Examining Digital Health Care Delivery Models Through Medicaid Collaborative

Hypertension Clinical Trial

— MIC  

Official title:

The Medicaid Innovation Collaborative (MIC) Experience: Transforming Care Through Digital Health: A Mixed Methods Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555095
• Other study ID #: 1876230
• Status: Recruiting
• Start date: September 26, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: OSF Healthcare System
• Contact: Colleen J. Klein, PhD, APRN
• Phone: 309-655-3899
• Email: colleen.klein[@]osfhealthcare.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19331
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension
• Maternal Health

Intervention

Behavioral:
• digital health delivered multicomponent intervention
The MIC program will have set minimum levels of connectivity for each of the three defined conditions under study.

Locations

Country	Name	City	State
United States	OSF HealthCare System	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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