Examining Digital Health Care Delivery Models Through Medicaid Collaborative

Study Overview
=================
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).

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

Conditions
-----------------
Hypertension, Diabetes Mellitus, Maternal Health

Intervention / Treatment
-----------------
* Behavioral: digital health delivered multicomponent intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSF HealthCare<br>Subjects from OSF HealthCare | Behavioral: digital health delivered multicomponent intervention<br>* The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.<br>* Other names: Digital Care Solution as supportive personalized care;|
| Federally Qualified Health Center (FQHC) - 1<br>Subjects from Eagle View Community Health System enrolled in MIC Program | Behavioral: digital health delivered multicomponent intervention<br>* The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.<br>* Other names: Digital Care Solution as supportive personalized care;|
| Federally Qualified Health Center (FQHC) - 2<br>Subjects from Chestnut Health System Inc. enrolled in MIC Program | Behavioral: digital health delivered multicomponent intervention<br>* The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.<br>* Other names: Digital Care Solution as supportive personalized care;|
| Federally Qualified Health Center (FQHC) - 3<br>Subjects from Heartland Community Health System enrolled in MIC Program | Behavioral: digital health delivered multicomponent intervention<br>* The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.<br>* Other names: Digital Care Solution as supportive personalized care;|
| Federally Qualified Health Center (FQHC) - 4<br>Subjects from Aunt Martha's enrolled in MIC Program | Behavioral: digital health delivered multicomponent intervention<br>* The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.<br>* 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 | 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 | 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 | 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 | 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 | Measure of patient's satisfaction, Participant's recommendation of program to others (Yes/No) | at exit from program, on average 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, diabetes, maternal health, digital health