NCT04180306

Brief Summary

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

  1. 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. 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. 3.Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

November 23, 2019

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to antibiotics

    1 year

  • Time to IV fluid bolus

    1 year

  • Volume of IV fluids

    1 year

  • Length of stay

    1 year

Study Arms (1)

Inpatient pediatric oncology patients

OTHER

All patients admitted to the pediatric oncology ward will be in the cohort

Other: pediatric early warning scoring system and resuscitation curriculum

Interventions

teaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting

Inpatient pediatric oncology patients

Eligibility Criteria

Age0 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beit Jala Hospital

Bethlehem, Palestinian Territories

Location

Rantisi Hospital

Gaza, Palestinian Territories

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Michelle Niescierenko, MD MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 23, 2019

First Posted

November 27, 2019

Study Start

September 1, 2019

Primary Completion

October 31, 2022

Study Completion

September 30, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations