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Идёт набор NCT04162938

Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

Без фазы С лечением Hepatitis C

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: Patient-Centered Electronic App.
Кому может быть актуально
Состояния в реестре: Hepatitis C. Базовые параметры: 18 лет — 100 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

Use of a Patient-Centered Electronic App to Increase Emergency Department Patient's Knowledge on HCV Infection, Disease Progression, and Care to Improve the HCV Care Continuum

Обзор

The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

Подробное описание

An estimated 40-85% of 2.4 million Americans infected with HCV remain unaware of the infection. Further even amongst those aware of the HCV status, the vast majority do not get linked to care or are offered the option for treatment. Busy emergency department (ED) settings, which provide care to 140 million individuals each year, have recently been demonstrated to be a key venue for large-scale HCV testing, with outcomes from several large cities showing rates of disease of upwards of 10%. Significant challenges remain however, as linkage to care (LTC) from EDs has proven particularly elusive. National ED HCV LTC rates typically range from 20-40%, which dramatically restricts the overall impact on patient outcomes. Varied and complex factors contribute to these challenges but include both individual patient level factors, as well as social and health care infrastructure barriers. One critical but potentially mutable factor associated with gaps in LTC, that has yet to be systematically evaluated for ED populations, is the role of patient's comprehension of the 'meaning' of patients' HCV diagnosis, which includes understanding the natural history of the disease, and the associated downstream health consequences of being infected. Placing HCV in the context of a patient based conceptual disease model provides a framework for studying knowledge gaps and misperceptions, which could be used to help improve patient engagement in care, and ultimately both clinical and public health outcomes. Leventhal's Common-Sense Model of Illness Representations provides a foundational framework for understanding an individual's belief and coping strategy to respond to his or her illness, with reliance on both concrete and abstract information (e.g. symptoms or acquired knowledge). For HCV, variables that may impact patient's engagement include a relative lack of urgency to receive care (due to the indolent nature of symptoms and often decades-long disease progression), a perception of ineffective treatment options (rooting from interferon therapy), and the perception of a relative low morbidity and mortality risk associated with HCV (versus e.g. HIV). Leveraging this Common-Sense Model theoretical framework, the investigators' research team proposes to design and evaluate the impact of a patient-centered HCV health belief conception framework for improving LTC interventions and the downstream HCV care continuum. Individualized risk information will be delivered in a patient-centric manner in the ED, gathering easily obtainable data that has proven to predict progression (i.e. Fibrosis-4 score). The investigators propose to first conduct a series of 3 focus group discussion sessions for participants to provide constructive comments and suggestions on the prototype of the personalized HCV educational app which has been blueprinted and is currently under development. This will be followed by development and pilot testing of a personalized patient-centered tablet-facilitated HCV educational program app, focusing on improving patient knowledge regarding HCV in real-time (including using and ED-based fibrosis staging service from precision medicine perspective). The patient informed staging service will include an estimated non-invasive Fibrosis-4 score; a serum fibrosis marker index (includes age, platelet count, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) values). The investigators hypothesize that providing individualized HCV disease progression staging information to ED patients, along with a structured educational LTC program to HCV-infected patients during patients' ED visit, will significantly change patient's health beliefs and perceptions of HCV, and motivate patients to achieve improved rates of LTC, retention in care, anti-viral treatment, and sustained virologic response along the HCV care cascade.

Вмешательства

  • Другое Patient-Centered Electronic App
    The coordinator will enter lab information to generate the patient's Fibrosis-4 score for liver fibrosis staging. With the information of liver fibrosis staging and survey responses, the app will generate individualized reports of the participant's comprehensive HCV disease progression, knowledge, and level of interest in receiving HCV care. The app will then deliver a streamlined, tailored, brief education message and include information regarding services and assistance for receiving HCV care.

Первичные конечные точки

  • Linkage to care rate (days) [Срок оценки: 28 months]
Вторичные конечные точки (6)
  • Change in HCV knowledge as assessed by True/False survey questions [Срок оценки: Immediately before and immediately after use of the education app, up to 1 hour]
  • Change in perceived barriers to HCV care as assessed by a Likert Scale [Срок оценки: Immediately before and immediately after use of the education app, up to 1 hour]
  • Change in level of motivation to receive HCV care as assessed by a Likert Scale [Срок оценки: Immediately before and immediately after use of the education app, up to 1 hour]
  • Number of patients who begin HCV antiviral treatment [Срок оценки: 28 months]
  • Number of patients who complete HCV antiviral treatment [Срок оценки: 28 months]
  • Number of patients who have an undetectable viral load 12 weeks after completing HCV antiviral treatment [Срок оценки: 28 months]

Критерии участия

Критерии включения

  • Johns Hopkins Hospital ED patient
  • 18 years or older
  • HCV positive without HCV RNA information

Критерии исключения

  • Younger than 18 years of age
  • Unable to provide informed consent
  • Altered mental status
  • Incarcerated
  • Critically ill

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Johns Hopkins University — Baltimore

Публикации

  • Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, Holmberg SD. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014 Mar 4;160(5):293-300. doi: 10.7326/M13-1133. PMID 24737271
  • Ly KN, Hughes EM, Jiles RB, Holmberg SD. Rising Mortality Associated With Hepatitis C Virus in the United States, 2003-2013. Clin Infect Dis. 2016 May 15;62(10):1287-1288. doi: 10.1093/cid/ciw111. Epub 2016 Mar 1. PMID 26936668
  • Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012 Aug 17;61(RR-4):1-32. PMID 22895429
  • Hofmeister MG, Rosenthal EM, Barker LK, Rosenberg ES, Barranco MA, Hall EW, Edlin BR, Mermin J, Ward JW, Ryerson AB. Estimating Prevalence of Hepatitis C Virus Infection in the United States, 2013-2016. Hepatology. 2019 Mar;69(3):1020-1031. doi: 10.1002/hep.30297. Epub 2018 Nov 6. PMID 30398671
  • Maier MM, Ross DB, Chartier M, Belperio PS, Backus LI. Cascade of Care for Hepatitis C Virus Infection Within the US Veterans Health Administration. Am J Public Health. 2016 Feb;106(2):353-8. doi: 10.2105/AJPH.2015.302927. Epub 2015 Nov 12. PMID 26562129
  • Viner K, Kuncio D, Newbern EC, Johnson CC. The continuum of hepatitis C testing and care. Hepatology. 2015 Mar;61(3):783-9. doi: 10.1002/hep.27584. Epub 2015 Jan 30. PMID 25348499
  • Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014. PMID 24988388
  • Rui P, Kang K, Ashman J. National Hospital Ambulatory Medical Care Survey: 2016 emergency department summary tables. 2016. Vol 2019. Atlanta, GA: Centers for Disease Control and Prevention; 2019.

Идентификаторы

NCT: NCT04162938 · IRB00227304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗