Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07166861

Supporting Practices In Respecting Elders Phase 2: Annual Wellness Visits Compared with GRACE-Augmented Care for Older Adults with Complex Needs

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

6080

Participants Needed

4

Research Sites

13 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

Researchers are evaluating the feasibility and impact of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) for older adults with complex health needs. This study aims to improve patient and caregiver outcomes and reduce hospitalizations among this vulnerable population. The study includes three main goals: designing a community-focused implementation strategy, creating a referral pathway to enroll eligible participants, and conducting a pilot clinical trial to assess the intervention's feasibility. The study compares two groups: one receiving the standard AWV and the other receiving AWVs augmented with the GRACE program. AWVs involve completing a structured questionnaire to guide personalized care plans, while the AWV+GRACE group receives additional in-home assessments by a nurse practitioner and social worker team. This team develops individualized care plans addressing various geriatric conditions using evidence-based protocols. Practices are randomized to either group, with around 90 participants recruited per practice. Participants will be involved in surveys before the intervention and 18 months later to assess outcomes such as hospitalizations, patient experience, physical and mental health, caregiver strain, and clinician well-being. Data collection includes the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) and other health measures. The study will last over two years, with monitoring at 12, 18, and 24 months to evaluate the impact of the interventions on high-risk older adults.

CONDITIONS

Brief 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 (Medicare/Medicare Advantage) during the study period
  • Live within a reachable distance for a home visit by the practice
  • Speak English or Spanish
  • Able to provide consent or have a proxy who can consent
  • Have complex health care needs defined by a Probability of Repeated Admissions score of 0.35 or higher and/or a Kim Syndrome on Aging score of 0.35 or higher
  • Caregivers must be 18 years or older, English or Spanish speaking, able to consent, and identified by an eligible patient
  • Clinicians must be 18 years or older, English or Spanish speaking, able to consent, and work at participating ACOs 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Annual Wellness Visits (AWV)

Duration - Ongoing annually during the study period

Participants complete a structured Annual Wellness Visit questionnaire administered by an assigned practice staff member to develop a personalized preventive care plan and receive routine primary care.

1 baseline visit and follow-up visits annually

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

Duration - Ongoing annually during the study period

Participants receive an in-home structured Annual Wellness Visit and GRACE assessment by a nurse practitioner and social worker team to create an individualized care plan addressing complex health needs.

1 baseline in-home visit and follow-up visits annually

Follow-up Surveys

Duration - 18 months

Participants complete surveys assessing patient experience, physical and mental health, caregiver strain, and clinician well-being at baseline and 18 months.

2 survey assessments (baseline and 18 months)

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

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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