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健康导航员干预措施,以满足澳大利亚一家大型大都市医院接受门诊治疗的癌症患者的未满足的社会需求:一项混合方法可行性试验的方案。

Health Navigator intervention to address the unmet social needs of populations living with cancer attending outpatient treatment at a major metropolitan hospital in Australia: protocol for a mixed-methods feasibility trial.

机构信息

The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia

Northern Adelaide Local Health Network, Adelaide, South Australia, Australia.

出版信息

BMJ Open. 2024 Nov 28;14(11):e080403. doi: 10.1136/bmjopen-2023-080403.

Abstract

INTRODUCTION

Integrating health and social care to address unmet social needs is an emerging priority for health systems worldwide. Screening and referral interventions for unmet social needs, also known as Health Navigator (HN) interventions, in healthcare settings have shown mixed but promising results, mostly due to a large variability in intervention design and outcomes assessed. Most HN interventions are implemented in primary care, despite evidence that disadvantaged populations face substantial barriers to accessing such care, and these interventions are limited in Australia. To address this gap, we designed a HN intervention to address the unmet social needs of a disadvantaged population living with cancer presenting at an outpatient cancer treatment facility in South Australia. To our knowledge, this paper presents a protocol for one of the first feasibility and acceptability studies of an HN intervention in an Australian healthcare setting.

METHODS AND ANALYSIS

We will conduct a single-centre study to explore the feasibility and acceptability of screening and referral for unmet social needs for patients attending an outpatient cancer clinic at a major metropolitan hospital serving a disadvantaged population in South Australia. Eligible participants are 18 years of age or older receiving treatment at the Northern Adelaide Cancer Centre, with an expected prognosis of minimum 6 months. During recruitment, a researcher will ask eligible participants to complete unmet social needs screening and baseline assessments. Participants with unmet social needs who request assistance will be connected with an HN. The HN will work with participants to prioritise their needs and provide referrals to community and government services with follow-up of over 6 months from enrolment. Post-HN intervention, all participants will be asked to complete repeat unmet social needs screening and repeat assessments. The primary criteria for determining feasibility success are: (1) recruitment rates, where 80% of eligible participants agree to unmet needs screening; (2) intervention uptake, where 80% of participants who report unmet social needs consent to assistance from a HN; (3) intervention completion, where 80% of participants receive HN assistance complete follow-up; (4) reasons for not completing intervention; and (5) participant and clinician acceptability of the intervention. Secondary outcomes include changes to unmet social needs and coping with cancer ability, quality of life and patient-reported experience measures. Thematic analysis will be applied to focus groups with clinicians and participants to assess intervention acceptability. Secondary clinical outcomes will be reported as effect size estimates for future trials. Based on previous work in this area, we will aim to recruit 350 participants. Study findings will be used to optimise recruitment and intervention components and develop suitable outcome measures for larger, randomised studies.

ETHICS AND DISSEMINATION

The protocol has ethical approval from the Central Adelaide Local Health Network Human Research Ethics Committee (approval ID: 16448). Findings will be disseminated in research publications and non-academic formats for a variety of audiences.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trial Registry (ACTRN12622000802707p).Protocol date and version: 07 June 2022, V1.

摘要

简介

将医疗保健和社会保健相结合以满足未满足的社会需求,这是全球卫生系统的一项新重点。在医疗保健环境中,针对未满足的社会需求的筛查和转介干预措施(也称为健康导航员(HN)干预措施)已显示出混合但有希望的结果,但主要是由于干预设计和评估结果的很大差异。大多数 HN 干预措施都在初级保健中实施,尽管有证据表明弱势群体在获得此类护理方面面临着实质性障碍,但这些干预措施在澳大利亚受到限制。为了弥补这一差距,我们设计了一项 HN 干预措施,以满足在南澳大利亚一家门诊癌症治疗机构就诊的癌症弱势群体的未满足的社会需求。据我们所知,本文提出了针对澳大利亚医疗保健环境中 HN 干预措施的首次可行性和可接受性研究之一的方案。

方法与分析

我们将进行一项单中心研究,以探索在南澳大利亚一家为弱势群体服务的主要大都市医院的门诊癌症诊所为患者进行未满足的社会需求筛查和转介的可行性和可接受性。符合条件的参与者为在北阿德莱德癌症中心接受治疗、预计生存时间至少为 6 个月的 18 岁或以上的患者。在招募期间,研究人员将要求符合条件的参与者完成未满足的社会需求筛查和基线评估。有未满足的社会需求并要求提供帮助的参与者将与 HN 联系。HN 将与参与者合作,确定其需求的优先级,并为社区和政府服务提供转介,从入组开始进行超过 6 个月的随访。在 HN 干预后,所有参与者都将被要求完成重复的未满足的社会需求筛查和重复评估。确定可行性成功的主要标准是:(1) 招募率,其中 80%的合格参与者同意进行未满足的需求筛查;(2) 干预参与率,其中 80%报告有未满足的社会需求的参与者同意接受 HN 的帮助;(3) 干预完成率,其中 80%接受 HN 帮助的参与者完成随访;(4) 不完成干预的原因;以及 (5) 干预的参与者和临床医生的可接受性。次要结果包括未满足的社会需求和应对癌症能力、生活质量和患者报告的体验措施的变化。将对临床医生和参与者的焦点小组进行专题分析,以评估干预措施的可接受性。次要临床结果将作为未来试验的效应大小估计值进行报告。基于该领域的先前工作,我们将目标是招募 350 名参与者。研究结果将用于优化招募和干预措施的组成部分,并为更大规模的随机试验开发合适的结果测量方法。

伦理与传播

该方案已获得中央阿德莱德地区卫生网络人类研究伦理委员会的批准(批准 ID:16448)。研究结果将以研究出版物和针对各种受众的非学术形式传播。

试验注册号

澳大利亚和新西兰临床试验注册中心(ACTRN12622000802707p)。方案日期和版本:2022 年 6 月 7 日,V1。

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