NCT07166861 Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2
| NCT ID | NCT07166861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,080 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,080 participants in total. It began in 2026-01-06 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07166861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07166861 currently recruiting?
Yes, NCT07166861 is actively recruiting participants. Contact the research team at csritchie@mgh.harvard.edu for enrollment information.
Where is the NCT07166861 trial being conducted?
This trial is being conducted at Derby, United States, Boston, United States, Winston-Salem, United States, Temple, United States.
Who is sponsoring the NCT07166861 clinical trial?
NCT07166861 is sponsored by Massachusetts General Hospital. The trial plans to enroll 6,080 participants.