Recruiting

AWV & GRACE

Sponsor:

Massachusetts General Hospital

Code:

NCT07166861

Conditions

Aging

Preventive Care

Multimorbidity

Palliative Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Annual Wellness Visit

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

Study Details

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.

Conditions

Aging

Preventive Care

Multimorbidity

Palliative Care

Study ID

NCT07166861

Start date

Jan 6, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

6080 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Annual Wellness Visits (AWV)

Randomize 16 practices to AWV and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later.

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

Randomize 16 practices to AWV+GRACE and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later.

Interventions

Annual Wellness Visit

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)

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.

Primary outcome measure

  • Hospitalizations [ Time Frame: 12, 18, and 24 months. ]
  • Patient experience: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS) [ Time Frame: Baseline and 18 months. ]

Central Contacts and Locations

Central contacts

Christine S Ritchie, MD, MPH

617-726-1382csritchie@mgh.harvard.edu

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jennifer Gabbard, MD

jgabbard@wakehealth.edu

Tom Houston, MD

tom.houston@advocatehealth.org

Principal Investigator:

Jennifer Gabbard, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • annual wellness visit
  • geriatric collaborative care
  • complex care needs
  • geriatric assessment
  • implementation
  • comparative effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-22.