NCT04000074

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

4 years

First QC Date

February 20, 2019

Last Update Submit

June 25, 2019

Conditions

Keywords

Social Determinants of HealthHigh-Needs, High-Cost PopulationsCase ManagementSocial PrescribingLinkage Services

Outcome Measures

Primary Outcomes (2)

  • Avoidable Emergency Room Visit Rate

    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)

    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 Visit Rate

    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.

    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.

Secondary Outcomes (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • +6 more secondary outcomes

Study Arms (4)

Telephonic Services - Intervention

EXPERIMENTAL

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

Behavioral: Telephonic Services

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.

Behavioral: In-Person Services

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.

Interventions

Provides linkage services to local programs that address the social determinants of health remotely via phone, email and/or fax

Also known as: CmCt Tier II
Telephonic Services - Intervention

Provides linkage services to local programs that address the social determinants of health directly to the client during face-to-face visits as well as remotely via phone, email, etc.

Also known as: CmCt Tier I
In-Person Services - Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contra Costa Whole Person Care Program

Concord, California, 94520, United States

RECRUITING

Related Publications (2)

  • Fleming MD, Guo C, Knox M, Brown DM, Hernandez EA, Brewster AL. Impact of Social Needs Case Management on Use of Medical and Behavioral Health Services: Secondary Analysis of a Randomized Controlled Trial. Ann Intern Med. 2023 Aug;176(8):1139-1141. doi: 10.7326/M23-0876. Epub 2023 Aug 8. No abstract available.

  • Brown DM, Hernandez EA, Levin S, De Vaan M, Kim MO, Lynch C, Roth A, Brewster AL. Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries : A Randomized Study. Ann Intern Med. 2022 Aug;175(8):1109-1117. doi: 10.7326/M22-0074. Epub 2022 Jul 5.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Potential enrollees are identified from a predictive model operating on an administrative database. There are two types of service delivery systems: in-home visits and telephonic. Each month, a population of the highest risk clients are identified as eligible for the home-visit and a population of elevated risk clients are identified as eligible for telephonic services. From these populations, sufficient new enrollees are identified to reach program capacity, and twice this number of controls. Persons previously identified as controls are eligible for enrollment into the program in subsequent months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

June 27, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations