Overcoming recruitment challenges in a randomized clinical trial of early palliative care.

Abstract

140 Background: Reasons why clinical trials of early palliative care (ePC) interventions have prolonged patient recruitment time frames have been researched mainly qualitatively. Our objective was to identify major recruitment barriers encountered in our ePC trial, as well as to implement actions to overcome them. The impact of these changes on recruitment was measured. Methods: Data from all patients screened at the main study site (Inselspital, University Hospital Bern) between October 2013 and April 2016 were prospectively analyzed for: date of contact, reporting department, eligibility status, as well as consent status. Data until march 2014 was used to identify the main recruitment barriers. Starting in march 2014 changes to the recruitment process were implemented and all data from then onwards was used to estimate the impact of these adaptations. Results: The three main barriers identified were: Logistic, motivational, or related to eligibility criteria. Logistic barriers were overcome by changing from voluntary referral by the treating physician to systematically screening outpatient clinics of medical oncology, radio-oncology, gyneco-oncology and the internal medicine ward. Motivational barriers were addressed through education and dedicated study staff. Eligibility criteria were widened to include pancreatic and urothelial cancer. The actions implemented increased the accrual rate from one patient during a five month period to 2,8 patients per month. The widening of the eligibility criteria contributed to this result by recruiting 0,5 patients per month. The implementation of a systematic screening procedure increased the number of eligible patients invited to participate from one per month to 4,8 per month. An increase in the study consent rate from 20 % to 58 % can be translated into an increased acceptance of early palliative care. Conclusions: Education and dedicated study staff in order to increase the acceptance of ePC as well as a tool to identify eligible patients in a time-efficient manner improved patient recruitment in our ePC trial. We suggest that these factors can be relevant for the successful integration of ePC in standard oncology care.