Examining Digital Health Care Delivery Models Through Medicaid Collaborative (MIC)

April 25, 2025 updated by: OSF Healthcare System

The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis

The purpose of this study is to examine the intervention effectiveness and dissemination of digital health care delivery models for improving selected health outcomes in the Medicaid population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a mixed method study that includes a controlled interrupted times series (CITS) design to study hypertension (HTN) and diabetes, a cohort to study pregnancy, and longitudinal patient and provider interviews to study experiences. This approach is appropriate when randomization is not desirable or feasible and is frequently utilized for evaluation of public health interventions (Lopez Bernal et al., 2018; Hategeka et al., 2020).

Study Type

Observational

Enrollment (Estimated)

19331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Recruiting
        • OSF Healthcare System
        • Contact:
          • Colleen J Klein, PhD, APRN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be comprised of individuals who are enrolled in a digital health care delivery model for improving selected health outcomes in the Medicaid population. The population will be obtained from the cohorts as listed above. All those enrolled in the MIC program will be strategically identified and used as the population from which to draw the sample for the quantitative and qualitative portions of the study.

Description

Inclusion Criteria:

  • Patient of one of four medically qualified health care centers and/or OSF HealthCare as defined by insurance type
  • Insured by Medicaid or dually eligible for Medicare or Medicaid
  • Has one or more of the three following conditions:

Hypertension, Diabetes Mellitus, or Pregnancy

  • Able to read and understand English or read translated materials in language provided (e.g. Spanish)
  • Minors who are pregnant and less 18 years of age who are enrolled in the MIC Program

Exclusion Criteria:

  • Not enrolled in the MIC Program
  • No one will be excluded on basis of sex or race

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSF HealthCare
Subjects from OSF HealthCare
Behavioral: digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
Other Names:
  • Digital Care Solution as supportive personalized care
Federally Qualified Health Center (FQHC) - 1
Subjects from Eagle View Community Health System enrolled in MIC Program
Behavioral: digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
Other Names:
  • Digital Care Solution as supportive personalized care
Federally Qualified Health Center (FQHC) - 2
Subjects from Chestnut Health System Inc. enrolled in MIC Program
Behavioral: digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
Other Names:
  • Digital Care Solution as supportive personalized care
Federally Qualified Health Center (FQHC) - 3
Subjects from Heartland Community Health System enrolled in MIC Program
Behavioral: digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
Other Names:
  • Digital Care Solution as supportive personalized care
Federally Qualified Health Center (FQHC) - 4
Subjects from Aunt Martha's enrolled in MIC Program
Behavioral: digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
Other Names:
  • Digital Care Solution as supportive personalized care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant's blood pressure control at three points in time
Time Frame: 3 months, 6 months, 12 months
Decrease in the average systolic and/or diastolic blood pressure
3 months, 6 months, 12 months
Change in participant's glycemic control at three points in time
Time Frame: 3 months, 6 months, 12 months
Defined as a reduction >1% in glycosylated hemoglobin (hemoglobin A1C)
3 months, 6 months, 12 months
Change in Patient Assessment of Chronic Illness Care scale (PACIC) from baseline to exit from program
Time Frame: baseline, end of program, on average of 1 year
Measure of patient's perception of care management for chronic disease - 20 items on a 5-point scale 1=no or never to 5=Always, with higher score indicating better care
baseline, end of program, on average of 1 year
Change in Patient Perception of Health Care Management (adapted form of PACIC to reflect pre/postnatal care) from baseline to exit from program
Time Frame: baseline, end of program, on average 6 months
Measure of patient-centered care and self-management - 20 items on a 5-point scale 1=no or never to 5=Always, with higher score indicating better care
baseline, end of program, on average 6 months
Patient satisfaction, 1-item researcher generated question
Time Frame: at exit from program, on average 1 year
Measure of patient's satisfaction, Participant's recommendation of program to others (Yes/No)
at exit from program, on average 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSF Healthcare System

Investigators

  • Principal Investigator: Melinda B Cooling, DNP, APRN, OSF Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1876230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on digital health delivered multicomponent intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe