A mixed methods approach to determining intervention components that drive improvement in medication adherence

About This Grant

PROJECT SUMMARY Each year, 500 children in the United States receive a liver transplant for the treatment of childhood liver failure or inherited liver diseases.1 Following this lifesaving procedure, children and their families must adhere to a daily immunosuppressant medication regimen to prevent organ rejection.2 Medication nonadherence, which is difficulty following a prescribed regimen from a health care provider,3 occurs in as many as 39% of children who have received a liver transplant and is the leading cause of mortality in this population.4,5 Interventions targeting nonadherence among pediatric liver transplant recipients have been developed and tested, but have largely been ineffective at improving transplant outcomes.6 This application proposes secondary data analysis of the Improving Medication Adherence in Adolescents who had a Liver Transplant (iMALT) trial utilizing a novel mixed methods approach. This recently completed trial included 72 patients randomized to a two-year remote, manualized intervention focused on improving medication adherence offering an innovative opportunity to further explore how session content may influence outcomes. For all intervention recipients, the sessions were recorded, and this proposal seeks to apply qualitative analyses to the content of the first three sessions. These results would then serve as predictors of adherence and clinical outcomes in models run with correspondence analysis. The aim of this proposed study is to investigate the relationship of session themes and response quality to intervention engagement and clinical outcomes. It is hypothesized that at least 1 session theme or the response quality identified in the first 3 intervention sessions will be significantly associated with increased intervention engagement. Secondly, it is hypothesized that at least 1 session theme or the response quality will be significantly associated with improved adherence and health outcomes. The ultimate goal of this proposed study would be to inform the next iteration of a manualized treatment for medication adherence among pediatric liver transplant recipients and provide insight into elements of the intervention that could be modified in real time to improve outcomes. Given the high rates of medication nonadherence in this population and how critical adherence is to long term survival for these patients, identifying elements of interventions that lead to improved adherence and clinical outcomes is paramount. This proposed fellowship is closely aligned with NICHD’s mission to “enhance the lives of children and adolescents.”7 The proposed training plan for this fellowship would provide the applicant with training in thematic analysis, a qualitative methodology in which texts are analyzed for themes,8 and correspondence analysis, a statistical technique in which cross-tabular data are plotted in a visual plane to analyze patterns of associated variables.9 The research training will take place at Fordham University and the Icahn School of Medicine at Mount Sinai. Both institutions will provide the applicant with training and mentorship to accomplish the goals of this fellowship and become a successful contributor to pediatric psychology research.