PEWS Implementation in an LMIC Setting (PEWSPAL)

Implementation of Pediatric Early Warning Scores and a Context-adapted Resuscitation Training Course to Improve Outcomes in an LMIC Pediatric Inpatient Oncology Ward

The PEWS implementation study will be undertaken with the following objectives:

1. Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients.
2. Assess the effectiveness of implementation of PEWS and resuscitation training to impact time sensitive clinical interventions made on patients at risk for clinical deterioration.
3. Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Other: pediatric early warning scoring system and resuscitation curriculum

• Study Type: Interventional
• Enrollment (Actual): 1850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Mills, MD; Phone Number: 651-402-7704; Email: david.mills@childrens.harvard.edu
• Study Contact Backup: Name: Michelle Niescierenko, MD MPH; Phone Number: 617-990-4289; Email: michelle.niescierenko@childrens.harvard.edu

Study Locations

• Palestinian Territory, occupied
  • Bethlehem, Palestinian Territory, occupied
    • Beit Jala Hospital
  • Gaza City, Palestinian Territory, occupied
    • Rantisi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients eligible for the study are defined as pediatric patients (between birth and 12 years of age) admitted and subsequently discharged from the pediatric oncology ward in Beit Jala, Palestine and Gaza City, Palestine between March 2019 to June 2020

Exclusion Criteria:

• Patients will be excluded if they are not admitted to inpatient status. No oncology outpatients such as those in the infusion program will be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Inpatient pediatric oncology patients; All patients admitted to the pediatric oncology ward will be in the cohort	Other: pediatric early warning scoring system and resuscitation curriculum; teaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elevated Pediatric Early Warning Score (PEWS)	frequency of patients whose PEWS score indicates 'risk for clinical deterioration' and receive a clinical intervention. PEWS 3 or greater (Scale is PEWS 0-6) is defined as at risk for clinical deterioration with a higher score concerning for worse clinical outcome.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to antibiotics	Time to antibiotics defined as time from documented vital signs/PEWS to time of antibiotic administration measured in minutes	1 year
Time to IV fluid bolus	Time to fluids defined as time from documented vital signs/PEWS to time of documented IV fluid bolus measured in minutes	1 year
Volume of IV fluids	Volume of fluids received defined as volume given up to 60 minutes after the initiation of the first fluid bolus measured in milliliters	1 year
Length of stay	Length of stay for all patients admitted to the inpatient ward	1 year

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Michelle Niescierenko, MD MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 23, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PEWSpalestine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No