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Barriers and solutions to conducting patient-reported outcomes (PRO) research in patients with pain.

227 Background: Cancer pain prevalence ranges from 52-77%. Poorly controlled pain contributes to patient suffering and increased health care utilization. Shared decision making (SDM), where patient preferences, goals, and concerns are discussed, can foster earlier identification and improved pain management. A study was proposed to determine if incorporating SDM into a pain care plan is feasible and effective. Methods: Patients with metastatic cancer reported their pain and symptom experiences on an electronic patient-reported outcome (ePRO) platform. A drill down pain assessment included questions on chronic and breakthrough pain and end of dose failure. The patient and provider jointly discussed ePROs; an individualized care plan was printed for each patient. One academic and two community sites planned to recruit 105 patients over 6 months. Accrual quickly fell behind predicted rates (1 vs 15 patients per month). Study teams met to identify and mitigate accrual barriers. Results: Using an implementation science framework, barriers were identified in study design, and patient, provider, and environmental issues. Literature reports challenges in accruing/ retaining patients with metastatic disease, such as uncontrolled symptoms, inability to complete measures, missed visits, hospice admission, and death. Researchers broadened eligibility requirements to include all cancer stages; study team members were re-educated to clarify the operational definition of pain (experiencing pain or controlled on opioids). Some patient-related barriers were solved with workflow modifications (pre-visit survey completion). Environmental issues such as privacy to complete ePRO measures and internet connection reliability were solved with clinical staff. Conclusions: Study accrual improved 500% (from 6 to 36 in 3 months) following design and process changes. While examining patients with metastatic disease is important, expanding eligibility allows researchers to still include these patients and yet answer research questions timelier with the expanded population. Applying implementation science principles during study design is relevant to broader studies of pain and symptom ePROs and SDM in cancer care. Clinical trial information: NCT03304145.