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Идёт набор NCT05555095

Examining Digital Health Care Delivery Models Through Medicaid Collaborative

Наблюдательное Hypertension Diabetes Mellitus Maternal Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: digital health delivered multicomponent intervention.
Кому может быть актуально
Состояния в реестре: Hypertension, Diabetes Mellitus, Maternal Health. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

  • Change in participant's blood pressure control at three points in time [Срок оценки: 3 months, 6 months, 12 months]
  • Change in participant's glycemic control at three points in time [Срок оценки: 3 months, 6 months, 12 months]
  • Change in Patient Assessment of Chronic Illness Care scale (PACIC) from baseline to exit from program [Срок оценки: 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 [Срок оценки: baseline, end of program, on average 6 months]
  • Patient satisfaction, 1-item researcher generated question [Срок оценки: at exit from program, on average 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Not enrolled in the MIC Program
  • No one will be excluded on basis of sex or race

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • OSF HealthCare System — Peoria

Публикации

  • 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

Идентификаторы

NCT: NCT05555095 · 1876230

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗