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年度健康访问与宽广的年度健康访问,适用于高需求的老年人 - 第2阶段 (SPIRE2)

2026年10月2日 更新者:Christine S. Ritchie, MD, MPH、Massachusetts General Hospital

尊重长者第2阶段的支持实践

This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:

  1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
  2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants
  3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.

研究概览

详细说明

In the United States, 10% of patients account for half of health care costs. Many of these are older adults with complex health and social care needs (referred to as "older adults with complex needs"). They see a doctor on average 9.6 times per year, 3 times more often than older adults overall. Patients, caregivers/care partners experience care as confusing and disorganized. Clinicians in primary care practices and accountable care organization (ACO) leaders face critical dilemmas about how best to care for older adults with complex needs. Patient stakeholders providing feedback on preferred care models worry about fragmented care. Many also prefer to be at home. Evidence suggests that optimal care of older adults with complex needs involves an interprofessional team of doctors, nurses, social workers and other health care staff in partnership with patients and care partners to provide person-centered care plans, guided by evidence-based geriatric assessments. Few primary care practices provide this type of care, but Medicare ACOs and other value-based care models such as Medicare Advantage plans are well positioned to link clinicians and provide support for complex patients, their caregivers and care partners. ACOs are groups of clinicians, often housed in healthcare systems, who share in savings if they deliver high-quality care. Unlike traditional fee-for-service payment arrangements, the payment models in ACOs reward efficient, patient centered care that also minimizes unhelpful (and sometimes harmful) institutional care. ACOs are eager to optimize effective care for their patients with complex needs, but best strategies are unknown.

In 2011, to encourage value-based care, Annual Wellness Visits (AWVs) were introduced as a new Medicare Part B benefit. AWVs, as conceived by Medicare, seek to incorporate routine comprehensive assessment by primary care practices of older adults' geriatric health risks using questionnaire-based assessments completed by the patient or care partner. The goal of an AWV is to produce a Personalized Preventive Plan (PPP) for older adults. While uptake by clinicians has accelerated, uptake is lower for more vulnerable older adults. In Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs), an average of 55% of beneficiaries had an AWV in 2021 vs only 42% for adults 75-85 years old and dually eligible for Medicaid and Medicare.

AWVs have potential value as an organizing tool for patients and families and clinician teams as one time each year that someone looks at all aspects of care including understanding the care team, determining needed screening and preventive care, reviewing needs for assistance with activities of daily living, testing cognition, reviewing medications from multiple providers, and care coordination that can prevent acute episodes and hospitalization. For consistent and predictable impact, AWVs would be conducted systematically using evidence-based tools and structured protocols in response to patient needs elicited in AWVs. Although there is growing evidence that AWVs lead to increased screenings and reduced use of inpatient care, some are concerned that they also lead to increased use of low value testing after a visit. Furthermore, studies suggest that AWVs are underutilized in minoritized and socially vulnerable populations.

An evidence-based approach to support geriatric care planning for complex patients that offers solutions to identified problems that has been tested in primary care is the Geriatric Resources for the Assessment and Care of Elders (GRACE) program. GRACE is a protocolized inter-professional co-management model that was developed to improve the patient experience of care, provide patients and care partners with a designated point of contact in a nurse/social worker team, reduce utilization costs, and supporting overburdened primary care physicians by managing complex patients. The core components of the GRACE model include: 1) an individualized care plan developed by a nursing/social work team based on 2) an initial in-home assessment, 3) structured protocols, and 4) close co-management with the patient's primary care provider, who reviews, provides their input and endorses the plan. The care plan is built using GRACE Protocols for common geriatric conditions and providing a checklist to ensure a standardized approach to care. The care model was developed using extensive feedback from patients and family care partners. The GRACE Support Team designed it as a patient/care partner support system interfacing with the patient's primary care team to implement the care plan. In a randomized, controlled trial, patients at high risk for hospital admission who received GRACE team care versus a 'usual care' control group had decreased acute care utilization and costs with positive return on investment; improved quality of care; increased patient and provider satisfaction; and improved quality of life. However, GRACE has not been adopted by many ACOs and its additional value to the more commonly used AWV has not been established.

The purpose of the Supporting Practices in Respecting Elders (SPIRE) study is to address this gap in knowledge with the overall goal of improving the lives of older adults with complex needs cared for in primary care practices. The study will opportunistically evaluate two primary care programs aimed at improving care in older adults. The AWV is currently standard of care and is being used regularly in primary care clinics. However, AWVs is a "one size fits all" approach and may not be effective or appropriate for older adults with functional limitations and complex care needs and may not adequately meet the wellness needs of a diverse population of older adults. GRACE is an Evidence-based Practice specifically designed for older adults with complex care needs. GRACE was designed to address the health and health care challenges faced by low-income seniors with multiple chronic conditions including a comprehensive in-home assessment performed by a nurse practitioner and social worker (the GRACE Support Team). This in-home physical and social evaluation will build on the self-report AWV screening questions (promoted as the standard by CMS/Medicare) and brings together information learned at the in-home assessment back to an expanded GRACE team, which is led by a geriatrician and includes a pharmacist and mental health liaison (typically a licensed clinical social worker). No complex care delivery model such as GRACE has yet been implemented at scale. To date, health systems appear to find it easier to implement AWVs rather than AWVs augmented by GRACE in their high-need older adult populations. Therefore, a test of the comparative effectiveness of AWVs (usual care) versus AWVs augmented by GRACE will inform health system leaders and clinicians on optimal approaches for high cost, high need older adults with complex health and social needs.

研究类型

介入性

注册 (估计的)

7140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Connecticut
      • Derby、Connecticut、美国、06418
        • 尚未招聘
        • Griffin Health
        • 接触:
        • 首席研究员:
          • Valentine Njike, MD, MPH
    • Massachusetts
      • Boston、Massachusetts、美国、02124
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
    • Texas
      • Temple、Texas、美国、76508
        • 尚未招聘
        • Baylor Scott & White Health
        • 接触:
        • 首席研究员:
          • Michael McNeal, MD, MSc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Patient Inclusion Criteria:

  • Age 65 years or older
  • Eligible for an AWV (Medicare/Medicare Advantage) during the study period
  • Residential mailing address within a radius of the practice that can be achievably reached via a home visit
  • English or Spanish speaking
  • Be able to provide consent and / or have a proxy able to consent to study participation.
  • Meet criteria for complex health care needs, by virtue of having a Probability of Repeated Admissions (PRA) score of 0.35 or greater AND/OR Kim Syndrome on Aging (efrailty indicator) score of 0.35 or greater

Caregiver Inclusion Criteria:

  • Age 18 years or older
  • English or Spanish speaking
  • Be able to provide consent to study participation
  • Be identified by an eligible patient for participation in the study

Clinician Inclusion Criteria:

  • Age 18 years or older
  • English or Spanish speaking
  • Be able to provide consent to study participation
  • Adult health professionals who work at participating ACOs and primary care practice sites (e.g. physicians, advanced practice clinicians, nurses, social workers, clinic staff.)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Annual Wellness Visits (AWV)

Randomize 16 practices to AWV and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later.

Completion of a structured Annual Wellness Visit (AWV) questionnaire administered by an assigned practice staff member for Medicare beneficiaries deemed by study algorithm as high-risk. Those responses will then be used by the primary care team to place any needed referrals and offer any indicated personal health advice and create a care plan for the coming year. Routine usual care from the primary care practice will occur.

其他名称:
  • 平均水流量
实验性的:Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

Randomize 16 practices to AWV+GRACE and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later.

Completion of a structured Annual Wellness Visit (AWV) questionnaire administered by an assigned practice staff member for Medicare beneficiaries deemed by study algorithm as high-risk. Those responses will then be used by the primary care team to place any needed referrals and offer any indicated personal health advice and create a care plan for the coming year. Routine usual care from the primary care practice will occur.

其他名称:
  • 平均水流量

The practice will initiate the Geriatric Resources and Assessment for the Care of Elders (GRACE) program for Medicare beneficiaries deemed by study algorithm as high-risk and meeting other study criteria (see below). After completion of the in-home structured annual wellness visit (AWV) and GRACE assessment by the NP/SW team, responses will be reviewed and applied to construct an individualized care plan using the GRACE protocols inclusive of advance care planning, health maintenance, medication management, assistance with any difficulty walking, falls, dementia, depression, chronic pain, malnutrition, weight loss, urinary incontinence, visual impairment, hearing impairment, or caregiver burden.

其他名称:
  • 优雅

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Hospitalizations
大体时间:12, 18, and 24 months.

Count of hospitalizations during the observation period, evaluated at the participant level.

12, 18, and 24 months.
Patient experience: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)
大体时间:Baseline and 18 months.

The CAHPS Clinician & Group Survey (CG-CAHPS) asks patients to report on their experiences with providers and staff in primary care and specialty care settings, using a 6 month recall period. The Patient-Centered Medical Home (PCMH) Item Set is a set of supplemental questions that is added to the adult version of the CAHPS Clinician & Group Survey (CG-CAHPS) to gather more information on patient experience with the domains of primary care that define a medical home.

Scoring for most items is on a 4 point scale 1=never 2=sometimes 3=usually 4=Always. Minimum and Maximum scores vary with the number of items used. The Provider Rating item is on a 11 point scale from 0 to 10,where 9,10 are considered "high" scores.

Baseline and 18 months.

次要结果测量

结果测量
措施说明
大体时间
Physical health
大体时间:Baseline and 18 months.

PROMIS Global PH

Baseline and 18 months.
Mental health
大体时间:Baseline and 18 months.

PROMIS Global MH

Baseline and 18 months.
Caregiver strain
大体时间:Baseline and 18 months.

Modified Caregiver Strain Index

Baseline and 18 months.
Professional Fulfillment
大体时间:Baseline and 18 months.

Professional Fulfillment Index

Baseline and 18 months.

其他结果措施

结果测量
措施说明
大体时间
Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes
大体时间:36 months

New ICD-10 diagnosis codes in cognitive status, physical function status or mood categories

36 months
Exploratory Geriatric Outcomes- number of participants that complete advanced care planning
大体时间:36 months

Number of participants with advanced care planning encounters

36 months
Exploratory Geriatric Outcomes - number of participants with inappropriate medications
大体时间:36 months

Number of participants with Medicare Part D with potentially inappropriate medications

36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月6日

初级完成 (估计的)

2029年9月30日

研究完成 (估计的)

2030年1月1日

研究注册日期

首次提交

2025年7月21日

首先提交符合 QC 标准的

2025年9月3日

首次发布 (实际的)

2025年9月10日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2025P000230
  • PLACER-2022C3-30604 (其他赠款/资助编号:Patient Centered Outcomes Research Institute)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.

IPD 共享时间框架

The data will become available upon request after academic journal publication.

IPD 共享访问标准

Access criteria will be determined and confirmed by the corresponding author upon review of the formal data request.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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