跳至主要内容
临床试验/NCT04489693
NCT04489693招募中不适用

Care in the Comprehensive Care Physician (CCP) Program vs. Care in the Comprehensive Care Community and Culture Program (C4P) vs. Care in the Traditional Care

University of Chicago2 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
2
主要终点
Quarterly hospitalization rate

研究概览

简要总结

This randomized trial is evaluating whether socioeconomically disadvantaged Medicare patients at increased risk of hospitalization experience fewer hospitalization if those patients are offered care in: 1) ACCT, where patients receive care from different physicians in the hospital and the clinic settings and have access to nurse and social worker care coordination services, 2) CCP where patients receive care from one physician in the inpatient and outpatient settings or 3) C4P which adds screening of unmet social needs, community health worker support and arts and culture programming to CCP. The study will determine how these programs affect patient activation and engagement in care, satisfaction with care, general health and mental health, and goal attainment.

详细描述

Health disparities and the health of communities are influenced both by the health care system and by the social context in which people live. Accordingly, interventions that seek to meaningfully reduce disparities should consider patients' medical and social needs. The fragmentation of medical care is one aspect of the health care system that adversely affects health, perhaps particularly for socioeconomically disadvantaged individuals with more limited resources to bridge gaps in care. Indeed, while many care coordination programs have been developed, evidence supporting their effectiveness is quite limited and especially for vulnerable populations. This study will fill important gaps in evidence concerning the effects of 3 diverse care coordination models on hospitalization rates for a socioeconomically disadvantaged population at increased risk of hospitalization that is served by the University of Chicago Medicine (UCM). Secondary outcomes include patient activation and engagement with care, satisfaction with care, general health and mental health and personal goal attainment.

The first model is an example of a commonly implemented class of care coordination models that relies primarily on the use of care coordinators. The specific care coordinator (CC) model that is being studied - the Partners HealthCare Care Management Program (PHCMP) - was initially developed and studied by Partners HealthCare. In PHCMP, "high-risk" patients (defined primarily as ≥2 hospitalizations in the year before enrollment) have access to nurse care coordinators who seek to help manage the patient's care across the continuum. UCM's Medicare Shared Savings Plan Accountable Care Organization has recently implemented a model based on PHCMP that it calls the Ambulatory Care Coordination Team (ACCT). In ACCT, nurses and social workers provide proactive care coordination to "high-risk" patients. CC and ACCT are representative of common care coordination models implemented nationally. The fact that these models typically involve hiring additional staff and increase the number of hand-offs may explain why programs such as these have often failed to produce desired improvements in health outcomes or decreases in utilization.

The second model is a novel care delivery program called the Comprehensive Care Physician (CCP) program. The CCP model seeks to more effectively integrate inpatient and outpatient care for patients at increased risk of hospitalization by offering them care from the same physician in the inpatient and the outpatient settings so that these patients can benefit from the advantages of continuity in the doctor patient relationship. Since 2012, the investigators have developed and tested this model at UCM in a randomized trial funded by the Center for Medicare and Medicaid Innovation comparing CCP to standard care (SC) in which patients receive inpatient and outpatient care from different doctors and do not have access to care coordinators. The investigators enrolled 2,000 patients in this study, of whom ~90% are African American, with a median income of ~$20,000 per year and 1-year mortality rate of 15-20%. The results are striking: care ratings on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures correspond to the 95th percentile nationally for CCP patients vs. the 80th for SC, about 30% of CCP patients have a 1 point improvement in self-rated mental health status (e.g., from good to very good) compared to SC patients, hospitalizations are 20% lower over 1 year follow-up and 26% lower for CCP patients who experienced ≥2 hospitalizations in the year before enrollment. We think the efficacy of this model comes from the deep connection that the CCP team develops with patients, understanding thise patients as individuals and recognizing and beginning to address the deeper social determinants of their health.

The third model, the Comprehensive Care, Community and Culture Program (C4P), builds on the CCP program to better engage patients in their care. C4P was motivated by the finding that ~30% of patients who enrolled in the CCP program did not engage with it despite having expressed interest in the program and that a wide range of social factors might be barriers to their engagement. To better address social determinants of health, C4P builds on CCP by adding 1) systematic screening of 17 domains of unmet social needs, 2) access to a community health worker and 3) access to community-based arts and culture programming. Preliminary findings from a pilot of C4P indicate that unmet social needs are diverse, highly concentrated in a small number of patients and linked to each other, presenting barriers to addressing these needs. However, unmet needs were also found to cluster in ways that suggested actionable strategies to address needs more effectively. Early results suggest that C4P increases patient activation and engagement in care compared to CCP and SC.

While we have rigorously compared CCP to SC and performed a pilot study of C4P, CCP and SC at UCM, we have not compared CCP or C4P to the more commonly-used CC model, nor have we performed an adequately powered study comparing CCP and C4P. The rigorous findings comparing these models that we will generate are sorely needed by patients and health systems to inform choices about care coordination models, and particularly for socioeconomically disadvantaged individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Must have Medicare Part A and Part B
  • Must have been hospitalized once in the past 2 years or be in emergency department at time recruitment is initiated

排除标准

  • 未提供

结局指标

主要结局

Quarterly hospitalization rate

时间窗: Through study completion, with a range of 1 to 4.5 years

Number of hospitalizations per quarter

次要结局

  • Health Outcomes General Health(Through study completion, with a range of 1 to 4.5 years)
  • Quarterly hospitalization rate from all sources(Through study completion, with a range of 1 to 4.5 years)
  • Patient Activation Measure (PAM)(Through study completion, with a range of 1 to 4.5 years)
  • Health Outcomes Mental Health(Through study completion, with a range of 1 to 4.5 years)
  • Goal Attainment(Through study completion, with a range of 1 to 4.5 years)
  • Patient experience(Through study completion, with a range of 1 to 4.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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