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. 2025 Sep 2:108072.
doi: 10.1016/j.cct.2025.108072. Online ahead of print.

Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study

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Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study

Thomas Travison et al. Contemp Clin Trials. .

Abstract

Older adults with complex health and social care needs comprise some 5 % of the United States population but contribute to roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs. NCT06287801.

Keywords: Annual wellness visit; Comparative effectiveness; Complex care needs; Geriatric assessment; Geriatric collaborative care; Implementation.

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