NCT06075108

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress43%
Aug 2024Aug 2028

First Submitted

Initial submission to the registry

September 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

August 5, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

September 12, 2023

Last Update Submit

January 14, 2026

Conditions

Global Child HealthPediatric Emergency MedicinePublic Health System ResearchHealth Care ProvidersImplementation ScienceAccidental Injuries

Keywords

Accidental InjuriesGlobal Child HealthPediatric Emergency MedicineHealth Care ProvidersPublic Health System ResearchImplementation Science

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality as binary outcome variable

    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)

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

    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

  • Patient disposition

    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

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

    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

Study Arms (1)

P-KIDs CARE

OTHER

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.

Other: P-KIDs CARE

Interventions

P-KIDs CAREOTHER

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.

Also known as: Health systems intervention
P-KIDs CARE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

RECRUITING

Related Publications (80)

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Related Links

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Elizabeth M. Keating, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth M. Keating, MD, MSPH

CONTACT

801-587-7450Elizabeth.Keating@hsc.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSPH - Assistant Professor

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 10, 2023

Study Start

August 5, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)