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

NCT ID: NCT03924713

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Health Care-utilizing Medicaid Beneficiaries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Supportive services

Intervention Type BEHAVIORAL

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.

Supportive services

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Molina Health Care of Michigan

UNKNOWN

Sponsor Role collaborator

Meridian Health Plan of Michigan

UNKNOWN

Sponsor Role collaborator

Blue Cross Complete

UNKNOWN

Sponsor Role collaborator

Detroit Department of Health

OTHER

Sponsor Role collaborator

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role collaborator

Ralph Wilson Foundation

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Ellen Michele Heisler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Heisler M, Lapidos A, Kieffer E, Henderson J, Guzman R, Cunmulaj J, Wolfe J, Meyer T, Ayanian JZ. Impact on Health Care Utilization and Costs of a Medicaid Community Health Worker Program in Detroit, 2018-2020: A Randomized Program Evaluation. Am J Public Health. 2022 May;112(5):766-775. doi: 10.2105/AJPH.2021.306700. Epub 2022 Mar 24.

Reference Type DERIVED
PMID: 35324259 (View on PubMed)

Heisler M, Lapidos A, Henderson J, Guzman RM, Wolfe J, Meyer P, Law D, Kieffer EC, Ernst C, Djelaj V, Khaldun J, Ayanian JZ. Study protocol for a Community Health Worker (CHW)-led comprehensive neighborhood-focused program for medicaid enrollees in detroit. Contemp Clin Trials Commun. 2019 Sep 30;16:100456. doi: 10.1016/j.conctc.2019.100456. eCollection 2019 Dec.

Reference Type DERIVED
PMID: 31646214 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00136277

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Healthy Lifetime - Phase 2
NCT05920733 RECRUITING NA
My Life, My Healthcare
NCT03017196 COMPLETED NA
Getting to Yes, Michigan! (G2YMI)
NCT05096260 ACTIVE_NOT_RECRUITING NA