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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Asthma; Acute Kidney Injury; Venous Thromboembolism; Community Acquired Pneumonia
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 341
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Jeddah, Makkah, Saudi Arabia, 21423
      • King Khalid National Guard Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in length of hospital stay by two days	During hospitalization period of 7 to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-Day Rehospitalization	To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis	After discharge up to 30 days
Determinants of the Length of Stay		Upon admission until discharge
Pathway Care Specific Clinical Outcomes	For pathway care, there are specific targeted outcomes that ought to be met.	Upon admission until discharge

Collaborators and Investigators

• Sponsor: Majed Aljeraisy
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 18, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Patient-Centered Care; Length of Stay; Clinical Pathways; Pragmatic Randomized Controlled Trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Embolism and Thrombosis; Acute Kidney Injury; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: RC 10/134/J