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 DUNCAN-PARK et Al. | 3113 AJT 1 | INTRODUC TI ON Remote communications (e.g., telephone, video, or text messaging) can improve access to medical services. 1 More recently, clinicians and institutions have turned to remote communication to minimize contagion during the COVID-19 pandemic. 2Remote contacts may have particular appeal in the long-term management of transplant recipients. First, reducing exposure to pathogens is especially important in immunosuppressed individuals, 3 and indeed, transplant programs have rapidly turned to telehealth in the context of COVID-19. [4][5][6] Second, many transplant recipients travel extensively for their care, 7,8 and remote technology may reduce this burden. Third, immunosuppressant nonadherence remains the leading cause of preventable graft failure, [9][10][11][12][13][14][15] and frequent remote encounters could facilitate adherence. But, there are challenges. Remote interventions may be less effective at communicating with patients than in-person encounters, confidentiality must be maintained, and some patients may not have the means or comfort with technology to participate. 16,17 Key components of a robust evaluation of telehealth interventions include assessing predefined outcomes in prospective multisite trials. 18 Yet, despite its promise, there is a dearth of such investigations into telehealth in pediatric populations. [19][20][21]

Implementing an integrated psychology preventative care model in pediatric solid organ transplant.

“…Integrated preventative behavioral health care is critical for pediatric SOT patients during the 3-year posttransplant period to prevent nonadherence and subsequent graft loss and/or mortality, and to address common emotional and behavioral issues that contribute to these medical concerns (Connelly et al, 2015; Duncan-Park et al, 2021; Killian et al, 2018; Reed-Knight et al, 2013; Shaw et al, 2003; Simons & Blount, 2007). In response to a growing patient population at this medical center and recognition of adherence challenges that may impact graft outcomes, the SOT psychology team implemented a targeted, preventative care model of psychology service delivery that included a standardized and more frequent schedule of integrated health and behavior assessments and interventions.…”

The improving Medication Adherence in Adolescents and young adults following Liver Transplantation (iMALT) multisite trial: Design and trial implementation considerations

“…NCT01960322, NCT02320422, NCT02266888). [38][39][40][41][42] Thirteen interventionists have been or are currently involved with the study. Interventionists are located offsite on the east and west coasts of the United States and have not met participants in person.…”

Detecting, preventing and treating non-adherence to immunosuppression after kidney transplantation

“…Moreover, it has been reported that the COVID-19 epidemic and the related logistical problems have increased the rejection rates [ 72 ]. One recent trial including paediatric lung transplant recipients found a reduction in the Tac IPV at 6 months in 10 patients undergoing 3-weekly phone calls and regular follow-up calls (Tac SD −1.84; 95% CI: −2.95, −0.74; P = 0.004) compared with 7 controls undergoing only regular follow-up calls (Tac SD 0.59; 95% CI: −1.42, 2.60; P = 0.46) [ 73 ]. Telemedicine may be integrated with home-based dried blood spots (DBS) sampling of Tac for the purpose of therapeutic drug monitoring [ 74 , 75 ].…”