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Clinical Information System Impact on Hospitalized Patients With Chronic Disease

19 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

124240

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Outro: 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.
Outros nomes:
  • Epic-Based Clinical Information System

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Acute care admission frequency
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Interrupted time series (ITS) slope and level changes
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Calgary

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de maio de 2026

Primeira postagem (Real)

27 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • REB24-1942

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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/

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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