Johns Hopkins University School of Nursing, Baltimore, MD, USA.
New York-Presbyterian Columbia University Medical Center, New York, NY, USA.
J Artif Organs. 2022 Jun;25(2):91-104. doi: 10.1007/s10047-021-01289-x. Epub 2021 Aug 3.
Self-management is a health behavior known to predict treatment outcomes in patients with multiple co-morbidities and/or chronic conditions. However, the self-management process and outcomes in the left-ventricular assist device (LVAD) population are understudied. This pilot randomized control trial (RCT) evaluated the feasibility of a novel "smartphone app-directed and nurse-supported self-management intervention" in patients implanted with durable LVADs. Assessments included behavioral (self-efficacy and adherence), clinical (complications), and healthcare utilization (unplanned clinic, emergency room (ER) visits, and re-hospitalization) outcomes, completed at baseline (pre-hospital discharge) and months 1, 3, and 6 post-hospital discharge. Intervention patients (n = 14) had favorable patterns/trends of results across study outcomes than control patients (n = 16). Notably, intervention patients had much lower complications and healthcare utilization rates than controls. For example, intervention patients had 2 (14.3%) driveline infections in 6 months while control patients had 3 (19.0%). Additionally, at month 3, intervention patients had 0% ER visits versus 36% of control patients. At month 6, the mean cumulative number of re-hospitalizations for the control group was higher (0.9 ± 0.93) than intervention (0.3 ± 0.61) group. Despite the small sample size and limitations of feasibility/pilot studies, our outcomes data appeared to favor the novel intervention. Lessons learned from this study suggest the intervention should be implemented for 6 months post-hospital discharge. Further research is needed including large and rigorous multi-center RCTs to generate knowledge explaining the mechanism of the effect of self-management on LVAD treatment outcomes.
自我管理是一种健康行为，已知可预测患有多种合并症和/或慢性病患者的治疗结果。然而，左心室辅助装置（LVAD）人群的自我管理过程和结果研究不足。这项试点随机对照试验（RCT）评估了一种新型“智能手机应用指导和护士支持的自我管理干预”在植入耐用性 LVAD 的患者中的可行性。评估包括行为（自我效能和依从性）、临床（并发症）和医疗保健利用（计划外就诊、急诊室（ER）就诊和再入院）结果，在基线（住院前出院）和出院后 1、3 和 6 个月完成。干预组（n=14）的研究结果比对照组（n=16）有更有利的结果模式/趋势。值得注意的是，干预组的并发症和医疗保健利用率明显低于对照组。例如，干预组在 6 个月内有 2 例（14.3%）的驱动线感染，而对照组有 3 例（19.0%）。此外，在第 3 个月，干预组无 ER 就诊，而对照组有 36%的患者就诊。在第 6 个月，对照组的平均累积再住院次数较高（0.9±0.93），而干预组较低（0.3±0.61）。尽管样本量较小且可行性/试点研究存在局限性，但我们的结果数据似乎有利于新型干预措施。从这项研究中吸取的经验表明，该干预措施应在出院后 6 个月实施。需要进一步开展包括大型严格的多中心 RCT 在内的研究，以产生关于自我管理对 LVAD 治疗结果影响的机制的知识。
