Pilot randomized controlled trial Protocol: Life context-informed pre-visit planning to improve care plans for primary care patients with multiple chronic conditions including diabetes

BACKGROUND: Multimorbidity is common, and care is impacted by patient life context. Effective, efficient interventions to improve patient-centered outcomes such as perceived treatment burden are limited. There is a need for interventions that integrate patient contextual information into primary care encounters to improve such outcomes. Patient life context is a multitude of factors that influence a patient’s life and healthcare, including social determinants of health and broader elements such as family and work demands. METHODS: This pilot randomized controlled trial (RCT) protocol will compare standard pre-visit planning to context-informed pre-visit planning that incorporates the patient’s life context, for patients with diabetes plus other chronic comorbid conditions. Primary outcomes include measures of trial protocol and intervention feasibility and acceptability: physician study and visit perceived burden, patient satisfaction, and patient, physician and staff experience with the trial. Additional measurements of intervention impact include: initial estimates of effect size on patient treatment burden and other patient-oriented outcomes, change in glycemic control, and other intermediate medical outcomes. DISCUSSION: This intervention is novel as it collects patient life context information using a direct person-to-person approach, allows physicians to review the information prior to patient arrival at the clinic and, where appropriate, incorporate it when negotiating treatment plans, and is longitudinal, summarizing evolving contextual information over time. This pilot RCT has the potential to demonstrate trial protocol and intervention feasibility and acceptability, and estimate effect size on patient and provider outcomes, to inform for a future, definitive RCT. Trial Registration: This trial was registered at ClinicalTrials.gov prior to patient enrollment: NCT04568382