An innovative approach to aligning healthcare with what matters most to patients: A hybrid type 1 trial protocol of patient priorities care for older adults with multiple chronic conditions

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-06-22 DOI:10.1016/j.cct.2024.107613
Aanand D. Naik , Mackenzie L. Shanahan , Lilian Dindo , Marcia C. Mecca , Jennifer Arney , Amber B. Amspoker , Sheena Wydermyer , Jack Banks , Richard L. Street Jr , Lea Kiefer , Maria Zenoni , Tracey Rosen , Raquel D. Gonzalez , Angela Catic , Terri R. Fried
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Abstract

Background

Providing healthcare for older adults with multiple chronic conditions (MCC) is challenging. Polypharmacy and complex treatment plans can lead to high treatment burden and risk for adverse events. For clinicians, managing the complexities of patients with MCC leaves little room to identify what matters and align care options with patients' health priorities. New care approaches are needed to navigate these challenges. In this clinical trial, we evaluate implementation and effectiveness outcomes of an innovative, structured, patient-centered care approach (Patient Priorities Care; PPC) for reducing treatment burden and aligning health care decisions with the health priorities of older adults with MCC.

Methods

This is a multisite, assessor-blind, two-arm, parallel hybrid type 1 randomized controlled trial. We are enrolling 396 older (65+) Veterans with MCC who receive primary care at the Veterans Affairs Medical Center. Veterans are randomly assigned to either PPC or usual care. In the PPC arm, Veterans have a brief telephone call with a study facilitator to identify their personal health priorities. Then, primary care providers use this information to align healthcare with Veteran priorities during their established clinic appointments. Data are collected at baseline and 4-month follow up to assess for changes in treatment burden and use of home and community services. Formative and summative evaluations are also collected to assess for implementation outcomes according to Proctor's implementation framework.

Conclusions

This work has the potential to significantly improve the standard of care by personalizing healthcare and helping patients achieve what is most important to them.

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采用创新方法,使医疗保健与患者最关心的问题保持一致:针对患有多种慢性疾病的老年人的患者优先护理混合 1 类试验方案。
背景:为患有多种慢性疾病(MCC)的老年人提供医疗保健服务具有挑战性。多重用药和复杂的治疗方案会导致较高的治疗负担和不良事件风险。对于临床医生来说,管理复杂的 MCC 患者几乎没有余地来确定什么是重要的,并根据患者的健康优先事项调整护理方案。我们需要新的护理方法来应对这些挑战。在这项临床试验中,我们评估了一种创新的、结构化的、以患者为中心的护理方法(患者优先护理;PPC)的实施情况和效果,该方法可减轻治疗负担,并根据患有 MCC 的老年人的健康优先事项调整医疗决策:这是一项多站点、评估者盲法、双臂、平行混合 1 型随机对照试验。我们招募了 396 名患有 MCC 的老年退伍军人(65 岁以上),他们在退伍军人事务医疗中心接受初级医疗服务。退伍军人被随机分配到 PPC 或常规护理。在 PPC 治疗组中,退伍军人将与研究促进者进行简短的电话沟通,以确定其个人健康优先事项。然后,初级医疗服务提供者会利用这些信息,在退伍军人既定的门诊预约中根据他们的优先事项调整医疗服务。在基线和 4 个月的随访中收集数据,以评估治疗负担的变化以及家庭和社区服务的使用情况。此外,还收集了形成性和总结性评价,以根据 Proctor 的实施框架评估实施成果:这项工作有可能通过个性化医疗保健和帮助患者实现对他们来说最重要的目标,大大提高医疗保健标准。
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来源期刊
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.
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