Annual Wellness Visits versus GRACE-augmented Annual Wellness Visits for Older Adults with High Needs

Older adults with complex medical and functional conditions experience considerable difficulty getting the patient-centered and coordinated services they need, due to a fragmented care delivery system and numerous structural barriers that limit access to care. The result is poor health outcomes and high use of emergency, hospital and institution-based long-term care. These challenges create substantial stress for patients and caregivers. Patients, caregivers, clinicians, primary care practices and accountable care organizations (ACOs) face critical dilemmas about how best to care for older adults with these complex healthcare needs, especially in a primary care setting. 

The primary study question is whether adding an interprofessional care delivery model that starts with an in-home visit, the Geriatric Resources for the Assessment and Care of Elders (GRACE), to structured Annual Wellness Visits (AWVs) improves patient and caregiver outcomes and reduces unwanted hospitalizations. This arm of the study will be known as AWV GRACE. 

The study aims are broken up into two phases of the project: 

PHASE 1: Phase 1 will be the planning and feasibility phase. 

• AIM 1.1: In the planning and testing phase, the study team will make sure they have a good way of identifying older adults who would benefit most from the study, and will work with patients, caregivers, primary care practices and health systems to develop the best way to implement the study in Phase 2. 
• AIM 1.2: Based on input from stakeholder groups, the study team will build statistical models and referral pathways to more accurately identify older adult populations with high healthcare needs, refine eligible populations and confirm sample size requirements. 
• AIM 1.3: The study team will conduct a pilot clinical trial in one health system, training two primary care teams in AWV or AWV GRACE, to establish feasibility and refine the study approach. 

PHASE 2: Phase 2 is the full-scale study phase. 

• AIM 2.1: The study team will conduct a multi-site clinical trial in 32 primary care practices that compares the value of AWV GRACE in primary care practices versus AWVs alone on healthcare utilization. 
• AIM 2.2: The study team will assess the comparative benefit of AWV vs. AWV GRACE on patient, clinician and care delivery outcomes at 18 months. 

Who can use the results from this study and how?
Primary care practices, health systems and payers can use this information to make decisions on how best to support primary care practices to care for older adults with complex care needs. Patients and caregivers can use this information to make decisions about primary care practices and choose practices and health systems who, based on the findings of this study, are taking the best care of older adults, especially those with high healthcare needs. 

Who will participate in this study and how they will be recruited?
Older adults ages 65 years and older who have many chronic or serious healthcare conditions and who are at high risk of being hospitalized will be invited by their primary care practices to participate in the study. 

The primary study intervention, called Geriatric Resources for the Assessment and Care of Elders (GRACE), is an interprofessional care delivery model that conducts an initial comprehensive in-home assessment as part of an Annual Wellness Visit by a nursing-social service interprofessional team and based on what is learned supports the development and completion of a thoughtful, structured care plan with the primary care team. This intervention will be compared to Annual Wellness Visits, which will be offered by comparison practices in a structured way. 

The two primary outcomes include hospitalization rates and patient satisfaction at 18 months compared to the start of the intervention. Secondary outcomes will also be measured at the start of the intervention (baseline) and 18 months later and will include patient physical and mental function, caregiver strain and clinician well-being. 

The study’s stakeholders represent the diversity of those impacted by the health needs and care of older adults. The Engagement Core will be guided by four major working groups: 

1. Patient and Caregiver Working Group. 
2. Clinician Stakeholder Working Group. 
3. ACO Health System and Policy Working Group. 
4. Technical Data Working Group. 

Representatives of the four groups will be a part of the study leadership team, attending project meetings and bringing the perspectives of their working group.