Evaluating the NeoTree in Malawi and Zimbabwe

NCT05127070 | Unknown

• 1 other identifier: 17123/001
• Study Type: observational
• Target: 19,000
• Locations: 2 countries
• Sites: 5

Brief Summary

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows:

1. 1.To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe
2. 2.To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice.
3. 3.To collect outcome data for newborns from representative sites where NeoTree is not implemented.
4. 4.To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses.
5. 5.To add dashboards and data linkage to the functionality of the NeoTree
6. 6.To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree
7. 7.To initiate a multi-country network of newborn health care workers, policy makers and academics.
8. 8.To estimate cost of implementing NeoTree at all sites and potential costs at scale

Conditions

Prematurity; Neonatal Encephalopathy; Neonatal Sepsis; Neonatal Death; Neonatal Seizure; Neonatal Jaundice; Neonatal Hypoglycemia; Neonatal Hypothermia; Neonatal Disorder; Neonatal Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• Acceptability of the Neotree as a digital tool to improve neonatal care and survival using the Theoretical framework of acceptability (TFA) among newborn health care providers and parents/ families of sick/ vulnerable newborns.

  Qualitative data collected via semi-structured interviews and focus groups will be collected. Topic guides will be informed by the TFA in order to assess acceptability of the Neotree to be embedded into usual clinical care to improve care and outcomes for sick and vulnerable babies in low resource settings.

  2.5 years

• Feasibility of the Neotree as a digital tool to improve neonatal care and survival using the Theoretical domains framework (TDF) of feasibility among newborn health care providers and parents/ families of sick/ vulnerable newborns.

  mplementation science evaluation of feasibility of the Neotree to be embedded into Qualitative data collected via semi-structured interviews and focus groups will be collected. Topic guides will be informed by the TDF in order to assess feasibility of the Neotree to be embedded into usual clinical care to improve care and outcomes for sick and vulnerable babies in low resource settings.

  2.5 years

• Quantitative Usability (Systems usability score) and qualitative usability of the Neotree and usage (percentage of admitted babies with Neotree admissions data) of the Neotree

  mplementation science evaluation of usability and usage of the Neotree to be for healthcare workers in low resource hospital settings in Malawi and Zimbabwe to optimise quality of care or newborns.

  2.5 years

Secondary Outcomes (5)

• Cost of implementation

  2.5 years

• Case fatality rates (deaths per 1000 babies admitted to newborn care unit) over time

  2.5 years

• Facility based neonatal mortality and stillbirth birth rates overtime

  1.5 years

• Measures of quality of newborn care (aligned with WHO standards of quality newborn care)

  2.5 years

• 5. number of babies with key diagnoses over time (e.g. prematurity, neonatal sepsis, neonatal encephalopathy)

  2.5 years

Study Arms (5)

Behavioural science and implementation research

The investigators will recruit adult health care professionals, senior hospital managers and parents/carers of neonates. Approximate sample sizes in each country are as follows: Zimbabwe: \~80 Healthcare Professionals ; \~20 Carers/ parents of newborn babies and \~10 Hospital administrators/ managers. Malawi: \~40 Healthcare Professionals (\~10 HCPs per focus group discussion); \~10 Carers/ parents of newborn babies and \~10 Hospital administrators/ managers. Total participants for new data collection: 180 (this number is likely to be much lower if there is limited staff turnover at neonatal units and if HCPs agree to participate in multiple research activities).

Cost data

A time-use survey will be conducted with a small sample of Healthcare professionals at all 3 hospitals where the Neotree is implemented (sample size \~30) to measure time spent for different activities/procedures carried out on or for a patient.

Neonatal admissions at Hospital sites where Neotree is implemented in Zimbabwe and Malawi

The investigators will record routine clinical admission, discharge and microbiological data for all newborns admitted to the newborn care units using the NeoTree as a replacement to paper-based forms. Individual-level patient data will be collected on all neonates admitted for care at Sally Mugabe Central (Oct 2019 to April 2022) and Chinhoyi Provincial Hospitals (Oct 2020 to April 2022) Zimbabwe, and Kamuzu Central Hospital (Oct 2019 to April 2022), Malawi. Given typical admission rates, this equates to a sample size \~12,000 babies in Zimbabwe and \~ 4000 babies in Malawi. Data will be collected from February 2019 to the end of the study, to explore trends over time and also include measures of quality newborn care.

Device: Neotree

Comparative case-fatality rates in units using NeoTree and representative control sites

The investigators will collect outcome data from neonatal clinical records at two additional representative hospital sites in Zimbabwe over a 6 month period (sample size \~1200), to inform our sample size calculation for a full evaluation at scale in the future. Individual level data will be collected retrospectively from Bindura Provincial Hospital and Parirenyatwa Hospital (1/4/2021 to 01/10/2021 or beyond depending on sample size).

Clinical validation sub-study

The sample size for our diagnostic sub-study has been calculated using sepsis as the index diagnosis. Assuming sensitivity and specificity of 92% (lower 95% CI: 84%) \>222 babies would need to be diagnosed with sepsis over five months, during which \~\>2000 babies will be admitted with sepsis across sites (Sally Mugabe Central Hospital, Zimbabwe and Kamuzu Central Hospital, Malawi). If necessary, the investigators will continue to collect data throughout the duration of the study until our sample size is achieved. These data will be collected as part of the routine Neotree data collection.

Device: Neotree

Interventions

Neotree DEVICE

The Neotree is a digital app, data collection and quality improvement system. collecting and collating routine health data at the bedside for babies on admission and discharge and for laboratory results. it provides point of care education and clinical decision support to optimise the clinical care of sick and vulnerable newborns according to approved and best available clinical guidelines.

Clinical validation sub-study; Neonatal admissions at Hospital sites where Neotree is implemented in Zimbabwe and Malawi

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: Healthcare professionals and managers working in newborn care units in the 3 hospitals. Group 2: Parents/ carers of babies admitted to the 3 hospital sites. Group 3: All neonates admitted to the hospital sites

You may qualify if:

• working as a healthcare professional or manager caring for newborns admitted to SMCH, KCH or CPH newborn care units during the study period
• Willing and able to give written or audio informed consent for participation.

You may not qualify if:

• Group 2: Parents/ carers
• A qualitative study will be conducted with families and carers of newborns admitted to the intervention hospitals to assess acceptability of the NeoTree (Sample size \~30, followed by analysis for thematic saturation prior to carrying out further interviews).
• Parent/carer of a live newborn requiring admission to SMCH, KCH or CPH newborn care units during the study period
• Willing and able to give written or audio informed consent for participation.
• ● Parents aged under 18 years (Malawi) and under 16 years (Zimbabwe)
• Group 3: Newborns admitted to newborn care units
• Anonymous individual data will be collected prospectively for all babies admitted to the newborn care units of SMCH, KCH and CPH until the end of the study (anticipated April 2022)
• anonymous individual data will be collected retrospectively for all babies admitted to newborn care units of Bindura Provincial Hospital and Parirenyatwa Hospital during April and October 2021 or beyond.
• ● none

Sponsors & Collaborators

• University College, London: lead
• Biomedical Research and Training Institute, Zimbabwe: collaborator
• PACHI Malawi - Parent and Child Health Initiative Trust: collaborator
• Ministry of Health and Child Welfare, Zimbabwe: collaborator

Study Sites (5)

Kamuzu Central Hospital

Lilongwe, Malawi

RECRUITING

Bindura Provincial Hospital

Bindura, Zimbabwe

RECRUITING

Chinhoyi Provincial Hospital

Chinhoyi, Zimbabwe

RECRUITING

Parirenyatwa Hospital

Harare, Zimbabwe

RECRUITING

Sally Mugabe Central Hospital

Harare, Zimbabwe

RECRUITING

Related Publications (4)

• Crehan C, Kesler E, Chikomoni IA, Sun K, Dube Q, Lakhanpaul M, Heys M. Admissions to a Low-Resource Neonatal Unit in Malawi Using a Mobile App: Digital Perinatal Outcome Audit. JMIR Mhealth Uhealth. 2020 Oct 21;8(10):e16485. doi: 10.2196/16485.

  PMID: 33084581 BACKGROUND

• Crehan C, Kesler E, Nambiar B, Dube Q, Lufesi N, Giaccone M, Normand C, Azad K, Heys M. The NeoTree application: developing an integrated mHealth solution to improve quality of newborn care and survival in a district hospital in Malawi. BMJ Glob Health. 2019 Jan 16;4(1):e000860. doi: 10.1136/bmjgh-2018-000860. eCollection 2019.

  PMID: 30713745 BACKGROUND

• Evans M, Corden MH, Crehan C, Fitzgerald F, Heys M. Refining clinical algorithms for a neonatal digital platform for low-income countries: a modified Delphi technique. BMJ Open. 2021 May 18;11(5):e042124. doi: 10.1136/bmjopen-2020-042124.

  PMID: 34006538 BACKGROUND

• Gannon H, Chimhuya S, Chimhini G, Neal SR, Shaw LP, Crehan C, Hull-Bailey T, Ferrand RA, Klein N, Sharland M, Cortina Borja M, Robertson V, Heys M, Fitzgerald FC. Electronic application to improve management of infections in low-income neonatal units: pilot implementation of the NeoTree beta app in a public sector hospital in Zimbabwe. BMJ Open Qual. 2021 Jan;10(1):e001043. doi: 10.1136/bmjoq-2020-001043.

  PMID: 33472853 RESULT

Related Links

• Neotree charity website
• open source code

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis; Perinatal Death; Jaundice, Neonatal; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Central Study Contacts

Michelle Heys, MD(Res)

CONTACT

07541381106; m.heys@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 19, 2021
• Study Start: October 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study protocol is underreview at BMJ Open (we will have a decision in next 3 months); statistical analysis plans have and will be published with each analytical manuscript. Final clinical study report will be published. Software code is already available on github.

Locations

MA (1); ZI (4)