protocolSection identificationModule nctId: NCT06287801, orgStudyIdInfo id: 2024P000271, briefTitle: Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1, acronym: SPIRE1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Brandeis University, collaborators name: Patient-Centered Outcomes Research Institute, collaborators name: Vanderbilt University Medical Center, collaborators name: Dartmouth-Hitchcock Medical Center, collaborators name: Indiana University, descriptionModule briefSummary: 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 arms2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention., conditionsModule conditions: Healthy Aging, conditions: Health Care Utilization, conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility of a clinical comparative effectiveness trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Annual Wellness Visit, interventions name: Geriatric Resources and Assessment for the Care of Elders, outcomesModule primaryOutcomes measure: Hospitalizations, primaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS), primaryOutcomes measure: Net Promotor Score, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH), secondaryOutcomes measure: Caregiver Strain, secondaryOutcomes measure: Patient's out-of-pocket costs for up to 180 days after enrollment, secondaryOutcomes measure: Caregiver's hours spent caregiving., secondaryOutcomes measure: Pilot ACOs Staffing costs, otherOutcomes measure: Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes, otherOutcomes measure: Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents, otherOutcomes measure: Exploratory Geriatric Outcomes - number of participants with inappropriate medications, otherOutcomes measure: Covariate - Demographics, otherOutcomes measure: Covariate - Medicare Entitlement Status, otherOutcomes measure: Covariate - Elixhauser comorbidity index, otherOutcomes measure: Covariate - Area Deprivation Index, otherOutcomes measure: Covariate - Loneliness, otherOutcomes measure: Exploratory - Hope, otherOutcomes measure: Covariate - Activities of daily living (ADL), otherOutcomes measure: Exploratory - ED visits, otherOutcomes measure: Exploratory - Observation visits, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False