MedMemos: A Program to Promote Medication Adherence in Pediatric Hematopoeitic Stem Cell Transplantation

About This Grant

PROJECT SUMMARY Pediatric allogeneic hematopoietic stem cell transplant (PAHCT) is an intensive and lengthy inpatient treatment followed by an exceedingly complex and frequently changing outpatient medication regimen. Caregivers assume responsibility for this complex medication regimen during the transition from inpatient to outpatient care making adherence extraordinarily challenging. Indeed, non-adherence to critical medications is common in the first months following discharge and places patients at risk for life-threatening graft-versus-host-disease (GVHD). Recognizing the need for better adherence-focused care, our multidisciplinary team of PAHCT experts developed MedMemos, a novel 4-session tailored adherence promotion intervention comprised of 2 inpatient and 2 outpatient sessions. MedMemos will provide caregivers with a combination of tailored and standardized medication and adherence education videos and a “Medication Management Kit” that provides tailored strategies to target identified barriers to successful medication management. Informed by the ORBIT model, the goals of this study are to 1) iteratively refine the content, timing, dosing, and delivery of MedMemos with patients, caregivers, and providers (Phase Ib) and 2) establish behavioral (adherence) proof-of-concept (Phase IIa). To achieve the first goal, MedMemos will be delivered to cohorts of 5 caregiver/patient dyads and refined based on participant and provider feedback using a mixed-methods, rapid cycle testing design (Aim 1). After completing all 4 MedMemos sessions, caregivers, and patients ≥8 years-old will provide feedback via acceptability, feasibility, and usability measures and brief structured interview to inform the refinement of MedMemos content and procedures. Following each revision, 10 providers will provide their perspective of the acceptability, feasibility, and usability of the revised MedMemos. MedMemos will then be delivered to the next cohort and evaluated until no feasible changes are indicated by participants or providers. To achieve the second study goal, the final MedMemos version will be administered to 10 caregiver/patient dyads in a quasi- experimental, within-subjects design (Aim 2). Acceptability will be demonstrated by caregivers rating MedMemos a mean of ≥ 4 as measured by the intervention acceptability questionnaires (H1). Feasibility of the refined MedMemos program will be assessed by calculating enrollment (≥80% enrollment rate), data completion (≥80% completion of all follow-up assessments), and intervention fidelity (≥80% of fidelity) and completion rates (>80% will attend all MedMemos Sessions) (H2). Finally, proof-of-concept will be demonstrated by ≥75% children taking ≥75% of their immunosuppressant doses at all follow-up time points (i.e., 1-, 2-, & 3-months post PAHCT discharge) as measured by electronic monitor (H3). The proposed study will lay important groundwork for a fully powered randomized clinical trial to test the efficacy of MedMemos. MedMemos will be developed to be a clinically integrated adherence promotion intervention that optimizes medication adherence and minimizes preventable adverse outcomes in children who receive a PAHCT.