年度健康访问与宽广的年度健康访问,适用于高需求的老年人 - 第2阶段 (SPIRE2)
尊重长者第2阶段的支持实践
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:
- Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms
- Develop a referral pathway and algorithm to optimize enrollment of eligible participants
- Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.
研究概览
地位
详细说明
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. Clinicians in primary care practices and accountable care organization (ACO) leaders 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.
In 2011, to encourage value-based care, Annual Wellness Visits (AWVs) were introduced as a new Medicare Part B benefit. AWVs, as conceived by Medicare, seek to incorporate routine comprehensive assessment by primary care practices of older adults' geriatric health risks using questionnaire-based assessments completed by the patient or care partner. The goal of an AWV is to produce a Personalized Preventive Plan (PPP) for older adults. While uptake by clinicians has accelerated, uptake is lower for more vulnerable older adults. In Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs), an average of 55% of beneficiaries had an AWV in 2021 vs only 42% for adults 75-85 years old and dually eligible for Medicaid and Medicare.
AWVs have potential value as an organizing tool for patients and families and clinician teams as one time each year that someone looks at all aspects of care including understanding the care team, determining needed screening and preventive care, reviewing needs for assistance with activities of daily living, testing cognition, reviewing medications from multiple providers, and care coordination that can prevent acute episodes and hospitalization. For consistent and predictable impact, AWVs would be conducted systematically using evidence-based tools and structured protocols in response to patient needs elicited in AWVs. Although there is growing evidence that AWVs lead to increased screenings and reduced use of inpatient care, some are concerned that they also lead to increased use of low value testing after a visit. Furthermore, studies suggest that AWVs are underutilized in minoritized and socially vulnerable populations.
An evidence-based approach to support geriatric care planning for complex patients that offers solutions to identified problems that has been tested in primary care is the Geriatric Resources for the Assessment and Care of Elders (GRACE) program. GRACE is a protocolized inter-professional co-management model that was developed to improve the patient experience of care, provide patients and care partners with a designated point of contact in a nurse/social worker team, reduce utilization costs, and supporting overburdened primary care physicians by managing complex patients. The core components of the GRACE model include: 1) an individualized care plan developed by a nursing/social work team based on 2) an initial in-home assessment, 3) structured protocols, and 4) close co-management with the patient's primary care provider, who reviews, provides their input and endorses the plan. The care plan is built using GRACE Protocols for common geriatric conditions and providing a checklist to ensure a standardized approach to care. The care model was developed using extensive feedback from patients and family care partners. The GRACE Support Team designed it as a patient/care partner support system interfacing with the patient's primary care team to implement the care plan. In a randomized, controlled trial, patients at high risk for hospital admission who received GRACE team care versus a 'usual care' control group had decreased acute care utilization and costs with positive return on investment; improved quality of care; increased patient and provider satisfaction; and improved quality of life. However, GRACE has not been adopted by many ACOs and its additional value to the more commonly used AWV has not been established.
The purpose of the Supporting Practices in Respecting Elders (SPIRE) study is to address this gap in knowledge with the overall goal of improving the lives of older adults with complex needs cared for in primary care practices. The study will opportunistically evaluate two primary care programs aimed at improving care in older adults. The AWV is currently standard of care and is being used regularly in primary care clinics. However, AWVs is a "one size fits all" approach and may not be effective or appropriate for older adults with functional limitations and complex care needs and may not adequately meet the wellness needs of a diverse population of older adults. GRACE is an Evidence-based Practice specifically designed for older adults with complex care needs. GRACE was designed to address the health and health care challenges faced by low-income seniors with multiple chronic conditions including a comprehensive in-home assessment performed by a nurse practitioner and social worker (the GRACE Support Team). This in-home physical and social evaluation will build on the self-report AWV screening questions (promoted as the standard by CMS/Medicare) and brings together information learned at the in-home assessment back to an expanded GRACE team, which is led by a geriatrician and includes a pharmacist and mental health liaison (typically a licensed clinical social worker). No complex care delivery model such as GRACE has yet been implemented at scale. To date, health systems appear to find it easier to implement AWVs rather than AWVs augmented by GRACE in their high-need older adult populations. Therefore, a test of the comparative effectiveness of AWVs (usual care) versus AWVs augmented by GRACE will inform health system leaders and clinicians on optimal approaches for high cost, high need older adults with complex health and social needs.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Christine S Ritchie, MD, MPH
- 电话号码:617-726-1382
- 邮箱:csritchie@mgh.harvard.edu
学习地点
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Connecticut
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Derby、Connecticut、美国、06418
- 尚未招聘
- Griffin Health
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接触:
- Valentine Njike, MD, MPH
- 邮箱:VNjike@Griffinhealth.org
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首席研究员:
- Valentine Njike, MD, MPH
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Massachusetts
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Boston、Massachusetts、美国、02124
- 尚未招聘
- Mass General Brigham
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接触:
- Kathryn Corelli, MD
- 邮箱:KMCORELLI@MGH.HARVARD.EDU
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接触:
- Mark Stoltenberg, MD, MPH
- 邮箱:MSTOLTENBERG@mgh.harvard.edu
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首席研究员:
- Kathryn Corelli, MD
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首席研究员:
- Mark Stoltenberg, MD, MPH
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- 招聘中
- Atrium Health Wake Forest Baptist
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接触:
- Jennifer Gabbard, MD
- 邮箱:jgabbard@wakehealth.edu
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接触:
- Tom Houston, MD
- 邮箱:tom.houston@advocatehealth.org
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首席研究员:
- Jennifer Gabbard, MD
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首席研究员:
- Thomas Houston, MD
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Texas
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Temple、Texas、美国、76508
- 尚未招聘
- Baylor Scott & White Health
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接触:
- Micheal McNeal, MD, MSc
- 邮箱:Michael.McNeal@BSWHealth.org
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首席研究员:
- Michael McNeal, MD, MSc
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Patient Inclusion Criteria:
- Age 65 years or older
- Eligible for an AWV (Medicare/Medicare Advantage) during the study period
- Residential mailing address within a radius of the practice that can be achievably reached via a home visit
- English or Spanish speaking
- Be able to provide consent and / or have a proxy able to consent to study participation.
- Meet criteria for complex health care needs, by virtue of having a Probability of Repeated Admissions (PRA) score of 0.35 or greater AND/OR Kim Syndrome on Aging (efrailty indicator) score of 0.35 or greater
Caregiver Inclusion Criteria:
- Age 18 years or older
- English or Spanish speaking
- Be able to provide consent to study participation
- Be identified by an eligible patient for participation in the study
Clinician Inclusion Criteria:
- Age 18 years or older
- English or Spanish speaking
- Be able to provide consent to study participation
- Adult health professionals who work at participating ACOs and primary care practice sites (e.g. physicians, advanced practice clinicians, nurses, social workers, clinic staff.)
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Annual Wellness Visits (AWV)
Randomize 16 practices to AWV and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later. |
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.
其他名称:
|
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实验性的:Annual Wellness Visits + Geriatric Resources and Assessment for the Care of Elders (AWV + GRACE)
Randomize 16 practices to AWV+GRACE and assess impact on the population deemed by study algorithm as high-risk and recruit 90 participants from each practice (n=90/practice) to complete surveys prior to the intervention and 18 months later. |
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.
其他名称:
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.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospitalizations
大体时间:12, 18, and 24 months.
|
Count of hospitalizations during the observation period, evaluated at the participant level. |
12, 18, and 24 months.
|
|
Patient experience: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS)
大体时间:Baseline and 18 months.
|
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. |
Baseline and 18 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical health
大体时间:Baseline and 18 months.
|
PROMIS Global PH |
Baseline and 18 months.
|
|
Mental health
大体时间:Baseline and 18 months.
|
PROMIS Global MH |
Baseline and 18 months.
|
|
Caregiver strain
大体时间:Baseline and 18 months.
|
Modified Caregiver Strain Index |
Baseline and 18 months.
|
|
Professional Fulfillment
大体时间:Baseline and 18 months.
|
Professional Fulfillment Index |
Baseline and 18 months.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes
大体时间:36 months
|
New ICD-10 diagnosis codes in cognitive status, physical function status or mood categories |
36 months
|
|
Exploratory Geriatric Outcomes- number of participants that complete advanced care planning
大体时间:36 months
|
Number of participants with advanced care planning encounters |
36 months
|
|
Exploratory Geriatric Outcomes - number of participants with inappropriate medications
大体时间:36 months
|
Number of participants with Medicare Part D with potentially inappropriate medications |
36 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.
- Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Measuring hope: Development of the Herth Hope Index. Journal of Nursing Scholarship, 32, 309-315.
- Singh GK. Area deprivation and widening inequalities in US mortality, 1969-1998. Am J Public Health. 2003 Jul;93(7):1137-43. doi: 10.2105/ajph.93.7.1137.
- Kind AJ, Jencks S, Brock J, Yu M, Bartels C, Ehlenbach W, Greenberg C, Smith M. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: a retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74. doi: 10.7326/M13-2946.
- Practice Transformation. American Medical Association. Accessed December 21, 2022. https://www.ama-assn.org/practice-management/sustainability/practice-transformation
- Maslach Burnout Inventory Manual, 4th Edition. ResearchGate. Accessed December 21, 2022. https://www.researchgate.net/project/Maslach-Burnout-Inventory-Manual-4th-Edition
- Katzan IL, Lapin B. PROMIS GH (Patient-Reported Outcomes Measurement Information System Global Health) Scale in Stroke: A Validation Study. Stroke. 2018 Jan;49(1):147-154. doi: 10.1161/STROKEAHA.117.018766.
- Thornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32. doi: 10.1093/geronb/58.2.s127.
- Fralick M, Bartsch E, Ritchie CS, Sacks CA. Estimating the Use of Potentially Inappropriate Medications Among Older Adults in the United States. J Am Geriatr Soc. 2020 Dec;68(12):2927-2930. doi: 10.1111/jgs.16779. Epub 2020 Aug 25.
- Gupta A, Jin G, Reich A, Prigerson HG, Ladin K, Kim D, Ashana DC, Cooper Z, Halpern SD, Weissman JS. Association of Billed Advance Care Planning with End-of-Life Care Intensity for 2017 Medicare Decedents. J Am Geriatr Soc. 2020 Sep;68(9):1947-1953. doi: 10.1111/jgs.16683. Epub 2020 Aug 27.
- Alexandre PK, Hwang S, Roth KB, Gallo JJ, Eaton WW. COSTS OF DEPRESSION FROM CLAIMS DATA FOR MEDICARE RECIPIENTS IN A POPULATION-BASED SAMPLE. J Health Hum Serv Adm. 2016 Summer;39(1):72-94.
- Subramaniam A, Ueno R, Tiruvoipati R, Darvall J, Srikanth V, Bailey M, Pilcher D, Bellomo R. Defining ICD-10 surrogate variables to estimate the modified frailty index: a Delphi-based approach. BMC Geriatr. 2022 May 13;22(1):422. doi: 10.1186/s12877-022-03063-x.
- Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
- Living Independently with GRACE Commonwealth Fund. Accessed July 20, 2022. https://www.commonwealthfund.org/publications/case-study/2021/oct/living-independently- grace
- Butler DE, Frank KI, Counsell SR. The GRACE Model. In: Malone ML, Capezuti EA, Palmer RM, eds. Geriatrics Models of Care: Bringing "Best Practice" to an Aging America. Springer International Publishing; 2015:125-138. doi:10.1007/978-3-319-16068-9_10
- Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.
- PROMIS. Accessed July 20, 2022. https://www.healthmeasures.net/explore-measurement- systems/promis
- Bickman L, Riemer M, Kelley SD, et al. Peabody Treatment Progress Battery PTPB 2010. Published online 2010:306
- Scholle SH, Vuong O, Ding L, Fry S, Gallagher P, Brown JA, Hays RD, Cleary PD. Development of and field test results for the CAHPS PCMH Survey. Med Care. 2012 Nov;50 Suppl(Suppl):S2-10. doi: 10.1097/MLR.0b013e3182610aba.
- Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020 Jun 1;49(3):979-995. doi: 10.1093/ije/dyz237.
- Shiny CRT Calculator. https://clusterrcts.shinyapps.io/rshinyapp/
- Accountable Care Organizations (ACOs) CMS. Accessed December 19, 2022. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ACO
- Auerbach DI, Levy DE, Maramaldi P, Dittus RS, Spetz J, Buerhaus PI, Donelan K. Optimal Staffing Models To Care For Frail Older Adults In Primary Care And Geriatrics Practices In The US. Health Aff (Millwood). 2021 Sep;40(9):1368-1376. doi: 10.1377/hlthaff.2021.00401.
- 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.
- 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
- 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.
- 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.
- 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.
- Feder JL. Predictive modeling and team care for high-need patients at HealthCare Partners. Health Aff (Millwood). 2011 Mar;30(3):416-8. doi: 10.1377/hlthaff.2011.0080. No abstract available.
- Conwell LJ, Cohen JW. Characteristics of Persons with High Medical Expenditures in the U.S. Civilian Noninstitutionalized Population, 2002. Published online 2002:6.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2025P000230
- PLACER-2022C3-30604 (其他赠款/资助编号:Patient Centered Outcomes Research Institute)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.
IPD 共享时间框架
The data will become available upon request after academic journal publication.
IPD 共享访问标准
Access criteria will be determined and confirmed by the corresponding author upon review of the formal data request.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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