Increase in recruitment upon integration of trial into a clinical care pathway: an observational study

Abstract

Introduction: Many respiratory clinical trials fail to reach their recruitment target and this problem exacerbates existing funding issues. Integration of the clinical trial recruitment process into a clinical care pathway (CCP) may represent an effective way to significantly increase recruitment numbers.

Methods: A respiratory support unit and a CCP for escalation of patients with severe COVID-19 were established on 11 January 2021. The recruitment process for the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the CCP on the same date. Recruitment data for the trial were collected before and after integration into the CCP.

Results: On integration of the recruitment process into a CCP, there was a significant increase in recruitment numbers. Fifty patients were recruited over 266 days before this process occurred whereas 108 patients were recruited over 49 days after this process. There was a statistically significant increase in both the proportion of recruited patients relative to the number of COVID-19 hospital admissions (change from 2.8% to 9.1%, p<0.0001) and intensive therapy unit admissions (change from 17.8% to 50.2%, p<0.001) over the same period, showing that this increase in recruitment was independent of COVID-19 prevalence.

Discussion: Integrating the trial recruitment process into a CCP can significantly boost recruitment numbers. This represents an innovative model that can be used to maximise recruitment without impacting on the financial and labour costs associated with the running of a respiratory clinical trial.

Keywords: COVID-19.

Figure 1

Flow diagram illustrating how recruitment into the Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial was integrated into the respiratory support unit (RSU) clinical care pathway. Patients with COVID-19 who needed fractional inspired oxygen (FiO₂)≥0.4 to maintain oxygen saturations ≥94% were considered for escalation to RSU for further management. Identified patients were screened by the RSU-lead respiratory physician or critical care physician and approached for potential recruitment. If the patient consented, they were randomised to one of the treatment arms: Continuous positive airway pressure (CPAP), high flow nasal oxygen (HFNO) or standard of care. Patients who were randomised to receive CPAP or HFNO were transferred to RSU for initiation of treatment whereas patients who were randomised to the standard care arm or declined enrolment into the trial were transferred to the same respiratory ward, but not to the beds that comprised RSU. SpO2, oxygen saturation.

Figure 2

Monthly trend of the proportion of patients recruited into Randomised Evaluation of COVID-19 Therapy-Respiratory Support trial to the number of COVID-19 hospital admissions and ITU admissions in Queen Elizabeth Hospital Birmingham. Stars denote the months where there were ≤40 COVID-19 inpatient admissions and ≤5 ITU admissions. ITU, intensive therapy unit; RSU, respiratory support unit.