NCT07166861

Brief 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. 1.Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
  2. 2.Develop a referral pathway and algorithm to optimize enrollment of eligible participants
  3. 3.Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,080

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

July 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

July 21, 2025

Last Update Submit

January 20, 2026

Conditions

AgingPreventive CareMultimorbidityPalliative Care

Keywords

annual wellness visitgeriatric collaborative carecomplex care needsgeriatric assessmentimplementationcomparative effectiveness

Outcome Measures

Primary Outcomes (2)

  • Hospitalizations

    Count of hospitalizations during the observation period, evaluated at the participant level.

    12, 18, and 24 months.

  • Patient experience: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)

    The CAHPS Clinician \& Group Survey (CG-CAHPS) asks patients to report on their experiences with providers and staff in primary care and specialty care settings, using a 6 month recall period. The Patient-Centered Medical Home (PCMH) Item Set is a set of supplemental questions that is added to the adult version of the CAHPS Clinician \& Group Survey (CG-CAHPS) to gather more information on patient experience with the domains of primary care that define a medical home. Scoring for most items is on a 4 point scale 1=never 2=sometimes 3=usually 4=Always. Minimum and Maximum scores vary with the number of items used. The Provider Rating item is on a 11 point scale from 0 to 10,where 9,10 are considered "high" scores.

    Baseline and 18 months.

Secondary Outcomes (4)

  • Physical health

    Baseline and 18 months.

  • Mental health

    Baseline and 18 months.

  • Caregiver strain

    Baseline and 18 months.

  • Clinician Well being

    Baseline and 18 months.

Other Outcomes (3)

  • Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes

    36 months

  • Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents

    36 months

  • Exploratory Geriatric Outcomes - number of participants with inappropriate medications

    36 months

Study Arms (2)

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/practice) to complete surveys prior to the intervention and 18 months later.

Other: Annual Wellness Visit

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/practice) to complete surveys prior to the intervention and 18 months later.

Other: Annual Wellness VisitOther: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

Interventions

Annual Wellness VisitOTHER

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.

Also known as: AWV
Annual Wellness Visits (AWV)Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)OTHER

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/SW 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.

Also known as: GRACE
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 65 years or older
  • Eligible for an AWV (Medicare/Medicare Advantage) during the study period
  • Residential mailing address within a radius of the practice that can be achievably reached via a home visit
  • English or Spanish speaking
  • Be able to provide consent and / or have a proxy able to consent to study participation.
  • Meet criteria for complex health care needs, by virtue of having a Probability of Repeated Admissions (PRA) score of 0.35 or greater AND/OR Kim Syndrome on Aging (efrailty indicator) score of 0.35 or greater
  • Age 18 years or older
  • English or Spanish speaking
  • Be able to provide consent to study participation
  • Be identified by an eligible patient for participation in the study
  • Age 18 years or older
  • English or Spanish speaking
  • Be able to provide consent to study participation
  • Adult health professionals who work at participating ACOs and primary care practice sites (e.g. physicians, advanced practice clinicians, nurses, social workers, clinic staff.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Griffin Health

Derby, Connecticut, 06418, United States

NOT YET RECRUITING

Mass General Brigham

Boston, Massachusetts, 02124, United States

NOT YET RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Baylor Scott & White Health

Temple, Texas, 76508, United States

NOT YET RECRUITING

Related Publications (33)

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  • Practice Transformation. American Medical Association. Accessed December 21, 2022. https://www.ama-assn.org/practice-management/sustainability/practice-transformation

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  • Maslach Burnout Inventory Manual, 4th Edition. ResearchGate. Accessed December 21, 2022. https://www.researchgate.net/project/Maslach-Burnout-Inventory-Manual-4th-Edition

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  • Katzan IL, Lapin B. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke. 2018 Jan;49(1):147-154. doi: 10.1161/STROKEAHA.117.018766.

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  • Thornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32. doi: 10.1093/geronb/58.2.s127.

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  • Fralick M, Bartsch E, Ritchie CS, Sacks CA. Estimating the Use of Potentially Inappropriate Medications Among Older Adults in the United States. J Am Geriatr Soc. 2020 Dec;68(12):2927-2930. doi: 10.1111/jgs.16779. Epub 2020 Aug 25.

    PMID: 32841366RESULT

  • Gupta A, Jin G, Reich A, Prigerson HG, Ladin K, Kim D, Ashana DC, Cooper Z, Halpern SD, Weissman JS. Association of Billed Advance Care Planning with End-of-Life Care Intensity for 2017 Medicare Decedents. J Am Geriatr Soc. 2020 Sep;68(9):1947-1953. doi: 10.1111/jgs.16683. Epub 2020 Aug 27.

    PMID: 32853429RESULT

  • Alexandre PK, Hwang S, Roth KB, Gallo JJ, Eaton WW. COSTS OF DEPRESSION FROM CLAIMS DATA FOR MEDICARE RECIPIENTS IN A POPULATION-BASED SAMPLE. J Health Hum Serv Adm. 2016 Summer;39(1):72-94.

    PMID: 27483975RESULT

  • Subramaniam A, Ueno R, Tiruvoipati R, Darvall J, Srikanth V, Bailey M, Pilcher D, Bellomo R. Defining ICD-10 surrogate variables to estimate the modified frailty index: a Delphi-based approach. BMC Geriatr. 2022 May 13;22(1):422. doi: 10.1186/s12877-022-03063-x.

    PMID: 35562684RESULT

  • Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.

    PMID: 29196982RESULT

  • Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

    PMID: 19543809RESULT

  • Living Independently with GRACE Commonwealth Fund. Accessed July 20, 2022. https://www.commonwealthfund.org/publications/case-study/2021/oct/living-independently- grace

    RESULT

  • Butler DE, Frank KI, Counsell SR. The GRACE Model. In: Malone ML, Capezuti EA, Palmer RM, eds. Geriatrics Models of Care: Bringing "Best Practice" to an Aging America. Springer International Publishing; 2015:125-138. doi:10.1007/978-3-319-16068-9_10

    RESULT

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  • PROMIS. Accessed July 20, 2022. https://www.healthmeasures.net/explore-measurement- systems/promis

    RESULT

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  • McNabney MK, Green AR, Burke M, Le ST, Butler D, Chun AK, Elliott DP, Fulton AT, Hyer K, Setters B, Shega JW. Complexities of care: Common components of models of care in geriatrics. J Am Geriatr Soc. 2022 Jul;70(7):1960-1972. doi: 10.1111/jgs.17811. Epub 2022 Apr 29.

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  • High-Need, High-Cost Patients: Who Are They and How Do They Use Health Care? Commonwealth Fund. Accessed September 3, 2019. https://www.commonwealthfund.org/publications/issue-briefs/2016/aug/high-need-high-cost-patients-who-are-they-and-how-do-they-use

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  • Weiss KB. Managing complexity in chronic care: an overview of the VA state-of-the-art (SOTA) conference. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):374-8. doi: 10.1007/s11606-007-0379-x.

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  • Feder JL. Predictive modeling and team care for high-need patients at HealthCare Partners. Health Aff (Millwood). 2011 Mar;30(3):416-8. doi: 10.1377/hlthaff.2011.0080. No abstract available.

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  • Conwell LJ, Cohen JW. Characteristics of Persons with High Medical Expenditures in the U.S. Civilian Noninstitutionalized Population, 2002. Published online 2002:6.

    RESULT

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Christine S Ritchie, MD, MPH

CONTACT

617-726-1382csritchie@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized clinical trial with 2 parallel arms. The investigators will enroll patients with complex care needs in each arm. Other participants studied will include caregivers and clinical team members.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Aging and Serious Illness

Study Record Dates

First Submitted

July 21, 2025

First Posted

September 10, 2025

Study Start

January 6, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available upon request after academic journal publication.
Access Criteria
Access criteria will be determined and confirmed by the corresponding author upon review of the formal data request.

Locations

US(4)