跳至主要内容
临床试验/NCT04000074
NCT04000074Unknown不适用

The Effect of Administrative Enrollment Into Case Management and Linkage Services on Health Behaviors, Utilization, and Outcomes in a High Risk Population

Contra Costa Health Services2 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60,000
试验地点
2
主要终点
Avoidable In-Patient Visit Rate

研究概览

简要总结

Contra Costa Health System's WPC Pilot Program, titled Community Connect (CMCT), delivers case management and linkage services to high-risk Medi-Cal members in Contra Costa County, California. This program is funded under the CMS/DHCS 1115 Waiver Whole Person Care (WPC) Pilot Program through 2020. High-risk individuals from the population of Contra Costa County full-scope Medi-Cal enrollees are connected with a case manager who provides linkage services to address their social determinants of health.

Program capacity is below the eligible population, so a tiered randomization strategy is used to identify enrollees and similarly risky controls (who are eligible for enrollment at later intervals). Health behaviors of enrollees and controls are tracked via electronic health records, billing claims, and other social service administrative databases to create a detailed record of post-randomization health behavior. The primary outcome of interest is avoidable utilization of emergency room and in-patient services.

详细描述

Program Description:

The goal of this proposal is to evaluate the effectiveness of a social needs case management program targeting a population of high-utilizers of multiple systems in Contra Costa County, primarily its health delivery system. The program to be evaluated through this study is funded through 2020 under the CMS/DHCS 1115 Waiver Whole Person Care (WPC) Pilot Program. Contra Costa Health System's WPC Pilot Program, titled Community Connect (CMCT), is implemented administratively for enrollment. High-risk individuals, 18 years of age or older, are identified from Contra Costa County full-scope Medi-Cal enrollees as preliminarily eligible for enrollment. A predictive-modeling algorithm is applied to this population to identify the members of the population at high risk for future avoidable emergency room (ED) visits and inpatient (IP) admissions. These highest risk individuals are then randomized to an administrative enrollment or a control groups. The enrolled program participants are then contacted by program staff for consent to participate in the program for services. They can decline services at that contact and then would remain in the intended to treat population that declined services at initiation. The primary hypothesis is that delivery of a social needs case management intervention will reduce avoidable ED and IP utilization among the target population.

High-risk individuals are identified for enrollment using a population health predictive-risk model. This model integrates variables from a number of Contra Costa Health Services databases, including the electronic health record used by all in-network providers and claims detailing all out-of-network utilization. This predictive-risk model has been continuously updated throughout the study to include more relevant features and change the model form. Diagnosis-based algorithms are used to determine the 'avoidability' of a given emergency room or in-patient visit.

Individuals enrolled in this program are cared for within the context of a multi-disciplinary care team that frequently consult with each other and seek consultation around specific expertise within context of social needs case management. After enrollment, patients are assigned to either a face-to-face visit case manager (Tier I) or to a telephonic case manager (Tier II) depending on the severity of their risk within the predictive risk model and other variables including program capacity. Tier enrollment counts have varied across time; currently the program is designed to enroll 5,977 patients simultaneously in Tier I care and 6,605 patients in Tier II care. Program design began in 2016, the first patients were enrolled in April 2017, and the program is projected to reached full staffing capacity in August 2018. New patients are added to the program rolls on a monthly basis as staffing capacity increases and to replace program dis-enrollments. Starting in September 2017, enrolled patients were matched with controls identified from the population with similar risk profiles. Controls were initially recruited at a 1:1 ratio with cases; this ratio was increased to 2:1 as of January 2018.

Currently a pool of the top 12,000 high-risk individuals in the population (as defined by the risk model) are eligible for Tier I care while the pool of those ranked 12,001 to 25,000 are eligible for Tier II care. Each month, open spaces in each Tier are filled with randomly chosen patients from the eligible pools, and twice as many matching controls from the same pool are identified simultaneously. All non-enrolled pool members, regardless of control status, are then returned to the eligible pool for enrollment the next month. The CMCT program lasts one year, providing that the patient is amenable to the case management relationship. At initial enrollment, every program participant is asked to answer a quality of life questionnaire and a social needs questionnaire. The quality of life questionnaire is repeated on an annual basis. The social needs questionnaire is used by the case manager to identify the client's social and health care goals. During the course of program participation, the case manager works with her/his clients using motivational interviewing techniques and change readiness assessments to identify and prioritize the client's care goals. Every case manager provides a group of core services that include navigation support and linkages to resources to help clients reach their goals. At the end of the year, if a client risk profile still makes them eligible for program inclusion, they are automatically re-enrolled for another year. Otherwise, they return to the client pool, but are eligible for a second enrollment if their risk increases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

  • Full Scope MediCal members administered by Contra Costa Health Services and in Contra Costa Regional Medical Centers network.
  • Having sufficiently high estimated risk of future avoidable utilization to rank within the top 25,000 of the potentially eligible population

排除标准

  • Not case managed under other locally administered plans
  • Not living outside Contra Costa County
  • Not in detention for the past month
  • Not hospitalized for the past month
  • Not previously enrolled in the program (some disenrollment reasons allow for subsequent re-eligibility)

研究组 & 干预措施

Telephonic Services - Intervention

Experimental

Persons in this group are linked with a telephonic case manager to help address their social needs.

干预措施: Telephonic Services (Behavioral)

Telephonic Services - Control

No Intervention

Persons in this group are similar in risk to those in the 'Telephonic Services - Intervention' arm, but are not linked with a case manager.

In-Person Services - Intervention

Experimental

Persons in this group are linked with an in-person case manager who makes home visits to help address their social needs.

干预措施: In-Person Services (Behavioral)

In-Person Services - Control

No Intervention

Persons in this group are similar in risk to those in the In-Person Services - Intervention' arm, but are not linked with a case manager.

结局指标

主要结局

Avoidable In-Patient Visit Rate

时间窗: Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.

Avoidable In-Patient visits are identified as any visit meeting one of the relevant categories of the Agency for Healthcare Research and Quality Prevention Quality Indicators #90 (PQI-90). The criteria used were numbers 1,3,5,7,8,10,11,12,13,14,15 and 16.

Avoidable Emergency Room Visit Rate

时间窗: Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.

Avoidable emergency room visits are defined using the New York University algorithm applied to the primary diagnosis for the ED visit. The percent avoidability of an ED visit is defined as the sum of the percentages identified as (Emergency Care Needed Preventable, Alcohol Use, Drug Use, Psych, Non-Emergent, and Emergency Primary Care Treatable)

次要结局

  • Specialty Care Visit Rate(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Medi-Cal Retention(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Change in Quality of Life Response During Enrollment: two questions from 5 point Likert scale(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Cal-Fresh / SNAP Enrollment Rates(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • No Show Rates(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Social Service Utilization(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Primary Care Visit Rate(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Mental Health and Alcohol/Drug Visit Rates(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Average HbA1c measurement(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Overall Health Costs(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)
  • Blood Pressure(Controls: From the date of identification to the earlier of 1) Date of subsequent enrollment or 2) End of Study, an average of 1 year Intervention: From the date of enrollment (or first goal) to the date of program disenrollment, average of 1 year.)

研究者

发起方
Contra Costa Health Services
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验