Diabete MellitusNCT07609381
Clinical Information System Impact on Hospitalized Patients With Chronic Disease
An observational study of Diabete Mellitus and Kidney Disease, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Kidney Disease, Heart Failure
- What is being tested?
- Clinical Information System (CIS) / Connect Care Implementation
- How many people
- 124,240 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Calgary
Calgary, Alberta, T2N 4N1
Nusrat S Shommu, PhD, 4032103991, nsshommu@ucalgary.ca
Matthew T James, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Diabete Mellitus, Kidney Disease, Heart Failure, Coronary Artery Disease, Chronic Lung Diseases
- Being tested
- Clinical Information System (CIS) / Connect Care Implementation
- Keywords
- Clinical Information System
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases, Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Information System (CIS) / Connect Care ImplementationOther
Also called Epic-Based Clinical Information System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Information System (CIS) / Connect Care Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 30 days after hospital discharge
Secondary outcomes (9)
Acute care admission frequency
Number of acute-care hospital admissions occurring during monthly intervals.
Measured: Monthly intervals across the 7-year follow-up (5 years pre-implementation, 2 years post-implementation
Length of stay in hospital
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.
Measured: 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
Death from any cause within 30 days after hospital discharge, assessed independently from readmission.
Measured: Within 30 days after each discharge.
30-day all-cause readmission
Any acute-care readmission occurring within 30 days after discharge, analyzed separately from mortality.
Measured: Within 30 days after each discharge.
Emergency department visits within 30 days of discharge
Count of emergency department visits within 30 days following discharge.
Measured: Within 30 days after each discharge.
Outpatient physician follow-up within 30 days
Completion of a primary care or specialist outpatient visit within 30 days after discharge (restricted to patients who survived to discharge).
Measured: Within 30 days after each discharge.
Medication dispensation within 120 days of 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).
Measured: Within 120 days after discharge.
Outpatient laboratory testing within 30 days of discharge
Completion of recommended outpatient laboratory testing during the early post-discharge period (restricted to patients who survived to discharge).
Measured: 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
Composite score based on three questions related to Information Understanding When Leaving the Hospital
Measured: Survey completed up to12 weeks following discharge among a 10% random sample of patients discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 124,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew T James, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609381
- Sponsor's protocol ID
- REB24-1942
- Status last verified
- Apr 2026
- First submitted
- 11 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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/
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07609381
- Acronym / sponsor ID
- REB24-1942
- Conditions
- Diabete Mellitus, Kidney Disease, Heart Failure, Coronary Artery Disease, Chronic Lung Diseases
- Keywords
- Clinical Information System
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 124,240 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Key NCDs Receiving Acute Care in AHS | – | Other: Clinical Information System (CIS) / Connect Care ImplementationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Information System (CIS) / Connect Care ImplementationAlso: Epic-Based Clinical Information SystemThe 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 | Adults with Key NCDs Receiving Acute Care in AHS |
Primary outcome
All-cause unplanned hospital readmission or death within 30 days after hospital discharge
Time frame: 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).
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew T James, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Kidney Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nusrat S Shommu, PhD (4032103991, nsshommu@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause unplanned hospital readmission or death within 30 days after hospital discharge (time frame: Within 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.