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OpenTrials
Completed

NCT Number: NCT07817407

Healthy Moms Healthy Babies Pilot Project Evaluation

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. Do additional resources provided to agencies help imporove participants economic stability, employment, housing, and social well-being? 2. Do additional resource help improve participants use of health care services, like postpartum visits and well-child visits? 3. 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal Infant Health Program

Lansing, Michigan, 48933, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for Medicaid
  • Identified as "high risk" based on responses to the Maternal Risk Identifier (MRI) or Infant Risk Identifier (IRI), administered upon enrollment.

Exclusion criteria

  • Participants under the age of 18.

Treatment and study plan

Enhanced Billing Opportunities

Other

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 Only

Other

Control group agencies were able to bill for typical services and a discharge visit for families deemed "high risk" on the initial screener.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. % of partcipants who were employed full-time

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable, equal to 1 if respondent indicated "Yes, employed full-time" and 0 otherwise. If no item was selected, the variable is set to missing.

  2. % of participants employed part-time

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable, equal to 1 if respondent indicated "Yes, employed full-time" and 0 otherwise. If no item was selected, the variable is set to missing.

  3. % of participants unemployed and contacted someone about a job

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    For those who indicated on surveys that they were not employed but looking for work, a dichotomous variable, equal to 1 if respondent indicated "Yes, contacted someone about a job" and 0 if respondent indicated "No". If no item was selected, the variable was set to missing.

  4. % of participants unemployed & applied to a job posting

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    For those who indicated they were not employed but looking for work, a dichotomous variable, equal to 1 if respondent indicated "Yes, Applied to a Job Posting" and 0 if respondent indicated "No". If no item was selected, the variable was set to missing.

  5. % of participants unemployed & had a job interview

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable, equal to 1 if respondent indicated "Yes" and 0 otherwise. If no item was selected, the variable was set to missing.

  6. % of participants with symptoms of anxiety

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    Parents answered questions from the Generalized Anxiety Disorder-2 (GAD-2), which is a pre-screener for having a generalized anxiety disorder. A dichotomous variable was created, equal to 1 if the parent scored a total of three or more points, which is the recommended cutoff for further diagnostic evaluation, and 0 if the parent scored less than three points. If no items were selected, the variable was set to missing.

  7. % of participants with symptoms of depression

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    Participants answered questions from the Patient Health Questionnaire-2 (PHQ-2), which is a pre-screener for having a depressive disorder. A dichotomous variable was created, equal to 1 if the participant scored a total of three or more points, which is the recommended cutoff for further diagnostic evaluation, and 0 if the participant scored less than three points. If no items were selected, the variable was set to missing.

  8. % of participants experiencing domestic abuse

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    Respondents were asked about various types of domestic abuse. A dichotomous variable was created, equal to 1 if respondent selected any response that did not include "none of the above" and 0 if respondent selected "none of the above". If no item was selected, the variable was set to missing.

  9. % of particpants with reliable transportation

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable was created, equal to 1 if respondent answered "Yes, I currently have concerns or worries about my housing situation" and 0 if "No". If no item was selected, the variable was set to missing.

  10. % of participants enrolled in school

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable was created, equal to 1 if respondent answered "Yes" I am currently enrolled in school and 0 if "No". If no item was selected, the variable was set to missing.

  11. % of participants experiencing homelessness

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable was created to represent the McKinney-Vento definition of homelessness using participants responses to questions about their living arrangements. Any response except "In a home that you/your family rents (apartment, house, trailer, etc.)" or "In a home that you/your family owns", was calculated as 1 = experiencing homelessness according to the McKinney-Vento definition. A selection of either "In a home that you/your family rents (apartment, house, trailer, etc.)" or "In a home that you/your family owns", was calculated as 0 = not experiencing homelessness according to the McKinney-Vento definition. If no item was selected, the variable was set to missing.

  12. % of participants experiencing homelessness (self-report)

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable was created, equal to 1 if respondent indicated "Yes" in response to the question "Are you homeless" and 0 if respondent indicated "No". If no item was selected, the variable was set to missing.

  13. % of participants who had concerns about their housing

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    A dichotomous variable was created, equal to 1 if respondent indicated "Yes" in response to the question "Do you currently have any concerns or worries about your housing situation" and 0 if respondent indicated "No". If no item was selected, the variable was set to missing.

  14. % of participants who indicated they had gone without water, gas, or or electricity in the past 30 days.

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    On surveys participants were asked the following: "In the past 30 days, have you gone without… (check all that apply) water; gas, oil or electricity; phone or internet; none of the above." A dichotomous variable was created to represent utility insecurity where a response of "none of the above" was assigned a value of 0=not experiencing utility insecurity, and any other response was assigned as 1=experiencing utility insecurity. If no item was selected, the variable was set to missing.

  15. % of participants who reported they cut meals in the last 30 days

    Time frame: Surveys were administered at program discharge, 6 to 18 months after enrollment.

    On surveys participants responded to the following, "In the past 30 days, did you or other adults in your household ever cut the size of your meals or skip meals because there wasn't enough money for food?" (1=yes; 0=no). If no item was selected, the variable was set to missing.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Michigan Department of Health and Human Services

Registry information

Acronym: HMHB

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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