NCT06075108 The P-KIDs CARE Health Systems Intervention in Tanzania
| NCT ID | NCT06075108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Accidental Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 284 participants in total. It began in 2024-08-05 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * AIM 1 (mixed methods research) 1. 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. 2. The investigators will conduct in-depth interviews with the following group: Family members of a pediatric injury patients seeking care at the study facilities. 3. 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) 1. The investigators will hold a 2-day intervention development workshop with the interdisciplinary study team. 2. The investigators will conduct focus group discussions with the following groups: 1. Health care providers providing care to pediatric injury patients at the study health facilities 2. A community-engaged panel including family members of pediatric injury patients * AIM 3 (pilot intervention) 1. 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. 2. The investigators will conduct surveys and exit interviews with the following groups: 1. Health care providers providing care to pediatric injury patients at the study health facilities. 2. Family members of pediatric injury patients.
Contact & Investigator
Elizabeth M. Keating, MD
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06075108 clinical trial?
This trial is open to participants of all sexes, studying Accidental Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06075108 currently recruiting?
Yes, NCT06075108 is actively recruiting participants. Contact the research team at Elizabeth.Keating@hsc.utah.edu for enrollment information.
Where is the NCT06075108 trial being conducted?
This trial is being conducted at Moshi, Tanzania.
Who is sponsoring the NCT06075108 clinical trial?
NCT06075108 is sponsored by University of Utah. The principal investigator is Elizabeth M. Keating, MD at University of Utah. The trial plans to enroll 284 participants.