P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for Injured Children in Tanzania
Phase: NA
Conditions: Accidental Injuries, Global Child Health, Pediatric Emergency Medicine, Public Health System Research, Health Care Providers, Implementation Science
Sponsor: University of Utah

Cover Page 
 
Official Title of the Study: P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for 
Injured Children in Tanzania 
 
NCT number: Not yet assigned  
 
Date: September 18, 2023 
 

RESEARCH STRATEGY  
 
SIGNIFICANCE 
Every day, 1900 children die from an injury, and more than 95% of these deaths occur in low-and-
middle-income countries (LMICs).18-20 Thus, the burden of pediatric injuries in LMICs is a significant public 
health problem that deserves urgent attention.18, 21 Yet, there remains a lack of data on strategies to improve 
the care and outcomes of injured children in LMICs.15, 22  
Scientific Premise for Aim 1: Pediatric injury morbidity and mortality can be improved with prompt 
arrival to definitive care. Research suggests that delaying arrival to definitive care in children is associated 
with higher mortality risk.23-29 One program in two LMICs decreased the time to definitive care for injured adults 
and children and lowered mortality from 40% to 9%.30 In my preliminary work at the tertiary zonal referral 
hospital Kilimanjaro Christian Medical Centre (KCMC) in Northern Tanzania, I found that 81% of injured 
children went to at least one health facility before presentation. The median time from injury to presentation 
was 8 hours [IQR 3.8, 39.1],17 which is drastically longer than the optimal trauma "golden hour." 25 My 
qualitative data identified significant delays in reaching definitive care at KCMC from the level of first medical 
contact, including a complex referral system (Fig 1) and shortcomings in healthcare provider knowledge of 
when and how to refer injured patients directly to KCMC.31-35 Formal prehospital care is not currently 
established in this region. Moreover, the first medical contact for injured children is a health center or district 
hospital, where healthcare 
providers do not have the 
capability to care for seriously ill 
children. Thus, there is an 
opportunity to streamline the 
healthcare system with an 
intervention at the first medical 
contact to get injured children to 
definitive care sooner.  
Streamlining the healthcare system requires intervention strategies rooted in implementation science. 
Implementation science frameworks, such as the Consolidated Framework for Implementation Research 
(CFIR), are helpful to develop or adapt interventions to improve care and outcomes. CFIR has been 
successfully used in many LMIC settings.36-46 A CFIR-guided mixed methods evaluation of pediatric injury care 
at the first medical contact can identify barriers to guide intervention development. Including the perspectives 
of family members and clinical stakeholders at the first medical contact will make an intervention more 
acceptable, feasible, and locally relevant.  
Scientific Premise for Aim 2: Evidence-based interventions to improve the triage of injury patients 
exist, but implementation science methods are needed to adapt these to a local healthcare system. 
When a patient presents to medical care, they undergo a triage process that includes assessment, 
stabilization, and through to disposition. I propose to develop an intervention to streamline the triage process at 
the first medical contact. The intervention will include adapting the World Health Organization Basic 
Emergency Care Course on patient assessment and stabilization to the local context.47 Next, the provider must 
judge the patient's injury severity and risk of poor outcome to decide whether or not to refer the patient to a 
higher level of care. To help with this decision, we will create a decision support tool by adapting measures of 
risk assessment, such as the Pediatric Resuscitation and Trauma Outcome (PRESTO) model48 and the Field 
Triage Decision Scheme.49 In high-income countries, the CDC and American College of Surgeons developed 
the Field Triage Decision Scheme to assist with referral decisions in injured patients.49 The literature on this 
tool mainly derives from adult trauma populations in high-income countries,50 and only a few pediatric studies 
exist.50-52 While these tools have the potential to assist with referral decisions in LMICs, they require local 
adaptation to be relevant to the skills and resources of the providers and patient population.52 This intervention 
could be a model for translation to other contexts.  
Local stakeholders co-designing a health systems intervention to solve challenges in their community 
can demonstrate best effect. We will have local stakeholders involved in developing the intervention and 
adaptation of the tools. Studies have demonstrated that stakeholder co-design can provide innovative solutions 
to implementation to make interventions more readily adopted.53-57  
Figure 1. Preliminary data from my Fogarty Fellowship showing the pathway to care for 
child X demonstrating the complex referral system in Northern Tanzania with location of 
proposed intervention. Child X’s time from injury to arrival at KCMC was 26 hours. 

Scientific Premise for Aim 3: A health systems intervention to improve the triage of injured children at 
the first medical contact is necessarily complex given the many potential barriers. Given the 
intervention's potential complexity, a pilot to identify potential challenges before full implementation can lead to 
improvements to increase the likelihood of success and lay a foundation for a future efficacy trial.  
Preliminary Data: I conducted a mixed methods study at KCMC during my Fogarty Fellowship. We 
established a pediatric injury registry, enrolling 365 children in 12 months. The mortality rate of injured children 
in our cohort was high (8.2%),16 compared to other similar studies (0.3-7.0%).21, 58-61 We also validated the 
PRESTO model in our population as a risk assessment.48 We found that 81% of injured children went to at 
least one health facility prior to presentation, and the median time from injury to presentation was 8 hours [IQR 
3.8, 39.1].17 We investigated the causes of delay in an exploratory qualitative study,62 showing delays in care 
from the perspective of family members of injured children at KCMC. Identified delays in reaching KCMC at the 
first medical contact included a complex referral system (Fig 1) that requires families to seek care at a health 
center or district hospital first and then be referred stepwise to higher levels of care. This system causes 
logistical challenges leading to delayed care and, for severely injured children or those needing specialist care, 
it causes unnecessary and deadly delays. We also found that healthcare providers at these health facilities 
often do not know when and how to refer injured children directly to KCMC, and instead refer these patients to 
secondary facilities unable to address their injuries.31-35 Such barriers could inform intervention development.  
This proposal is significant because it introduces to Northern Tanzania a healthcare system 
intervention, P-KIDs CARE, that will streamline the triage process from patient assessment and 
stabilization through disposition. The goal is to decrease time to definitive care and improve the outcomes 
of injured children. It aligns with NIH's strategic goals by focusing on advancing emergency care research, 
such as trauma in LMICs, and NICHD's Strategic Plan, which lists traumatic injury in children as a scientific 
priority to advance public health.63-69 It responds to calls to action by the WHO and the Lancet Global Health 
Commission for increased research on access to quality healthcare for the injured in LMICs.70, 71   
INNOVATION 
This proposal is innovative in four ways. 1] Creating upstream solutions for improved outcomes: Most 
trauma systems research in LMICs focuses on tertiary referral hospitals. Our work showed that most delays 
within the health system occur between the first medical contact and definitive care. By innovatively focusing 
on the first medical contact, we are more likely to improve trauma outcomes across the whole health system. 
2] Focusing on the patient care continuum: Most pediatric trauma registries in LMICs are established at 
tertiary referral hospitals. This study establishes a data collection system from first medical contact to the 
referral hospital, which innovatively spans the patient continuum through the health system. 3] P-KIDs CARE 
optimizes resources with a process improvement: Health systems in LMICs work with limited resources. 
This study uses community-based participatory research to develop a health systems intervention optimizing 
limited resources, a generalizable solution for other low-resource settings. 4] Capacity building to address 
pediatric trauma challenges. This award will combine skills in PEM and Global Health, implementation 
science, intervention development, and global clinical trials to advance pediatric injury care and outcomes in 
Sub-Saharan Africa (SSA). The collaborations and networks developed through this award will advance the 
global pediatric injury research field and build my capacity as an independent researcher. 
APPROACH 
Study Design & Timeline: We will use the CFIR across aims to inform intervention development and ensure it 
is ready for implementation (Table 3). In Aim 1, we will use a sequential mixed methods design involving 1) 
quantitative pediatric injury registry data and health facility capacity assessments to identify barriers to pediatric 
injury care and 2) qualitative in-depth interviews (IDIs) with family members and focus group discussions 
(FGDs) with healthcare providers to explore barriers. Aim 2 is a participatory design involving an intervention 
development workshop with the interdisciplinary study team to develop P-KIDs CARE and refinement after 
feedback from stakeholders. Aim 3 is an intervention pilot with healthcare providers of up to 24 injured children, 
with an implementation-focused formative evaluation to finalize the intervention and prepare for a clinical trial. 
Table 3. Timeline of research activities during the award 
Activities 
Y1 
Y2 
Y3 
Y4 
Y5 
Preparation 
Planning/Training/IRB approvals 
 
 
 
 
 
 
 
 
 
 
Aim 1: Barriers at first 
medical contact 
Pediatric registry establishment and Capacity assessments 
 
 
 
 
 
 
 
 
 
FGDs and IDIs 
 
 
 
 
 
 
 
 
 
Data analysis + Publications 
 
 
 
 
 
 
 
 
 
Develop P-KIDs CARE intervention 
 
 
 
 
 
 
 
 
 

Setting & Sample Size: Our study setting is the KCMC referral system. We are choosing two health facilities 
that are common first medical contacts for injured children: Hai District Hospital and Pasua Health Center (see 
Letters of Support). These were chosen for proximity, logistic ease, representativeness, and number of 
injured children referring to KCMC (Table 4). The two sites differ in level and distance from KCMC to improve 
the generalizability of the results. Our preliminary data show that 49 injured children were transferred to KCMC 
from these two facilities over 12 months (November 2020-October 2021). Local healthcare providers estimate 
that approximately 40% are transferred, meaning that an additional 74 could be enrolled that were not 
transferred. Based on these estimates, we could potentially evaluate the care for 123 pediatric patients 
annually in this health system care process, so we estimate a conservative sample size of 100. 
Table 4. Preliminary data from the study facilities 
Health facility 
Level 
Setting 
Approx driving 
distance from 
KCMC (min) 
Median time from 
injury to arrival at 
KCMC (min) 
Injured children 
transferred to KCMC from 
Nov 2020-Oct 2021 (N) 
Potential number of 
injured children for 
enrollment (N) 
Hai District 
Hospital 
Government 
District Hospital 
Semi-
urban 
35 
480 
41 
103 
Pasua Health 
Center 
Government 
Health Centre 
Urban 
20 
180 
8 
20 
Project Team: Dr. Keating will lead the interdisciplinary 
study team (Fig 2). A community-engaged panel (CEP) 
will include 2-3 family members of injured children that 
have been through this healthcare system, 2 senior 
advisors from the community, and 2 community health 
workers (CHWs) to ensure the context of recipients and 
systems are well understood. We will identify CEP 
participants in Aim 1, purposively select family members 
from Aim 1 participants, and identify senior advisors and 
CHWs in consultation with KCMC community health 
department contacts and health facility leadership. We 
will convene CEP in FGDs in Aim 2. Due to ethical 
concerns about the power dynamic, we will ensure that 
the interdisciplinary study team and CEP meet separately for project discussions.  
Overview of CFIR: CFIR provides a structured approach to assess barriers to implementing interventions 
across five domains: outer setting, inner setting, characteristics of individuals, intervention characteristics, and 
implementation process.72 We will apply the CFIR framework and community-based participatory research 
across study aims to inform the development of an intervention that considers local contexts, the actors in 
these contexts (i.e., family members and healthcare workers), and the processes that must occur to improve 
pediatric injury care, triage, and referral (Fig 3). In Aim 1, we will apply outer setting, inner setting, and 
characteristics of individuals. In Aim 2, we will apply intervention characteristics pre-intervention and 
implementation process. In Aim 3, we will apply process and intervention characteristics post-
implementation. 
 
Aim 2: P-KIDs CARE 
development 
Pre-implementation assessment and refinement of intervention 
 
 
 
 
 
 
 
 
 
 
Data analysis + Publications 
 
 
 
 
 
 
 
 
 
Aim 3: P-KIDs CARE pilot  
Pilot P-KIDs CARE  
 
 
 
 
 
 
 
 
 
Formative Evaluation of P-KIDs CARE 
 
 
 
 
 
 
 
 
 
Data analysis + Publications 
 
 
 
 
 
 
 
 
 
Preparation for the Future 
R01 Protocol and Grant Development 
 
 
 
 
 
 
 
 
R01 Submission 
 
 
 
 
 
 
 
 
 
 
Figure 3. CFIR framework mapped to our aims with outcomes. 
Intervention
Characteristics 
(Pre)
Intervention
Characteristics (Post)
- Adaptability
- Complexity
R01: 
Intervention 
implementation and 
evaluation
Aim 3: 
Intervention pilot 
and formative 
evaluation
Aim 2: 
Intervention development 
and pre-implementation 
assessment and adaptation
Implementation 
Outcomes
-
Feasibility
-
Acceptability
-
Fidelity
Patient-level Outcomes
-
Mortality
-
Morbidity 
-
Time to definitive care
-
Successful referral
Aim 1:
With a mixed methods 
approach, describe 
barriers to pediatric 
injury care
Implementation Process
Outer Setting
-
Patient needs and 
resources
Inner Setting
-
Implementation climate
-
Readiness
-
Culture
Characteristics of 
Individuals
-
Knowledge & beliefs
-
Healthcare provider 
needs & preferences
Figure 2. Project team. 
Interdisciplinary Study Team
Community-Engaged Panel
KCMC representation:
Local mentor Dr. Mmbaga
Consultants:
-
Dr. Muro, community health 
physician
-
Dr. Massawe, orthopedic 
surgeon
-
Dr. Nkoronko, general surgeon
-
Dr. Sakita, emergency medicine 
physician 
Health facility representation:
Health facility physicians 
Health facility nurses 
Health facility administrators
- 2-3 family members of pediatric injury patients
- 2 Senior advisors from community
- 2 Community health workers

 
Research Design: We will 
conduct a sequential mixed 
methods study of pediatric 
injury care at two study 
facilities (Fig 4). We will use 
quantitative methods to 1) 
identify the patient-level data 
and priorities by implementing 
a pediatric injury registry (CFIR outer setting), and 2) identify institutional-level barriers in pediatric injury care 
by performing capacity assessments with the HEAT tool (CFIR inner setting). We will then use qualitative 
methods to explore and describe the context of the barriers identified and find potential solutions with IDIs and 
FGDs with key stakeholders (CFIR outer setting, inner setting, and characteristics of individuals). 
Quantitative Methodology: Registry Data 
Collection: We will implement a pediatric injury 
registry at the two study facilities to collect 
baseline data over 12 months. It will mirror the 
pediatric injury registry we implemented at 
KCMC, creating a data collection system that 
spans the KCMC referral system.16 Pediatric 
patients who present to a study facility with 
WHO-defined injuries will be enrolled in the 
registry by trained Tanzanian research 
assistants (RAs). Patients and caregivers will 
be informed at enrollment that they will be 
contacted for follow-up. If a patient is referred 
to KCMC, their data (Table 5) will be 
continued in the KCMC pediatric injury 
registry. Post-discharge data will be collected from patients' caregivers by phone call at 2 weeks and 3 months. 
Data will be recorded on tablets in REDCap,73 and the PI will review the quality of all entries.  
Registry Variables: Outcomes will be recorded, including disposition, mortality, and morbidity. Two morbidity 
instruments will be used as they represent different ways of measuring morbidity: the Glasgow Outcome Scale-
Extended Pediatrics (GOS-E Peds),74 as an external assessment of capacity, and the Patient Specific 
Functional Scale (PSFS),75 which is a personalized assessment of return to function.  
Health Emergency Unit Assessment Tool (HEAT) Data Collection & Variables: Concurrently, we will perform 
capacity assessments of the study facilities using an adapted validated WHO HEAT.76-79 We have experience 
using this tool in this region.80 HEAT is a tool designed to evaluate the vital functions of an emergency unit for 
acutely injured patients. It includes availability rating questions used to assess the ability to perform vital 
functions in the emergency care time frame. The availability rating responses are 1-generally unavailable, 2-
somewhat available, or 3-adequate. Our team will complete the assessments with input from administrators 
and healthcare providers. Findings will be used to identify systems gaps to target in our intervention. 
Qualitative Methodology: FGDs: Two FGDs will be conducted with 10-15 healthcare providers (nurses and 
physicians) at each of the 2 study facilities. FGDs will assess barriers and facilitators to care and referral of 
injured children, including patient assessment, patient stabilization, and timely disposition, as well as key 
elements needed in an intervention to improve pediatric care and referral. The FGD guide will explore CFIR 
constructs in the inner setting, such as culture, implementation climate, and readiness for implementation, as 
well as characteristics of individuals, such as knowledge and beliefs and healthcare provider needs.  
IDIs: We will conduct IDIs with 15 family members of injured children who were referred and made it to KCMC 
and 15 who were referred but did not make it to KCMC. Interview guides will aim to understand: the reasons 
for the choice of first medical contact, delays to care, barriers to care and referral to KCMC, and proposed 
solutions for a successful intervention. Interviews will explore CFIR constructs in the outer setting, such as 
patient needs and resources. Participants will be selected through purposive sampling to include children of 
Table 5. Variables Collected in Pediatric Injury Registry during Health 
Facility Stay and at Disposition 
Data Collected – Health Facility and Disposition 
Acute 
Presentation  
Mechanism of injury 
Mode of transportation to health center 
Patient demographics  
Timing of injury and arrival to first medical contact 
Health facility-
based care 
Patient education 
Treatment, procedures, and complications 
Length of stay 
Outcomes 
Disposition – referral or no referral 
Mortality 
Morbidity: GOS-E Peds74 and PSFS75 
Data Collected – Post-Discharge at 2 weeks and 3 months 
Outcomes 
Disposition - did patient make it to disposition location? 
Mortality 
Morbidity: GOS-E Peds and PSFS 
Specific Aim 1: With a mixed methods approach, describe the barriers to pediatric injury care at the 
first medical contact. 
Figure 4. Sequential mixed methods study to describe barriers to pediatric injury care at the 
first medical contact 

different ages, injury types, injury severity, and those who are and are not referred to KCMC. Participants will 
undergo a consent process approved by the Tanzanian and University of Utah ethics committees before 
joining the FGD or IDI. Participants will be >18 years of age and fluent in Kiswahili. Face-to-face FGDs and 
IDIs will be conducted in Kiswahili by our research team, with previous experience conducting interviews in 
Tanzania.17 Interviews will be recorded, transcribed, and translated into English for analysis.  
Analytical Approach: Data from the quantitative and qualitative analyses will be triangulated to describe 
barriers to pediatric injury care and referral at the study facilities and to identify potential solutions.  
Quantitative Analysis: Based on Dr. Keating's Fogarty preliminary data, we anticipate a sample size of 100 
patients in the pediatric injury registry in the 12-month enrollment period (see Setting & Sample Size). 
Pediatric injury registry data will identify priorities for intervention development by describing the differences 
between patients referred to KCMC and those not referred. The primary outcome will be in-hospital mortality. 
Secondary outcomes will include time from first medical contact to definitive care at KCMC, disposition 
(discharge to home, referral to KCMC, referral to other health facilities, or admission), and morbidity. We will 
summarize data using descriptive statistics for all patients and assess differences by sex, age, injury type, 
sociodemographic features, mechanism of injury, and injury severity. We will assess differences in the 
aforementioned descriptive statistics by disposition using analysis of variance (ANOVA) or Chi-squared tests in 
SAS (Version 9.4). The registry will collect baseline data we will compare with data collected after intervention 
implementation (Aim 3). We will analyze data with descriptive analysis using SAS (Version 9.4) for the HEAT 
results. For the availability ratings of less than 3 (less than adequate), we will identify reasons for the rating.  
Qualitative Analysis: In qualitative methods, a sufficient sample size relies on saturation, or the point at which 
no additional themes are identified with subsequent data points.81 Work with IDI data found that thematic 
saturation was present after twelve interviews,82, 83 which is below our current estimated sample sizes for our 
IDIs and FGDs. Our data analysis will be iterative to assess for thematic saturation, with additional data 
collection added as needed. Thematic analysis will be conducted using Dedoose. De-identified data will be 
coded through a team-based approach informed by applied thematic analysis.84 The CFIR framework will 
inform an a-priori, deductive code list, and we will identify emerging, inductive themes under each construct. All 
transcripts will be coded by two independent coders, and discrepancies will be resolved by consensus. Coded 
data will be retrieved and synthesized in analytic memos, with robust comparisons of themes that emerge 
across the groups. Our team has used a similar approach in prior qualitative studies in Tanzania.17  
Potential Challenges & Alternative Approaches: One potential limitation is that our estimates for enrollment 
into the pediatric injury registry are potentially optimistic. To address this, we have built-in flexibility to increase 
our enrollment period for Aim 1 from 12 to 15 months if enrollment is insufficient. If this does not adequately 
increase enrollment, we have identified a third facility, Same District Hospital, where we can collect data (see 
Letter of Support). Another possible limitation is loss to follow-up of registry patients. We will collect all patient 
phone numbers to prevent this and emphasize follow-up importance. Using identical protocols in our 
preliminary study, we achieved a follow-up rate of 97.5%. A further challenge is potential difficulties with data 
quality, given that we will have 24-hour enrollment in a registry with limited personnel performing quantitative 
and qualitative work simultaneously. To combat this challenge, we will ensure each study facility has a RA who 
will work with local facility staff to ensure they are alerted when a pediatric injured patient presents for care so 
that no patients are missed. However, if we cannot enroll simultaneously at both sites with the proposed team, 
we will have time to collect data at each health facility sequentially. Another potential limitation is being unable 
to recruit healthcare providers or family members for FGDs or IDIs. We do not anticipate this being a major 
barrier since we have performed a similar methodology in our preliminary studies.17 However, we can collect 
data at our third facility if necessary. An additional possible challenge is the need for Aim 1 before completion 
of Aim 2. We developed our aims to be informative rather than interdependent so that we can accurately 
include findings of Aim 1, if pertinent, in informing system plan changes in Aim 2 intervention development.  
Expected Outcomes: Includes 3 manuscripts: 1) differences between injured children who are referred to 
KCMC and those who are not; 2) systems-level barriers in pediatric injury care assessed by WHO HEAT 
capacity assessments; and 3) barriers and facilitators to pediatric injury care and transfer at health facilities 
from healthcare provider and family member perspectives.  
  
Specific Aim 2: Iteratively develop the P-KIDs CARE intervention using a nominal group technique 
and conduct a pre-implementation assessment and refinement. 

Research Design: Guided by CFIR 
evaluation strategies,85 we will synthesize 
the barriers and facilitators identified from 
our preliminary data and Aim 1 and 
identify potential strategies to address 
them. This information will form the 
foundation of a 2-day intervention 
development workshop where the 
interdisciplinary study team (see Project 
Team) will use a nominal group technique 
(NGT) to refine the identified strategies for 
local context and review the existing tools that could be adapted for the local context. The workshop outcome 
will be a template for the P-KIDs CARE intervention. The workshop will be NGT-guided to ensure that 
consensus is reached on the appropriate intervention design to solve the barriers. After the workshop, we will 
perform a pre-implementation assessment and refinement of the intervention by convening two FGDs using a 
modified NGT with 1) healthcare providers and 2) the CEP (Fig 5). The pre-implementation assessment aims 
to obtain feedback on the intervention to enhance its likelihood of success and ensure it is locally relevant and 
perceived as acceptable and feasible.  
Step 1 - Identify Intervention Strategies: We will convene the study team to discuss the barriers and facilitators 
identified from preliminary data and Aim 1 and select intervention strategies to address them. 
Intervention Framework: Based on our prior research, we anticipate that the intervention will streamline the 
triage process (Fig 6). P-KIDs CARE will include two components: 1) the WHO Basic Emergency Care 
Course47 for training on patient assessment 
and stabilization, and 2) a decision support 
tool that integrates adaptation of two 
evidence-based tools: a) the PRESTO 
model for mortality risk assessment21, 48 and 
b) the Field Triage Decision Scheme.49 The 
decision support tool will be online and 
adapted for use in Northern Tanzania, with 
attention to contextual and cultural factors. 
Step 2 - Intervention Development: In a 2-day workshop using an NGT, we will develop the locally-relevant 
intervention by adapting or creating the components (Fig 7). We selected the NGT process as it is a structured 
method for group brainstorming that encourages contributions and facilitates quick agreement on the relative 
importance of barriers. First, the intervention components will be introduced and reviewed on the morning of 
the first day. Then, we will convene small groups to answer key questions: 1) What is the actual degree of less-
than-best practice of the current care of injured children?, 2) What about the existing tools could work in 
Tanzania?, 3) What about the existing tools will not work in Tanzania?, 4) What are the necessary adaptations 
for Tanzania?, and 5) What are the organizational conditions necessary for it to work? The large group will 
come together and an expert facilitator (PI) will lead a guided discussion of 
answers to the key questions regarding each core intervention component. 
At the end of the first day, preliminary voting will occur on the 
appropriateness of each intervention component. On the second day, the 
large group will discuss the preliminary voting results, and final voting with 
determination of consensus will occur. Consensus will be defined as 75% 
agreement that the intervention design is appropriate to solve the barriers. 
Step 3 - Pre-implementation Assessment & Refinement: Once the 
intervention is developed, we will conduct a pre-implementation 
assessment and refinement to obtain preliminary feedback to enhance its 
likelihood of success and ensure it is perceived as acceptable and 
feasible. This will be done by convening FGDs using a modified NGT with 
only steps 1, 3, and 6 (Fig 7) with 2 groups: 1) healthcare providers at the 
study facilities who are not interdisciplinary study team members but could 
have participated in Aim 1, and 2) the CEP (see Project Team). During 
the FGD, a facilitator (PI) will present each intervention component 
Figure 7. Nominal group technique used 
in Steps 2 and 3 for each intervention 
component.  
1. Preparation
2. Small group 
idea generation
3. Large group 
discussion
4. Preliminary 
voting
5. Discussion of 
vote results
6. Final voting
Figure 6. Proposed P-KIDs CARE Intervention with intervention components 
Figure 5. Development process for the P-KIDs CARE intervention 

developed during the workshop to the group. The facilitator will ask questions on the potential barriers and 
facilitators to the implementation of the intervention and the perceived acceptability and feasibility of the 
intervention. Based on feedback, the interdisciplinary study team will refine the intervention as necessary until 
consensus is reached. Consensus will be defined as a 75% agreement that this is the final intervention. After 
finalization, the intervention will be translated into Kiswahili.  
Potential Challenges & Alternative Approaches: There are three potential limitations. First, if Aim 1 
identifies different barriers than we have anticipated, we will change strategies as appropriate and be flexible 
and responsive to changes. Second, the inability to recruit healthcare providers or family members for the 
FGDs. We have recruited healthcare providers for FGDs in our preliminary study17 and do not anticipate this 
being a problem. If it is, we could recruit from our third study facility, Same District Hospital. Finally, the inability 
to reach a consensus in the NGT. We will continue to discuss and edit the intervention until we reach 75% 
consensus. If there is a disagreement between groups, we will defer to the healthcare providers as these 
individuals will use the intervention.  
Expected Outcomes: Includes the P-KIDs CARE intervention and 2 manuscripts: 1) intervention strategies to 
address barriers and improve pediatric care and referral, and 2) P-KIDs CARE development process. 
  
Research Design: We will pilot P-KIDs 
CARE with healthcare providers at the 
study facilities over 12 months to 1) 
improve and finalize the intervention and 2) 
prepare for a clinical trial (Fig 8). We will 
perform a formative evaluation with exit 
interviews with healthcare providers and 
family members of injured children and revise until our intervention is final. 
Early Implementation/Training: The first 3 months of implementation, the PI will train healthcare providers at 
the study facilities on P-KIDs CARE, including pediatric assessment and stabilization using the WHO Basic 
Emergency Care Course and use of the decision support tool. Healthcare providers will receive Basic 
Emergency Care Workbooks.47 All injured children will be enrolled in the registry developed in Aim 1. 
Ongoing Implementation: From months 3-12, we will implement the decision support tool component of the 
intervention. We will encourage all healthcare providers at the study facilities to use the decision support tool 
when caring for a pediatric injury patient over this time.  
From months 3-12, we will evaluate P-KIDs CARE with an implementation-focused formative evaluation. We 
will purposively select 12 injured children who are seen at the study facilities and referred to KCMC for 
definitive care and 12 injured children who are seen and not referred to KCMC for definitive care. We will 
perform the formative evaluation with the healthcare provider who cared for each of these 24 patients. If one 
provider sees more than one patient, they will participate in multiple interviews. The RA at each study facility 
will alert the PI when an injured child is seen and check the decision support tool online for each patient to 
record if it was used. If it was not used, we will follow up with the healthcare provider to see why it was not 
used. If it was used, the RA would contact the healthcare provider of that patient to have them complete a 
survey and exit interview. The interview guide will include questions on healthcare provider experience with the 
intervention, components of the intervention that were or were not implemented, and ways to improve the 
intervention. The RA will contact the family member of each of the 24 pediatric injury patients and consent 
them to complete an IDI. The interview guide will include questions on family member experience with the 
intervention and satisfaction with the disposition decision. Data collection and analysis will be similar to Aim 1. 
During this formative evaluation period, we will iteratively identify challenges and refine components of the 
intervention to move progressively toward the best intervention.  
Outcomes & Sample Size: We anticipate that 100 injured children will be seen at the 2 study facilities to pilot 
the intervention, and at least 24 will undergo the entire intervention, with 12 referred to KCMC and 12 not 
referred. Based on preliminary estimates from local healthcare providers, over 100 patients are seen at the 
study facilities in a 12-month period and 40% are transferred to KCMC. Our possible enrollment of 24 patients 
is a conservative estimate and should be easily attainable.  
Specific Aim 3: Pilot P-KIDs CARE and perform an implementation-focused formative evaluation . 
Figure 8. Pilot testing and formative evaluation of P-KIDs CARE 

Sample Size: We anticipate following 24 patients through their entire health system journey will be sufficient to 
provide qualitative saturation in barriers during the transfer process for those sent to KCMC and satisfaction 
with the disposition decision for the entire cohort. We anticipate enrolling 81% (100 out of 123) of the eligible 
injured children during the pilot study; the 95% exact interval for the enrollment rate is (72.9%, 87.5%) of 
eligible patients. Thus, with 95% confidence the expected number of enrollments in a similarly designed trial 
with 600 eligible patients would be between 440 and 527. We will use enrollment and outcomes estimates from 
this pilot to adequately power a future clinical trial of our intervention.  
Implementation Outcomes: With 24 patients, we will collect implementation outcomes (feasibility, acceptability, 
and fidelity) that will help us to refine the intervention (Table 6).  
Potential Trial Outcomes: With 100 patients we will collect patient-level, potential trial outcomes to prepare for 
a fully powered clinical trial (Table 6). We are evaluating four potential trial outcomes to determine the most 
feasible primary outcome for our trial. While not powered to determine an effect size, we hope that preliminary 
analysis will suggest a signal of difference between groups in the pre- and post-intervention periods.86, 87  
Table 6. Outcomes for Implementation and Planned Trial 
Implementation outcomes 
How we will measure 
Feasibility 
- Exit interview with healthcare providers after treatment of eligible patient.  
- Asking providers how feasible the intervention was when piloting it on injured children. 
Acceptability 
- Surveys to healthcare providers that pilot the intervention to assess acceptability.  
- In exit interviews, asking their perception of how it impacted patient triage and referral. 
- Interviews with family members to assess satisfaction with intervention and disposition decision. 
Fidelity 
- By assessing protocol deviations via decision support tool forms online to determine what 
components of the intervention were completed for each patient. 
Potential Trial Outcomes 
Primary  
Mortality 
Pediatric injury registry 
Secondary 
Time to KCMC 
Pediatric injury registry 
Successful referral 
Morbidity 
Analytical Approach: We will conduct a quantitative analysis of the pediatric injury registry similar to Aim 1 
and compare data to determine preliminary impact. We will analyze qualitative data using Dedoose software 
and quantitative survey data using SAS (Version 9.4). We anticipate recruiting up to 10 healthcare providers 
that used the intervention with up to 24 patients. The data generated from this pilot and evaluation will finalize 
P-KIDs CARE for future evaluation with a clinical trial. 
Potential Challenges & Alternative Approaches: It is possible that we may have challenges motivating 
healthcare providers to use the intervention, especially if time-consuming. We will combat this by including 
healthcare providers in the development of P-KIDs CARE, so that it will be perceived as acceptable at origin. 
An additional potential limitation is if we do not enroll 24 injured children to perform the formative evaluation. 
However, we do not anticipate this being a problem given preliminary data that shows that over a 12 month 
period the 2 study facilities transferred more than 24 injured children to KCMC (Table 4). It is likely that a 
sample size of 24 for the formative evaluation will not give us a great assessment of patient-level outcomes. 
Thus, we will focus on implementation outcomes that will enable us to refine and finalize the intervention.  
Expected Outcomes: Includes R01 grant application, P-KIDs CARE Evaluation through a Clinical Trial in 
Northern Tanzania, and 2 manuscripts: 1) preliminary impact of P-KIDs CARE measured with feasibility, 
acceptability, fidelity, and intervention effectiveness, and 2) process of piloting and formatively evaluating P-
KIDs CARE.  
Rigor & Reproducibility: We are using a rigorous design with a solid scientific premise. We will use validated 
tools, including the WHO Basic Emergency Care Course,47 the PRESTO model that has been validated in our 
population,21, 48 and the Field Triage Decision Scheme.49 We will use framework guided processes, translated 
and validated tools, and will report all trial methods. To ensure rigorous data, intensive quality assurance 
processes and audits are planned. We have considered potential sources of biologic variability in our study 
including sex and age. In our preliminary study, 65.8% of our pediatric injury population was male.48 We will 
enroll all injured children <18 years that present to the two study facilities regardless of sex, and analyze data 
by sex to address sex differences and by age to address any potential differences. 
FUTURE DIRECTIONS:  
P-KIDs CARE has the potential to improve care of injured children in SSA and reduce time from first medical 
contact to definitive care. In year 5, we will submit an R01 proposal to evaluate P-KIDs CARE in additional 

health centers in Northern Tanzania in a clinical trial. By focusing on reducing time to definitive care, P-KIDs 
CARE will be a crucial first step towards improving care and outcomes of injured children in Northern 
Tanzania. We will seek additional grant support to address other aspects along the pediatric injury care 
continuum such as primary injury prevention, family member care-seeking, transportation barriers, 
communication between health facilities, and family member communication barriers. This grant is the first step 
in building a comprehensive research program focused on improving morbidity and mortality in injured children 
in Northern Tanzania.