AgingSPIRE2NCT07166861
Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2
A study testing Annual Wellness Visit and Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) in people with Aging and Preventive Care, run by Massachusetts General Hospital at 4 sites in United States.
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 18 years and older
- Conditions the study is for
- Aging, Preventive Care, Multimorbidity
- What is being tested?
- Annual Wellness Visit and Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,140 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jan 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- 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
Caregiver Inclusion Criteria:
- 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
Clinician Inclusion Criteria:
- 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.)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Mass General Brigham
Boston, Massachusetts, 02124
Kathryn Corelli, MD, KMCORELLI@MGH.HARVARD.EDU
Mark Stoltenberg, MD, MPH, MSTOLTENBERG@mgh.harvard.edu
- Not yet recruiting
Griffin Health
Derby, Connecticut, 06418
Valentine Njike, MD, MPH, VNjike@Griffinhealth.org
Valentine Njike, MD, MPH
- Not yet recruiting
Baylor Scott & White Health
Temple, Texas, 76508
Micheal McNeal, MD, MSc, Michael.McNeal@BSWHealth.org
Michael McNeal, MD, MSc
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Jennifer Gabbard, MD, jgabbard@wakehealth.edu
Tom Houston, MD, tom.houston@advocatehealth.org
About this study
Official title: Supporting Practices In Respecting Elders Phase 2
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:
- Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
- Develop a referral pathway and algorithm to optimize enrollment of eligible participants
- 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. Clinicians in primary care practices and accountable care organization (ACO) leaders 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.
In 2011, to encourage value-based care, Annual Wellness Visits (AWVs) were introduced as a new Medicare Part B benefit. AWVs, as conceived by Medicare, seek to incorporate routine comprehensive assessment by primary care practices of older adults' geriatric health risks using questionnaire-based assessments completed by the patient or care partner. The goal of an AWV is to produce a Personalized Preventive Plan (PPP) for older adults. While uptake by clinicians has accelerated, uptake is lower for more vulnerable older adults. In Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs), an average of 55% of beneficiaries had an AWV in 2021 vs only 42% for adults 75-85 years old and dually eligible for Medicaid and Medicare.
AWVs have potential value as an organizing tool for patients and families and clinician teams as one time each year that someone looks at all aspects of care including understanding the care team, determining needed screening and preventive care, reviewing needs for assistance with activities of daily living, testing cognition, reviewing medications from multiple providers, and care coordination that can prevent acute episodes and hospitalization. For consistent and predictable impact, AWVs would be conducted systematically using evidence-based tools and structured protocols in response to patient needs elicited in AWVs. Although there is growing evidence that AWVs lead to increased screenings and reduced use of inpatient care, some are concerned that they also lead to increased use of low value testing after a visit. Furthermore, studies suggest that AWVs are underutilized in minoritized and socially vulnerable populations.
An evidence-based approach to support geriatric care planning for complex patients that offers solutions to identified problems that has been tested in primary care is the Geriatric Resources for the Assessment and Care of Elders (GRACE) program. GRACE is a protocolized inter-professional co-management model that was developed to improve the patient experience of care, provide patients and care partners with a designated point of contact in a nurse/social worker team, reduce utilization costs, and supporting overburdened primary care physicians by managing complex patients. The core components of the GRACE model include: 1) an individualized care plan developed by a nursing/social work team based on 2) an initial in-home assessment, 3) structured protocols, and 4) close co-management with the patient's primary care provider, who reviews, provides their input and endorses the plan. The care plan is built using GRACE Protocols for common geriatric conditions and providing a checklist to ensure a standardized approach to care. The care model was developed using extensive feedback from patients and family care partners. The GRACE Support Team designed it as a patient/care partner support system interfacing with the patient's primary care team to implement the care plan. In a randomized, controlled trial, patients at high risk for hospital admission who received GRACE team care versus a 'usual care' control group had decreased acute care utilization and costs with positive return on investment; improved quality of care; increased patient and provider satisfaction; and improved quality of life. However, GRACE has not been adopted by many ACOs and its additional value to the more commonly used AWV has not been established.
The purpose of the Supporting Practices in Respecting Elders (SPIRE) study is to address this gap in knowledge with the overall goal of improving the lives of older adults with complex needs cared for in primary care practices. The study will opportunistically evaluate two primary care programs aimed at improving care in older adults. The AWV is currently standard of care and is being used regularly in primary care clinics. However, AWVs is a "one size fits all" approach and may not be effective or appropriate for older adults with functional limitations and complex care needs and may not adequately meet the wellness needs of a diverse population of older adults. GRACE is an Evidence-based Practice specifically designed for older adults with complex care needs. GRACE was designed to address the health and health care challenges faced by low-income seniors with multiple chronic conditions including a comprehensive in-home assessment performed by a nurse practitioner and social worker (the GRACE Support Team). This in-home physical and social evaluation will build on the self-report AWV screening questions (promoted as the standard by CMS/Medicare) and brings together information learned at the in-home assessment back to an expanded GRACE team, which is led by a geriatrician and includes a pharmacist and mental health liaison (typically a licensed clinical social worker). No complex care delivery model such as GRACE has yet been implemented at scale. To date, health systems appear to find it easier to implement AWVs rather than AWVs augmented by GRACE in their high-need older adult populations. Therefore, a test of the comparative effectiveness of AWVs (usual care) versus AWVs augmented by GRACE will inform health system leaders and clinicians on optimal approaches for high cost, high need older adults with complex health and social needs.
- Conditions
- Aging, Preventive Care, Multimorbidity, Palliative Care
- Being tested
- Annual Wellness Visit, Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)
- Keywords
- annual wellness visit, geriatric collaborative care, complex care needs, geriatric assessment, implementation, comparative effectiveness
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.
Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)Other
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Annual Wellness Visit; Other: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalizations
Count of hospitalizations during the observation period, evaluated at the participant level.
Measured: 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.
Measured: Baseline and 18 months.
Secondary outcomes (4)
Physical health
PROMIS Global PH
Measured: Baseline and 18 months.
Mental health
PROMIS Global MH
Measured: Baseline and 18 months.
Caregiver strain
Modified Caregiver Strain Index
Measured: Baseline and 18 months.
Professional Fulfillment
Professional Fulfillment Index
Measured: Baseline and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start6 Jan 2026
- Primary completion30 Sep 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brandeis University, Indiana University, Dartmouth-Hitchcock Medical Center, Atrium Health Wake Forest Baptist, Griffin Hospital, Patient-Centered Outcomes Research Institute, Baylor Scott and White Health
- Responsible party
- Principal investigator, Christine S. Ritchie, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166861
- Sponsor's protocol ID
- 2025P000230
- Other IDs
- PLACER-2022C3-30604
- Acronym
- SPIRE2
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2025
- Last updated
- 6 Oct 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
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506Measuring hope: Development of the Herth Hope Index. Journal of Nursing Scholarship, 32, 309-315.
Singh GK. Area deprivation and widening inequalities in US mortality, 1969-1998. Am J Public Health. 2003 Jul;93(7):1137-43. doi: 10.2105/ajph.93.7.1137.
PubMed 12835199Kind AJ, Jencks S, Brock J, Yu M, Bartels C, Ehlenbach W, Greenberg C, Smith M. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: a retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74. doi: 10.7326/M13-2946.
PubMed 25437404Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.
PubMed 9431328Practice Transformation. American Medical Association. Accessed December 21, 2022. https://www.ama-assn.org/practice-management/sustainability/practice-transformation
Maslach Burnout Inventory Manual, 4th Edition. ResearchGate. Accessed December 21, 2022. https://www.researchgate.net/project/Maslach-Burnout-Inventory-Manual-4th-Edition
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.
PubMed 29273595Thornton 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.
PubMed 12646602Fralick 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.
PubMed 32841366Gupta 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.
PubMed 32853429Alexandre 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.
PubMed 27483975Subramaniam 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.
PubMed 35562684Trockel 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.
PubMed 29196982Hays 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.
PubMed 19543809
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Practices In Respecting Elders Phase 2
- ClinicalTrials.gov ID
- NCT07166861
- Acronym / sponsor ID
- SPIRE2 / 2025P000230
- Conditions
- Aging, Preventive Care, Multimorbidity, Palliative Care
- Keywords
- annual wellness visit, geriatric collaborative care, complex care needs, geriatric assessment, implementation, comparative effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,140 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brandeis University, Indiana University, Dartmouth-Hitchcock Medical Center, Atrium Health Wake Forest Baptist, Griffin Hospital, Patient-Centered Outcomes Research Institute, Baylor Scott and White Health
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
- Develop a referral pathway and algorithm to optimize enrollment of eligible participants
- Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.
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. Clinicians in primary care practices and accountable care organization (ACO) leaders 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.
In 2011, to encourage value-based care, Annual Wellness Visits (AWVs) were introduced as a new Medicare Part B benefit. AWVs, as conceived by Medicare, seek to incorporate routine comprehensive assessment by primary care practices of older adults' geriatric health risks using questionnaire-based assessments completed by the patient or care partner. The goal of an AWV is to produce a Personalized Preventive Plan (PPP) for older adults. While uptake by clinicians has accelerated, uptake is lower for more vulnerable older adults. In Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs), an average of 55% of beneficiaries had an AWV in 2021 vs only 42% for adults 75-85 years old and dually eligible for Medicaid and Medicare.
AWVs have potential value as an organizing tool for patients and families and clinician teams as one time each year that someone looks at all aspects of care including understanding the care team, determining needed screening and preventive care, reviewing needs for assistance with activities of daily living, testing cognition, reviewing medications from multiple providers, and care coordination that can prevent acute episodes and hospitalization. For consistent and predictable impact, AWVs would be conducted systematically using evidence-based tools and structured protocols in response to patient needs elicited in AWVs. Although there is growing evidence that AWVs lead to increased screenings and reduced use of inpatient care, some are concerned that they also lead to increased use of low value testing after a visit. Furthermore, studies suggest that AWVs are underutilized in minoritized and socially vulnerable populations.
An evidence-based approach to support geriatric care planning for complex patients that offers solutions to identified problems that has been tested in primary care is the Geriatric Resources for the Assessment and Care of Elders (GRACE) program. GRACE is a protocolized inter-professional co-management model that was developed to improve the patient experience of care, provide patients and care partners with a designated point of contact in a nurse/social worker team, reduce utilization costs, and supporting overburdened primary care physicians by managing complex patients. The core components of the GRACE model include: 1) an individualized care plan developed by a nursing/social work team based on 2) an initial in-home assessment, 3) structured protocols, and 4) close co-management with the patient's primary care provider, who reviews, provides their input and endorses the plan. The care plan is built using GRACE Protocols for common geriatric conditions and providing a checklist to ensure a standardized approach to care. The care model was developed using extensive feedback from patients and family care partners. The GRACE Support Team designed it as a patient/care partner support system interfacing with the patient's primary care team to implement the care plan. In a randomized, controlled trial, patients at high risk for hospital admission who received GRACE team care versus a 'usual care' control group had decreased acute care utilization and costs with positive return on investment; improved quality of care; increased patient and provider satisfaction; and improved quality of life. However, GRACE has not been adopted by many ACOs and its additional value to the more commonly used AWV has not been established.
The purpose of the Supporting Practices in Respecting Elders (SPIRE) study is to address this gap in knowledge with the overall goal of improving the lives of older adults with complex needs cared for in primary care practices. The study will opportunistically evaluate two primary care programs aimed at improving care in older adults. The AWV is currently standard of care and is being used regularly in primary care clinics. However, AWVs is a "one size fits all" approach and may not be effective or appropriate for older adults with functional limitations and complex care needs and may not adequately meet the wellness needs of a diverse population of older adults. GRACE is an Evidence-based Practice specifically designed for older adults with complex care needs. GRACE was designed to address the health and health care challenges faced by low-income seniors with multiple chronic conditions including a comprehensive in-home assessment performed by a nurse practitioner and social worker (the GRACE Support Team). This in-home physical and social evaluation will build on the self-report AWV screening questions (promoted as the standard by CMS/Medicare) and brings together information learned at the in-home assessment back to an expanded GRACE team, which is led by a geriatrician and includes a pharmacist and mental health liaison (typically a licensed clinical social worker). No complex care delivery model such as GRACE has yet been implemented at scale. To date, health systems appear to find it easier to implement AWVs rather than AWVs augmented by GRACE in their high-need older adult populations. Therefore, a test of the comparative effectiveness of AWVs (usual care) versus AWVs augmented by GRACE will inform health system leaders and clinicians on optimal approaches for high cost, high need older adults with complex health and social needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Annual Wellness Visits (AWV) | Active comparator | Other: Annual Wellness VisitRandomize 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. |
| Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) | Experimental | Other: Annual Wellness Visit, Other: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annual Wellness VisitAlso: AWVCompletion 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. | Other | 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)Also: GRACEThe 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. | Other | Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) |
Primary outcome
Hospitalizations
Time frame: 12, 18, and 24 months.
Count of hospitalizations during the observation period, evaluated at the participant level.
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)
Time frame: Baseline and 18 months.
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.
4 secondary outcomes
Physical health
Time frame: Baseline and 18 months.
Mental health
Time frame: Baseline and 18 months.
Caregiver strain
Time frame: Baseline and 18 months.
Professional Fulfillment
Time frame: Baseline and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 18504506Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Results publicationMeasuring hope: Development of the Herth Hope Index. Journal of Nursing Scholarship, 32, 309-315.
- Results publication: PubMed 12835199Singh GK. Area deprivation and widening inequalities in US mortality, 1969-1998. Am J Public Health. 2003 Jul;93(7):1137-43. doi: 10.2105/ajph.93.7.1137.
- Results publication: PubMed 25437404Kind AJ, Jencks S, Brock J, Yu M, Bartels C, Ehlenbach W, Greenberg C, Smith M. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: a retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74. doi: 10.7326/M13-2946.
- Results publication: PubMed 9431328Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.
- Results publicationPractice Transformation. American Medical Association. Accessed December 21, 2022. https://www.ama-assn.org/practice-management/sustainability/practice-transformation
- Results publicationMaslach Burnout Inventory Manual, 4th Edition. ResearchGate. Accessed December 21, 2022. https://www.researchgate.net/project/Maslach-Burnout-Inventory-Manual-4th-Edition
- Results publication: PubMed 29273595Katzan 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.
- Results publication: PubMed 12646602Thornton 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.
- Results publication: PubMed 32841366Fralick 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.
- Results publication: PubMed 32853429Gupta 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.
- Results publication: PubMed 27483975Alexandre 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annual Wellness Visit and Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) in people with Aging and Preventive Care, run by Massachusetts General Hospital at 4 sites 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?
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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine S Ritchie, MD, MPH (617-726-1382, csritchie@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalizations (time frame: 12, 18, and 24 months.). The study lists 2 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 NCT07166861, which also lists 33 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 6 Oct 2026.