Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial

Abstract

Remote interventions are increasingly used in transplant medicine but have rarely been rigorously evaluated. We investigated a remote intervention targeting immunosuppressant management in pediatric lung transplant recipients. Patients were recruited from a larger multisite trial if they had a Medication Level Variability Index (MLVI) ≥2.0, indicating worrisome tacrolimus level fluctuation. The manualized intervention included three weekly phone calls and regular follow-up calls. A comparison group included patients who met enrollment criteria after the subprotocol ended. Outcomes were defined before the intent-to-treat analysis. Feasibility was defined as ≥50% of participants completing the weekly calls. MLVI was compared pre- and 180 days postenrollment and between intervention and comparison groups. Of 18 eligible patients, 15 enrolled. Seven additional patients served as the comparison. Seventy-five percent of participants completed ≥3 weekly calls; average time on protocol was 257.7 days. Average intervention group MLVI was significantly lower (indicating improved blood level stability) at 180 days postenrollment (2.9 ± 1.29) compared with pre-enrollment (4.6 ± 2.10), p = .02. At 180 days, MLVI decreased by 1.6 points in the intervention group but increased by 0.6 in the comparison group (p = .054). Participants successfully engaged in a long-term remote intervention, and their medication blood levels stabilized. NCT02266888.

Keywords: clinical research/practice; compliance/adherence; immunosuppressant; pediatrics; social sciences.

Figure 1.. Participant recruitment flowchart.

Figure 2.. Change in MLVI pre-enrollment, 180 days post-enrollment, and 180 days after final session

Paired analysis of change in MLVI from pre-enrollment to 1) 180 days post-enrollment (n=14, p=0.015) and 2) 180 days after final session (n=10, p=0.004). Boxes represent interquartile ranges. Whiskers extend to minimum/maximum values. Red horizontal lines represent group medians; red circles represent group means. Black diamonds indicate individual subject MLVIs.

Figure 3.. Change in MLVI for eligible patients flagged after enrollment ended (the comparison group)

Comparison subjects’ MLVI over time. Green circles represent MLVI when initial MLVI ≥ 2.0 and 180 and 360 days later. Data for individual subjects (n=5) are connected by a line. MLVI did not differ when criteria were met (3.3 ± 0.84) compared to 180 days after (3.9 ± 1.45), p=0.461.

Figure 4.. Comparison of change in MLVI between intervention participants and patients eligible after enrollment ended (the comparison group)

Average change in MLVI at the 180-day benchmark in the intervention (n=14, −1.6 ± 2.16) versus comparison (n=5, 0.6 ± 1.62) group. Boxes represent interquartile ranges. Whiskers extend to minimum/maximum values. Red horizontal lines represent group medians; red circles represent group means. Black diamonds indicate individual subject change in MLVI.