RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07166861

Registry updated: 2026-10-06

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Description

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.

Interventions

Annual Wellness Visit (Other)
Completion of a structured Annual Wellness Visit (AWV) questionnaire administered by an assigned practice staff member for Medicare beneficiaries deemed by study algorithm as high-risk. Those responses will then be used by the primary care team to place any needed referrals and offer any indicated personal health advice and create a care plan for the coming year. Routine usual care from the primary care practice will occur.
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) (Other)
The practice will initiate the Geriatric Resources and Assessment for the Care of Elders (GRACE) program for Medicare beneficiaries deemed by study algorithm as high-risk and meeting other study criteria (see below). After completion of the in-home structured annual wellness visit (AWV) and GRACE assessment by the NP/SW team, responses will be reviewed and applied to construct an individualized care plan using the GRACE protocols inclusive of advance care planning, health maintenance, medication management, assistance with any difficulty walking, falls, dementia, depression, chronic pain, malnutrition, weight loss, urinary incontinence, visual impairment, hearing impairment, or caregiver burden.

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.)

Conditions

Aging Preventive Care Multimorbidity Palliative Care

Locations

Griffin Health — Derby, Connecticut, United States
Mass General Brigham — Boston, Massachusetts, United States
Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
Baylor Scott & White Health — Temple, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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