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

NCT06287801 | Completed DMC

• 1 other identifier: 2024P000271
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. The objectives are to:

1. 1.Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
2. 2.Develop a referral pathway and algorithm to optimize enrollment of eligible participants
3. 3.Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.

Conditions

Healthy Aging; Health Care Utilization; Health-Related Behavior

Keywords

high-risk elderly; ACO; Medicare; Annual Wellness Visits (AWV); Geriatric collaborative care

Outcome Measures

Primary Outcomes (3)

• Hospitalizations

  Rate of inpatient hospitalizations evaluated at the participant level

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

• 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.

  Within 1 month of intervention and 6 months after intervention

• 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.

  Within 1 month of intervention and 6 months after intervention

Secondary Outcomes (5)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH)

  Within 1 month of intervention and 6 months after intervention

• Caregiver Strain

  Within 1 month of intervention and 6 months after intervention

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

  Up to 6 months after enrollment

• Caregiver's hours spent caregiving.

  Within 1 month of intervention and 6 months after intervention

• Pilot ACOs Staffing costs

  At the completion of the pilot phase

Other Outcomes (12)

• Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes

  Within 1 month of intervention and 6 months after intervention

• Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents

  Within 1 month of intervention and 6 months after intervention

• Exploratory Geriatric Outcomes - number of participants with inappropriate medications

  Within 1 month of intervention and 6 months after intervention

Study Arms (2)

Annual Wellness Visits (AWV)

EXPERIMENTAL

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.

Other: Annual Wellness Visit

Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

EXPERIMENTAL

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.

Other: Annual Wellness Visit; Other: Geriatric Resources and Assessment for the Care of Elders

Interventions

Annual Wellness Visit OTHER

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.

Also known as: AWV

Annual Wellness Visits (AWV); Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

Geriatric Resources and Assessment for the Care of Elders OTHER

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.

Also known as: GRACE

Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brandeis University: collaborator
• Vanderbilt University Medical Center: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Indiana University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (23)

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• 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

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  BACKGROUND

• 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

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  PMID: 35808929 BACKGROUND

• 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.

  PMID: 31584462 BACKGROUND

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  PMID: 30875175 BACKGROUND

• Counsell SR, Callahan CM, Buttar AB, Clark DO, Frank KI. Geriatric Resources for Assessment and Care of Elders (GRACE): a new model of primary care for low-income seniors. J Am Geriatr Soc. 2006 Jul;54(7):1136-41. doi: 10.1111/j.1532-5415.2006.00791.x.

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  PMID: 8340558 BACKGROUND

• Travison TG, Pham E, Donelan K, Bartels SJ, Carter JA, Corelli K, Counsell SR, Crean M, Flaherty E, Michael C, Moran DS, Murff HJ, Perloff J, Ritchie CS. Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study. Contemp Clin Trials. 2025 Dec;159:108072. doi: 10.1016/j.cct.2025.108072. Epub 2025 Sep 2.

  PMID: 40907942 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care; Health Behavior

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Feasibility of a clinical comparative effectiveness trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 1, 2024
• Study Start: August 29, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: January 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available upon request after academic journal publication.
• Access Criteria: Access criteria will be determined and confirmed by the corresponding author upon review of the formal data request.

Locations

US (1)