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Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01561885
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to determine if by providing a collaborative, integrated pathway-based healthcare compared to the usual healthcare, whether or not this would be superior in reducing the length of hospital stay across five high frequency /high risk medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.

Condition or disease Intervention/treatment
Heart Failure Community Acquired Pneumonia Venous Thromboembolism Acute Kidney Injury Asthma Other: Pathway-Based Care

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : March 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Patients on Pathway Care Other: Pathway-Based Care
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.
No Intervention: Patients on Usual Care

Outcome Measures

Primary Outcome Measures :
  1. Decrease in length of hospital stay by two days [ Time Frame: During hospitalization period of 7 to 10 days ]

Secondary Outcome Measures :
  1. 30-Day Rehospitalization [ Time Frame: After discharge up to 30 days ]
    To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis

  2. Determinants of the Length of Stay [ Time Frame: Upon admission until discharge ]
  3. Pathway Care Specific Clinical Outcomes [ Time Frame: Upon admission until discharge ]
    For pathway care, there are specific targeted outcomes that ought to be met.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. Inclusion Criteria (Overall Criteria):

    • One principle diagnosis
    • Hemodynamic Stability
  2. 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


    • Acute exacerbation of Asthma
  3. Exclusion Criteria (Overall Criteria):

    • Intensive Care Unit (ICU) patients
    • Pregnancy
  4. 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


  • Patients with Chronic Obstructive Pulmonary Disease (COPD) and Bronchiectasis
  • Severe Asthma (Peak Expiratory Flow Rate (PEFR) less than 40 percent)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561885

Saudi Arabia
King Khalid National Guard Hospital
Jeddah, Makkah, Saudi Arabia, 21423
Sponsors and Collaborators
Majed Aljeraisy
Principal Investigator: Mujtaba Quadri, MD National Guard Health Affairs
Principal Investigator: Sherine Esmail, PharmD National Guard Health Affairs
Principal Investigator: Saliman Karsou, MD National Guard Health Affairs
Principal Investigator: Abdulhameed Gasim, MD National Guard Health Affairs
Principal Investigator: Zeyad Zahrani, MD National Guard Health Affairs
Principal Investigator: Majed Al Jeraisy, PharmD King Abdullah International Medical Research Center
More Information

Responsible Party: Majed Aljeraisy, Research Office Head, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT01561885     History of Changes
Other Study ID Numbers: RC 10/134/J
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Majed Aljeraisy, King Abdullah International Medical Research Center:
Clinical Pathways
Length of Stay
Patient-Centered Care
Pragmatic Randomized Controlled Trial

Additional relevant MeSH terms:
Heart Failure
Acute Kidney Injury
Venous Thromboembolism
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases