Examining Digital Health Care Delivery Models Through Medicaid Collaborative

Recruiting

• Conditions: Diabetes Mellitus; Maternal Health; Hypertension

• Registration Number: NCT05555095
• Lead Sponsor: OSF Healthcare System

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Study Start: 2022-09-26
• Study First Posted: 2022-09-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19331

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in participant's blood pressure control at three points in time	3 months, 6 months, 12 months	Decrease in the average systolic and/or diastolic blood pressure
Change in participant's glycemic control at three points in time	3 months, 6 months, 12 months	Defined as a reduction \>1% in glycosylated hemoglobin (hemoglobin A1C)
Change in Patient Assessment of Chronic Illness Care scale (PACIC) from baseline to exit from program	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
Patient satisfaction, 1-item researcher generated question	at exit from program, on average 1 year	Measure of patient's satisfaction, Participant's recommendation of program to others (Yes/No)
Change in Patient Perception of Health Care Management (adapted form of PACIC to reflect pre/postnatal care) from baseline to exit from program	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

Trial Locations

Locations (1)

OSF HealthCare System; 🇺🇸 Peoria, Illinois, United States