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

Healthy Aging Clinical Trial

— SPIRE1  

Official title:

Supporting Practices In Respecting Elders Phase 1

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287801
• Other study ID #: 2024P000271
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Christine Ritchie, MD, MPH
• Phone: 617-726-1382
• Email: csritchie[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Care Utilization
• Healthy Aging

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brandeis University, Dartmouth-Hitchcock Medical Center, Indiana University, Patient-Centered Outcomes Research Institute, Vanderbilt University Medical Center

References & Publications (22)

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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. — View Citation

Counsell SR, Callahan CM, Clark DO, Tu W, Buttar AB, Stump TE, Ricketts GD. Geriatric care management for low-income seniors: a randomized controlled trial. JAMA. 2007 Dec 12;298(22):2623-33. doi: 10.1001/jama.298.22.2623. — View Citation

Counsell SR, Callahan CM, Tu W, Stump TE, Arling GW. Cost analysis of the Geriatric Resources for Assessment and Care of Elders care management intervention. J Am Geriatr Soc. 2009 Aug;57(8):1420-6. doi: 10.1111/j.1532-5415.2009.02383.x. — View Citation

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Fraze TK, Beidler LB, Briggs ADM, Colla CH. Translating Evidence into Practice: ACOs' Use of Care Plans for Patients with Complex Health Needs. J Gen Intern Med. 2021 Jan;36(1):147-153. doi: 10.1007/s11606-020-06122-4. Epub 2020 Oct 1. — View Citation

Grant RW, Ashburner JM, Hong CS, Chang Y, Barry MJ, Atlas SJ. Defining patient complexity from the primary care physician's perspective: a cohort study. Ann Intern Med. 2011 Dec 20;155(12):797-804. doi: 10.7326/0003-4819-155-12-201112200-00001. Erratum In: Ann Intern Med. 2012 Jul 17;157(2):152. Hong, Clemens C [corrected to Hong, Clemens S]. — View Citation

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

Huang H, Zhu X, Wehby GL. Primary care physicians' participation in the Medicare shared savings program and preventive services delivery: Evidence from the first 7 years. Health Serv Res. 2022 Oct;57(5):1182-1190. doi: 10.1111/1475-6773.14030. Epub 2022 Jul 18. — View Citation

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. — View Citation

McNabney MK, Green AR, Burke M, Le ST, Butler D, Chun AK, Elliott DP, Fulton AT, Hyer K, Setters B, Shega JW. Complexities of care: Common components of models of care in geriatrics. J Am Geriatr Soc. 2022 Jul;70(7):1960-1972. doi: 10.1111/jgs.17811. Epub 2022 Apr 29. — View Citation

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

Ochieng N, Damico A, 2023. Medicare Advantage in 2023: Enrollment Update and Key Trends. KFF. Published August 9, 2023. Accessed August 17, 2023. https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2023-enrollment-update-and-key-trends/

Rodriguez, S, Munevar, D, Delaney, C, Yang, L, Tumlinson, A. Effective Management of High-Risk Medicare Populations. Published online September 2014.

Sayer C. "Time Spent at Home" - A Patient-Defined Outcome. NEJM Catalyst. Published online April 26, 2016. Accessed December 21, 2022. https://catalyst.nejm.org/doi/abs/10.1056/CAT.16.0854

Shafir A, Garrigues SK, Schenker Y, Leff B, Neil J, Ritchie C. Homebound Patient and Caregiver Perceptions of Quality of Care in Home-Based Primary Care: A Qualitative Study. J Am Geriatr Soc. 2016 Aug;64(8):1622-7. doi: 10.1111/jgs.14244. Epub 2016 Jul 7. — View Citation

Weiss KB. Managing complexity in chronic care: an overview of the VA state-of-the-art (SOTA) conference. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):374-8. doi: 10.1007/s11606-007-0379-x. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes	New ICD-10 diagnosis codes in cognitive status, physical function status or mood categories	Within 1 month of intervention and 6 months after intervention
Other	Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents	Completion of health care proxy or advance care planning documents	Within 1 month of intervention and 6 months after intervention
Other	Exploratory Geriatric Outcomes - number of participants with inappropriate medications	Numbers of potentially inappropriate medications	Within 1 month of intervention and 6 months after intervention
Other	Covariate - Demographics	age, sex, race/ethnicity	Within 1 month of intervention
Other	Covariate - Medicare Entitlement Status	Identify patients as Medicare qualifying due to age, non-dual Medicare, dually eligible for Medicaid and Medicare, disabled Medicare, end-stage renal disease Medicare entitlement status	Within 1 month of intervention
Other	Covariate - Elixhauser comorbidity index	The Elixhauser index categorizes 30 morbidities based on the International Classification of Diseases (ICD) codes found in administrative data and is associated with resource use and in-hospital mortality. Each comorbidity category is dichotomous. A weighting algorithm was developed, based on the association between comorbidity and death, in order to produce an overall score for the Elixhauser Index.	Within 1 month of intervention and 6 months after intervention
Other	Covariate - Area Deprivation Index	The ADI is an indicator of structural barriers to health and well-being that uses the Zip+4 code listed for the patient's residence in the Medicare Beneficiary Summary File to link to the census block group with the same Zip+4 area in US Census data. ADI scores are based on Singh's Census indicators weighted by Singh's factor score coefficients for each indicator.	Within 1 month of intervention
Other	Covariate - Loneliness	The University of California, Los Angeles (UCLA) 3-item loneliness scale assess relational connectedness, social connectedness and self-perceived isolation.; The scores for each individual question can be added together to give participants a possible range of scores from 3 to 9. Researchers in the past have grouped people who score 3 - 5 as "not lonely" and people with the score 6 - 9 as "lonely".	Within 1 month of intervention and 6 months after intervention
Other	Exploratory - Hope	The Hearth Hope Index (HHI) measures hope along three dimensions: Temporality and future: This dimension assesses the individual's belief in the future and their ability to set and achieve goals.; Positive readiness and expectancy: This dimension assesses the individual's sense of optimism and their belief in their ability to overcome challenges.; Interconnectedness: This dimension assesses the individual's sense of connection to others and their belief in the power of relationships.; The HHI scale has been shown to be a reliable and valid measure of hope. It has been used in a variety of settings, including clinical practice, research, and education.; The HHI measures various dimensions of hope using a 4-point Likert scale that ranges from 1 (strongly disagree) to 4 (strongly agree) with items #3 and #6 reverse-coded. The scale has one global score that ranges from 12 to 48, as well as single-item scores that range from 1 to 4; higher scores indicate greater hopefulness.	Within 1 month of intervention and 6 months after intervention
Other	Covariate - Activities of daily living (ADL)	Activities of daily living rated on a scale of INDEPENDENT (1), NEED HELP (2), DEPENDENT (3), CANNOT DO (4).	Within 1 month of intervention and 6 months after intervention
Other	Exploratory - ED visits	Rate of emergency department visits that do not result in an inpatient hospitalization evaluated at the participant level	Up to 12 months prior to intervention vs 6 months after intervention
Other	Exploratory - Observation visits	Rate of observation visits that do not result in an inpatient hospitalization evaluated at the participant level	Up to 12 months prior to intervention vs 6 months after intervention
Primary	Hospitalizations	Rate of inpatient hospitalizations evaluated at the participant level	Up to 12 months prior to intervention vs 6 months after intervention
Primary	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
Primary	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	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH)	These measures are derived from 10 items covering self-reported assessment of physical health, physical functioning, pain intensity, fatigue, overall quality of life, mental health, satisfaction with social activities, and emotional problems. Items are scored on a 1-5 Likert scale.	Within 1 month of intervention and 6 months after intervention
Secondary	Caregiver Strain	We will use the Modified Caregiver Strain Questionnaire-Short Form developed originally by Bickman and revalidated for use with caregivers of older adults to assess the subjective and objective burden of care-giving. The tool asks about events (financial stress) or feelings (guilt) as a result of caring for a family member with chronic health problems.; There are 13 items, each item is scored from 0 to 2 (0=no, 1=yes, sometimes, and 2=yes, on a regular basis), and total scores can range from 0 to 26. Any positive response may indicate a need for intervention in that area. Higher scores on the MCSI indicate greater caregiver strain; a score of 7 or higher indicates a high level of stress	Within 1 month of intervention and 6 months after intervention
Secondary	Patient's out-of-pocket costs for up to 180 days after enrollment	Within Medicare, out-of-pocket costs can vary depending on things like the length of an inpatient stay or the choice to administer a drug at home versus in the hospital. As a result, we will assess patient out of pocket costs for the two study arms using Medicare claims data. These data include details on all copayment and deductible paid by Medicare beneficiaries.	Up to 6 months after enrollment
Secondary	Caregiver's hours spent caregiving.	As care shifts from institutional to home and community-based settings, one potential unintended consequence is increased caregiver burden. Although we are already assessing caregiver strain, a measure of psychological distress, we will add a focused assessment of the amount of time dedicated to caregiving. These data will be collected via survey	Within 1 month of intervention and 6 months after intervention
Secondary	Pilot ACOs Staffing costs	To assess this, we will ask each participating ACO to complete an annual costing worksheet that has been developed by the Institute for Accountable Care as part of a return-on-investment tool commonly shared with ACOs.	At the completion of the pilot phase