Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)
A Pragmatic Randomized Controlled Trial of Patient-Centered Integrated Clinical Pathways Based Versus Usual Care in an Academic Center: National Guard Health Affairs Western Region Experience
調査の概要
詳細な説明
This study is a pragmatic randomized controlled trial. To date, there is a scarcity of randomized controlled trials looking at pathway-based, patient-centered healthcare versus usual care in several high-risk or high volume diagnoses that account for the vast majority of hospitalizations in medical settings.
In this study, the pathway care intervention is a collaborative effort that involves healthcare professionals from multiple departments, including pharmacists, health educators, nurses, social workers, nutritionists, and quality management.
For patients allocated to the usual care, these healthcare professionals will deliver standardized care when consulted. For pathway care patients, this collaborative healthcare will be default.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Makkah
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Jeddah、Makkah、サウジアラビア、21423
- King Khalid National Guard Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria (Overall Criteria):
- One principle diagnosis
- Hemodynamic Stability
Inclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- New onset / in-patient
Acute Kidney Injury:
- Patients with increased serum creatinine of more than 50% from baseline
Community Acquired Pneumonia:
- Age limit
Adult Left Ventricular Heart Failure:
- Age limit
Asthma
- Acute exacerbation of Asthma
Exclusion Criteria (Overall Criteria):
- Intensive Care Unit (ICU) patients
- Pregnancy
- Exclusion Criteria (Specific to each Diagnosis):
Acute Venous Thromboembolism:
- Hemodynamic instability (Systolic Blood Pressure (SBP) less than 90 mmHg or massive Pulmonary Embolism (PE)
- PE patients with an sPESI Score ≥ 1
Acute Kidney Injury:
- Critical care patients (ICU, Coronary Care Unit, burn units)
- Stage 4 and 5 chronic kidney diseases
- Kidney allograft recipients
- Obstructive uropathy
- Glomerulonephritis
- Interstitial nephritis
Community Acquired Pneumonia:
- Intensive Care Unit (ICU) patients
- Pregnancy
Adult Left Ventricular Heart Failure:
- All non-cardiogenic pulmonary edema
- Patients requiring Inotropic agents
Asthma
- Patients with Chronic Obstructive Pulmonary Disease (COPD) and Bronchiectasis
- Severe Asthma (Peak Expiratory Flow Rate (PEFR) less than 40 percent)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Patients on Pathway Care
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Patients who are randomly allocated to Pathway Care will be treated by the Pathway Clinical Teaching Unit as well as other collaborative healthcare professionals (pharmacists, nurses, health educators, nutritionists, and social workers).
The Pathway Care physicians will have access to the Clinical Care Plan on the QuadraMed, which is a detailed, organized, day-to-day treatment plan that includes pre-set orders and medications.
Physicians for the patients on Usual Care will not have access to this information, and the collaborative healthcare will only be provided upon consultation.
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介入なし:Patients on Usual Care
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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 |
時間枠 |
|---|---|
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Decrease in length of hospital stay by two days
時間枠:During hospitalization period of 7 to 10 days
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During hospitalization period of 7 to 10 days
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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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30-Day Rehospitalization
時間枠:After discharge up to 30 days
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To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis
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After discharge up to 30 days
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Determinants of the Length of Stay
時間枠:Upon admission until discharge
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Upon admission until discharge
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Pathway Care Specific Clinical Outcomes
時間枠:Upon admission until discharge
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For pathway care, there are specific targeted outcomes that ought to be met.
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Upon admission until discharge
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mujtaba Quadri, MD、National Guard Health Affairs
- 主任研究者:Sherine Esmail, PharmD、National Guard Health Affairs
- 主任研究者:Saliman Karsou, MD、National Guard Health Affairs
- 主任研究者:Abdulhameed Gasim, MD、National Guard Health Affairs
- 主任研究者:Zeyad Zahrani, MD、National Guard Health Affairs
- 主任研究者:Majed Al Jeraisy, PharmD、King Abdullah International Medical Research Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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