[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605772":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":116,"collaborators":119,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":135,"sex":141,"minAge":142,"maxAge":32,"enrollmentInfo":143,"targetDuration":32,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":81,"whyStopped":32,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Annual Wellness Visits (AWV)","ACTIVE_COMPARATOR","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\u002Fpractice) to complete surveys prior to the intervention and 18 months later.",[13],"Other: Annual Wellness Visit",{"label":15,"type":16,"description":17,"interventionNames":18},"Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)","EXPERIMENTAL","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\u002Fpractice) to complete surveys prior to the intervention and 18 months later.",[13,19],"Other: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Annual Wellness Visit","Completion of a structured Annual Wellness Visit (AWV) questionnaire administered by an assigned practice staff member for Medicare beneficiaries deemed by study algorithm as high-risk. Those responses will then be used by the primary care team to place any needed referrals and offer any indicated personal health advice and create a care plan for the coming year. Routine usual care from the primary care practice will occur.",[9,15],[26],"AWV",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The practice will initiate the Geriatric Resources and Assessment for the Care of Elders (GRACE) program for Medicare beneficiaries deemed by study algorithm as high-risk and meeting other study criteria (see below). After completion of the in-home structured annual wellness visit (AWV) and GRACE assessment by the NP\u002FSW team, responses will be reviewed and applied to construct an individualized care plan using the GRACE protocols inclusive of advance care planning, health maintenance, medication management, assistance with any difficulty walking, falls, dementia, depression, chronic pain, malnutrition, weight loss, urinary incontinence, visual impairment, hearing impairment, or caregiver burden.",[15],[31],"GRACE",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Christine S Ritchie, MD, MPH","CONTACT","617-726-1382","csritchie@mgh.harvard.edu",[40,60,79,100],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Griffin Health","NOT_YET_RECRUITING","Derby","Connecticut","06418","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-73.089,41.32065,{"lat":52,"lon":51},[55,58],{"name":56,"role":36,"phone":32,"phoneExt":32,"email":57},"Valentine Njike, MD, MPH","VNjike@Griffinhealth.org",{"name":56,"role":59,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":42,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Mass General Brigham","Boston","Massachusetts","02124",{"type":49,"coordinates":66},[67,68],-71.05977,42.35843,{"lat":68,"lon":67},[71,74,77,78],{"name":72,"role":36,"phone":32,"phoneExt":32,"email":73},"Kathryn Corelli, MD","KMCORELLI@MGH.HARVARD.EDU",{"name":75,"role":36,"phone":32,"phoneExt":32,"email":76},"Mark Stoltenberg, MD, MPH","MSTOLTENBERG@mgh.harvard.edu",{"name":72,"role":59,"phone":32,"phoneExt":32,"email":32},{"name":75,"role":59,"phone":32,"phoneExt":32,"email":32},{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":46,"countryCode":47,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Atrium Health Wake Forest Baptist","RECRUITING","Winston-Salem","North Carolina","27157",{"type":49,"coordinates":86},[87,88],-80.24422,36.09986,{"lat":88,"lon":87},[91,94,97,98],{"name":92,"role":36,"phone":32,"phoneExt":32,"email":93},"Jennifer Gabbard, MD","jgabbard@wakehealth.edu",{"name":95,"role":36,"phone":32,"phoneExt":32,"email":96},"Tom Houston, MD","tom.houston@advocatehealth.org",{"name":92,"role":59,"phone":32,"phoneExt":32,"email":32},{"name":99,"role":59,"phone":32,"phoneExt":32,"email":32},"Thomas Houston, MD",{"facility":101,"status":42,"city":102,"state":103,"zip":104,"country":46,"countryCode":47,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Baylor Scott & White Health","Temple","Texas","76508",{"type":49,"coordinates":106},[107,108],-97.34278,31.09823,{"lat":108,"lon":107},[111,114],{"name":112,"role":36,"phone":32,"phoneExt":32,"email":113},"Micheal McNeal, MD, MSc","Michael.McNeal@BSWHealth.org",{"name":115,"role":59,"phone":32,"phoneExt":32,"email":32},"Michael McNeal, MD, MSc",{"type":59,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Christine S. Ritchie, MD, MPH","Director, Center for Aging and Serious Illness",[120,122,124,126,127,129,131],{"name":121,"class":6},"Brandeis University",{"name":123,"class":6},"Indiana University",{"name":125,"class":6},"Dartmouth-Hitchcock Medical Center",{"name":80,"class":6},{"name":128,"class":6},"Griffin Hospital",{"name":130,"class":6},"Patient-Centered Outcomes Research Institute",{"name":132,"class":6},"Baylor Scott and White Health","100605772","annual-wellness-visits-vs-grace-augmented-annual-wellness-visits-for-older-adults-with-high-needs---phase-2-100605772",false,"NCT07166861","Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2","Supporting Practices In Respecting Elders Phase 2","SPIRE2","Patient Inclusion Criteria:\n\n* Age 65 years or older\n* Eligible for an AWV (Medicare\u002FMedicare Advantage) during the study period\n* Residential mailing address within a radius of the practice that can be achievably reached via a home visit\n* English or Spanish speaking\n* Be able to provide consent and \u002F or have a proxy able to consent to study participation.\n* Meet criteria for complex health care needs, by virtue of having a Probability of Repeated Admissions (PRA) score of 0.35 or greater AND\u002FOR Kim Syndrome on Aging (efrailty indicator) score of 0.35 or greater\n\nCaregiver Inclusion Criteria:\n\n* Age 18 years or older\n* English or Spanish speaking\n* Be able to provide consent to study participation\n* Be identified by an eligible patient for participation in the study\n\nClinician Inclusion Criteria:\n\n* Age 18 years or older\n* English or Spanish speaking\n* Be able to provide consent to study participation\n* Adult health professionals who work at participating ACOs and primary care practice sites (e.g. physicians, advanced practice clinicians, nurses, social workers, clinic staff.)","ALL","18 Years",{"count":144,"type":145},6080,"ESTIMATED","INTERVENTIONAL",[148],"NA","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:\n\n1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms\n2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants\n3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.",[151,152,153,154],"Aging","Preventive Care","Multimorbidity","Palliative Care",[156,157,158,159,160,161],"annual wellness visit","geriatric collaborative care","complex care needs","geriatric assessment","implementation","comparative effectiveness","2026-01-20",{"date":164,"type":165},"2026-01-22","ACTUAL",{"date":167,"type":165},"2026-01-06",{"date":169,"type":145},"2030-01",{"name":5,"class":6},4]