aspirin? (SITA) trial, initiated just before the pandemic in Victoria, Australia, faced recruitment challenges due to pandemic-related disruptions.

Discussion:

• Traditional general practice waiting room recruitment methods became unfeasible due to increased telehealth and restricted in-person attendance.
• A novel teletrial model was developed, incorporating pre-appointment eligibility calls and a hybrid virtual/face-to-face delivery approach.
• This adaptation aimed to mitigate risks to participants and staff while minimizing recruitment bias.

Key Insights:

• The developed teletrial model proved effective in completing recruitment for the SITA trial at a high rate.
• The model facilitated recruitment despite the altered landscape of general practice operations during the pandemic.
• Recruitment rates were comparable to previous studies, demonstrating the model's efficacy.

Outlook:

• The successful teletrial model is being implemented in other primary care trials.
• This adaptive strategy allows for continued research progress amidst the ongoing impacts of the COVID-19 pandemic.
• The model offers a sustainable solution for conducting clinical trials in evolving healthcare environments.