Evaluation of a Community Health Worker (CHW)-Led Program

October 13, 2020 updated by: Mary Ellen Michele Heisler, University of Michigan

Evaluation of a Community Health Worker (CHW)-Led Comprehensive Neighborhood-Based Program for Medicaid Enrollees in Detroit

The investigators are comparing health care utilization claims data of Medicaid beneficiaries who participated in a CHW program led by three Medicaid health plans' salaried CHWs in the Cody Rouge neighborhood of Detroit, Michigan with eligible beneficiaries who were not invited to participate in the program but received usual health plan services.

Study Overview

Detailed Description

This program evaluation examines the effectiveness, barriers and facilitators of implementing a geographically targeted program led by salaried CHWs from three Medicaid health plans in collaboration with the Detroit Health Department and Joy Southfield Community Development Corporation. Beneficiaries who reside in the Cody Rouge neighborhood and had more than 3 Emergency Department (ED) visits or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months are randomized to the CHW program or to usual outreach from the health plans. CHWs reach out to eligible beneficiaries to provide a comprehensive assessment of health, behavioral, and social needs; link them to needed resources; and provide necessary follow-up. At 12- month follow up, health plan claims data on ED visits, ambulatory care-sensitive hospitalizations, primary care visits and all related costs will be compared between participants who participated in this program compared with other participants who would have been eligible but were not offered the program (with no effort to contact them).

The investigators hypothesize that patients enrolled in the CHW intervention will experience a reduction in acute care usage resulting in cost savings compared to those receiving usual health plan CHW outreach. This study is among the first to evaluate the impact on health care utilization of augmented services delivered by health plan CHWs for high-utilizing health plan members. This study will provide important information on the sustainability of future health plan CHW programs and provide insights into effective implementation of such programs.

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons who have been enrolled at least 12 months in one of three Medicaid health plans serving Detroit and who reside in zip codes corresponding to the Cody Rouge neighborhood of Detroit.

Description

Inclusion Criteria:

  • Either have had more than 3 ED visits in the prior 12 months, or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months

Exclusion Criteria:

  • None if they meet above criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Community Health Worker
  1. initial comprehensive health, behavioral, and social needs assessment;
  2. development of an individualized 'action plan' to address identified needs;
  3. linkage to necessary services and work with neighborhood-based health care and social services organization to address each individual's unique needs; and 4) provide follow-up support as needed.
Assessment of behavioral, medical, and social needs, development of individual goals and action plan, follow-up to assist and work to ensure identified needs/goals are met. CHWs use their professional judgement to assess how long follow-up is required.
Usual Health Plan Services
1) receipt of other plan services besides the CHW program for which they are eligible.
Assessment of behavioral, medical, and social needs, development of individual goals and action plan, follow-up to assist and work to ensure identified needs/goals are met. CHWs use their professional judgement to assess how long follow-up is required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Visits
Time Frame: 12-month period after participant enrolls in the program
Number of Emergency Department visits in health plan claims data
12-month period after participant enrolls in the program
Hospitalizations
Time Frame: 12-month period after participant enrolls in the program
Number and length of stay of hospitalizations in health plan claims data
12-month period after participant enrolls in the program
Primary care visits
Time Frame: 12-month period after participant enrolls in the program
Number of primary care visits in health plan claims data
12-month period after participant enrolls in the program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

October 2, 2020

Study Completion (Actual)

October 2, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00136277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the investigators have the de-identified data set with NO identifiers that will be used for analyses, the data can be shared once analyses are completed. The de-identified data set would be shared with any researchers who would like to duplicate the analyses.

IPD Sharing Time Frame

The data will be made available once analyses are completed for as long as the data set is retained as per requirements. It will be made available upon request.

IPD Sharing Access Criteria

Researchers or others who would like to double-check/replicate the analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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