Annual Wellness Visits with or without GRACE support for older adults with complex needs
Official title: Supporting Practices In Respecting Elders Phase 2
Run by Massachusetts General Hospital · NCT07166861 · Data updated 2026-11-12
This project will see if adding the GRACE geriatric care approach to Medicare Annual Wellness Visits helps older adults with complex needs and their caregivers stay healthier and avoid hospital visits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 7140 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 4 sites (Derby, Connecticut and 3 other locations) |
| Status | Recruiting |
| Started | January 6, 2026 |
| Main results expected | September 30, 2029 |
| Study ends | January 2030 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07166861 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are Medicare-eligible adults age 65 or older with complex needs indicated by a PRA score ≥0.35 and/or a Kim frailty score ≥0.35, who live within the study's home-visit radius and can communicate in English or Spanish and provide consent or have a proxy.
✕Probably not a fit
Patients without elevated risk/frailty, those not eligible for an AWV, those who live outside the reachable home-visit area, or those unable to communicate in English or Spanish are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot compares usual Annual Wellness Visits (AWVs) to AWVs augmented by the GRACE geriatric team model (AWV + GRACE) for older adults with complex health and social needs. The work includes co-designing a community-centered implementation strategy, building a referral algorithm to optimize eligible enrollment, and running a pilot clinical trial across ACO-affiliated primary care sites. Eligible patients are Medicare beneficiaries age 65+ with elevated risk of repeated admissions or frailty who live within reach of home visits and speak English or Spanish. Outcomes will include feasibility measures, patient and caregiver-reported outcomes, and health care use such as hospitalizations.
Why it matters
Potential benefit: If successful, this approach could improve care coordination, patient and caregiver experience, and reduce avoidable hospital use for high-need older adults.
How similar studies have gone: Prior studies of the GRACE geriatric collaborative-care model have shown improved care coordination and reduced acute care use in older adults, though combining GRACE with structured AWVs and community co-design is less well tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.)
Where it's running
-
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States Recruiting -
Griffin Health
Derby, Connecticut, United States Not yet recruiting -
Mass General Brigham
Boston, Massachusetts, United States Not yet recruiting -
Baylor Scott & White Health
Temple, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Christine S Ritchie, MD, MPH
- Email: csritchie@mgh.harvard.edu
- Phone: 617-726-1382
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.