Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07166861

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

Led by Massachusetts General Hospital · Updated on 2026-01-22

6080

Participants Needed

4

Research Sites

208 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Brandeis University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Eligible for an Annual Wellness Visit during the study period
  • Residential address reachable by home visit within practice area
  • English or Spanish speaking
  • Able to provide consent or have proxy consent
  • Have complex health care needs with specific risk scores (PRA score ≥ 0.35 and/or Kim Syndrome on Aging score ≥ 0.35)
  • Caregivers aged 18 or older, English or Spanish speaking, able to consent, identified by eligible patient
  • Clinicians aged 18 or older, English or Spanish speaking, able to consent, working at participating ACO or primary care sites
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Griffin Health

Derby, Connecticut, United States, 06418

Not Yet Recruiting

2

Mass General Brigham

Boston, Massachusetts, United States, 02124

Not Yet Recruiting

3

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

4

Baylor Scott & White Health

Temple, Texas, United States, 76508

Not Yet Recruiting

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Research Team

C

Christine S Ritchie, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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