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

Summary

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.

Conditions

• Aging
• Preventive Care
• Multimorbidity
• Palliative Care

Interventions

OTHER

Annual Wellness Visit

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.

OTHER

Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

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.

Sponsors & Collaborators

• Brandeis University

  collaborator OTHER

• Indiana University School of Medicine

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Atrium Health Wake Forest Baptist

  collaborator OTHER

• Griffin Hospital

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Baylor Scott and White Health

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-06

Primary Completion

2029-09-30

Completion

2030-01-31

Countries

• United States

Study Locations