The Genesis of The CHAMP-Path: Pragmatic RCTs Methodology

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Sherine Elsayed Mohamed Ismail
Maryam Khalil
Jani Hafez
Oyndamola Yusuf
Jane Thomson
Muhammed Siddiqui
K.H. Mujtaba Quadri

Abstract

A clinical pathway is an evidence-based integrated plan of care within a pre-defined time frame by multidisciplinary health care professionals. There is conflicting evidence about the utility of clinical pathways in real life settings. The aim of the study is to determine if collaborative, clinical pathway-based care (PC) vs. Usual care (UC) will decrease the length of stay (LOS) across multiple medical diagnoses. CHAMP-Path is a pragmatic, parallel, single blind, and randomized controlled trial. Physicians were randomized into two teams. Patient randomization was computer-generated through permuted blocks in 1:1 ratio, and allocation concealed. Eligibility criteria is age ≥ fourteen years, hemodynamic stability, and pathway-specific inclusion and exclusion criteria. The intervention is PC compared to UC. The primary outcome is the reduction in LOS. The secondary outcomes are patient- centered outcomes, determinants of LOS, and 30-day re-admission rate. A sample of 512 patients was estimated (Venous Thromboembolism: 128, Asthma: 90, Heart Failure: 90, Community Acquired Pneumonia: 166, Acute kidney injury: 38) to provide 80% power, alpha of 5% and accounting for 20% attrition. Mean LOS ± SD, 95% CI, p-value will be performed for LOS and regression analysis to identify determinants of LOS. 

Article Details

How to Cite
Ismail, S. E. M., Khalil, M., Hafez, J., Yusuf, O., Thomson, J., Siddiqui, M., & Quadri, K. M. (2017). The Genesis of The CHAMP-Path: Pragmatic RCTs Methodology. Principles and Practice of Clinical Research, 3(1). Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/46
Section
Study Design
Author Biographies

Sherine Elsayed Mohamed Ismail, king Saud Bin Abdulaziz University, king Abdulaziz Medical City , King Khalid hospital, Pharmaceutical Care Department

Sherine Ismail, BSc, PharmD, BCPS, BCACP is a co-principal investigator for the CHAMP-Path Study, and currently works as a Nephrology Clinical Pharmacist, at King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia. She is candidate for MPH-EPI by Harvard T.H. Chan School of Public Health.

Maryam Khalil, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia

Maryam is the Research Assistant for the CHAMP-Path Study currently being conducted at the King Abdulaziz Medical City in Jeddah, Saudi Arabia. She has a Bachelor of Science degree in Community Development with a concentration in Community Services from Central Michigan University (USA).

Jani Hafez, King Abdullah International Medical Research Center, King Khalid hospital, Quality Management Department, Jeddah, Saudi Arabia

Jani is a registered Nurse from Canada with a Bachelor’s degree in Health Administration and CPHQ, currently employed as a Quality Management Specialist and a co-investigator for the CHAMP-Path Study, since its inception in the development of fifteen (15) clinical pathways.

Oyndamola Yusuf, currently ( Department of Epidemiology and Medical statistics, College of Medicine, University of Ibadan, Nigeria)

PhD is co-investigator and biostatistician for the CHAMP-Path study, she used to work at King Abullah International Medical Research Center, Jeddah, KSA. Currently she is working as a senior lecturer at the Department of Epidemiology and Medical statistics, College of Medicine, University of Ibadan, Nigeria.

Jane Thomson, King Abdullah International Medical Research Center, King Khalid hospital, Nursing Department, Jeddah, Saudi Arabia

co-investigator for the CHAMP-Path Study, and is currently the Director of Clinical Nursing for Medical & Surgical Services at the King Abdulaziz Medical City in Jeddah, Saudi Arabia.

Muhammed Siddiqui, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia

co-investigator for the CHAMP-Path Study, and works as a Research Assistant with the King Abdullah International Medical Research Center (KAIMRC) in Jeddah, Saudi Arabia. He has a diploma in CRPC and an MBBS degree from Pakistan. 

K.H. Mujtaba Quadri, National University of Medical sciences, Rawalpindi, Pakistan

Professor of Medicine and Dean of innovation commercialization and academic development

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