Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol.

Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol.
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通过患者导航,通过与父母联系(CHHIRP)来帮助婴儿的社区:一种混合实施有效性逐步楔形试验方案。

DOI:
10.1136/bmjopen-2021-054548
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发表时间:
2022-04-19
期刊:
影响因子:
2.9
通讯作者:
Creel, Liza
Creel, Liza
中科院分区:
医学3区
文献类型:
--
作者:
Bush, Matthew;Hatfield, Miranda;Schuh, Marissa;Balasuriya, Beverly;Mahairas, Anthony;Jacobs, Julie;Studts, Christina;Westgate, Philip;Schoenberg, Nancy;Shinn, Jennifer;Creel, Liza

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婴儿听力损失是美国最常见的新生儿感官障碍,其发病率为每1000名新生儿中有1.7例。延迟诊断以及未能及时干预的后果包括严重的交流障碍和负面的社会经济影响。早期听力检测与干预(EHDI)国家标准规定,所有婴儿应在3个月大时接受筛查和诊断,并且需要有促进及时诊断依从性的干预措施。患者导航(PN)已被证明能有效减少婴儿听力诊断护理的不依从情况;然而,PN尚未在不同社区进行测试,也未在现实环境中实施。 拟议的研究是一项社区参与的1型混合有效性 - 实施试验,针对在新生儿听力筛查未通过后减少婴儿听力诊断不依从情况的PN干预措施,在由州政府资助的EHDI诊所中开展。在我们的社区咨询委员会和合作伙伴的指导下,我们的目标是:(1)使用阶梯式楔形试验设计,测试PN在减少婴儿出生后3个月内未接受听力诊断的情况方面的有效性;(2)调查实施结果以及影响实施的因素;(3)从第三方支付者的角度确定PN的成本效益。该研究将从2019年4月持续到2024年3月。 本方案已获得肯塔基大学机构审查委员会的批准。尽管所有涉及人类受试者的研究都存在一定风险,但参与本研究预计不会有已知的严重风险。我们将寻求以系统的方式向患者、关键利益相关者、政策制定者和科学界传播我们的研究结果。我们的研究结果将通过与社区合作,为这种创新的患者支持性干预措施的推广提供信息,从而影响该领域,以创建高效的EHDI项目并最大限度地提高公共卫生影响。 Clinicaltrials.gov(预结果阶段):NCT03875339
As the most common neonatal sensory disorder in the USA, infant hearing loss has an incidence of 1.7 per 1000 births. The consequences of delayed diagnosis and failure to obtain timely intervention include significant communication impairment and negative socioeconomic effects. Early Hearing Detection and Intervention (EHDI) national standards dictate that all infants should be screened and diagnosed by 3 months of age and there is a need for interventions that promote adherence to timely diagnosis. Patient navigation (PN) has been shown to be efficacious to decrease non-adherence with infant hearing diagnostic care; however, PN has yet to be tested in diverse communities or implemented into real-world settings. The proposed research is a community-engaged, type 1 hybrid effectiveness-implementation trial of a PN intervention aimed at decreasing infant hearing diagnosis non-adherence after failed newborn hearing screening, delivered in state-funded EHDI clinics. Guided by our community advisory board and partners, we aim to (1) test the effectiveness of PN to decrease non-adherence to receipt of infant hearing diagnosis within 3 months after birth using a stepped-wedge trial design, (2) investigate implementation outcomes and factors influencing implementation and (3) determine the cost-effectiveness of PN from the perspective of third-party payers. The study will be conducted from April 2019 until March 2024. This protocol was approved by the University of Kentucky Institutional Review Board. Although all research involving human subjects contains some risk, there are no known serious risks anticipated from participating in this study. We will seek to disseminate our results in a systematic fashion to patients, key stakeholder, policymakers and the scientific community. Our results will impact the field by partnering with communities to inform the scale-up of this innovative patient supportive intervention to create efficient and effective EHDI programmes and maximise public health impact. Clinicaltrials.gov (Pre-results phase): NCT03875339.
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期刊: Implementation science : IS
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