High Health Care-utilizing Medicaid BeneficiariesNCT03924713
Evaluation of a Community Health Worker (CHW)-Led Program
An observational study of High Health Care-utilizing Medicaid Beneficiaries, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Health Care-utilizing Medicaid Beneficiaries
- What is being tested?
- Supportive services
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 2 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None if they meet above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Supportive services
- Keywords
- Community health worker, health care utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive servicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supportive services | |
| Usual Health Plan Services | 1) receipt of other plan services besides the CHW program for which they are eligible. Receives: Behavioral: Supportive services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Visits
Number of Emergency Department visits in health plan claims data
Measured: 12-month period after participant enrolls in the program
Hospitalizations
Number and length of stay of hospitalizations in health plan claims data
Measured: 12-month period after participant enrolls in the program
Primary care visits
Number of primary care visits in health plan claims data
Measured: 12-month period after participant enrolls in the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Mar 2018
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Health Care-utilizing Medicaid BeneficiariesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Mary Ellen Michele Heisler, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924713
- Sponsor's protocol ID
- HUM00136277
- Status last verified
- Oct 2020
- First submitted
- 29 Mar 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35324259Heisler 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.
PubMed 31646214
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Community Health Worker (CHW)-Led Comprehensive Neighborhood-Based Program for Medicaid Enrollees in Detroit
- ClinicalTrials.gov ID
- NCT03924713
- Acronym / sponsor ID
- HUM00136277
- Keywords
- Community health worker, health care utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- 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
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker | – | Behavioral: Supportive services1. 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. |
| Usual Health Plan Services | – | Behavioral: Supportive services1) receipt of other plan services besides the CHW program for which they are eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None if they meet above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive servicesAssessment 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. | Behavioural | Community Health Worker, Usual Health Plan Services |
Primary outcome
Emergency Department Visits
Time frame: 12-month period after participant enrolls in the program
Number of Emergency Department visits in health plan claims data
Hospitalizations
Time frame: 12-month period after participant enrolls in the program
Number and length of stay of hospitalizations in health plan claims data
Primary care visits
Time frame: 12-month period after participant enrolls in the program
Number of primary care visits in health plan claims data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 35324259Heisler 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.
- Derived from this study: PubMed 31646214Heisler 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Health Care-utilizing Medicaid Beneficiaries, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Visits (time frame: 12-month period after participant enrolls in the program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.