NCT03924713

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

March 29, 2019

Last Update Submit

October 13, 2020

Conditions

Keywords

Community health workerhealth care utilization

Outcome Measures

Primary Outcomes (3)

  • Emergency Department Visits

    Number of Emergency Department visits in health plan claims data

    12-month period after participant enrolls in the program

  • Hospitalizations

    Number and length of stay of hospitalizations in health plan claims data

    12-month period after participant enrolls in the program

  • Primary care visits

    Number of primary care visits in health plan claims data

    12-month period after participant enrolls in the program

Study Arms (2)

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

Usual Health Plan Services

1\) receipt of other plan services besides the CHW program for which they are eligible.

Behavioral: Supportive services

Interventions

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.

Community Health WorkerUsual Health Plan Services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None if they meet above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 23, 2019

Study Start

March 1, 2018

Primary Completion

October 2, 2020

Study Completion

October 2, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations