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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by King Abdullah International Medical Research Center
Sponsor:
Information provided by (Responsible Party):
Majed Aljeraisy, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:
NCT01561885
First received: March 18, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention
Clinical Pathways
Other: Pathway-Based Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by King Abdullah International Medical Research Center:

Primary Outcome Measures:
  • Decrease in length of hospital stay by two days [ Time Frame: During hospitalization period of 7 to 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-Day Rehospitalization [ Time Frame: After discharge up to 30 days ] [ Designated as safety issue: No ]
    To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis

  • Determinants of the Length of Stay [ Time Frame: Upon admission until discharge ] [ Designated as safety issue: No ]
  • Pathway Care Specific Clinical Outcomes [ Time Frame: Upon admission until discharge ] [ Designated as safety issue: No ]
    For pathway care, there are specific targeted outcomes that ought to be met.


Estimated Enrollment: 504
Study Start Date: March 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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

    Asthma

    • 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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561885

Contacts
Contact: Mujtaba Quadri, MD +966 2 624000 ext 21665 QuadriMU@ngha.med.sa

Locations
Saudi Arabia
King Khalid National Guard Hospital Recruiting
Jeddah, Makkah, Saudi Arabia, 21423
Contact: Mujtaba Quadri, MD    +966 2 624000 ext 21665    QuadriMU@ngha.med.sa   
Principal Investigator: Mujtaba Quadri, MD         
Sponsors and Collaborators
Majed Aljeraisy
Investigators
Principal Investigator: Mujtaba Quadri, MD National Guard Health Affairs
Principal Investigator: Sherine Esmail, PharmD National Guard Health Affairs
Principal Investigator: Suliman 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

No publications provided

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
Study First Received: March 18, 2012
Last Updated: June 30, 2014
Health Authority: Saudi Arabia: National Guard Health Affairs

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

ClinicalTrials.gov processed this record on August 28, 2014