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评估一种用于异基因干细胞移植的电子健康促进综合护理模式的成本、成本效益和生存率:德国SMILe随机对照实施科学试验的结果。

Evaluating the cost, cost-effectiveness and survival of an eHealth-facilitated integrated care model for allogeneic stem cell transplantation: Results of the German SMILe randomized, controlled implementation science trial.

作者信息

Leppla Lynn, Kaier Klaus, Schmid Anja, Valenta Sabine, Ribaut Janette, Mielke Juliane, Teynor Alexandra, Zeiser Robert, De Geest Sabina

机构信息

Department of Medicine I, Medical Center - University of Freiburg, Faculty of Medicine, Germany; Institute of Nursing Science, Department Public Health, University of Basel, Switzerland.

Institute for Medical Biometry and Statistics, University of Freiburg, Germany.

出版信息

Eur J Oncol Nurs. 2025 Feb;74:102740. doi: 10.1016/j.ejon.2024.102740. Epub 2024 Nov 19.

DOI:10.1016/j.ejon.2024.102740
PMID:39591883
Abstract

PURPOSE

eHealth-facilitated integrated care models (eICMs) have proved effective in improving outcomes for chronically ill patients. However, evidence on cost-effectiveness of eICMs is scarce so far. Allogeneic stem cell transplantation (alloSCT) recipients' post-discharge treatment costs and mortality are greatly influenced by complications. Within the international, multicentric SMILe implementation science project, the eHealth-facilitated SMILe integrated care model (SMILe-ICM) was developed to support patients minimize complications' effects within the first year post-alloSCT. Using initial effectiveness findings from the first center that implemented the SMILe-ICM, this study provides a cost and cost-effectiveness evaluation considering one-year and long-term survival effects, post-discharge costs, and patient-related factors.

METHODS

A single-center hybrid effectiveness implementation randomized controlled trial was conducted at a German university hospital from 2/2020 to 8/2022. Eligible alloSCT patients were randomized to the SMILe-ICM or usual care, i.e., one pre-transplant educational nursing visit followed by a physician-led follow-up. The intervention group received usual care plus the SMILe-ICM's four intervention modules (i.e., monitoring of medical/symptom-related parameters, medication adherence, infection prevention, physical activity). All modules were delivered by Advanced Practice Nurses (APNs) in face-to-face visits, combined with continuous online support. Daily, patients entered seventeen medical and symptom-related parameters to the SMILe App, so that APNs could monitor for and investigate possible pre-complication signs. Healthcare utilization costs were assessed at eight time-points (d+30 post-alloSCT-d365) on fourteen self-reported cost indicators and validated against health records. To calculate costs, we applied German standardized unit costs. Cost- and cost-effectiveness were analyzed in five steps: 1.) Calculate total costs, including for the alloSCT inpatient stay and post-discharge follow-up. 2.) Determine life-years gained (survival) as a health benefit unit. 3.) Calculate overall and rehospitalization-free survival estimates. 4.) Calculate the intervention's long-term cost-effectiveness, including extended follow-up, rate of survival until day 1000, and restricted mean survival time. 5.) Contrast these long-term estimates to current post-discharge costs with comparable patient-related factors (age ≥ or < 65, living alone, gender).

RESULTS

Seventy-two patients participated (n = 36/group). Total intergroup healthcare utilization and post-discharge costs differed, but non-significantly. Survival rates improved with the SMILe-ICM (88% vs. 80%) at least until day +1000. Rehospitalization-free survival showed improvement (38% vs. 30%); however, considering this sample size, both findings were nonsignificant. Cost-effectiveness analysis showed an overall post-discharge cost-effectiveness of 35,364.01€/patient and 6,742€/life year gained - a mean of 79.21 additional days of life for an intervention investment of 1.464€/patient in the first year post-alloSCT. One-year cost-effectiveness was highest for patients living alone. Younger age correlated with longer survival but higher costs.

CONCLUSION

The SMILe-ICM appears to offer survival and rehospitalization benefits, particularly for vulnerable groups, e.g., patients living alone. Larger, adequately powered studies are needed to validate these findings.

摘要

目的

电子健康促进的综合护理模式(eICMs)已被证明能有效改善慢性病患者的治疗效果。然而,迄今为止,关于eICMs成本效益的证据还很稀少。异基因干细胞移植(alloSCT)受者出院后的治疗成本和死亡率受并发症影响很大。在国际多中心SMILe实施科学项目中,开发了电子健康促进的SMILe综合护理模式(SMILe-ICM),以支持患者在alloSCT后的第一年内将并发症的影响降至最低。本研究利用实施SMILe-ICM的第一个中心的初步有效性结果,提供了一项考虑一年和长期生存影响、出院后成本以及患者相关因素的成本和成本效益评估。

方法

2020年2月至2022年8月,在一家德国大学医院进行了一项单中心混合有效性实施随机对照试验。符合条件的alloSCT患者被随机分为SMILe-ICM组或常规护理组,即移植前进行一次教育护理访视,随后由医生进行随访。干预组接受常规护理加SMILe-ICM的四个干预模块(即监测医疗/症状相关参数、药物依从性、感染预防、身体活动)。所有模块均由高级执业护士(APNs)在面对面访视中提供,并辅以持续的在线支持。患者每天在SMILe应用程序中输入17个医疗和症状相关参数,以便APNs能够监测和调查可能的并发症前体征。在14个自我报告的成本指标的8个时间点(alloSCT后第30天至第365天)评估医疗保健利用成本,并与健康记录进行验证。为了计算成本,我们应用了德国标准化单位成本。成本和成本效益分析分五步进行:1.)计算总成本,包括alloSCT住院期间和出院后随访的成本。2.)确定获得的生命年(生存)作为健康效益单位。3.)计算总体生存率和无再住院生存率估计值。4.)计算干预措施的长期成本效益,包括延长随访、到第1000天的生存率以及受限平均生存时间。5.)将这些长期估计值与具有可比患者相关因素(年龄≥或<65岁、独居、性别)的当前出院后成本进行对比。

结果

72名患者参与研究(每组n = 36)。组间医疗保健利用和出院后成本存在差异,但无统计学意义。至少到第1000天,SMILe-ICM组的生存率有所提高(88%对80%)。无再住院生存率有所改善(38%对30%);然而,考虑到样本量,这两个结果均无统计学意义。成本效益分析显示,出院后总体成本效益为35364.01欧元/患者,每获得一个生命年的成本为6742欧元——在alloSCT后的第一年,每患者投资1464欧元可平均延长79.21天的生命。独居患者的一年成本效益最高。年龄较小与生存期较长但成本较高相关。

结论

SMILe-ICM似乎能带来生存和再住院方面的益处,特别是对弱势群体,如独居患者。需要更大规模、有足够效力的研究来验证这些发现。

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