Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT05555095
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2022-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining Digital Health Care Delivery Models Through Medicaid Collaborative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19331}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in participant's blood pressure control at three points in time", 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Decrease in the average systolic and/or diastolic blood pressure'}, {'measure': "Change in participant's glycemic control at three points in time", 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Defined as a reduction \\>1% in glycosylated hemoglobin (hemoglobin A1C)'}, {'measure': 'Change in Patient Assessment of Chronic Illness Care scale (PACIC) from baseline to exit from program', 'timeFrame': 'baseline, end of program, on average of 1 year', 'description': "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"}, {'measure': 'Change in Patient Perception of Health Care Management (adapted form of PACIC to reflect pre/postnatal care) from baseline to exit from program', 'timeFrame': 'baseline, end of program, on average 6 months', 'description': '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'}, {'measure': 'Patient satisfaction, 1-item researcher generated question', 'timeFrame': 'at exit from program, on average 1 year', 'description': "Measure of patient's satisfaction, Participant's recommendation of program to others (Yes/No)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'diabetes', 'maternal health', 'digital health'], 'conditions': ['Hypertension', 'Diabetes Mellitus', 'Maternal Health']}, 'referencesModule': {'references': [{'pmid': '25380699', 'type': 'BACKGROUND', 'citation': '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': '34608377', 'type': 'BACKGROUND', 'citation': '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': '33778982', 'type': 'BACKGROUND', 'citation': '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': '33978593', 'type': 'BACKGROUND', 'citation': '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': '33055094', 'type': 'BACKGROUND', 'citation': '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': '30422224', 'type': 'BACKGROUND', 'citation': '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': '30537958', 'type': 'BACKGROUND', 'citation': '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': '28965183', 'type': 'BACKGROUND', 'citation': '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': '26802756', 'type': 'BACKGROUND', 'citation': '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': '29982445', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of one of four medically qualified health care centers and/or OSF HealthCare as defined by insurance type\n* Insured by Medicaid or dually eligible for Medicare or Medicaid\n* Has one or more of the three following conditions:\n\nHypertension, Diabetes Mellitus, or Pregnancy\n\n* Able to read and understand English or read translated materials in language provided (e.g. Spanish)\n* Minors who are pregnant and less 18 years of age who are enrolled in the MIC Program\n\nExclusion Criteria:\n\n* Not enrolled in the MIC Program\n* No one will be excluded on basis of sex or race'}, 'identificationModule': {'nctId': 'NCT05555095', 'acronym': 'MIC', 'briefTitle': 'Examining Digital Health Care Delivery Models Through Medicaid Collaborative', 'organization': {'class': 'OTHER', 'fullName': 'OSF Healthcare System'}, 'officialTitle': 'The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis', 'orgStudyIdInfo': {'id': '1876230'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSF HealthCare', 'description': 'Subjects from OSF HealthCare', 'interventionNames': ['Behavioral: digital health delivered multicomponent intervention']}, {'label': 'Federally Qualified Health Center (FQHC) - 1', 'description': 'Subjects from Eagle View Community Health System enrolled in MIC Program', 'interventionNames': ['Behavioral: digital health delivered multicomponent intervention']}, {'label': 'Federally Qualified Health Center (FQHC) - 2', 'description': 'Subjects from Chestnut Health System Inc. enrolled in MIC Program', 'interventionNames': ['Behavioral: digital health delivered multicomponent intervention']}, {'label': 'Federally Qualified Health Center (FQHC) - 3', 'description': 'Subjects from Heartland Community Health System enrolled in MIC Program', 'interventionNames': ['Behavioral: digital health delivered multicomponent intervention']}, {'label': 'Federally Qualified Health Center (FQHC) - 4', 'description': "Subjects from Aunt Martha's enrolled in MIC Program", 'interventionNames': ['Behavioral: digital health delivered multicomponent intervention']}], 'interventions': [{'name': 'digital health delivered multicomponent intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Digital Care Solution as supportive personalized care'], 'description': 'The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen J Klein, PhD, APRN', 'role': 'CONTACT'}], 'facility': 'OSF HealthCare System', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}], 'centralContacts': [{'name': 'Colleen J. Klein, PhD, APRN', 'role': 'CONTACT', 'email': 'colleen.klein@osfhealthcare.org', 'phone': '309-655-3899'}, {'name': 'Melinda B Cooling, DNP, APRN', 'role': 'CONTACT', 'email': 'melinda.b.cooling@osfhealthcare.org', 'phone': '309-624-4649'}], 'overallOfficials': [{'name': 'Melinda B Cooling, DNP, APRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSF Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OSF Healthcare System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}