The P-KIDs CARE Health Systems Intervention in Tanzania (NCT06075108) | Clinical Trial Compass
RecruitingNot Applicable
The P-KIDs CARE Health Systems Intervention in Tanzania
Tanzania284 participantsStarted 2024-08-05
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality
Timeframe: 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
. 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.