Condition category
Neonatal Diseases
Date applied
09/07/2019
Date assigned
12/07/2019
Last edited
11/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pediatric palliative care (PPC) is a human right and, in many cases, a foundational component of the best available standard of care. Across the world, PPC is not adequately available in a variety of clinical environments, including in many pediatric and neonatal intensive care units (PICUs/NICUs). While PPC is most popularly integrated into such units through consultative models of care in which external teams are called to address PPC needs as they are identified, integrative models of care (IMOC) also exist in which ICU personnel identify and address PPC needs within the unit as they arise. The less common IMOC may be uniquely beneficial in its ability to facilitate the delivery of care to special needs patients, maximize available resources, build local PPC capacity, and make PC available in under-resourced environments. Building international PC capacity and integrating the IMOC into PICUs/NICUs depend upon a chain of interventions like The Initiative for Pediatric Palliative Care (IPPC) guidelines, which outline six domains of quality PPC. The objective of this multicenter study was to assess how different PICU/NICU centers around the world currently implement an IMOC of PPC and pediatric critical care in relation to the IPPC recommendations. In addition, this study sought to identify whether the physical environment, technological infrastructure, and human resources of each unit may shape the provision and outcomes of care in relation to IPPC guidelines.

Who can participate?
PICUs/NICUs representing countries from the Americas, Europe, Asia, and Africa.

What does the study involve?
Two questionnaires with multiple choice and open-ended questions were applied to all PICU/NICU centers to develop detailed descriptions of the participating units and the level of IMOC they apply.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Colegio de Ciencias de la Salud (College of Health Sciences), Quito, Ecuador

When is the study starting and how long is it expected to run for?
June 2016 to February 2019

Who is funding the study?
Universidad San Francisco de Quito (Ecuador)

Who is the main contact?
Dr Michelle Grunauer
mgrunauer@usfq.edu.ec

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michelle Grunauer

ORCID ID

http://orcid.org/0000-0002-5821-7603

Contact details

Colegio de Ciencias de la Salud
COCSA
Diego de Robles y Vía Interoceánica
Quito
170157
Ecuador
(+593) 2 297-1700 ext. 1795
mgrunauer@usfq.edu.ec

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2016-091IN

Study information

Scientific title

PICU MIC: Integrated care in pediatric/neonatal intensive care units around the world

Acronym

PICU MIC

Study hypothesis

Participating pediatric intensive care units (PICUs)/neonatal intensive care units (NICUs) implement an integrated model of care combining pediatric intensive and palliative care according to the domains outlined in the Initiative for Pediatric Palliative Care (IPPC) guidelines

Ethics approval

Approved 15/06/2016, Comité de Ética de Investigación en Seres Humanos de la Universidad San Francisco de Quito-Committee of Bioethics Research in Human Beings (IRB) (Campus Cumbáy - Diego de Robles y Via Interoceánica Oficina G206 Casilla Postal 17-1200-841 Quito, Ecuador; (+593) 2-297-1700, ext 1149; comitebioetica@usfq.edu.ec), ref: 2016-091IN.

Study design

Cross-sectional prospective observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant informatin sheet.

Condition

Pediatric palliative and intensive care, pediatric and neonatal diseases

Intervention

This cross-sectional prospective study included a convenience sample of 33 participating PICUs/NICUs representing 18 countries from the Americas, Europe, Asia, and Africa.
Two questionnaires with multiple choice and open-ended questions were applied to all centers to develop detailed descriptions of the participating units.
Questionnaire 1 focused exclusively on unit infrastructure, technology availability, and personnel ratios. Questionnaire 2 gathered further data on personnel, policies, and limited clinical and demographic data on a small sample of currently admitted patients.
Based on the IPPC recommendations, Questionnaire 2 inquired about practices related to the IPPC (The Initiative for Pediatric Palliative Care (IPPC): Quality domains, goals and indicators for family-centered care of children living with life-threatening conditions) domains:
1. Holistic care
2. Family support
3. Child-family unit involvement in care
4. Control of pain and other symptoms
5. Continuity of care
6. Support for grief and bereavement
The sum of these data reflects important aspects of the models of care employed in participating PICUs

Intervention type

Other

Phase

Drug names

Primary outcome measure

Adherence of PICUs/NICUs to the IPPC’s recommendations assessed using questionnaire 2.

Secondary outcome measures

PICUs/NICUs unit infrastructure, technology availability, and personnel ratios assessed by questionnaire 1.

Overall trial start date

19/10/2015

Overall trial end date

01/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. PICUs/NICUs
2. Local IRB approval to take part in the study

Participant type

Other

Age group

Other

Gender

Not Specified

Target number of participants

33 centers

Participant exclusion criteria

ICUs that are not solely for pediatric/neonatal patients.

Recruitment start date

01/06/2016

Recruitment end date

01/07/2018

Locations

Countries of recruitment

Argentina, Bolivia, Chile, China, Ecuador, Ethiopia, Ghana, India, Italy, Kazakhstan, Malaysia, Mexico, Philippines, Spain, Switzerland, Turkey, Ukraine, United States of America

Trial participating centre

PICU- The CHILDS TRust Medical Research Foundation
12-A Nageswara Road Nungambakkam
Chennai
600034
India

Trial participating centre

PICU-Nirmal Hospital, Ltd.
Ring Road
Surat
395002
India

Trial participating centre

Dayanand Medical College & Hospital
Civil Lines
Ludhiana
141001
India

Trial participating centre

University of Florida COM-PICU
841 Prudential Drive
Jacksonville, Florida
32207
United States of America

Trial participating centre

Geneva University Hospitals-Commission cantonale d’éthique de la recherche (CCER) Pharmacien cantonal Rue Adrien-Lachenal 8 1207 Genève N/réf. : OH/fr Dre Marie SAINT-FAUST Service des Soins Intensifs Pédiatriques Dpt des Enfants et Adolescents HUG-PICU
Rue Gabrielle Perret-Gentil 4 1211 Genève 14
Geneva
1205
Switzerland

Trial participating centre

Hospital General Universitario Gregorio Marañón-UCIP
Calle del Dr. Esquerdo, 46
Madrid
28007
Spain

Trial participating centre

Dicel University Medical Hospital-PICU
Dicle Üniversitesi Rektörlüğü
Diyarbakır
21280
Turkey

Trial participating centre

Istanbul University Faculty of Medicine PICU
Beyazıt
Fatih/Istanbul
31387
Turkey

Trial participating centre

Akdeniz University-Faculty of Medicine PICU
Pınarbaşı Mahallesi Akdeniz Ünv.
Antalya
07070
Turkey

Trial participating centre

Gaziosmanpasa University School of Medicine Tokat- PICU
Tokat Gaziosmanpaşa Üniversitesi Taşlıçiftlik Yerleşkesi
Tokat
60250
Turkey

Trial participating centre

Nazarbayev University- PICU at Astana
53 Kabanbay Batyr Ave Nur-Sultan
Astana
010000
Kazakhstan

Trial participating centre

Nazarbayev University- PICU at Karaganda
53 Kabanbay Batyr Ave Nur-Sultan
Karaganda
010000
Kazakhstan

Trial participating centre

Hospìtal del Niño Manuel Ascencio Villarroel, Cochabamba-PICU
HN MAV Av Aniceto Arce esq. G. Urquidi
Cochabamba
4220232
Bolivia

Trial participating centre

Çukurova University Medical Faculty
Balcalı, Çukurova Üniversitesi Rektörlüğü
Adana
01330
Turkey

Trial participating centre

Hospital de Niños Roberto del Río-UPC
Prof. Zañartu 1085 Independencia Región Metropolitana
Santiago
8380000
Chile

Trial participating centre

University Malaya Medical Center-PICU
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Trial participating centre

Vinnitsa National Medical University-PICU
Pyrohova St 56 Vinnytsia Vinnyts'ka oblast
Vinnitsa
21018
Ukraine

Trial participating centre

Pediatric hospital of Fudan University-PICU
399 Wanyuan Rd Minhang Qu Shanghai Shi
Fudan
200032
China

Trial participating centre

Pediatric Critical Care Medicine
20 York St New Haven
New Haven, CT
06510
United States of America

Trial participating centre

Hospital de los Valles- UCIP/UCIN
Avenida Interoceanica y avenida Florencia Torre 2 piso 1 consultorio 134 Edificio Especialidades Médicas Hospital de los Valles
Cumbaya, Quito
170157
Ecuador

Trial participating centre

UCIP
Hospital Regional De Alta Especialidad De Ixtapaluca
Ixtapaluca
56530
Mexico

Trial participating centre

PICU Directorate of child Health Komfo Anokye Teaching Hospital
Room 7 Block J School of Medical Sciences, KNUST
Kumasi
23321
Ghana

Trial participating centre

Unidad Pediatrica de Quemados de los Servicios de Salud del Estado de Puebla, Mexico
Calzada Zalvareta Hospital para El Niño Poblano
Puebla
72000
Mexico

Trial participating centre

Hospital Sotero Del Rio-UCIP
Av. Concha Y Toro 3459 Puente Alto Región Metropolitana
Gran Santiago
8150215
Chile

Trial participating centre

Ospedale Pediatrico Bambino Gesù-PICU
Viale Ferdinando Baldelli n.41-00146
Roma
00146
Italy

Trial participating centre

Division of Pediatric Critical Care Medicine at Stanford University Medical Center-PICU
300 Pasteur Dr. ‎Stanford
Stanford
94305
United States of America

Trial participating centre

Koru Hospital-PICU
Kızılırmak, 1450. Sk. No:13 Çankaya
Ankara
06510
Turkey

Trial participating centre

Azienda Ospedaliera Universitaria Integrata Verona- PICU
Piazzale Aristide Stefani, 1
Verona
37126
Italy

Trial participating centre

Universidad Austral Argentina-PICU
Mariano Acosta 1611 B1630FHB Pilar
Buenos Aires
B1629WWA
Argentina

Trial participating centre

University Hospitals Cleveland Medical Center-PICU
11100 Euclid Avenue
Cleveland, Ohio
44106
United States of America

Trial participating centre

AMANG Rodriguez Memorial Medical Center-PICU
Sumulong Highway Sto. Nino Marikina 1800 Metro Manila
Manila
54025002
Philippines

Trial participating centre

Addis Ababa University, College of Health Sciences-PICU
TikurAnbessa Hospital School of medicine building 4th floor Lideta sub-city Addis Ababa
Addis Ababa
9086
Ethiopia

Trial participating centre

The Johns Hopkins Children's Center PICU
Johns Hopkins Children's Center 1800 Orleans Street
Baltimore, MD
21287
United States of America

Sponsor information

Organisation

Universidad San Francisco de Quito

Sponsor details

Diego de Robles y Vía Interoceánica
Cumbayá
Quito
170157
Ecuador
(593) 2-297-1700, ext 1149
comitebioetica@usfq.edu.ec

Sponsor type

University/education

Website

https://www.usfq.edu.ec/investigacion_y_creatividad/comite_de_etica/Paginas/contactos.aspx

Funders

Funder type

University/education

Funder name

Universidad San Francisco de Quito (Ecuador)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A manuscript on this research is being prepared for publication. It will be submitted to the New England Journal of Medicine in August 2019.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

15/08/2019

Participant level data

Available on request

Basic results (scientific)

Our sample included 33 participating PICUs/NICUs representing 18 countries from the Americas, Europe, Asia, and Africa; HIC units made up 33.33% of the sample, while UMICs made up 42.42% and LMIC/LIC made up 24.24%. Centers in higher income countries generally had higher numbers of doctors, nurses and respiratory therapists per unit, although the relationship between beds per HCP was less consistent. Similarly, HIC units had the greatest number of patients, fastest patient turnover, and lowest percentage of bed use. Units in higher income countries reported a greater number of beds and unit area. Meanwhile, UMIC and LMIC/LIC units had higher ratios of ventilators/resuscitation equipment per bed than HIC units.All groups reported some level of fulfillment of all domains and no group reported perfect fulfillment of any domain of the IPPC recommendations (Table 3). After adjusting for age and sex of each patient, and clustering by unit, centers in HICs had a higher total score than centers in UMICs or LMIC/LICs (63.1% versus 47.4% and 46.5%, respectively). However, this effect was only statistically significant for the comparison between HICs and UMICs (p-value=0.036). Across all the IPPC goals in each domain, centers in HICs generally had higher scores than units in lower resource settings but not all comparisons were statistically significant. When considering the goal of Domain 1 (Holistic care of the child), units in HICs had a score of 73.1% (SD:22.5) while those in UMIC scored 46.2% (SD:22.0) (p-value adjusted for age, sex and clustering by unit = 0.008). Similarly, units in HICs scored 26 percent points higher in Goal 3B (involvement of the family in the communication, decision-making and care planning) and this was statistically significant (adjusted p-value=0.013). Finally, we found an association between HICs and higher scores in both goals of Domain 6 (grief and bereavement support of the family (Goal 6A) and health care providers (Goal 6B).In addition to evaluating IPPC fulfillment scores across centers in countries of different income levels, we investigated if any characteristic of the patients or the center were associated with IPPC scores. A detailed analysis of the different diagnoses of PICU/NICU patients showed no evidence that IPPC guidelines were applied differently depending on the diagnosis of each child (Table 4). Table 5 shows total scores across all domains by different patient characteristics and center characteristics. Results from the univariate GLM model suggested that patients with multiple comorbidities had, on average, slightly higher scores than patients with single comorbidities (p-value = 0.047), but this was not statistically significant once we adjusted for other covariates (p-value = 0.059). In terms of center-level characteristics, we did not find a statistically significant association between equipment availability, percent daily bed use, or patient load per HCP and IPPC scores. However, we found that centers with shorter shift lengths (<8 hours) had higher IPPC scores than centers with increasing shift lengths, after adjusting for other covariates.

Publication list

Publication citations

Additional files

Editorial Notes

11/07/2019: Trial’s existence confirmed by Comité de Ética de Investigación en Seres Humanos de la Universidad San Francisco de Quito-Committee of Bioethics Research in Human Beings (IRB).