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The P-KIDs CARE Health Systems Intervention in Tanzania

Sponsor
University of Utah (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06075108
Collaborator
Kilimanjaro Christian Medical Centre, Tanzania (Other), Kilimanjaro Clinical Research Institute (Other)
284
Enrollment
1
Location
1
Arm
54
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: P-KIDs CARE
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
284 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
P-KIDs CARE: An Intervention to Address Health Systems Delays to Care for Injured Children in Tanzania
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Aug 31, 2028
Anticipated Study Completion Date :
Aug 31, 2028

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Health systems intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [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]

      Mortality as binary outcome variable

    Secondary Outcome Measures

    1. Time from patients' injury to definitive care at Kilimanjaro Christian Medical Center (KCMC) 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]

      Time from patient's injury to definitive care at KCMC as continuous variable measured via a pediatric injury registry

    2. Patient disposition [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]

      Location of patient disposition after care at health facility with options including: discharge home, admission to health facility, transfer to other health facility

    3. Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics [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]

      Patient morbidity as measured by the Glasgow Outcomes Scale-Extended Pediatrics; binary variable with 1-2 indicating good outcome, 3-8 indicating poor outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. Health care providers providing care to pediatric injury patients at the study health facilities

    4. 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:

    3. Health care providers providing care to pediatric injury patients at the study health facilities.

    4. Family members of pediatric injury patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kilimanjaro Christian Medical Centre Moshi Tanzania

    Sponsors and Collaborators

    • University of Utah
    • Kilimanjaro Christian Medical Centre, Tanzania
    • Kilimanjaro Clinical Research Institute

    Investigators

    • Principal Investigator: Elizabeth M. Keating, MD, University of Utah

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Elizabeth M. Keating, MD, MSPH - Assistant Professor, University of Utah
    ClinicalTrials.gov Identifier:
    NCT06075108
    Other Study ID Numbers:
    • IRB_00169039
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elizabeth M. Keating, MD, MSPH - Assistant Professor, University of Utah
    Accidental Injuries
    Global Child Health
    Pediatric Emergency Medicine
    Health Care Providers
    Public Health System Research
    Implementation Science
    Additional relevant MeSH terms:
    Emergencies
    Accidental Injuries

    Study Results

    No Results Posted as of Oct 10, 2023