Clinical trial NCT05555095: Examining Digital Health Care Delivery Models Through Medicaid Collaborative
Official title: The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Diabetes Mellitus
Maternal Health
Keywords: hypertension
diabetes
maternal health
digital health
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 19331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Change in participant's blood pressure control at three points in time
timeFrame: 3 months, 6 months, 12 months
measure: Change in participant's glycemic control at three points in time
timeFrame: 3 months, 6 months, 12 months
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
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
measure: Patient satisfaction, 1-item researcher generated question
timeFrame: at exit from program, on average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF HealthCare System
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: Melinda B Cooling, DNP, APRN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.