Examining Digital Health Care Delivery Models Through Medicaid Collaborative

NCT ID: NCT05555095

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

19331 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2028-12-31

Brief Summary

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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

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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).

Conditions

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Hypertension Diabetes Mellitus Maternal Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSF HealthCare

Subjects from OSF HealthCare

digital health delivered multicomponent intervention

Intervention Type BEHAVIORAL

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Federally Qualified Health Center (FQHC) - 1

Subjects from Eagle View Community Health System enrolled in MIC Program

digital health delivered multicomponent intervention

Intervention Type BEHAVIORAL

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Federally Qualified Health Center (FQHC) - 2

Subjects from Chestnut Health System Inc. enrolled in MIC Program

digital health delivered multicomponent intervention

Intervention Type BEHAVIORAL

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Federally Qualified Health Center (FQHC) - 3

Subjects from Heartland Community Health System enrolled in MIC Program

digital health delivered multicomponent intervention

Intervention Type BEHAVIORAL

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Federally Qualified Health Center (FQHC) - 4

Subjects from Aunt Martha's enrolled in MIC Program

digital health delivered multicomponent intervention

Intervention Type BEHAVIORAL

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Interventions

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digital health delivered multicomponent intervention

The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Intervention Type BEHAVIORAL

Other Intervention Names

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Digital Care Solution as supportive personalized care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OSF Healthcare System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melinda B Cooling, DNP, APRN

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare System

Locations

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OSF HealthCare System

Peoria, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colleen J. Klein, PhD, APRN

Role: CONTACT

309-655-3899

Melinda B Cooling, DNP, APRN

Role: CONTACT

309-624-4649

Facility Contacts

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Colleen J Klein, PhD, APRN

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25380699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34608377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33778982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33978593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33055094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30422224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30537958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28965183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26802756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29982445 (View on PubMed)

Other Identifiers

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1876230

Identifier Type: -

Identifier Source: org_study_id

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