Social Determinants of Health (SDOH)HMHBNCT07817407
Healthy Moms Healthy Babies Pilot Project Evaluation
A study testing Enhanced Billing Opportunities and Discharge Visit Only in people with Social Determinants of Health (SDOH) and Health Care Utilization, run by University of Michigan at 1 site in United States.
Trial summary
This study is designed to learn whether providing additional resources to home visiting agencies in Michigan's Maternal Infant Health Program (MIHP) help them better serve families with high levels of need for basic services. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Social Determinants of Health (SDOH), Health Care Utilization
- What is being tested?
- Enhanced Billing Opportunities and Discharge Visit Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,927 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 15 Jan 2026
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for Medicaid
- Identified as "high risk" based on responses to the Maternal Risk Identifier (MRI) or Infant Risk Identifier (IRI), administered upon enrollment.
Who cannot join
- Participants under the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maternal Infant Health Program
Lansing, Michigan, 48933
About this study
This study is designed to learn whether providing additional resources to home visiting agencies in Michigan's Maternal Infant Health Program (MIHP) help them better serve families with high levels of need for basic services. The main questions it aims to answer are:
- Do additional resources provided to agencies help imporove participants economic stability, employment, housing, and social well-being?
- Do additional resource help improve participants use of health care services, like postpartum visits and well-child visits?
- Do the additional resources benefit some participants more than others?
Researchers will compare partipants who are served by agencies who receive additional resources to participants who are served by agencies who do not recieve additional resources to see if the additional resources have a positive impact on participants. Participants across all agencies will take a brief survey when they are discharged from the home visiting program and researchers will collect information from billing records to learn about health care utilization.
- Being tested
- Enhanced Billing Opportunities, Discharge Visit Only
- Keywords
- social determinants of health, home visiting, Medicaid, billing, health care utilization, maternal and infant health
- 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.
Enhanced Billing OpportunitiesOther
Home visiting agencies in the treatment arm were able to bill for the following additional services 1) an additional home visit; 2) a complex home visit with additional face-to-face time (30 additional minutes allowed for visits longer than 60 minutes in length); 3) care coordination (including phone calls or other activities to coordinate services that lasted more than 30 minutes); and 4) a discharge visit (billed at a higher rate than a typical visit and designed to develop a plan for transitioning the family out of MIHP services).
Discharge Visit OnlyOther
Control group agencies were able to bill for typical services and a discharge visit for families deemed "high risk" on the initial screener.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group agencies had the opportunity to bill for additional services for eligible families who scored as "high risk" on an enrollment screener. Receives: Other: Enhanced Billing Opportunities |
| Control Group | Active comparator | Control group agencies were only able to bill for typical services and a discharge visit for families deemed "high risk" based on the initial screener. Receives: Other: Discharge Visit Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total MIHP visits participant had with provider
A variable was created to represent the total number of MIHP visits a parent had with their provider using the Medicaid claims procedural codes.
Measured: Administrative data was collected after participation in the program was completed.
Total participant prenatal visits
A variable was created to represent the total number of prenatal visits the parent had after their MIHP screening based on distinct claims to Medicaid.
Measured: Administrative data was collected after participation in the program was completed.
Total participant ER Visits
A variable was created to represent the total number of unique ER visits a parent had during the study period after their MIHP screening date using revenue codes. The variable was set to 0 if no claims were found.
Measured: Administrative data was collected after participation in the program was completed.
Participant ever had a postpartum visit
A dichotomous variable was created to represent whether the parent ever had a postpartum visit claim after their MIHP screening, equal to 1 if there was a claim and service date after the infant's data of birth. The variable was set to 0 if no claims were found.
Measured: Administrative data was collected after participation in the program was completed.
Total ER Visits Infant
A variable was created to represent the total number of unique ER visits an infant of a participant had during the study period using revenue codes. The variable was set to 0 if no claims were found.
Measured: Administrative data was collected after participation in the program was completed.
Total well child visits
A variable was created to represent the total number of unique well child visits a child had during the study period using diagnosis codes and procedure codes. The variable was set to 0 if no claims were found. Any infant who did not appear in the Medicaid eligibility file or who had a date of death within a year of birth had all values related to well child visits set to missing.
Measured: Administrative data was collected after participation in the program was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Aug 2021
- Primary completion31 Dec 2023
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of Health (SDOH)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Robin Tepper Jacob, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817407
- Sponsor's protocol ID
- HUM00195929
- Acronym
- HMHB
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The terms of the data use agreement with the State of Michigan preclude the sharing of data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Moms Healthy Babies Pilot Project Evaluation
- ClinicalTrials.gov ID
- NCT07817407
- Acronym / sponsor ID
- HMHB / HUM00195929
- Keywords
- social determinants of health, home visiting, Medicaid, billing, health care utilization, maternal and infant health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,927 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 14 Sep 2026 (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.
This study is designed to learn whether providing additional resources to home visiting agencies in Michigan's Maternal Infant Health Program (MIHP) help them better serve families with high levels of need for basic services. The main questions it aims to answer are:
- Do additional resources provided to agencies help imporove participants economic stability, employment, housing, and social well-being?
- Do additional resource help improve participants use of health care services, like postpartum visits and well-child visits?
- Do the additional resources benefit some participants more than others?
Researchers will compare partipants who are served by agencies who receive additional resources to participants who are served by agencies who do not recieve additional resources to see if the additional resources have a positive impact on participants. Participants across all agencies will take a brief survey when they are discharged from the home visiting program and researchers will collect information from billing records to learn about health care utilization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Enhanced Billing OpportunitiesTreatment group agencies had the opportunity to bill for additional services for eligible families who scored as "high risk" on an enrollment screener. |
| Control Group | Active comparator | Other: Discharge Visit OnlyControl group agencies were only able to bill for typical services and a discharge visit for families deemed "high risk" based on the initial screener. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for Medicaid
- Identified as "high risk" based on responses to the Maternal Risk Identifier (MRI) or Infant Risk Identifier (IRI), administered upon enrollment.
Key exclusion criteria (1 listed)
- Participants under the age of 18.
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 |
|---|---|---|
| Enhanced Billing OpportunitiesHome visiting agencies in the treatment arm were able to bill for the following additional services 1) an additional home visit; 2) a complex home visit with additional face-to-face time (30 additional minutes allowed for visits longer than 60 minutes in length); 3) care coordination (including phone calls or other activities to coordinate services that lasted more than 30 minutes); and 4) a discharge visit (billed at a higher rate than a typical visit and designed to develop a plan for transitioning the family out of MIHP services). | Other | Treatment Group |
| Discharge Visit OnlyControl group agencies were able to bill for typical services and a discharge visit for families deemed "high risk" on the initial screener. | Other | Control Group |
Primary outcome
Total MIHP visits participant had with provider
Time frame: Administrative data was collected after participation in the program was completed.
A variable was created to represent the total number of MIHP visits a parent had with their provider using the Medicaid claims procedural codes.
Total participant prenatal visits
Time frame: Administrative data was collected after participation in the program was completed.
A variable was created to represent the total number of prenatal visits the parent had after their MIHP screening based on distinct claims to Medicaid.
Total participant ER Visits
Time frame: Administrative data was collected after participation in the program was completed.
A variable was created to represent the total number of unique ER visits a parent had during the study period after their MIHP screening date using revenue codes. The variable was set to 0 if no claims were found.
Participant ever had a postpartum visit
Time frame: Administrative data was collected after participation in the program was completed.
A dichotomous variable was created to represent whether the parent ever had a postpartum visit claim after their MIHP screening, equal to 1 if there was a claim and service date after the infant's data of birth. The variable was set to 0 if no claims were found.
Total ER Visits Infant
Time frame: Administrative data was collected after participation in the program was completed.
A variable was created to represent the total number of unique ER visits an infant of a participant had during the study period using revenue codes. The variable was set to 0 if no claims were found.
Total well child visits
Time frame: Administrative data was collected after participation in the program was completed.
A variable was created to represent the total number of unique well child visits a child had during the study period using diagnosis codes and procedure codes. The variable was set to 0 if no claims were found. Any infant who did not appear in the Medicaid eligibility file or who had a date of death within a year of birth had all values related to well child visits set to missing.
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 Sep 2026.
- Study was originally pre-registered at Open Science Framework. The original pre-registration information can be found here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The terms of the data use agreement with the State of Michigan preclude the sharing of data.
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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?
A study testing Enhanced Billing Opportunities and Discharge Visit Only in people with Social Determinants of Health (SDOH) and Health Care Utilization, 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 2 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 Sep 2026. 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?
Total MIHP visits participant had with provider (time frame: Administrative data was collected after participation in the program was completed.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.