Clinical Trial

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

Study acronym: SPIRE2

Recruiting

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2025-09-03; most recent amendment 2026-01-20.

Status change: Not Yet Recruiting → Recruiting 2026-01-20

Trial Details

NCT Number	NCT07166861
Lead Sponsor	Massachusetts General Hospital Collaborators: Brandeis University, Indiana University, Dartmouth-Hitchcock Medical Center, Atrium Health Wake Forest Baptist, Griffin Hospital, Patient-Centered Outcomes Research Institute, Baylor Scott and White Health
Conditions	Aging, Preventive Care, Multimorbidity, Palliative Care
Enrollment	6,080 participants
Start Date	2026-01-06
Primary Completion	2029-09-30 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-22