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Supporting Practices In Respecting Elders Phase 2

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

• 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.)

Locations
United States
Connecticut
Griffin Health
NOT_YET_RECRUITING
Derby
Massachusetts
Mass General Brigham
NOT_YET_RECRUITING
Boston
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Texas
Baylor Scott & White Health
NOT_YET_RECRUITING
Temple
Contact Information
Primary
Christine S Ritchie, MD, MPH
csritchie@mgh.harvard.edu
617-726-1382
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2030-01
Participants
Target number of participants: 6080
Treatments
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.
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Dartmouth-Hitchcock Medical Center, Indiana University School of Medicine, Atrium Health Wake Forest Baptist, Griffin Hospital, Brandeis University, Baylor Scott and White Health, Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov