Clinical trial NCT06287801: Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1
Official title: Supporting Practices In Respecting Elders Phase 1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Health Care Utilization
Health-Related Behavior
Keywords: high-risk elderly
ACO
Medicare
Annual Wellness Visits (AWV)
Geriatric collaborative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brandeis University
name: Vanderbilt University Medical Center
name: Dartmouth-Hitchcock Medical Center
name: Indiana University
name: Patient-Centered Outcomes Research Institute
First posted: 2024-03-01
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility of a clinical comparative effectiveness trial
Primary purpose: PREVENTION

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. 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.

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 (the investigators will refer to caregivers and care partners interchangeably here, reflecting preferences of our stakeholder reviewers). Clinicians in primary care practices and accountable care organization leaders (ACOs) 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. ACO stakeholders working with us in the development of this proposal seek effective approaches to care for their older adult patients with complex needs and report readiness to engage in collaborative processes to develop alternate care models. Medicare Advantage (or Medicare Part C) is a capitated form of value based care, which is rapidly growing in market share among Medicare beneficiaries.

In 2011, Annual Wellness Visits (AWVs) were introduced as a Medicare Part B benefit on January 1st 2011. AWVs seek to incorporate routine geriatric assessments in primary care practices of older adults' to produce a Personalized Preventive Plan (PPP) to be reviewed with the patient by primary care clinical staff. AWVs have required elements which need to be addressed by a health provider, who then files charges to CMS for the administration of these services. However, there is wide variation in the approach to administration of the AWV (ranging from in-person interviews by physician and non-physician practitioners to completion by the patient or caregiver prior to the visit using self-report questionnaires. While uptake by clinicians has accelerated, uptake is lower for more older adults who face disparities in care due to income, race and ethnicity. In Medicare Shared Savings Program (MSSP) ACOs, 55% of beneficiaries received an AWV in 2021. Yet among adults 75-85 years old who were dually eligible for Medicaid and Medicare, fewer than half (42%) received an AWV (authors' analysis of Institute for Accountable Care Medicare Part B claims). In addition, office-based AWV's are not necessarily oriented to high-need, complex older adults, who warrant more nuanced attention to their living environment and longitudinal care needs. Few interventions have pursued the study of a more robust AWV conducted in patients' homes and linked to clear geriatric care paths in an effort to more effectively navigate the biopsychosocial needs of this aging population.

The Geriatric Resources and Assessment for the Care of Elders (GRACE) Program offers an evidence-based approach to support geriatric assessment and care planning for complex patients receiving AWVs. GRACE is a protocolized interprofessional co-management model that was developed to improve the patient experience of care, provide patients and caregivers with a designated point of contact, reduce utilization costs, and support overburdened primary care providers by co-managing complex patients. The care plan was built collaboratively (including patients and family caregivers) using GRACE Protocols for common geriatric conditions and provides a checklist to ensure a standardized approach to care. GRACE protocols were also developed in partnership with primary care physicians and address 12 common geriatric conditions to support and complement primary care: advance care planning, health maintenance, medication management, difficulty walking/falls, malnutrition/weight loss, visual impairment, hearing loss, dementia, chronic pain, urinary incontinence, depression, caregiver burden. Even though GRACE has been demonstrated in a randomized controlled trial among patients at high risk for hospital to improve quality and decrease cost, GRACE has not been adopted by the majority of ACOs, in contrast to the more common use of AWVs.

Based on our hypothesis that patients with complex needs require annual wellness visits and an integrated program of complex care management (i.e., AWVs + GRACE) to achieve improved health outcomes and a commitment from our proposed study partners to fund additional staff to support AWV + GRACE care delivery, the investigators plan to study the intervention AWVs + GRACE as defined by the following components:

1. The investigators will apply a community-engaged approach and co-design an optimal implementation strategy for effectively delivering structured AWVs vs. AWVs with GRACE-augmented care (AWV GRACE). Stakeholder input from Vanderbilt Health Affiliated Network (VHAN) clinical teams, clinical and community leads and other health system collaborators will inform the formation and operation of implementation support communities, implementation coaching, and technical assistance. This process will guide specific adaptations of these implementation domains for high-need older adults within accountable care organization (ACO) and Medicare Advantage- supported primary care practices.
2. The investigators will assess existing ACO algorithms for identifying older adults with complex needs and determine which criteria are most appropriate for inclusion in the study for screening and enrollment at two primary care practices within the VHAN for a pilot trial to be performed (discussed below). Based on input from our stakeholder working groups, the investigators will build statistical models and referral pathways to more accurately identify high need older adult populations and refine our eligible populations and confirm our sample size requirements.
3. The investigators will determine the feasibility of conducting a clinical comparative effectiveness trial of structured AWV alone vs. AWV + GRACE at two primary care practices within Vanderbilt Health Affiliated Network (VHAN) by conducting a pilot trial. Designated VHAN primary care practices (N=2) will be randomized to the intervention (AWV GRACE) or the control arm (AWV) and practice staff will be trained to deliver the assigned intervention per protocol.

Eligibility criteria: Inclusion Criteria:

1. be 65 years of age or older
2. be eligible for an AWV during the study period
3. have a residential mailing address within a 45-mile radius of the Vanderbilt clinics
4. have a working home/mobile telephone number where they can be reached
5. be English or Spanish speaking
6. be able to provide consent and /or have a proxy able to consent to study participation

Exclusion Criteria:

1. are receiving hospice care
2. are currently housed at Long Term Care Facilities
3. are incarcerated

Primary outcomes:
measure: Hospitalizations
timeFrame: Up to 12 months prior to intervention vs 6 months after intervention
measure: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Net Promotor Score
timeFrame: Within 1 month of intervention and 6 months after intervention
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH)
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Caregiver Strain
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Patient's out-of-pocket costs for up to 180 days after enrollment
timeFrame: Up to 6 months after enrollment
measure: Caregiver's hours spent caregiving.
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Pilot ACOs Staffing costs
timeFrame: At the completion of the pilot phase
Other outcomes:
measure: Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Exploratory Geriatric Outcomes - number of participants with inappropriate medications
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Covariate - Demographics
timeFrame: Within 1 month of intervention
measure: Covariate - Medicare Entitlement Status
timeFrame: Within 1 month of intervention
measure: Covariate - Elixhauser comorbidity index
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Covariate - Area Deprivation Index
timeFrame: Within 1 month of intervention
measure: Covariate - Loneliness
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Exploratory - Hope
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Covariate - Activities of daily living (ADL)
timeFrame: Within 1 month of intervention and 6 months after intervention
measure: Exploratory - ED visits
timeFrame: Up to 12 months prior to intervention vs 6 months after intervention
measure: Exploratory - Observation visits
timeFrame: Up to 12 months prior to intervention vs 6 months after intervention
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
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