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

Study acronym: SPIRE2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 6080 → 7140 participants Eligibility criteria expanded, about 14 words · Secondary endpoints revised (4) · Site details revised at 1 of 4 sites · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (4)
    • Site details revised at 1 of 4 sites
    • Publications: details revised at 29 of 33 entries
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 1, 2026 to Jan 6, 2026 · Site details revised at 4 of 4 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Jan 1, 2026 to Jan 6, 2026
    • Site details revised at 4 of 4 sites
  3. Re-verified, no change to tracked fieldsv4
  4. Interventions: Annual Wellness Visit (Other), Geriatric Resources and Assessment for the Care of Elders (Other) to Annual Wellness Visit (Other), Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) (Other) Publications: details revised at 33 of 33 entriesv3 Show 1 more changeShow less
    • Publications: details revised at 33 of 33 entries
  5. Primary completion date: Jan 2028 to Sep 30, 2029 Start date: Jan 2026 to Jan 1, 2026v2 Show 1 more changeShow less
    • Start date: Jan 2026 to Jan 1, 2026
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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 7,140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov