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Recruiting NCT05555095

Examining Digital Health Care Delivery Models Through Medicaid Collaborative

Observational Hypertension Diabetes Mellitus Maternal Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: digital health delivered multicomponent intervention.
Who it may be relevant to
Registry conditions: Hypertension, Diabetes Mellitus, Maternal Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Change in participant's blood pressure control at three points in time [Time frame: 3 months, 6 months, 12 months]
  • Change in participant's glycemic control at three points in time [Time frame: 3 months, 6 months, 12 months]
  • 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]
  • 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]
  • Patient satisfaction, 1-item researcher generated question [Time frame: at exit from program, on average 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • OSF HealthCare System — Peoria

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. PMID 25380699
  • 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 34608377
  • 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 33778982
  • 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 33978593
  • 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 33055094
  • 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 30422224
  • 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 PMID 30537958
  • 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 28965183

Identifiers

NCT: NCT05555095 · 1876230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗