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Clinical Information System Impact on Hospitalized Patients With Chronic Disease

19 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

124240

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University Of Calgary
        • Contact:
        • Chercheur principal:
          • Matthew T James, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: 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.
Autres noms:
  • Epic-Based Clinical Information System

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Acute care admission frequency
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Interrupted time series (ITS) slope and level changes
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Calgary

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REB24-1942

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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/

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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