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The P-KIDs CARE Health Systems Intervention in Tanzania (P-KIDs CARE)

Primary Purpose

Accidental Injuries, Global Child Health, Pediatric Emergency Medicine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
P-KIDs CARE
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Accidental Injuries focused on measuring Accidental Injuries, Global Child Health, Pediatric Emergency Medicine, Health Care Providers, Public Health System Research, Implementation Science

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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.

Sites / Locations

  • Kilimanjaro Christian Medical Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

P-KIDs CARE

Arm Description

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.

Outcomes

Primary Outcome Measures

Mortality
Mortality as binary outcome variable

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 12, 2023
Last Updated
October 3, 2023
Sponsor
University of Utah
Collaborators
Kilimanjaro Christian Medical Centre, Tanzania, Kilimanjaro Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06075108
Brief Title
The P-KIDs CARE Health Systems Intervention in Tanzania
Acronym
P-KIDs CARE
Official Title
P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for Injured Children in Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2024 (Anticipated)
Primary Completion Date
August 31, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Kilimanjaro Christian Medical Centre, Tanzania, Kilimanjaro Clinical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Injuries, Global Child Health, Pediatric Emergency Medicine, Public Health System Research, Health Care Providers, Implementation Science
Keywords
Accidental Injuries, Global Child Health, Pediatric Emergency Medicine, Health Care Providers, Public Health System Research, Implementation Science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-KIDs CARE
Arm Type
Other
Arm Description
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
Intervention Name(s)
P-KIDs CARE
Other Intervention Name(s)
Health systems intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality as binary outcome variable
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
Secondary Outcome Measure Information:
Title
Time from patients' injury to definitive care at Kilimanjaro Christian Medical Center (KCMC) measured via a pediatric injury registry
Description
Time from patient's injury to definitive care at KCMC as continuous variable measured via a pediatric injury registry
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
Title
Patient disposition
Description
Location of patient disposition after care at health facility with options including: discharge home, admission to health facility, transfer to other health facility
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
Title
Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics
Description
Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics; binary variable with 1-2 indicating good outcome, 3-8 indicating poor outcome
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth M. Keating, MD, MSPH
Phone
801-587-7450
Email
Elizabeth.Keating@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth M. Keating, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kilimanjaro Christian Medical Centre
City
Moshi
Country
Tanzania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blandina Mmbaga, MD, PhD
Phone
+255272754201
Email
b.mmbaga@kcri.ac.tz

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://doi.org/10.1016/j.afjem.2022.04.008
Description
A cohort of pediatric injury patients from a hospital-based trauma registry in Northern Tanzania
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https://apps.who.int/iris/bitstream/handle/10665/149798/9789241508018_eng.pdf?sequence=1
Description
WHO. Injuries and Violence: the facts 2014 [cited 2019 September 17]
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https://www.who.int/publications/i/item/basic-emergency-care-approach-to-the-acutely-ill-and-injured
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WHO. Basic emergency care: approach to the acutely ill and injured Geneva2018 [9/6/2022]
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https://doi.org/10.1016/0277-9536(94)90226-7
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https://www.fic.nih.gov/News/GlobalHealthMatters/july-august-2019/Documents/fogarty-nih-global-health-matters-newsletter-july-august-2019.pdf
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Center FI. Fogarty-led project aims to advance emergency care research in low- and middle-income countries: National Institutes of Health, Department of Health and Human Services; 2019 [cited 2019 September 18]
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https://www.nichd.nih.gov/sites/default/files/2019-09/NICHD_Strategic_Plan.pdf
Description
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

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