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Clinical Information System Impact on Hospitalized Patients With Chronic Disease

19 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

124240

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
        • Contatto:
        • Investigatore principale:
          • Matthew T James, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.
Altri nomi:
  • Epic-Based Clinical Information System

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute care admission frequency
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Interrupted time series (ITS) slope and level changes
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Calgary

Investigatori

  • Investigatore principale: Matthew T James, MD, PhD, University of Calgary

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

27 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • REB24-1942

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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/

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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