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Každoroční návštěvy wellness vs Grace -Augmented Roční návštěvy wellness pro starší dospělé s vysokými potřebami - fáze 2 (SPIRE2)

2. října 2026 aktualizováno: Christine S. Ritchie, MD, MPH, Massachusetts General Hospital

Podpůrné postupy při respektování fáze 2

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

7140

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Connecticut
      • Derby, Connecticut, Spojené státy, 06418
        • Zatím nenabíráme
        • Griffin Health
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Valentine Njike, MD, MPH
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02124
        • Zatím nenabíráme
        • Mass General Brigham
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Kathryn Corelli, MD
        • Vrchní vyšetřovatel:
          • Mark Stoltenberg, MD, MPH
    • North Carolina
      • Winston-Salem, North Carolina, Spojené státy, 27157
    • Texas
      • Temple, Texas, Spojené státy, 76508
        • Zatím nenabíráme
        • Baylor Scott & White Health
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Michael McNeal, MD, MSc

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.

Ostatní jména:
  • AWV
Experimentální: 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.

Ostatní jména:
  • AWV

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.

Ostatní jména:
  • MILOST

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hospitalizations
Časové okno: 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)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical health
Časové okno: Baseline and 18 months.

PROMIS Global PH

Baseline and 18 months.
Mental health
Časové okno: Baseline and 18 months.

PROMIS Global MH

Baseline and 18 months.
Caregiver strain
Časové okno: Baseline and 18 months.

Modified Caregiver Strain Index

Baseline and 18 months.
Professional Fulfillment
Časové okno: Baseline and 18 months.

Professional Fulfillment Index

Baseline and 18 months.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes
Časové okno: 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
Časové okno: 36 months

Number of participants with advanced care planning encounters

36 months
Exploratory Geriatric Outcomes - number of participants with inappropriate medications
Časové okno: 36 months

Number of participants with Medicare Part D with potentially inappropriate medications

36 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

6. ledna 2026

Primární dokončení (Odhadovaný)

30. září 2029

Dokončení studie (Odhadovaný)

1. ledna 2030

Termíny zápisu do studia

První předloženo

21. července 2025

První předloženo, které splnilo kritéria kontroly kvality

3. září 2025

První zveřejněno (Aktuální)

10. září 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2025P000230
  • PLACER-2022C3-30604 (Jiné číslo grantu/financování: Patient Centered Outcomes Research Institute)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .