Overcoming Challenges to Conducting an Embedded Summative Evaluation of the PAL-LIVER Cluster RCT for ESLD Patients (RP318)

Outcomes1. Appreciate the components of a summative evaluation process.2. Describe how to avoid potential sources of bias that can influence a qualitative sudy.Key MessageThis qualitative summative evaluation study of PAL-LIVER, a 19-site cluster randomized trial of hepatologist- vs palliative specialist-led palliative care for ESLD patients used a rigorous sampling plan, recruitment procedures, interviewer training, secure data management, & transdisciplinary coding, analysis, & interpretation team ensured rigor, credibility, trustworthiness, and avoided potential bias.ImportanceQualitative summative evaluation studies are recommended for rigorous intervention evaluation. We conducted a summative evaluation to have an indepth understanding of the Pal-Liver comparative effectiveness intervention arms and study outcomes .Objective(s)Review the process of intervention summative evaluation in intervention development.Scientific Methods UtilizedMethods: An embedded summative evaluation study of PAL-LIVER, a 19-site cluster RCT of trained hepatologist (HEP)- vs PC specialist-led care for patients with ESLD using qualitative interviews of patients, caregivers, and clinicians from both study arms. This study comprised a rigorous sampling plan, recruitment procedures, interviewer training, secure data management, and a transdisciplinary coding, analysis, and interpretation team. Design procedures were especially attentive to ensuring rigor, credibility, and trustworthiness of data analysis, to avoid potential sources of bias.ResultsThe PAL-LIVER summative evaluation study comprised semi-structured interviews with a purposive, maximum variation sample of patients (n=62), caregivers (n=43), & clinicians (HEP=18; PC=15). Study patient & caregiver samples, drawn from all study sites, were representative of the parent study relative to age, gender, race/ethnicity, disease, & illness severity. Thematic results supported quantitative intervention fidelity measures & identified opportunities for modification. HEPs evaluated their primary PC-specific training, & described confidence & preparation to implement primary PC with study participants. Data saturation on patient, caregiver, and clinician pre- and post-study experiences was reached.Conclusion(s)Intervention evaluation is a systematic, complex, time-consuming, and resource-intensive process, but critical to ensure intervention feasibility, acceptability, fidelity, patient-centeredness, & effectiveness.ImpactCritical summative evaluation outcomes will inform the need for future intervention adaptations or alterations.KeywordsModels of palliative/hospice care delivery/Palliative care in chronic, non-malignant illness