跳至主要内容
临床试验/NCT06287801
NCT06287801已完成不适用

Supporting Practices In Respecting Elders Phase 1

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年8月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Annual Wellness Visit (Other)

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.

干预措施: Annual Wellness Visit (Other)

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.

干预措施: Geriatric Resources and Assessment for the Care of Elders (Other)

结局指标

主要结局

Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)

时间窗: Within 1 month of intervention and 6 months after intervention

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.

Hospitalizations

时间窗: Up to 12 months prior to intervention vs 6 months after intervention

Rate of inpatient hospitalizations evaluated at the participant level

Net Promotor Score

时间窗: Within 1 month of intervention and 6 months after intervention

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.

次要结局

  • 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's hours spent caregiving.(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 Strain(Within 1 month of intervention and 6 months after intervention)
  • Pilot ACOs Staffing costs(At the completion of the pilot phase)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine S. Ritchie, MD, MPH

Professor of Medicine

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验