Pediatric intensive and palliative care in pediatric/neonatal intensive care units around the world
| ISRCTN | ISRCTN12556149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12556149 |
| Secondary identifying numbers | 2016-091IN |
- Submission date
- 09/07/2019
- Registration date
- 12/07/2019
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Colegio de Ciencias de la Salud, COCSA
Diego de Robles y Vía Interoceánica
Quito
170157
Ecuador
 ORCID ID |
0000-0002-5821-7603 |
|---|---|
| Phone | (+593) 2 297-1700 ext. 1795 |
| mgrunauer@usfq.edu.ec |
Study information
| Study design | Cross-sectional prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant informatin sheet. |
| Scientific title | PICU MIC: Integrated care in pediatric/neonatal intensive care units around the world |
| Study acronym | PICU MIC |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 19/10/2015 |
| Completion date | 01/02/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target number of participants | 34 centers |
| Key inclusion criteria | 1. PICUs/NICUs 2. Local IRB approval to take part in the study |
| Key exclusion criteria | ICUs that are not solely for pediatric/neonatal patients. |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 01/07/2018 |
Locations
Countries of recruitment
- Argentina
- Bolivia
- Chile
- China
- Ecuador
- Ethiopia
- Ghana
- India
- Italy
- Kazakhstan
- Malaysia
- Mexico
- Philippines
- Spain
- Switzerland
- Türkiye
- Ukraine
- United States of America
Study participating centres
Nungambakkam
Chennai
600034
India
Surat
395002
India
Ludhiana
141001
India
Jacksonville, Florida
32207
United States of America
Geneva
1205
Switzerland
Madrid
28007
Spain
Diyarbakır
21280
Türkiye
Fatih/Istanbul
31387
Türkiye
Akdeniz Ünv.
Antalya
07070
Türkiye
Taşlıçiftlik Yerleşkesi
Tokat
60250
Türkiye
Nur-Sultan
Astana
010000
Kazakhstan
Nur-Sultan
Karaganda
010000
Kazakhstan
Cochabamba
4220232
Bolivia
Adana
01330
Türkiye
Independencia
Región Metropolitana
Santiago
8380000
Chile
Kuala Lumpur
59100
Malaysia
Vinnytsia
Vinnyts'ka oblast
Vinnitsa
21018
Ukraine
Minhang Qu
Shanghai Shi
Fudan
200032
China
New Haven
New Haven, CT
06510
United States of America
Cumbaya, Quito
170157
Ecuador
Ixtapaluca
56530
Mexico
School of Medical Sciences, KNUST
Kumasi
23321
Ghana
Hospital para El Niño Poblano
Puebla
72000
Mexico
Puente Alto
Región Metropolitana
Gran Santiago
8150215
Chile
Roma
00146
Italy
Stanford
94305
United States of America
Çankaya
Ankara
06510
Türkiye
Verona
37126
Italy
B1630FHB Pilar
Buenos Aires
B1629WWA
Argentina
Cleveland, Ohio
44106
United States of America
Marikina
1800 Metro Manila
Manila
54025002
Philippines
Lideta sub-city Addis Ababa
Addis Ababa
9086
Ethiopia
1800 Orleans Street
Baltimore, MD
21287
United States of America
Astana
010000
Kazakhstan
Sponsor information
University/education
Diego de Robles y Vía Interoceánica
Cumbayá
Quito
170157
Ecuador
| Phone | (593) 2-297-1700, ext 1149 |
|---|---|
| comitebioetica@usfq.edu.ec | |
| Website | https://www.usfq.edu.ec/investigacion_y_creatividad/comite_de_etica/Paginas/contactos.aspx |
"ROR" |
https://ror.org/01r2c3v86 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/10/2021 | 26/11/2021 | Yes | No | |
| Results article | 05/10/2021 | 26/11/2021 | Yes | No | |
| Results article | 15/11/2021 | 18/08/2023 | Yes | No |
Editorial Notes
18/08/2023: Publication reference added.
26/11/2021: Publication references added.
30/09/2019: A typographical error in the publication and dissemination plan was corrected.
02/09/2019: The following changes were made to the trial record:
1. The interventions were changed.
2. The target number of participants was changed from 33 centres to 34 centres.
3. PICU of National Research Center for Maternal and Child Health was added to the trial participating centres.
29/08/2019: Internal review.
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).
