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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
観察的
入学 (推定)
124240
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nusrat S Shommu, PhD
- 電話番号：4032103991
- メール：nsshommu@ucalgary.ca
研究場所
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Alberta
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Calgary、Alberta、カナダ、T2N 4N1
- University Of Calgary
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コンタクト：
- Nusrat S Shommu, PhD
- 電話番号：4032103991
- メール：nsshommu@ucalgary.ca
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主任研究者：
- Matthew T James, MD, PhD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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All-cause unplanned hospital readmission or death within 30 days after hospital discharge
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acute care admission frequency
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Interrupted time series (ITS) slope and level changes
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Matthew T James, MD, PhD、University Of Calgary
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月19日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月27日
QC基準を満たした最後の更新が送信されました
2026年5月19日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- REB24-1942
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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/
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。