评估虚拟导航干预对提高癌症幸存者健康保险素养和减轻经济负担的影响：HINT II研究方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-12 DOI:10.1016/j.cct.2025.107952

Elyse R. Park , Anne C. Kirchhoff , Calli O. Mitchell , Natalie Durieux , Allyson Foor , Karen Kuhlthau , Giselle K. Perez , Lakisa Ards , Shani Alston , Gregory T. Armstrong , Perla L. Vaca Lopez , Aaron McDonald , Vikki G. Nolan , Douglas E. Levy , Wendy M. Leisenring , Alison A. Galbraith , Paul C. Nathan , Chris Vukadinovich , Christie L. Cooper , Karen Donelan

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引用次数: 0

摘要

背景：儿童癌症幸存者经常面临高昂的医疗保健费用，以监测和管理他们的治疗的新的或持久的影响。提高幸存者的健康保险素养（HIL），即参与和驾驭健康计划的知识、能力和信心，对于尽量减少经济负担至关重要。很少有研究评估健康保险导航项目对改善幸存者HIL的影响。我们提出了一项正在进行的随机对照试验（RCT）的方案，评估两个健康保险导航计划（HINT-S和HINT-A）在改善儿童癌症成年幸存者的HIL、经济负担、自付费用和医疗保健利用方面的有效性。方法：这项三组随机对照试验评估了两种数字化提供的健康保险导航干预和增强常规护理（EUC）在改善全国儿童癌症幸存者6个月和12个 月时HIL的有效性。HINT-S是由五个同步的、导航引导的视频组成，而HINT-A是一个异步的、预先录制的五个视频集。EUC参与者只收到一本健康保险信息小册子。在12个 月时评估经济负担、医疗自付费用和医疗保健利用情况（接受预防性护理、建议的筛查/疫苗接种和急性护理）。将调查干预措施有效性的调节因素，以及实施结果（可行性、可接受性、适当性、保真度和成本效益）。结论：有强烈的需要干预，以改善癌症幸存者的HIL，帮助他们导航复杂的美国医疗保健系统。这项试验将阐明健康保险导航计划的潜在有效性和实施，这可能使许多癌症幸存者受益。试验注册：NCT05527392。

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Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden in cancer survivors: The HINT II study protocol

Background

Childhood cancer survivors often face high healthcare costs to monitor and manage new or lasting effects of their treatment. Enhancing survivors' health insurance literacy (HIL) – the knowledge, ability, and confidence in enrolling in and navigating health plans – is vital for minimizing financial burden. Few studies have assessed the effect of a health insurance navigation program on improving HIL among survivors. We present the protocol for an ongoing randomized controlled trial (RCT) assessing the effectiveness of two health insurance navigation programs (HINT-S and HINT-A) on improving HIL, financial burden, out-of-pocket costs, and healthcare utilization for adult survivors of childhood cancer.

Methods

This three-arm RCT assesses the effectiveness of two digitally delivered health insurance navigation interventions and enhanced usual care (EUC) on improving HIL at six and 12 months in a national cohort of childhood cancer survivors. While HINT-S is composed of five synchronous, navigator-led sessions, HINT-A is an asynchronous, prerecorded set of five videos. EUC participants receive only a health insurance informational booklet. Financial burden, medical out-of-pocket costs, and healthcare utilization (receipt of preventive care, recommended screenings/vaccinations, and acute care) are assessed at 12 months. Moderators to the interventions' effectiveness will be investigated, as well as implementation outcomes (feasibility, acceptability, appropriateness, fidelity, and cost-effectiveness).

Conclusions

There is a strong need for interventions to improve cancer survivors' HIL, helping them navigate the complexity of the U.S. healthcare system. This trial will elucidate the potential effectiveness and implementation of health insurance navigation programs that may benefit many cancer survivors.

Trial registration: NCT05527392

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.