- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609381
Clinical Information System Impact on Hospitalized Patients With Chronic Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nusrat S Shommu, PhD
- Phone Number: 4032103991
- Email: nsshommu@ucalgary.ca
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- University of Calgary
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Contact:
- Nusrat S Shommu, PhD
- Phone Number: 4032103991
- Email: nsshommu@ucalgary.ca
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Principal Investigator:
- Matthew T James, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Time Frame: Within 30 days after hospital discharge
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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).
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Within 30 days after hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acute care admission frequency
Time Frame: Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation
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Number of acute-care hospital admissions occurring during monthly intervals.
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Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation
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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
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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.
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From hospital admission date to date of discharge or switch to alternate level of care, up to a maximum of 30 days
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30-day all-cause mortality
Time Frame: Within 30 days after each discharge.
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Death from any cause within 30 days after hospital discharge, assessed independently from readmission.
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Within 30 days after each discharge.
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30-day all-cause readmission
Time Frame: Within 30 days after each discharge.
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Any acute-care readmission occurring within 30 days after discharge, analyzed separately from mortality.
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Within 30 days after each discharge.
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Emergency department visits within 30 days of discharge
Time Frame: Within 30 days after each discharge.
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Count of emergency department visits within 30 days following discharge.
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Within 30 days after each discharge.
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Outpatient physician follow-up within 30 days
Time Frame: Within 30 days after each discharge.
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Completion of a primary care or specialist outpatient visit within 30 days after discharge (restricted to patients who survived to discharge).
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Within 30 days after each discharge.
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Medication dispensation within 120 days of discharge
Time Frame: Within 120 days after discharge.
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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).
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Within 120 days after discharge.
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Outpatient laboratory testing within 30 days of discharge
Time Frame: Within 30 days after each discharge.
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Completion of recommended outpatient laboratory testing during the early post-discharge period (restricted to patients who survived to discharge).
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Within 30 days after each discharge.
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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.
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Composite score based on three questions related to Information Understanding When Leaving the Hospital
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Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Interrupted time series (ITS) slope and level changes
Time Frame: Monthly intervals for 5 years pre-implementation and 2 years post-implementation.
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Estimated changes in outcome level and trend immediately following CIS implementation and over time, using monthly segmented regression across staggered site launch dates.
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Monthly intervals for 5 years pre-implementation and 2 years post-implementation.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew T James, MD, PhD, University of Calgary
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Nutritional and Metabolic Diseases
- Heart Failure
- Diabetes Mellitus
- Coronary Artery Disease
- Kidney Diseases
- Organization and Administration
- Health Services Administration
- Management Information Systems
- cytokine inducible SH2-containing protein
Other Study ID Numbers
- REB24-1942
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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