The P-KIDs CARE Health Systems Intervention in Tanzania
NCT ID: NCT06075108
Last Updated: 2024-12-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
284 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-05
Study Completion Date
2028-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Accidental Injuries
Global Child Health
Pediatric Emergency Medicine
Public Health System Research
Health Care Providers
Implementation Science
Keywords
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Accidental Injuries
Global Child Health
Pediatric Emergency Medicine
Health Care Providers
Public Health System Research
Implementation Science
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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P-KIDs CARE
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.
Group Type
OTHER
P-KIDs CARE
Intervention Type
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.
Interventions
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P-KIDs CARE
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.
Intervention Type
OTHER
Other Intervention Names
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Health systems intervention
Eligibility Criteria
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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.
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.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kilimanjaro Christian Medical Centre, Tanzania
OTHER
Sponsor Role
collaborator
Kilimanjaro Clinical Research Institute
OTHER
Sponsor Role
collaborator
University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Elizabeth M. Keating
MD, MSPH - Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elizabeth M. Keating, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Kilimanjaro Christian Medical Centre
Moshi, , Tanzania
Site Status
RECRUITING
Countries
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Tanzania
Central Contacts
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Facility Contacts
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Blandina Mmbaga, MD, PhD
Role: primary
References
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://doi.org/10.1016/j.afjem.2022.04.008
A cohort of pediatric injury patients from a hospital-based trauma registry in Northern Tanzania
https://apps.who.int/iris/bitstream/handle/10665/149798/9789241508018_eng.pdf?sequence=1
WHO. Injuries and Violence: the facts 2014 \[cited 2019 September 17\]
https://www.who.int/publications/i/item/basic-emergency-care-approach-to-the-acutely-ill-and-injured
WHO. Basic emergency care: approach to the acutely ill and injured Geneva2018 \[9/6/2022\]
https://doi.org/10.1016/0277-9536(94)90226-7
Thaddeus S, Maine D. Too far to walk: Maternal mortality in context. Soc Sci Med. 1994;38(8):1091-110
https://www.nichd.nih.gov/sites/default/files/2019-09/NICHD_Strategic_Plan.pdf
Eunice Kennedy Shriver National Institute of Child Health and Development. NICHD Strategic Plan 2020. Healthy pregnancies. Healthy children. Healthy and optimal lives.2020 October 4, 2022
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB_00169039
Identifier Type: -
Identifier Source: org_study_id