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Accidental InjuriesP-KIDs CARENCT06075108

The P-KIDs CARE Health Systems Intervention in Tanzania

A study testing P-KIDs CARE in people with Accidental Injuries and Global Child Health, run by University of Utah at 1 site in Tanzania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of the proposed research is to develop and pilot a locally-relevant, multicomponent intervention to streamline the triage process (e.g. patient assessment, stabilization, and disposition) for pediatric injury patients in Tanzania. Read more about this study

Who is it for?
Any age
What is being tested?
P-KIDs CARE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteTanzania
Study dates
5 Aug 2024to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • AIM 1 (mixed methods research)
  • Enroll into the pediatric injury registry all pediatric (<18 years old) patients seeking care at one of the study health facilities for an acute injury.
  • The investigators will conduct in-depth interviews with the following group: Family members of a pediatric injury patients seeking care at the study facilities.
  • The investigators will conduct focus group discussions with the following group: Health care providers providing care to pediatric injury patients at the study facilities.
  • AIM 2 (develop intervention)
  • The investigators will hold a 2-day intervention development workshop with the interdisciplinary study team.
Show all 14Show fewer
  • The investigators will conduct focus group discussions with the following groups:
  • Health care providers providing care to pediatric injury patients at the study health facilities
  • A community-engaged panel including family members of pediatric injury patients
  • AIM 3 (pilot intervention)
  • The investigators will enroll into the pediatric injury registry all pediatric (<18 years old) patients seeking care at one of the study health facilities for an acute injury.
  • The investigators will conduct surveys and exit interviews with the following groups:
  • Health care providers providing care to pediatric injury patients at the study health facilities.
  • Family members of pediatric injury patients.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth M. Keating, MD, MSPH contact

801-587-7450

Elizabeth.Keating@hsc.utah.edu

Tanzania1 site, 1 recruiting

  • Kilimanjaro Christian Medical Centre

    Moshi

    Blandina Mmbaga, MD, PhD, +255272754201, b.mmbaga@kcri.ac.tz

    Recruiting

Other trials in Tanzania

About this study

Official title: P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for Injured Children in Tanzania

The objective of the proposed research is to develop and pilot a locally-relevant, multicomponent intervention to streamline the triage process (e.g. patient assessment, stabilization, and disposition) for pediatric injury patients in Tanzania. This health systems intervention will work at the first level of medical contact (e.g., health center and district hospital), in order to facilitate timely disposition and referrals, and subsequently decrease time to definitive care. The proposed study has three aims: 1) With a mixed methods approach, describe the barriers to pediatric injury care at the first medical contact; 2) Iteratively develop the P-KIDs CARE intervention using a nominal group technique and conduct a pre-implementation assessment and refinement; 3) Pilot the P-KIDs CARE intervention and perform an implementation-focused formative evaluation. The proposed study focuses on pediatric injury patients and the family members and healthcare providers that care for them in Kilimanjaro, Tanzania. The investigators will recruit pediatric injury patients, family members, and healthcare providers from 2 health facilities in the Kilimanjaro Region.

Read the detailed description

In Aim 1, the investigators will conduct formative research to inform development of the P-KIDs CARE intervention. The investigators will enroll 100 children into the pediatric injury registry and conduct capacity assessments of the two study facilities using the WHO Health Emergency Unit Assessment Tool. The investigators will conduct in-depth interviews (IDIs) with 15 family members of pediatric injury patients who were referred and made it to Kilimanjaro Christian Medical Centre (KCMC), and 15 family members of pediatric injury patients who were referred but did not make it to KCMC. The investigators will conduct 2 focus group discussions (FGDs) with approximately 10-15 healthcare providers of pediatric injury patients at each of the 2 the study facilities. In Aim 2, the investigators will use this formative data to develop the P-KIDs CARE intervention during a 2-day intervention development workshop with an interdisciplinary study team. The investigators will then perform a pre-implementation assessment and refinement by convening focus group discussions with healthcare providers and a community-engaged panel. This step will enable us to obtain feedback and refine the intervention. In Aim 3, the investigators will pilot the intervention in 2 study facilities in the Kilimanjaro Region. The investigators anticipate 10 total healthcare providers will be enrolled across the 2 study facilities. The investigators expect to enroll approximately 200 pediatric injury patients, 100 in the pre-intervention period and 100 in the post-intervention period. The investigators will conduct post-surveys and exit interviews for healthcare providers using the intervention, assessing implementation outcomes including feasibility, healthcare provider acceptability, and fidelity. The investigators will also conduct interviews with family members of 12 patients referred to KCMC and 12 patients not referred, assessing acceptability and satisfaction with the disposition decision. The investigators will also collect patient-level, potential trial outcomes including time from first care to definitive care, disposition, morbidity, and mortality. The primary outcome will be mortality. The second outcomes will be time to definitive care, disposition, and morbidity. While not powered to determine effect size, the investigators hope that preliminary analysis will suggest a signal of difference between groups.

Being tested
P-KIDs CARE
Keywords
Accidental Injuries, Global Child Health, Pediatric Emergency Medicine, Health Care Providers, Public Health System Research, Implementation Science
Medical subject headings
Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-KIDs CAREOther

    Also called Health systems intervention

    The P-KIDs CARE intervention will include two components: 1) the World Health Organization (WHO) Basic Emergency Care Course for training on patient assessment and stabilization, and 2) a decision support tool which integrates adaptation of two evidence-based tools: a) the Pediatric Resuscitation and Trauma Outcome model for mortality risk assessment, and 3) the Field Triage Decision Scheme to assist with timely referral decisions. WHO Basic Emergency Care Course includes modules delivered via PowerPoint with hands-on training components. The decision support tool will be online with checkboxes that healthcare providers can cross as they fill it out in real time. The team will adapt the tool for use in Northern Tanzania, with particular attention to local contextual and cultural factors.

Study groups in NCT06075108
Study groupRoleWhat they receive
P-KIDs CAREOtherThe P-KIDs CARE intervention will include two components: 1) the World Health Organization (WHO) Basic Emergency Care Course for training on patient assessment and stabilization, and 2) a decision support tool which integrates adaptation of two evidence-based tools: a) the Pediatric Resuscitation and Trauma Outcome model for mortality risk assessment, and 3) the Field Triage Decision Scheme to assist with timely referral decisions. WHO Basic Emergency Care Course includes modules delivered via PowerPoint with hands-on training components. The decision support tool will be online with checkboxes that healthcare providers can cross as they fill it out in real time. The team will adapt the tool for use in Northern Tanzania, with particular attention to local contextual and cultural factors.
Receives: Other: P-KIDs CARE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Mortality as binary outcome variable

    Measured: Baseline (baseline data collection over 1 year in study years 1-2) and post intervention implementation (data collection over 1 year in study year 4); two data collection periods will be separated by 1.5 years

Secondary outcomes (3)

  1. Time from patients' injury to definitive care at Kilimanjaro Christian Medical Center (KCMC) measured via a pediatric injury registry

    Time from patient's injury to definitive care at KCMC as continuous variable measured via a pediatric injury registry

    Measured: Baseline (baseline data collection over 1 year in study years 1-2) and post intervention implementation (data collection over 1 year in study year 4); two data collection periods will be separated by 1.5 years

  2. Patient disposition

    Location of patient disposition after care at health facility with options including: discharge home, admission to health facility, transfer to other health facility

    Measured: Baseline (baseline data collection over 1 year in study years 1-2) and post intervention implementation (data collection over 1 year in study year 4); two data collection periods will be separated by 1.5 years

  3. Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics

    Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics; binary variable with 1-2 indicating good outcome, 3-8 indicating poor outcome

    Measured: Baseline (baseline data collection over 1 year in study years 1-2) and post intervention implementation (data collection over 1 year in study year 4); two data collection periods will be separated by 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start5 Aug 2024
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
284 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06075108
Sponsor's protocol ID
IRB_00169039
Acronym
P-KIDs CARE
Status last verified
Jan 2026
First submitted
12 Sep 2023
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Keating EM, Nget P, Kea S, Kuong S, Daly L, Phearom S, Enders F, Cheryk LA, Topazian M, Fischer PR, Kumar V. Thiamine deficiency in tachypnoeic Cambodian infants. Paediatr Int Child Health. 2015;35(4):312-8. doi: 10.1080/20469047.2015.1109226. Epub 2014 Oct 27.

    PubMed 26744155

  • Keating EM, Lukolyo H, Crouse HL, Pitt MB, St Clair N, Butteris S. Socially Awkward Abroad: A Call for Social Media Policies in Residencies that Offer Global Health Electives. Am J Trop Med Hyg. 2018 Nov;99(5):1275-1282. doi: 10.4269/ajtmh.18-0501.

    PubMed 30226146

  • Keating EM, Lukolyo H, Rees CA, Dziuban EJ, Ferris MG, Schutze GE, Marton SA. Beyond the learning curve: length of global health electives. Int J Med Educ. 2016 Sep 11;7:295-6. doi: 10.5116/ijme.57c1.4e07. No abstract available.

    PubMed 27614032

  • Lukolyo H, Rees CA, Keating EM, Swamy P, Schutze GE, Marton S, Turner TL. Perceptions and Expectations of Host Country Preceptors of Short-Term Learners at Four Clinical Sites in Sub-Saharan Africa. Acad Pediatr. 2016 May-Jun;16(4):387-93. doi: 10.1016/j.acap.2015.11.002. Epub 2015 Nov 12.

    PubMed 26581780

  • Rees CA, Keating EM, Lukolyo H, Danysh HE, Scheurer ME, Mehta PS, Lubega J, Slone JS; Baylor Pediatric HIV-Related Malignancy Consortium. Mapping the Epidemiology of Kaposi Sarcoma and Non-Hodgkin Lymphoma Among Children in Sub-Saharan Africa: A Review. Pediatr Blood Cancer. 2016 Aug;63(8):1325-31. doi: 10.1002/pbc.26021. Epub 2016 Apr 15.

    PubMed 27082516

  • Rees CA, Keating EM, Lukolyo H, Swamy P, Turner TL, Marton S, Sanders J, Mohapi EQ, Kazembe PN, Schutze GE. Host clinical preceptors' perceptions of professionalism among learners completing global health electives. Int J Med Educ. 2018 Jul 27;9:206-212. doi: 10.5116/ijme.5b40.6e4b.

    PubMed 30055101

  • Rees CA, Lukolyo H, Keating EM, Dearden KA, Luboga SA, Schutze GE, Kazembe PN. Authorship in paediatric research conducted in low- and middle-income countries: parity or parasitism? Trop Med Int Health. 2017 Nov;22(11):1362-1370. doi: 10.1111/tmi.12966. Epub 2017 Sep 20.

    PubMed 28857354

  • Slusher TM, Zamora TG, Appiah D, Stanke JU, Strand MA, Lee BW, Richardson SB, Keating EM, Siddappa AM, Olusanya BO. Burden of severe neonatal jaundice: a systematic review and meta-analysis. BMJ Paediatr Open. 2017 Nov 25;1(1):e000105. doi: 10.1136/bmjpo-2017-000105. eCollection 2017.

    PubMed 29637134

  • Keating EM, Sanders J, Ngo K, Mohapi EQ, Mandalakas AM. Development of a Tool for Health Screening and Assessment in Orphanages in Lesotho. Am J Trop Med Hyg. 2019 May;100(5):1290-1293. doi: 10.4269/ajtmh.18-0853.

    PubMed 30915954

  • Lukolyo H, Keating EM, Rees CA. Creating a collaborative peer writing group during residency. Med Educ Online. 2019 Dec;24(1):1563421. doi: 10.1080/10872981.2018.1563421.

    PubMed 30813852

  • Rees CA, Keating EM, Dearden KA, Haq H, Robison JA, Kazembe PN, Bourgeois FT, Niescierenko M. Importance of authorship and inappropriate authorship assignment in paediatric research in low- and middle-income countries. Trop Med Int Health. 2019 Oct;24(10):1229-1242. doi: 10.1111/tmi.13295. Epub 2019 Aug 21.

    PubMed 31374140

  • Rees CA, Keating EM, Dearden KA, Haq H, Robison JA, Kazembe PN, Bourgeois FT, Niescierenko M. Improving Pediatric Academic Global Health Collaborative Research and Agenda Setting: A Mixed-Methods Study. Am J Trop Med Hyg. 2020 Mar;102(3):649-657. doi: 10.4269/ajtmh.19-0555.

    PubMed 31933470

  • Keating EM, Chiume M, Fitzgerald E, Mgusha Y, Mvalo T, Fino N, Crouse HL, Eckerle M, Gorman K, Ciccone EJ, Airewele G, Robison JA. Blood transfusion and mortality in children with severe anaemia in a malaria-endemic region. Paediatr Int Child Health. 2021 May;41(2):129-136. doi: 10.1080/20469047.2021.1881270. Epub 2021 Apr 19.

    PubMed 33874852

  • Keating EM, Robison JA, Chiume M, Taddie M, VanDerslice JA, Benson LS, Fitzgerald E, Crouse HL, Eckerle MD, Ciccone EJ, Porucznik CA. Relationship between distance of referring facilities and haemoglobin change in children in Malawi. Paediatr Int Child Health. 2021 Nov;41(4):253-261. doi: 10.1080/20469047.2022.2044674. Epub 2022 Mar 1.

    PubMed 35230927

  • Keating EM, Price RR, Robison JA. Paediatric trauma epidemic: a call to action. BMJ Paediatr Open. 2019 Aug 1;3(1):e000532. doi: 10.1136/bmjpo-2019-000532. eCollection 2019. No abstract available.

    PubMed 31423470

Questions about this trial

What is this clinical trial studying?

A study testing P-KIDs CARE in people with Accidental Injuries and Global Child Health, run by University of Utah at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth M. Keating, MD, MSPH (801-587-7450, Elizabeth.Keating@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Baseline (baseline data collection over 1 year in study years 1-2) and post intervention implementation (data collection over 1 year in study year 4); two data collection periods will be separated by 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06075108, which also lists 80 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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