Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2

Part of paid clinical trials in Derby, Connecticut.

Sponsor
Massachusetts General Hospital
Study ID
NCT07166861
Status
Recruiting
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Conditions

  • Aging
  • Multimorbidity
  • Palliative Care
  • Preventive Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Annual Wellness Visit — OTHER
    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.
  • Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
6,080 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Hospitalizations [ Time Frame: 12, 18, and 24 months. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Griffin HealthDerbyConnecticut06418
Valentine Njike, MD, MPH
[email protected]
Valentine Njike, MD, MPH (PRINCIPAL_INVESTIGATOR)
Mass General BrighamBostonMassachusetts02124
Kathryn Corelli, MD
[email protected]
Mark Stoltenberg, MD, MPH
[email protected]
Kathryn Corelli, MD (PRINCIPAL_INVESTIGATOR)
Mark Stoltenberg, MD, MPH (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Jennifer Gabbard, MD
[email protected]
Tom Houston, MD
[email protected]
Jennifer Gabbard, MD (PRINCIPAL_INVESTIGATOR)
Thomas Houston, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White HealthTempleTexas76508
Micheal McNeal, MD, MSc
[email protected]
Michael McNeal, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Derby, CT

By research site
Griffin Health· Derby, CTMass General Brigham· Boston, MAAtrium Health Wake Forest Baptist· Winston-Salem, NCBaylor Scott & White Health· Temple, TX

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