Examining Digital Health Care Delivery Models Through Medicaid Collaborative

NCT05555095 | Recruiting

• 1 other identifier: 1876230
• Study Type: observational
• Target: 19,331
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus; Maternal Health

Keywords

hypertension; diabetes; maternal health; digital health

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (5)

OSF HealthCare

Subjects from OSF HealthCare

Behavioral: digital health delivered multicomponent intervention

Federally Qualified Health Center (FQHC) - 1

Subjects from Eagle View Community Health System enrolled in MIC Program

Behavioral: digital health delivered multicomponent intervention

Federally Qualified Health Center (FQHC) - 2

Subjects from Chestnut Health System Inc. enrolled in MIC Program

Behavioral: digital health delivered multicomponent intervention

Federally Qualified Health Center (FQHC) - 3

Subjects from Heartland Community Health System enrolled in MIC Program

Behavioral: digital health delivered multicomponent intervention

Federally Qualified Health Center (FQHC) - 4

Subjects from Aunt Martha's enrolled in MIC Program

Behavioral: digital health delivered multicomponent intervention

Interventions

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.

Also known as: Digital Care Solution as supportive personalized care

Federally Qualified Health Center (FQHC) - 1; Federally Qualified Health Center (FQHC) - 2; Federally Qualified Health Center (FQHC) - 3; Federally Qualified Health Center (FQHC) - 4; OSF HealthCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF HealthCare System

Peoria, Illinois, 61602, United States

RECRUITING

Related Publications (11)

• Aung E, Ostini R, Dower J, Donald M, Coll JR, Williams GM, Doi SA. Patient Assessment of Chronic Illness Care (PACIC) in Type 2 Diabetes: A Longitudinal Study. Eval Health Prof. 2016 Jun;39(2):185-203. doi: 10.1177/0163278714556674. Epub 2014 Nov 6.

  PMID: 25380699 BACKGROUND

• Cooling M, Klein CJ, Pierce LM, Delinski N, Lotz A, Vozenilek JA. Access to Care: End-to-End Digital Response for COVID-19 Care Delivery. J Nurse Pract. 2022 Feb;18(2):232-235. doi: 10.1016/j.nurpra.2021.09.011. Epub 2021 Sep 25.

  PMID: 34608377 BACKGROUND

• Dalstrom M, Weinzimmer LG, Foulger R, Klein CJ. Medicaid expansion and accessibility to healthcare: The Illinois experience. Public Health Nurs. 2021 Sep;38(5):720-729. doi: 10.1111/phn.12899. Epub 2021 Mar 29.

  PMID: 33778982 BACKGROUND

• Etminani K, Goransson C, Galozy A, Norell Pejner M, Nowaczyk S. Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension: Protocol for an Interrupted Time Series Study. JMIR Res Protoc. 2021 May 12;10(5):e24494. doi: 10.2196/24494.

  PMID: 33978593 BACKGROUND

• Hategeka C, Ruton H, Karamouzian M, Lynd LD, Law MR. Use of interrupted time series methods in the evaluation of health system quality improvement interventions: a methodological systematic review. BMJ Glob Health. 2020 Oct;5(10):e003567. doi: 10.1136/bmjgh-2020-003567.

  PMID: 33055094 BACKGROUND

• Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630.

  PMID: 30422224 BACKGROUND

• Nijagal MA, Wissig S, Stowell C, Olson E, Amer-Wahlin I, Bonsel G, Brooks A, Coleman M, Devi Karalasingam S, Duffy JMN, Flanagan T, Gebhardt S, Greene ME, Groenendaal F, R Jeganathan JR, Kowaliw T, Lamain-de-Ruiter M, Main E, Owens M, Petersen R, Reiss I, Sakala C, Speciale AM, Thompson R, Okunade O, Franx A. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018 Dec 11;18(1):953. doi: 10.1186/s12913-018-3732-3.

  PMID: 30537958 BACKGROUND

• Roman LA, Raffo JE, Dertz K, Agee B, Evans D, Penninga K, Pierce T, Cunningham B, VanderMeulen P. Understanding Perspectives of African American Medicaid-Insured Women on the Process of Perinatal Care: An Opportunity for Systems Improvement. Matern Child Health J. 2017 Dec;21(Suppl 1):81-92. doi: 10.1007/s10995-017-2372-2.

  PMID: 28965183 BACKGROUND

• Williams JS, Walker RJ, Egede LE. Achieving Equity in an Evolving Healthcare System: Opportunities and Challenges. Am J Med Sci. 2016 Jan;351(1):33-43. doi: 10.1016/j.amjms.2015.10.012.

  PMID: 26802756 BACKGROUND

• Lopez Bernal J, Cummins S, Gasparrini A. The use of controls in interrupted time series studies of public health interventions. Int J Epidemiol. 2018 Dec 1;47(6):2082-2093. doi: 10.1093/ije/dyy135.

  PMID: 29982445 BACKGROUND

• Dalstrom MD, Jordan S, Klein CJ, Cooling M. Examining a Remote Patient Monitoring Program with Medicaid Patients Managing Diabetes and Hypertension: A Qualitative Study. J Patient Exp. 2026 Jan 14;13:23743735251414380. doi: 10.1177/23743735251414380. eCollection 2026.

  PMID: 41551717 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melinda B Cooling, DNP, APRN

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen J. Klein, PhD, APRN

CONTACT

309-655-3899; colleen.klein@osfhealthcare.org

Melinda B Cooling, DNP, APRN

CONTACT

309-624-4649; melinda.b.cooling@osfhealthcare.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)