Improving Oral Medication Adherence in Pediatric IBD by Teaching Problem Solving Skills: Year 2 Results of the PHONE Trial

Abstract

BACKGROUND: Despite the prevalence of oral medication nonadherence among youth with inflammatory bowel disease (IBD), few evidence-based tools exist to address this issue. Development of brief interventions that can be implemented in regular clinical practice is needed. Problem solving skills training (PSST), which involves teaching families a structured approach to identifying and solving adherence barriers, is a promising intervention that has been used to successfully address nonadherence in other pediatric chronic diseases. We report on the Year 2 outcomes of a randomized clinical trial of a phone-delivered PSST intervention (Figure Presented) to reduce adherence barriers and improve adherence in youth with IBD. Recruitment for this study is ongoing. METHODS: English speaking youth ages 11-18 followed in one of two Pediatric IBD clinics in the Midwest, with a confirmed diagnosis of IBD, who had a parent/ guardian willing to participate, and who were prescribed an oral IBD maintenance medication were eligible to participate. Families completed a baseline assessment of adherence barriers (A1), and follow-up assessments at approximately 3 months (A2) and 5 months post recruitment (A3). The primary outcome was improvement in adherence to an oral maintenance medication, which was assessed via electronic monitoring. Following A1, families were randomized to either immediate treatment (i.e., 2 phone PSST sessions) or a wait list comparison group. Following A2, those in the immediate treatment group were re-randomized to either a maintenance condition or to receive two additional phone PSST intervention sessions, while those in the wait list group were automatically given treatment (i.e., 2 phone PSST intervention sessions). See Figure 1 for a diagram of the study procedure. RESULTS: To date, 76 participants (parent-child dyads or triads) have been consented and 38 have complete data available for the current analyses. Participating youth were predominately male (56%) and Caucasian (88%). Most participants had Crohn's disease (71%). Eighteen of 38 youth (47%) had perfect adherence (i.e.,100%) during the baseline-monitoring interval and thus, had no improvement in adherence following the two intervention sessions. The remaining twenty youth had a mean pre-intervention adherence rate of 62% (SD = 28%), which improved to 75% (SD = 28%) following two phone intervention sessions. This finding was consistent with a medium effect size (d = 0.59). Little additional benefit on adherence was seen among those receiving an additional 2 (4 total) PSST intervention sessions; however, this subsample was small (n = 8). In addition, families reported high satisfaction with key intervention components. On an Intervention Satisfaction Scale ranging from 1 to 5, with higher scores reflecting higher satisfaction, mean youth satisfaction ratings ranged from 3.9 to 4.4. Mean mother satisfaction ratings ranged from 3.5 to 4.5. See Table 1 for satisfaction ratings by item. CONCLUSION(S): Results to date support phone-delivered PSST as a useful intervention for families of youth with IBD who have adherence problems. Additional analyses will explore differences in intervention efficacy as a function of youth age, SES, and disease severity. Analyses will also explore cost-savings of delivering the intervention via phone versus in person.