The P-KIDs CARE Health Systems Intervention in Tanzania

Implementation Science Clinical Trial

— P-KIDs CARE  

Official title:

P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for Injured Children in Tanzania

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075108
• Other study ID #: IRB_00169039
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Elizabeth M. Keating, MD, MSPH
• Phone: 801-587-7450
• Email: Elizabeth.Keating[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 284
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Health Care Providers
• Implementation Science
• Pediatric Emergency Medicine

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Tanzania	Kilimanjaro Christian Medical Centre	Moshi

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Kilimanjaro Christian Medical Centre, Tanzania, Kilimanjaro Clinical Research Institute

Country where clinical trial is conducted

Tanzania, 

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* Note: There are 80 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality as binary outcome variable	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	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	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	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	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	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	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

External Links

•   A cohort of pediatric injury patients from a hospital-based trauma registry in Northern Tanzania
•   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]
•   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
•   Thaddeus S, Maine D. Too far to walk: Maternal mortality in context. Soc Sci Med. 1994;38(8):1091-110
•   WHO. Basic emergency care: approach to the acutely ill and injured Geneva2018 [9/6/2022]
•   WHO. Injuries and Violence: the facts 2014 [cited 2019 September 17]