HypertensionMICNCT05555095
Examining Digital Health Care Delivery Models Through Medicaid Collaborative
An observational study of Hypertension and Diabetes Mellitus, run by OSF Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Maternal Health
- What is being tested?
- digital health delivered multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22,340 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not enrolled in the MIC Program
- No one will be excluded on basis of sex or race
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis
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.
Read the 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).
- Conditions
- Hypertension, Diabetes Mellitus, Maternal Health
- Being tested
- digital health delivered multicomponent intervention
- Keywords
- hypertension, diabetes, maternal health, digital health
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital health delivered multicomponent interventionBehavioural
Also called Digital Care Solution as supportive personalized care
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.
| Study group | Role | What they receive |
|---|---|---|
| OSF HealthCare | Subjects from OSF HealthCare Receives: Behavioral: digital health delivered multicomponent intervention | |
| Federally Qualified Health Center (FQHC) - 1 | Subjects from Eagle View Community Health System enrolled in MIC Program Receives: Behavioral: digital health delivered multicomponent intervention | |
| Federally Qualified Health Center (FQHC) - 2 | Subjects from Chestnut Health System Inc. enrolled in MIC Program Receives: Behavioral: digital health delivered multicomponent intervention | |
| Federally Qualified Health Center (FQHC) - 3 | Subjects from Heartland Community Health System enrolled in MIC Program Receives: Behavioral: digital health delivered multicomponent intervention | |
| Federally Qualified Health Center (FQHC) - 4 | Subjects from Aunt Martha's enrolled in MIC Program Receives: Behavioral: digital health delivered multicomponent intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant's blood pressure control at three points in time
Decrease in the average systolic and/or diastolic blood pressure
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: at exit from program, on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda B Cooling, DNP, APRN, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555095
- Sponsor's protocol ID
- 1876230
- Acronym
- MIC
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25380699Cooling 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.
PubMed 34608377Dalstrom 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.
PubMed 33778982Etminani 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.
PubMed 33978593Hategeka 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.
PubMed 33055094Kangovi 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.
PubMed 30422224Nijagal 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.
PubMed 30537958Roman 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.
PubMed 28965183Williams 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.
PubMed 26802756Lopez 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.
PubMed 29982445Cooling M, Klein CJ, Dalstrom MD, Foulger R, Junis J, Handler JA. Increasing access to care through digital health for the Medicaid population: a novel community case study. Front Digit Health. 2025 Sep 19;7:1524590. doi: 10.3389/fdgth.2025.1524590. eCollection 2025.
PubMed 41049159Klein CJ, Dalstrom M, Bond WF, McGarvey J, Cooling M, Zumpf K, Pierce L, Stoecker B, Handler JA. The feasibility of implementing a digital pregnancy and postpartum support program in the Midwestern United States and the association with maternal and infant health. Prev Med Rep. 2024 Dec 20;49:102953. doi: 10.1016/j.pmedr.2024.102953. eCollection 2025 Jan.
PubMed 39834381Dalstrom MD, Cioni J, Klein CJ, Cooling M. Examining digital care relationships of medicaid participants in the pre/postnatal care period: a qualitative study. BMC Pregnancy Childbirth. 2025 Apr 23;25(1):473. doi: 10.1186/s12884-025-07587-z.
PubMed 40269798Dalstrom 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.
PubMed 41551717
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis
- ClinicalTrials.gov ID
- NCT05555095
- Acronym / sponsor ID
- MIC / 1876230
- Conditions
- Hypertension, Diabetes Mellitus, Maternal Health
- Keywords
- hypertension, diabetes, maternal health, digital health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,340 participants (estimated)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| OSF HealthCare | – | Behavioral: digital health delivered multicomponent interventionSubjects from OSF HealthCare |
| Federally Qualified Health Center (FQHC) - 1 | – | Behavioral: digital health delivered multicomponent interventionSubjects from Eagle View Community Health System enrolled in MIC Program |
| Federally Qualified Health Center (FQHC) - 2 | – | Behavioral: digital health delivered multicomponent interventionSubjects from Chestnut Health System Inc. enrolled in MIC Program |
| Federally Qualified Health Center (FQHC) - 3 | – | Behavioral: digital health delivered multicomponent interventionSubjects from Heartland Community Health System enrolled in MIC Program |
| Federally Qualified Health Center (FQHC) - 4 | – | Behavioral: digital health delivered multicomponent interventionSubjects from Aunt Martha's enrolled in MIC Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Not enrolled in the MIC Program
- No one will be excluded on basis of sex or race
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital health delivered multicomponent interventionAlso: Digital Care Solution as supportive personalized careThe MIC program will have set minimum levels of connectivity for each of the three defined conditions under study. | Behavioural | 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 |
Primary outcome
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
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)
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 25380699Aung 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.
- Background: PubMed 34608377Cooling 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.
- Background: PubMed 33778982Dalstrom 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.
- Background: PubMed 33978593Etminani 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.
- Background: PubMed 33055094Hategeka 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.
- Background: PubMed 30422224Kangovi 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.
- Background: PubMed 30537958Nijagal 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.
- Background: PubMed 28965183Roman 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.
- Background: PubMed 26802756Williams 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.
- Background: PubMed 29982445Lopez 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.
- Background: PubMed 41049159Cooling M, Klein CJ, Dalstrom MD, Foulger R, Junis J, Handler JA. Increasing access to care through digital health for the Medicaid population: a novel community case study. Front Digit Health. 2025 Sep 19;7:1524590. doi: 10.3389/fdgth.2025.1524590. eCollection 2025.
- Results publication: PubMed 39834381Klein CJ, Dalstrom M, Bond WF, McGarvey J, Cooling M, Zumpf K, Pierce L, Stoecker B, Handler JA. The feasibility of implementing a digital pregnancy and postpartum support program in the Midwestern United States and the association with maternal and infant health. Prev Med Rep. 2024 Dec 20;49:102953. doi: 10.1016/j.pmedr.2024.102953. eCollection 2025 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda B Cooling, DNP, APRN principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, run by OSF Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's blood pressure control at three points in time (time frame: 3 months, 6 months, 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555095, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.