Prematurity Clinical Trial
Official title:
Evaluating the NeoTree: An eHealth Solution to Reduce Neonatal Mortality in Two Low Income Countries: Malawi and Zimbabwe
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. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 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. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 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. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale
Status | Recruiting |
Enrollment | 19000 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Group 1: Healthcare professionals w HCP will be recruited to the behaviour change and implementation science evaluation study at SMCH, KCH and CPH. Qualitative and quantitative methods will assess acceptability, feasibility and usability of the NeoTree. We estimate a sample size of 160 across sites addressing each aspect, and will carry out an assessment for data thematic saturation before conducting any further interviews (Sample size ~160). An additional 30 HCPs will be recruited to the health economic cost data. Inclusion criteria: - 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. Exclusion criteria: ? aged over 65 years (Zimbabwe only); No upper exclusion age in Malawi 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). Inclusion criteria: - 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. Exclusion criteria: ? Parents aged under 18 years (Malawi) and under 16 years (Zimbabwe) Group 3: Newborns admitted to newborn care units Inclusion criteria: - 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. Exclusion criteria: ? none |
Country | Name | City | State |
---|---|---|---|
Malawi | Kamuzu Central Hospital | Lilongwe | |
Zimbabwe | Bindura Provincial Hospital | Bindura | |
Zimbabwe | Chinhoyi Provincial Hospital | Chinhoyi | |
Zimbabwe | Parirenyatwa Hospital | Harare | |
Zimbabwe | Sally Mugabe Central Hospital | Harare |
Lead Sponsor | Collaborator |
---|---|
University College, London | Biomedical Research and Training Institute, Zimbabwe, Ministry of Health and Child Welfare, Zimbabwe, PACHI Malawi - Parent and Child Health Initiative Trust |
Malawi, Zimbabwe,
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. — View Citation
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. — View Citation
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. — View Citation
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: pil — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Cost of implementation | Costs of implementation of the Neotree to 3 newborn care units, 2 in Zimbabwe and 1 in Malawi | 2.5 years | |
Secondary | Case fatality rates (deaths per 1000 babies admitted to newborn care unit) over time | Case fatality rates of admitted babies to the 3 hospital units using the Neotree over time | 2.5 years | |
Secondary | Facility based neonatal mortality and stillbirth birth rates overtime | Overall deaths per 1000 live births and still birth rates in the 3 hospital units using the Neotree over time. | 1.5 years | |
Secondary | Measures of quality of newborn care (aligned with WHO standards of quality newborn care) | Quantiative measures of standards of quality newborn care measured using the Neotree data. in the 3 hospital facilities where it is implemented. | 2.5 years | |
Secondary | 5. number of babies with key diagnoses over time (e.g. prematurity, neonatal sepsis, neonatal encephalopathy) | Number and outcome (death/discharge) for key diagnostic groups | 2.5 years |
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