Recruiting patients into a healthcare services trial: lessons learned from a feasibility study to investigate a...

Interventions to improve care coordination, like patient navigation programs, aim to dismantle barriers faced by patients in accessing optimal care. A variety of interventions are currently being evaluated in Germany and internationally. A key challenge of these studies, as for trials in general, is finding an effective recruitment strategy to reach the intended sample size in the targeted population.

Detailed documentation of the recruitment process was conducted as part of the process evaluation for a mixed-methods feasibility study including randomized trials and parallel cohort studies to evaluate a patient-oriented navigation program. Patients with lung cancer and stroke were actively recruited in inpatient and specialized outpatient settings in a rural and a metropolitan area in Germany between June 2021 and September 2022. Reasons for excluding or not approaching patients were documented and patients' reasons for refusal were assessed. All quantitative data were analysed in a descriptive manner. Experiences during the recruitment process were investigated through interviews with recruiting personnel and analysed through thematic analysis.

The data from the screening and recruitment process show that 74-76.5% of stroke patients and 91-93% of lung cancer patients were eligible to take part in the study. Of these, 44-46.9% of inpatients and 73% of outpatients were actively approached for recruitment. Reasons for not approaching patients were mainly due to organizational and contextual factors. Documented reasons for patients' refusal to participate in the study included feeling overwhelmed (stroke patients) and not perceiving the study as relevant (lung cancer patients).

The presented experiences and barriers during the recruitment process for a feasibility study of a patient navigation program provide important lessons for future planning of appropriate recruitment strategies to enrol patients with age-associated diseases.

The study was registered at the German Clinical Trials Register (DRKS-ID: DRKS00025476, Registration Date: 04/06/2021).