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

110 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Geriatric Resources and Assessment for the Care of Elders?

The GRACE model, which involves a team-based approach to care for older adults, has been shown to improve the quality of geriatric care, optimize health and functional status, and prevent long-term nursing home placement. This model includes comprehensive assessments and personalized care plans, which have been effective in managing common geriatric conditions and coordinating care across different providers. ^{1 2 3 4 5}

How is the GRACE-augmented Wellness Visits treatment different from other treatments for healthy aging?

The GRACE-augmented Wellness Visits treatment is unique because it integrates the '4Ms' framework (mentation, medication, mobility, and what matters) into the Medicare Annual Wellness Visit, promoting whole-person care for older adults. This approach is part of an Age-Friendly Health System, which is not typically included in standard wellness visits, making it a more comprehensive and personalized care strategy for healthy aging. ^{3 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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 65 years old or older.

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

I live within 45 miles of Vanderbilt clinics.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The OASIS program: redesigning hospital care for older adults. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

A home-based geriatric assessment, follow-up and health promotion program: design, methods, and baseline findings from a 3-year randomized clinical trial. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating 4Ms Assessment through Medicare Annual Wellness Visits: Comparison of Quality Improvement Strategies in Primary Care Clinics. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Geriatric assessment. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Geriatric Resources for Assessment and Care of Elders (GRACE): a new model of primary care for low-income seniors. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Geriatric Helper: An mHealth Application to Support Comprehensive Geriatric Assessment. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Using informatics to capture older adults' wellness. [2021]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Health and needs assessment of geriatric patients: results of a survey at a teaching hospital in Karachi. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the Wearable Sensor-based Ambient Intelligent Geriatric Management (AmbIGeM) System in Preventing Falls in Older People in Hospitals. [2022]