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Идёт набор NCT05480930

Improving Nighttime Access to Care and Treatment; Part 4-Haiti

Без фазы С лечением Telemedicine Pediatrics

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: paper-based clinical decision support (dCDS) tool, digital clinical decision support (dCDS) tool.
Кому может быть актуально
Состояния в реестре: Telemedicine, Pediatrics. Базовые параметры: до 10 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
Haiti
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti

Обзор

Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency. A telemedicine and medication delivery service (TMDS) is a viable healthcare delivery option to bridge the gap in nighttime care. This interrupted time series study (pre/post) will evaluate a digital clinical decision-support (dCDS) tool. The objective is to assess if the tool is associated with an improvement in guideline adherence by TMDS providers.

Подробное описание

Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a digital clinical decision support (dCDS) tool designed for use at a pediatric TMDS in an interrupted time series study. The pre-intervention is use of the existing paper CDS tool and the intervention is use of the dCDS tool. This initiative is significant because it uses telemedicine and medication delivery to address one of the most fundamental challenges in pediatrics early access to pediatric healthcare.

Вмешательства

  • Другое paper-based clinical decision support (dCDS) tool
    The paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.
  • Другое digital clinical decision support (dCDS) tool
    The intervention is a digitized version of the paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.

Первичные конечные точки

  • Change in provider guideline adherence rates at the call center between use of the paper and digital clinical decision support tools (CDS). [Срок оценки: Two 16 month intervention periods less the 2 week wash out.]
Вторичные конечные точки (3)
  • Enumeration of clinical status of participants at 10-day follow up [Срок оценки: 10 days]
  • Change in call duration between use of the paper and digital clinical decision support tools (CDS). [Срок оценки: From time incoming call is answered until treatment plan has been explained (approximately 10 to 20 minutes).]
  • Change in time to medication delivery between use of the paper and digital clinical decision support tools (CDS). [Срок оценки: From time incoming call is answered until medication is delivered to the participant's home (approximately 45-120 minutes).]

Критерии участия

Inclusion criteria for child, parent/guardian participants:

  • Children 10 years of age or younger with an acute illness
  • Parent/guardian contacts the TMDS in regards to the illness during hours of operation
  • Parental/guardian agreement to a waiver of documentation of consent when contact is by phone only OR written consent/assent at the household from the parent/guardian and child (7yrs and older) for participants who receive a household visit.

Exclusion criteria for child, parent/guardian participants:

  • No consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Haiti · 1 центр
  • CV Foundation — Gressier

Идентификаторы

NCT: NCT05480930 · IRB202201220 · R21TW012332

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗