Clinical Information System Impact on Hospitalized Patients With Chronic Disease
2026年5月19日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
观察性的
注册 (估计的)
124240
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nusrat S Shommu, PhD
- 电话号码：4032103991
- 邮箱：nsshommu@ucalgary.ca
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 4N1
- University Of Calgary
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接触：
- Nusrat S Shommu, PhD
- 电话号码：4032103991
- 邮箱：nsshommu@ucalgary.ca
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首席研究员：
- Matthew T James, MD, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All-cause unplanned hospital readmission or death within 30 days after hospital discharge
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acute care admission frequency
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Interrupted time series (ITS) slope and level changes
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew T James, MD, PhD、University Of Calgary
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- REB24-1942
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.