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Healthy AgingSPIRE1NCT06287801

Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1

A study testing Annual Wellness Visit and Geriatric Resources and Assessment for the Care of Elders in people with Healthy Aging and Health Care Utilization, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Annual Wellness Visit and Geriatric Resources and Assessment for the Care of Elders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
29 Aug 2024to 18 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • be 65 years of age or older
  • be eligible for an AWV during the study period
  • have a residential mailing address within a 45-mile radius of the Vanderbilt clinics
  • have a working home/mobile telephone number where they can be reached
  • be English or Spanish speaking
  • be able to provide consent and /or have a proxy able to consent to study participation

Who cannot join

  • are receiving hospice care
  • are currently housed at Long Term Care Facilities
  • are incarcerated

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Supporting Practices In Respecting Elders Phase 1

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.
Read the detailed description

In the United States, 10% of patients account for half of health care costs. Many of these are older adults with complex health and social care needs (referred to as "older adults with complex needs"). They see a doctor on average 9.6 times per year, 3 times more often than older adults overall. Patients, caregivers/care partners experience care as confusing and disorganized (the investigators will refer to caregivers and care partners interchangeably here, reflecting preferences of our stakeholder reviewers). Clinicians in primary care practices and accountable care organization leaders (ACOs) face critical dilemmas about how best to care for older adults with complex needs. Patient stakeholders providing feedback on preferred care models worry about fragmented care. Many also prefer to be at home.

Evidence suggests that optimal care of older adults with complex needs involves an interprofessional team of doctors, nurses, social workers and other health care staff in partnership with patients and care partners to provide person-centered care plans, guided by evidence-based geriatric assessments. Few primary care practices provide this type of care, but Medicare ACOs and other value-based care models such as Medicare Advantage plans are well positioned to link clinicians and provide support for complex patients, their caregivers and care partners. ACOs are groups of clinicians, often housed in healthcare systems, who share in savings if they deliver high-quality care. Unlike traditional fee-for-service payment arrangements, the payment models in ACOs reward efficient, patient centered care that also minimizes unhelpful (and sometimes harmful) institutional care. ACOs are eager to optimize effective care for their patients with complex needs, but best strategies are unknown. ACO stakeholders working with us in the development of this proposal seek effective approaches to care for their older adult patients with complex needs and report readiness to engage in collaborative processes to develop alternate care models. Medicare Advantage (or Medicare Part C) is a capitated form of value based care, which is rapidly growing in market share among Medicare beneficiaries.

In 2011, Annual Wellness Visits (AWVs) were introduced as a Medicare Part B benefit on January 1st 2011. AWVs seek to incorporate routine geriatric assessments in primary care practices of older adults' to produce a Personalized Preventive Plan (PPP) to be reviewed with the patient by primary care clinical staff. AWVs have required elements which need to be addressed by a health provider, who then files charges to CMS for the administration of these services. However, there is wide variation in the approach to administration of the AWV (ranging from in-person interviews by physician and non-physician practitioners to completion by the patient or caregiver prior to the visit using self-report questionnaires. While uptake by clinicians has accelerated, uptake is lower for more older adults who face disparities in care due to income, race and ethnicity. In Medicare Shared Savings Program (MSSP) ACOs, 55% of beneficiaries received an AWV in 2021. Yet among adults 75-85 years old who were dually eligible for Medicaid and Medicare, fewer than half (42%) received an AWV (authors' analysis of Institute for Accountable Care Medicare Part B claims). In addition, office-based AWV's are not necessarily oriented to high-need, complex older adults, who warrant more nuanced attention to their living environment and longitudinal care needs. Few interventions have pursued the study of a more robust AWV conducted in patients' homes and linked to clear geriatric care paths in an effort to more effectively navigate the biopsychosocial needs of this aging population.

The Geriatric Resources and Assessment for the Care of Elders (GRACE) Program offers an evidence-based approach to support geriatric assessment and care planning for complex patients receiving AWVs. GRACE is a protocolized interprofessional co-management model that was developed to improve the patient experience of care, provide patients and caregivers with a designated point of contact, reduce utilization costs, and support overburdened primary care providers by co-managing complex patients. The care plan was built collaboratively (including patients and family caregivers) using GRACE Protocols for common geriatric conditions and provides a checklist to ensure a standardized approach to care. GRACE protocols were also developed in partnership with primary care physicians and address 12 common geriatric conditions to support and complement primary care: advance care planning, health maintenance, medication management, difficulty walking/falls, malnutrition/weight loss, visual impairment, hearing loss, dementia, chronic pain, urinary incontinence, depression, caregiver burden. Even though GRACE has been demonstrated in a randomized controlled trial among patients at high risk for hospital to improve quality and decrease cost, GRACE has not been adopted by the majority of ACOs, in contrast to the more common use of AWVs.

Based on our hypothesis that patients with complex needs require annual wellness visits and an integrated program of complex care management (i.e., AWVs + GRACE) to achieve improved health outcomes and a commitment from our proposed study partners to fund additional staff to support AWV + GRACE care delivery, the investigators plan to study the intervention AWVs + GRACE as defined by the following components:

  1. The investigators will apply a community-engaged approach and co-design an optimal implementation strategy for effectively delivering structured AWVs vs. AWVs with GRACE-augmented care (AWV GRACE). Stakeholder input from Vanderbilt Health Affiliated Network (VHAN) clinical teams, clinical and community leads and other health system collaborators will inform the formation and operation of implementation support communities, implementation coaching, and technical assistance. This process will guide specific adaptations of these implementation domains for high-need older adults within accountable care organization (ACO) and Medicare Advantage- supported primary care practices.
  2. The investigators will assess existing ACO algorithms for identifying older adults with complex needs and determine which criteria are most appropriate for inclusion in the study for screening and enrollment at two primary care practices within the VHAN for a pilot trial to be performed (discussed below). Based on input from our stakeholder working groups, the investigators will build statistical models and referral pathways to more accurately identify high need older adult populations and refine our eligible populations and confirm our sample size requirements.
  3. The investigators will determine the feasibility of conducting a clinical comparative effectiveness trial of structured AWV alone vs. AWV + GRACE at two primary care practices within Vanderbilt Health Affiliated Network (VHAN) by conducting a pilot trial. Designated VHAN primary care practices (N=2) will be randomized to the intervention (AWV GRACE) or the control arm (AWV) and practice staff will be trained to deliver the assigned intervention per protocol.
Being tested
Annual Wellness Visit, Geriatric Resources and Assessment for the Care of Elders
Keywords
high-risk elderly, ACO, Medicare, Annual Wellness Visits (AWV), Geriatric collaborative care
Medical subject headings
Patient Acceptance of Health Care, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Annual Wellness VisitOther

    Also called AWV

    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.

  • Geriatric Resources and Assessment for the Care of EldersOther

    Also called GRACE

    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.

Study groups in NCT06287801
Study groupRoleWhat they receive
Annual Wellness Visits (AWV)ExperimentalRandomized Vanderbilt Health Affiliated Network (VHAN) practice to AWV and assess impact on the population deemed by study algorithm as high-risk and recruit 50 participants from the VHAN primary care clinical practice (n=50/practice) to complete surveys prior to the intervention and 6 months later.
Receives: Other: Annual Wellness Visit
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)ExperimentalRandomized Vanderbilt Health Affiliated Network (VHAN) practice to AWV + GRACE and assess impact on the population deemed by study algorithm as high-risk and recruit 50 participants from the VHAN primary care clinical practice (n=50/practice) to complete surveys prior to the intervention and 6 months later.
Receives: Other: Annual Wellness Visit; Other: Geriatric Resources and Assessment for the Care of Elders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalizations

    Rate of inpatient hospitalizations evaluated at the participant level

    Measured: Up to 12 months prior to intervention vs 6 months after intervention

  2. 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.

    Measured: Within 1 month of intervention and 6 months after intervention

  3. Net Promotor Score

    The single question - "How likely are you to recommend X to a friend [or colleague]?" is rated from 0 - Not at all likely to 10 - Extremely likely.

    Measured: Within 1 month of intervention and 6 months after intervention

Secondary outcomes (5)
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH)

    These measures are derived from 10 items covering self-reported assessment of physical health, physical functioning, pain intensity, fatigue, overall quality of life, mental health, satisfaction with social activities, and emotional problems. Items are scored on a 1-5 Likert scale.

    Measured: Within 1 month of intervention and 6 months after intervention

  2. Caregiver Strain

    We will use the Modified Caregiver Strain Questionnaire-Short Form developed originally by Bickman and revalidated for use with caregivers of older adults to assess the subjective and objective burden of care-giving. The tool asks about events (financial stress) or feelings (guilt) as a result of caring for a family member with chronic health problems.

    There are 13 items, each item is scored from 0 to 2 (0=no, 1=yes, sometimes, and 2=yes, on a regular basis), and total scores can range from 0 to 26. Any positive response may indicate a need for intervention in that area. Higher scores on the MCSI indicate greater caregiver strain; a score of 7 or higher indicates a high level of stress

    Measured: Within 1 month of intervention and 6 months after intervention

  3. Patient's out-of-pocket costs for up to 180 days after enrollment

    Within Medicare, out-of-pocket costs can vary depending on things like the length of an inpatient stay or the choice to administer a drug at home versus in the hospital. As a result, we will assess patient out of pocket costs for the two study arms using Medicare claims data. These data include details on all copayment and deductible paid by Medicare beneficiaries.

    Measured: Up to 6 months after enrollment

  4. Caregiver's hours spent caregiving.

    As care shifts from institutional to home and community-based settings, one potential unintended consequence is increased caregiver burden. Although we are already assessing caregiver strain, a measure of psychological distress, we will add a focused assessment of the amount of time dedicated to caregiving. These data will be collected via survey

    Measured: Within 1 month of intervention and 6 months after intervention

  5. Pilot ACOs Staffing costs

    To assess this, we will ask each participating ACO to complete an annual costing worksheet that has been developed by the Institute for Accountable Care as part of a return-on-investment tool commonly shared with ACOs.

    Measured: At the completion of the pilot phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start29 Aug 2024
  3. Primary completion18 Jul 2025
  4. Study completion18 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility of a clinical comparative effectiveness trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287801
Sponsor's protocol ID
2024P000271
Acronym
SPIRE1
Status last verified
May 2025
First submitted
13 Feb 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

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

  • 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.

    PubMed 21383355
  • 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.

    PubMed 18026804
  • Grant RW, Ashburner JM, Hong CS, Chang Y, Barry MJ, Atlas SJ. Defining patient complexity from the primary care physician's perspective: a cohort study. Ann Intern Med. 2011 Dec 20;155(12):797-804. doi: 10.7326/0003-4819-155-12-201112200-00001.

    PubMed 22184686
  • 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

  • Shafir A, Garrigues SK, Schenker Y, Leff B, Neil J, Ritchie C. Homebound Patient and Caregiver Perceptions of Quality of Care in Home-Based Primary Care: A Qualitative Study. J Am Geriatr Soc. 2016 Aug;64(8):1622-7. doi: 10.1111/jgs.14244. Epub 2016 Jul 7.

    PubMed 27384919
  • Sayer C. "Time Spent at Home" - A Patient-Defined Outcome. NEJM Catalyst. Published online April 26, 2016. Accessed December 21, 2022. https://catalyst.nejm.org/doi/abs/10.1056/CAT.16.0854

  • 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.

    PubMed 35485287
  • Auerbach DI, Levy DE, Maramaldi P, Dittus RS, Spetz J, Buerhaus PI, Donelan K. Optimal Staffing Models To Care For Frail Older Adults In Primary Care And Geriatrics Practices In The US. Health Aff (Millwood). 2021 Sep;40(9):1368-1376. doi: 10.1377/hlthaff.2021.00401.

    PubMed 34495726
  • Accountable Care Organizations (ACOs) | CMS. Accessed December 19, 2022. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ACO

  • Fraze TK, Beidler LB, Briggs ADM, Colla CH. Translating Evidence into Practice: ACOs' Use of Care Plans for Patients with Complex Health Needs. J Gen Intern Med. 2021 Jan;36(1):147-153. doi: 10.1007/s11606-020-06122-4. Epub 2020 Oct 1.

    PubMed 33006083
  • Ochieng N, Damico A, 2023. Medicare Advantage in 2023: Enrollment Update and Key Trends. KFF. Published August 9, 2023. Accessed August 17, 2023. https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2023-enrollment-update-and-key-trends/

  • MLN6775421 - Medicare Wellness Visits. Accessed December 21, 2022. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html

  • Huang H, Zhu X, Wehby GL. Primary care physicians' participation in the Medicare shared savings program and preventive services delivery: Evidence from the first 7 years. Health Serv Res. 2022 Oct;57(5):1182-1190. doi: 10.1111/1475-6773.14030. Epub 2022 Jul 18.

    PubMed 35808929
  • Lind KE, Hildreth KL, Perraillon MC. Persistent Disparities in Medicare's Annual Wellness Visit Utilization. Med Care. 2019 Dec;57(12):984-989. doi: 10.1097/MLR.0000000000001229.

    PubMed 31584462

Questions about this trial

What is this clinical trial studying?

A study testing Annual Wellness Visit and Geriatric Resources and Assessment for the Care of Elders in people with Healthy Aging and Health Care Utilization, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalizations (time frame: Up to 12 months prior to intervention vs 6 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06287801, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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