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Clinical Information System Impact on Hospitalized Patients With Chronic Disease

19 de mayo de 2026 actualizado por: University of Calgary

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

124240

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Nusrat S Shommu, PhD
  • Número de teléfono: 4032103991
  • Correo electrónico: nsshommu@ucalgary.ca

Ubicaciones de estudio

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N1
        • University Of Calgary
        • Contacto:
        • Investigador principal:
          • Matthew T James, MD, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of adult Alberta residents receiving acute-care services in Alberta Health Services (AHS) facilities who have one or more of five key noncommunicable diseases: diabetes mellitus, chronic kidney disease, coronary artery disease, heart failure, or chronic lung disease. Participants are identified from routinely collected administrative, laboratory, and pharmacy datasets, with hospital admissions included regardless of most responsible diagnosis. The population is broadly representative of adults with chronic conditions experiencing transitions from hospital to home across the province. Patient experience survey data are available for a random 10% sample of eligible discharges.

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Adults with Key NCDs Receiving Acute Care in AHS
This single cohort includes adult patients in Alberta with one of five key noncommunicable diseases (diabetes mellitus, chronic kidney disease, coronary artery disease, heart failure, or chronic lung disease) who received care in Alberta Health Services (AHS) acute-care facilities during the study period. The cohort is followed over a 7-year window (5 years pre-implementation and 2 years post-implementation of the Clinical Information System), with outcomes measured in into quarterly intervals, both pre- and post-launch of the CIS at each site for this analysis. Sub-cohorts will be identified based on the presence of each NCD and hospitalization history, but all belong to one predefined observational study cohort for the interrupted time series analysis.
Otro: 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 patient-facing portal allowing access to personal health information. The CIS rollout occurred at multiple sites with staggered launch dates and represents one of the largest Epic deployments.
Otros nombres:
  • Epic-Based Clinical Information System

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Periodo de tiempo: Within 30 days after hospital discharge
This primary outcome captures whether a patient experiences either (1) the unplanned hospital readmission for any cause or (2) death from any cause within 30 days following discharge from an acute-care hospitalization. The outcome is restricted to patients who survived to hospital discharge. Analyses will also be stratified by the presence of each of the five key NCDs (diabetes, CKD, CAD, heart failure, chronic lung disease) and by multimorbidity (two or more of the NCDs).
Within 30 days after hospital discharge

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute care admission frequency
Periodo de tiempo: Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation
Number of acute-care hospital admissions occurring during monthly intervals.
Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation
Length of stay in hospital
Periodo de tiempo: From hospital admission date to date of discharge or switch to alternate level of care, up to a maximum of 30 days
Duration of index hospitalization in days, excluding days coded as alternate level of care (occupying a hospital bed but no longer needing acute care while waiting for a transfer to a more suitable setting like long-term care, rehab, or home support), measured from admission to discharge, including multi-facility episodes.
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
Periodo de tiempo: Within 30 days after each discharge.
Death from any cause within 30 days after hospital discharge, assessed independently from readmission.
Within 30 days after each discharge.
30-day all-cause readmission
Periodo de tiempo: Within 30 days after each discharge.
Any acute-care readmission occurring within 30 days after discharge, analyzed separately from mortality.
Within 30 days after each discharge.
Emergency department visits within 30 days of discharge
Periodo de tiempo: Within 30 days after each discharge.
Count of emergency department visits within 30 days following discharge.
Within 30 days after each discharge.
Outpatient physician follow-up within 30 days
Periodo de tiempo: Within 30 days after each discharge.
Completion of a primary care or specialist outpatient visit within 30 days after discharge (restricted to patients who survived to discharge).
Within 30 days after each discharge.
Medication dispensation within 120 days of discharge
Periodo de tiempo: Within 120 days after discharge.
ACE-I/ARB/ARNI prescription dispensed within 120 days for patients with heart failure, CAD, or CKD with ACR >30 mg/mmol.Statin prescription dispensed within 120 days for patients with ASCVD, diabetes (age >40 years), or CKD (age >50 years).
Within 120 days after discharge.
Outpatient laboratory testing within 30 days of discharge
Periodo de tiempo: Within 30 days after each discharge.
Completion of recommended outpatient laboratory testing during the early post-discharge period (restricted to patients who survived to discharge).
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
Periodo de tiempo: Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.
Composite score based on three questions related to Information Understanding When Leaving the Hospital
Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Interrupted time series (ITS) slope and level changes
Periodo de tiempo: Monthly intervals for 5 years pre-implementation and 2 years post-implementation.
Estimated changes in outcome level and trend immediately following CIS implementation and over time, using monthly segmented regression across staggered site launch dates.
Monthly intervals for 5 years pre-implementation and 2 years post-implementation.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Calgary

Investigadores

  • Investigador principal: Matthew T James, MD, PhD, University Of Calgary

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • REB24-1942

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Investigators are not able to make study data available due to contractual requirements of the data custodian - Alberta Health Services. Other researchers may request IPD for the study from the data custodian through the Alberta SPOR Support Unit: https://absporu.ca/research-services/service-application/

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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