The P-KIDs CARE Health Systems Intervention in Tanzania

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 P

Первичные конечные точки

• Mortality [Срок оценки: 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]

Вторичные конечные точки (3)

• Time from patients' injury to definitive care at Kilimanjaro Christian Medical Center (KCMC) measured via a pediatric injury registry [Срок оценки: 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 disposition [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Tanzania · 1 центр

• Kilimanjaro Christian Medical Centre — Moshi

Публикации

• Keating EM, Nget P, Kea S, Kuong S, Daly L, Phearom S, Enders F, Cheryk LA, Topazian M, Fischer PR, Kumar V. Thiamine deficiency in tachypnoeic Cambodian infants. Paediatr Int Child Health. 2015;35(4):312-8. doi: 10.1080/20469047.2015.1109226. Epub 2014 Oct 27. PMID 26744155
• Keating EM, Lukolyo H, Crouse HL, Pitt MB, St Clair N, Butteris S. Socially Awkward Abroad: A Call for Social Media Policies in Residencies that Offer Global Health Electives. Am J Trop Med Hyg. 2018 Nov;99(5):1275-1282. doi: 10.4269/ajtmh.18-0501. PMID 30226146
• Keating EM, Lukolyo H, Rees CA, Dziuban EJ, Ferris MG, Schutze GE, Marton SA. Beyond the learning curve: length of global health electives. Int J Med Educ. 2016 Sep 11;7:295-6. doi: 10.5116/ijme.57c1.4e07. No abstract available. PMID 27614032
• Lukolyo H, Rees CA, Keating EM, Swamy P, Schutze GE, Marton S, Turner TL. Perceptions and Expectations of Host Country Preceptors of Short-Term Learners at Four Clinical Sites in Sub-Saharan Africa. Acad Pediatr. 2016 May-Jun;16(4):387-93. doi: 10.1016/j.acap.2015.11.002. Epub 2015 Nov 12. PMID 26581780
• Rees CA, Keating EM, Lukolyo H, Danysh HE, Scheurer ME, Mehta PS, Lubega J, Slone JS; Baylor Pediatric HIV-Related Malignancy Consortium. Mapping the Epidemiology of Kaposi Sarcoma and Non-Hodgkin Lymphoma Among Children in Sub-Saharan Africa: A Review. Pediatr Blood Cancer. 2016 Aug;63(8):1325-31. doi: 10.1002/pbc.26021. Epub 2016 Apr 15. PMID 27082516
• Rees CA, Keating EM, Lukolyo H, Swamy P, Turner TL, Marton S, Sanders J, Mohapi EQ, Kazembe PN, Schutze GE. Host clinical preceptors' perceptions of professionalism among learners completing global health electives. Int J Med Educ. 2018 Jul 27;9:206-212. doi: 10.5116/ijme.5b40.6e4b. PMID 30055101
• Rees CA, Lukolyo H, Keating EM, Dearden KA, Luboga SA, Schutze GE, Kazembe PN. Authorship in paediatric research conducted in low- and middle-income countries: parity or parasitism? Trop Med Int Health. 2017 Nov;22(11):1362-1370. doi: 10.1111/tmi.12966. Epub 2017 Sep 20. PMID 28857354
• Slusher TM, Zamora TG, Appiah D, Stanke JU, Strand MA, Lee BW, Richardson SB, Keating EM, Siddappa AM, Olusanya BO. Burden of severe neonatal jaundice: a systematic review and meta-analysis. BMJ Paediatr Open. 2017 Nov 25;1(1):e000105. doi: 10.1136/bmjpo-2017-000105. eCollection 2017. PMID 29637134

Идентификаторы

NCT: NCT06075108 · IRB_00169039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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