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Not yet recruiting NCT07609381

Clinical Information System Impact on Hospitalized Patients With Chronic Disease

Observational Diabete Mellitus Kidney Disease Heart Failure Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Information System (CIS) / Connect Care Implementation.
Who it may be relevant to
Registry conditions: Diabete Mellitus, Kidney Disease, Heart Failure, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • All-cause unplanned hospital readmission or death within 30 days after hospital discharge [Time frame: Within 30 days after hospital discharge]
Secondary outcome measures (9)
  • Acute care admission frequency [Time frame: Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation]
  • Length of stay in hospital [Time frame: 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 [Time frame: Within 30 days after each discharge.]
  • 30-day all-cause readmission [Time frame: Within 30 days after each discharge.]
  • Emergency department visits within 30 days of discharge [Time frame: Within 30 days after each discharge.]
  • Outpatient physician follow-up within 30 days [Time frame: Within 30 days after each discharge.]
  • Medication dispensation within 120 days of discharge [Time frame: Within 120 days after discharge.]
  • Outpatient laboratory testing within 30 days of discharge [Time frame: 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 [Time frame: Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Canada · 1 center
  • University of Calgary — Calgary

Identifiers

NCT: NCT07609381 · REB24-1942

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗