GRACE-Augmented Wellness Visits for Aging

(SPIRE2 Trial)

Not yet recruiting at 3 trial locations

Overseen By Christine S Ritchie, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) program to regular wellness check-ups can improve health outcomes for older adults with complex health needs. The study tests two approaches: standard wellness visits and enhanced visits with the GRACE model. Researchers aim to determine if the enhanced visits can reduce hospitalizations and improve the lives of patients and caregivers. This trial may suit individuals aged 65 and older who have frequent health issues, are on Medicare, and live close enough to the practice for a home visit. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the GRACE model is safe for older adults?

Research has shown that the GRACE model, used in this study, is generally well-received by older adults. This method supports and manages care for seniors with complex health needs. Studies have found that it helps manage care with few reports of negative effects. The goal is to improve healthcare delivery and reduce unnecessary hospital visits, benefiting patient well-being. Although specific safety data for this study's use of GRACE is limited, its use in similar situations has not raised major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GRACE-Augmented Wellness Visits for Aging because it aims to enhance the standard Annual Wellness Visits by incorporating Geriatric Resources and Assessment for the Care of Elders (GRACE). Unlike typical wellness visits that primarily focus on general health assessments, the GRACE model brings a more comprehensive approach by addressing the specific needs of older adults, particularly those at high risk. This involves a tailored plan that includes coordinated care and personalized interventions to better manage health conditions and improve quality of life. By integrating GRACE, there's potential for more effective management of complex geriatric issues, which could lead to better health outcomes for aging populations.

What evidence suggests that the AWV and AWV + GRACE interventions could be effective for improving outcomes in older adults with complex health needs?

Research has shown that the GRACE model, included in one of the treatment arms of this trial, can enhance care for older adults, particularly those with complex health needs. Studies have found that it improves the quality of care and health outcomes for low-income seniors. It manages care for patients with high needs while reducing healthcare costs over time. Some research suggests that the GRACE model is cost-neutral, meaning it does not add extra costs while improving care. Overall, the GRACE model has been linked to better care and increased independence for seniors. In this trial, participants will receive either Annual Wellness Visits (AWV) alone or AWV combined with the GRACE model to assess its impact. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for older adults with complex health needs who could benefit from preventive and palliative care. It aims to improve their well-being and reduce hospital visits. Participants should be eligible for Annual Wellness Visits (AWVs) but cannot already be receiving GRACE services.

Inclusion Criteria

Clinicians must be able to provide consent to study participation

Patients must be eligible for an AWV (Medicare/Medicare Advantage) during the study period

Patients must have a residential mailing address within a radius of the practice that can be achievably reached via a home visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Annual Wellness Visits (AWV) or AWV augmented by GRACE intervention

18 months

Annual visits with additional in-home assessments for GRACE group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Monitoring of exploratory geriatric outcomes and hospitalizations

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Resources and Assessment for the Care of Elders

Trial Overview The study compares regular AWVs with AWVs enhanced by the GRACE model, which adds geriatric resources and assessments. The goal is to see if this combination can better support high-need older adults.

How Is the Trial Designed?

Group I: Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE) Experimental Treatment 2 Interventions

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.

Group II: Annual Wellness Visits (AWV) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Indiana University School of Medicine

Collaborator

Trials

194

Recruited

181,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Baylor Scott and White Health

Collaborator

Trials

18

Recruited

61,200+

Griffin Hospital

Collaborator

Trials

25

Recruited

1,500+

Brandeis University

Collaborator

Trials

22

Recruited

14,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Atrium Health Wake Forest Baptist

Collaborator

Trials

3

Recruited

250+

Atrium Health Wake Forest Baptist

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10087268/

Effectiveness of the VA‐Geriatric Resources for Assessment ... We compared outcomes among patients who received VA‐GRACE services after discharge and a control group of Veterans who were potentially ...

2. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/j.1532-5415.2006.00791.x

Geriatric Resources for Assessment and Care of Elders ... The Geriatric Resources for Assessment and Care of Elders (GRACE) model of primary care was developed to improve the quality of care for low- ...

3. commonwealthfund.org commonwealthfund.org/publications/case-study/2021/oct/living-independently-grace

Living Independently with GRACE The GRACE model helps primary care practices provide geriatric care management for high-need, high-cost patients while reducing costs over time.

4. datasharescc.org datasharescc.org/promisepractice/index/view?pid=30483

Geriatric Resources for Assessment and Care of Elders ... The GRACE model has been shown to improve quality of care and health outcomes in low-income seniors. It has also recently been shown to be cost neutral from the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16866688/

a new model of primary care for low-income seniors - PubMed The Geriatric Resources for Assessment and Care of Elders (GRACE) model of primary care for low-income seniors and their primary care physicians (PCPs)

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06287801

Study Details | NCT06287801 | Annual Wellness Visits vs ... 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 ...