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Набор скоро начнётся NCT07609381

Clinical Information System Impact on Hospitalized Patients With Chronic Disease

Наблюдательное Diabete Mellitus Kidney Disease Heart Failure Coronary Artery Disease

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: Clinical Information System (CIS) / Connect Care Implementation.
Кому может быть актуально
Состояния в реестре: Diabete Mellitus, Kidney Disease, Heart Failure, Coronary Artery Disease. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating the Impact of Alberta Health Services' New Provincial Clinical Information System on Patient Outcomes and Experiences With Chronic Diseases - Study Protocol for a Multi-center Interrupted Time Series Analysis

Обзор

This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.

Подробное описание

The design of the protocol is a multiple-baseline interrupted time series (ITS) analysis to assess effects of the CIS on patient outcomes with five pre-specified NCDs (diabetes mellitus, coronary artery disease, heart failure, chronic kidney disease, and chronic lung disease) before versus after implementation at each cluster of sites, accounting for pre-existing trends in outcomes and correlation between different time points and sites. The primary outcome will be unplanned hospital readmission and death within 30 days of discharge. Secondary outcomes will include readmission and death as individual outcomes, length of hospital stay, processes of care, and measures of patient experience with care transitions.

The study uses retrospective administrative, clinical, and patient experience data collected between 2019 and 2024, covering periods before and after clinical information system implementation at each site. All observations will be recorded prior to study initiation and will be analyzed retrospectively within a multiple baseline interrupted time series framework.

Вмешательства

  • Другое Clinical Information System (CIS) / Connect Care Implementation
    The intervention (exposure) is the implementation of the Connect Care Clinical Information System (CIS) across Alberta Health Services (AHS) acute-care facilities. Connect Care integrates comprehensive electronic health records, clinician communication tools, pharmacy dispensing data, laboratory and diagnostic imaging results, standardized medication reconciliation, and electronic discharge summaries. It supports coordination across hospital, specialty, and primary care settings and includes a p

Первичные конечные точки

  • All-cause unplanned hospital readmission or death within 30 days after hospital discharge [Срок оценки: Within 30 days after hospital discharge]
Вторичные конечные точки (9)
  • Acute care admission frequency [Срок оценки: Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation]
  • Length of stay in hospital [Срок оценки: From hospital admission date to date of discharge or switch to alternate level of care, up to a maximum of 30 days]
  • 30-day all-cause mortality [Срок оценки: Within 30 days after each discharge.]
  • 30-day all-cause readmission [Срок оценки: Within 30 days after each discharge.]
  • Emergency department visits within 30 days of discharge [Срок оценки: Within 30 days after each discharge.]
  • Outpatient physician follow-up within 30 days [Срок оценки: Within 30 days after each discharge.]
  • Medication dispensation within 120 days of discharge [Срок оценки: Within 120 days after discharge.]
  • Outpatient laboratory testing within 30 days of discharge [Срок оценки: Within 30 days after each discharge.]
  • Multi-question composite score of Information Understanding When Leaving the Hospital from the Canadian Patient Experiences Survey on Inpatient Care [Срок оценки: Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.]

Критерии участия

Критерии включения

  • Adults aged 18 years or older at the time of hospital admission.
  • Residents of Alberta eligible to receive acute-care services in AHS facilities.
  • Hospitalized for any cause during the study period (5 years pre-implementation and 2 years post-implementation of the CIS).
  • Meet the validated case definition for one or more of the five key NCDs (diabetes mellitus, chronic kidney disease, coronary artery disease, heart failure, or chronic lung disease) based on ICD codes, laboratory measures, or pharmacy records during standardized lookback periods (up to 5 years for diagnoses; up to 1 year for labs/pharmacy).
  • Have a qualifying date for the NCD(s) that occurs prior to or during the index hospital admission.
  • Eligible for inclusion in the primary and patient experience outcomes if they survive to hospital discharge.
  • May enter multiple sub-cohorts if more than one NCD is present.

Критерии исключения

  • Individuals younger than 18 years at the time of hospital admission.
  • Non-residents of Alberta or individuals not eligible for care within AHS facilities.
  • Hospitalizations that end in death (excluded from analyses of the primary outcome and patient experience measures).
  • Patients without evidence of any of the five key NCDs during the lookback period or at the index hospital admission.
  • Admissions outside the study period or admissions for which necessary administrative, laboratory, or pharmacy data are unavailable.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Канада · 1 центр
  • University of Calgary — Calgary

Идентификаторы

NCT: NCT07609381 · REB24-1942

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗