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

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ClinicalTrials.gov Identifier: NCT03924713
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
Molina Health Care of Michigan
Meridian Health Plan of Michigan
Blue Cross Complete
Detroit Department of Health
Blue Cross Blue Shield of Michigan Foundation
Ralph Wilson Foundation
Information provided by (Responsible Party):
Mary Ellen Michele Heisler, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment
High Health Care-utilizing Medicaid Beneficiaries Behavioral: Supportive services

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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of a Community Health Worker (CHW)-Led Comprehensive Neighborhood-Based Program for Medicaid Enrollees in Detroit
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

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.
Behavioral: Supportive services
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.
Behavioral: Supportive services
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.




Primary Outcome Measures :
  1. Emergency Department Visits [ Time Frame: 12-month period after participant enrolls in the program ]
    Number of Emergency Department visits in health plan claims data

  2. Hospitalizations [ Time Frame: 12-month period after participant enrolls in the program ]
    Number and length of stay of hospitalizations in health plan claims data

  3. Primary care visits [ Time Frame: 12-month period after participant enrolls in the program ]
    Number of primary care visits in health plan claims data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924713


Contacts
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Contact: Michele Heisler, MD 734-649-7986 mheisler@umich.edu
Contact: Adrienne Lapidos, PhD 917-597-0964 alapidos@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Michele Heisler, MD    734-649-7986    mheisler@umich.edu   
Contact: Adrienne Lapidos, PhD    917-597-0964    alapidos@umich.edu   
Sponsors and Collaborators
University of Michigan
Molina Health Care of Michigan
Meridian Health Plan of Michigan
Blue Cross Complete
Detroit Department of Health
Blue Cross Blue Shield of Michigan Foundation
Ralph Wilson Foundation

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Responsible Party: Mary Ellen Michele Heisler, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03924713     History of Changes
Other Study ID Numbers: HUM00136277
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
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.
Access Criteria: Researchers or others who would like to double-check/replicate the analyses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Ellen Michele Heisler, University of Michigan:
Community health worker
health care utilization