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

Sponsor

Majed Aljeraisy (Other)

Overall Status

Completed

CT.gov ID

NCT01561885

Collaborator

(none)

341

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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	Phase
Heart Failure Community Acquired Pneumonia Venous Thromboembolism Acute Kidney Injury Asthma	Other: Pathway-Based Care	N/A

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

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 :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 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

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

Decrease in length of hospital stay by two days [During hospitalization period of 7 to 10 days]

Secondary Outcome Measures

30-Day Rehospitalization [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
Determinants of the Length of Stay [Upon admission until discharge]
Pathway Care Specific Clinical Outcomes [Upon admission until discharge]
For pathway care, there are specific targeted outcomes that ought to be met.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Khalid National Guard Hospital	Jeddah	Makkah	Saudi Arabia	21423

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: 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