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Recruiting

NCT Number: NCT05555095

Examining Digital Health Care Delivery Models Through Medicaid Collaborative

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OSF HealthCare System

Peoria, Illinois, 61602, United States

Location status: Recruiting

Location contact

Colleen J Klein, PhD, APRN

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

digital health delivered multicomponent intervention

Behavioral

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

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen J. Klein, PhD, APRN

CONTACT

[email protected]

309-655-3899

Melinda B Cooling, DNP, APRN

CONTACT

[email protected]

309-624-4649

Sponsors and collaborators

Lead sponsor

OSF Healthcare System

Other

Registry information

Official study title

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

Acronym: MIC

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 26, 2022
Registry last updated
Apr 30, 2025

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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