NCT07609381

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124,240

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 11, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

May 11, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Clinical Information System

Outcome Measures

Primary Outcomes (1)

  • All-cause unplanned hospital readmission or death 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

Secondary Outcomes (9)

  • Acute care admission frequency

    Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation

  • Length of stay in hospital

    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

    Within 30 days after each discharge.

  • 30-day all-cause readmission

    Within 30 days after each discharge.

  • Emergency department visits within 30 days of discharge

    Within 30 days after each discharge.

  • +4 more secondary outcomes

Other Outcomes (1)

  • Interrupted time series (ITS) slope and level changes

    Monthly intervals for 5 years pre-implementation and 2 years post-implementation.

Study Arms (1)

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.

Other: Clinical Information System (CIS) / Connect Care Implementation

Interventions

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.

Also known as: Epic-Based Clinical Information System
Adults with Key NCDs Receiving Acute Care in AHS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.
  • May enter multiple sub-cohorts if more than one NCD is present.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusKidney DiseasesHeart FailureCoronary Artery Disease

Interventions

Management Information Systemscytokine inducible SH2-containing protein

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Officials

  • Matthew T James, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nusrat S Shommu, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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/

Locations