GRACE-augmented Wellness Visits for Healthy Aging

(SPIRE1 Trial)

Overseen By Christine Ritchie, MD, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Hospice care, Long term care, Incarceration

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding the GRACE (Geriatric Resources and Assessment for the Care of Elders) model to regular Annual Wellness Visits benefits older adults with complex health needs. Researchers seek to find out if this approach improves health and reduces hospital visits. Participants will be divided into two groups: one will receive only the wellness visits, while the other will receive the visits plus the GRACE care model. This trial suits individuals aged 65 or older who live near Vanderbilt clinics and can attend wellness visits. As an unphased trial, it offers participants a unique opportunity to contribute to innovative healthcare solutions 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.

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

Research has shown that the GRACE model, which stands for Geriatric Resources and Assessment for the Care of Elders, has been well-received. This program provides detailed check-ups and care for older adults at high risk. Previous use of GRACE improved the quality of care and health outcomes for seniors, especially those with complex health issues. No major reports of negative effects have emerged from using the GRACE model in these situations. This suggests that adding GRACE to Annual Wellness Visits is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GRACE-augmented Wellness Visits because they offer a fresh approach to promoting healthy aging. Unlike typical wellness check-ups that focus mainly on immediate health assessments, this protocol integrates Geriatric Resources and Assessment for the Care of Elders (GRACE) into annual visits. This approach emphasizes personalized care plans tailored to high-risk individuals, aiming to enhance their long-term health outcomes. By combining comprehensive assessments with targeted geriatric resources, this method seeks to provide a more holistic view of aging health, potentially improving the quality of life for older adults.

What evidence suggests that the GRACE model is effective for improving outcomes in older adults with complex health needs?

Research shows that the GRACE model, which stands for Geriatric Resources and Assessment for the Care of Elders, improves the quality of care and health for older adults. Studies have found that GRACE enhances health, reduces unnecessary doctor visits, and prevents long-term stays in nursing homes. It has proven especially helpful for low-income seniors, improving the quality of care they receive and managing costs over time. In this trial, one group of participants will receive Annual Wellness Visits (AWV) alone, while another group will receive AWV combined with the GRACE model. The GRACE model also aids primary care doctors in managing the care of patients who need significant attention and resources. Overall, GRACE has successfully boosted the health and independence of older adults, making it a valuable addition to their yearly wellness check-ups. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above who are eligible for an Annual Wellness Visit during the study period. They must live within a 45-mile radius of Vanderbilt clinics, have a working phone, and speak English or Spanish. Participants need to consent themselves or have a proxy who can.

Inclusion Criteria

I am eligible for an Annual Wellness Visit during the study.

I live within 45 miles of Vanderbilt clinics.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either Annual Wellness Visits (AWV) or AWV + GRACE intervention

6 months

Initial visit and follow-up surveys

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

Surveys and assessments at 1 month and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Resources and Assessment for the Care of Elders

Trial Overview The study is testing if adding the GRACE model to Annual Wellness Visits helps improve outcomes and reduce hospital visits in seniors with complex health needs. It involves co-designing implementation strategies, developing referral pathways, and conducting a pilot trial.

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

Randomized 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.

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

Randomized 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Brandeis University

Collaborator

Trials

22

Recruited

14,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

A pilot project in an assisted living facility is using various technologies, such as telehealth and cognitive assessment software, to assess multiple aspects of wellness in older adults over an eight-week period.

Preliminary results show that older adults are open to using technology for wellness assessments when provided with proper training, suggesting that informatics can enhance healthcare and support holistic wellness evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using informatics to capture older adults' wellness. Demiris, G., Thompson, HJ., Reeder, B., et al.[2021]

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 goal of the GRACE model is to optimize health and functional status, decrease excess healthcare use, and prevent long-term nursing home ...

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)