Annual Wellness Visits with or without GRACE support for older adults with complex needs
Supporting Practices In Respecting Elders Phase 2
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6080 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 4 sites (Derby, Connecticut and 3 other locations) |
| Trial ID | NCT07166861 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Derby, Connecticut and 3 other locations
- Griffin Health — Derby, Connecticut, United States (Not_yet_recruiting)
- Mass General Brigham — Boston, Massachusetts, United States (Not_yet_recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.