Patient and healthcare providers' perspectives on participation in a postpartum pilot trial of venous thromboembolism prophylaxis: a qualitative study

Background: There is a need to better understand barriers to recruitment and participation in randomized controlled trials evaluating postpartum thromboprophylaxis, as previous trials had low recruitment and were not feasible.

Objectives: In a qualitative interview study of a feasibility trial of low-dose aspirin vs placebo for 6 weeks postpartum (pilot PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) trial), we explored the facilitators and barriers to trial involvement.

Methods: Patients eligible for the pilot PARTUM trial, including those who declined to join the trial, were invited to participate in a qualitative study. Physicians whose clinical practice included caring for eligible patients were also invited to participate. Thirty-minute semistructured interviews were conducted by 2 researchers. Data were analyzed iteratively using reflexive thematic analysis.

Results: There were 19 patients and 13 physician interviews conducted at a single Canadian center. Nine pilot PARTUM participants and 10 nonparticipants were included. Patients identified the simple study design and familiar oral medication ("Participating as an Easy Ask") and helping other parents ("Helping Other Parents by Providing Knowledge") as facilitators to participate in the trial. Most patients invoked altruism; however, their decision to participate in the trial was influenced by their perception of venous thromboembolism risk ("Venous Thromboembolism Risk Perception and Communication"), their birth experience ("Birth Experience Informs Perspective"), and their opinion of their obstetrical care provider ("Engaging Trusted Care Providers").

Conclusion: Trial participation is uniquely affected by experiences during pregnancy, delivery, and new parenthood. Improved understanding of the factors most important to patients will inform the design and conduct of future patient-focused clinical trials.