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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03924713

Recruitment Status Completed

First Posted April 23, 2019

Last update posted October 14, 2020

Study Description

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:High Health Care-utilizing Medicaid Beneficiaries
  • Intervention/Treatment: Behavioral: Supportive services
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 198 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 2018
  • Actual Primary Completion Date: October 2020
  • Actual Study Completion Date: October 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Community Health Worker
initial comprehensive health, behavioral, and social needs assessment; development of an individualized 'action plan' to address identified needs; 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.
Outcome Measures
  • Primary Outcome Measures: 1. Primary care visits [ Time Frame: 12-month period after participant enrolls in the program ]
    Number of primary care visits in health plan claims data
  • 2. Emergency Department Visits [ Time Frame: 12-month period after participant enrolls in the program ]
    Number of Emergency Department visits in health plan claims data
  • 3. Hospitalizations [ Time Frame: 12-month period after participant enrolls in the program ]
    Number and length of stay of hospitalizations in health plan claims data
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations

United States, Michigan
University of Michigan
Ann Arbor

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

More Information
  • Responsible Party: 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: October 14, 2020
  • Last Verified: October 2020
  • 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Michigan: Community health worker health care utilization