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 34 (updated 02/09/2019, previously: 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
34 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
Trial participating centre
PICU of National Research Center for Maternal and Child Health
Turan ave. 32
Astana
010000
Kazakhstan
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
Planned publication in a high-impact peer-reviewed journal.
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)
Publication list