Clinical trial NCT01561885: Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Community Acquired Pneumonia
Venous Thromboembolism
Acute Kidney Injury
Asthma
Keywords: Clinical Pathways
Length of Stay
Patient-Centered Care
Pragmatic Randomized Controlled Trial
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 341
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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)
* 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)

Primary outcomes:
measure: Decrease in length of hospital stay by two days
timeFrame: During hospitalization period of 7 to 10 days
Secondary outcomes:
measure: 30-Day Rehospitalization
timeFrame: After discharge up to 30 days
measure: Determinants of the Length of Stay
timeFrame: Upon admission until discharge
measure: Pathway Care Specific Clinical Outcomes
timeFrame: Upon admission until discharge
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Khalid National Guard Hospital
state: Makkah
Study officials:
affiliation: National Guard Health Affairs
name: Mujtaba Quadri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs
name: Sherine Esmail, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs
name: Saliman Karsou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs
name: Abdulhameed Gasim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs
name: Zeyad Zahrani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Abdullah International Medical Research Center
name: Majed Al Jeraisy, PharmD
role: PRINCIPAL_INVESTIGATOR
References: