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. 2020 Dec 18;5:265. Originally published 2020 Nov 5. [Version 2] doi: 10.12688/wellcomeopenres.16379.2

Table 2. Specific questions - sub-study designs and methods.

Study design and methodology Study site; study populations; sampling procedures; and
data collection procedures
1. Does co-design of job aides and communications skills training support improve adoption of innovations and the quality of
medical and nursing care
Rapid cycle co-design meetings with hospital staff of job aides
(e.g. to support better documentation of vital signs observations
and feed prescribing), structured team based case review (TCR
audit) tools and to adapt an existing communications training will
be used with pilot testing in these sites for an initial six months.
(Completed)
Currently - Introduction of new job aides and TCR audit tools is
being progressively extended to MPN hospitals in the closing
part of Phase 1 in preparation for Phase 2 when feedback on key
indicators and MPN peer engagement will be used to promote
their use. The adoption of job aides and their early effects on
process measures of quality of care will be evaluated in Phase 2 to
inform continued efforts to promote adoption.
Study sites: We will seek 2 - 3 MPN hospitals as volunteers for
the rapid-cycle co-design activities prior to progressive pilot
implementation in the remaining 8 - 9 hospitals. Study populations:
Nurses and medical staff will be identified by hospitals to work
with researchers to co-design job-aides and mortality audit tools
and subsequently implement these. For piloting adoption of job
aides, medical records of NBU admissions in the pilot period will
be sampled. Procedures: Hospital records for NBU admissions for
whom a co-designed job aide should be used / completed will be
used to ascertain adoption and use these pilot studies data on up
to 30 cases in 2-3 hospitals, allowing further redesign of job aides
as needed. Notes and results of group meetings to co-design
TCR audit tools and communications training will be used to
assess the design process and improve tools prior to wider scale
implementation as part of a Human Centred Design approach.
2. Description of common modifiable factors in providing effective feeding to sick babies.
We will promote use of the structured neonatal TCR audit
approach co-designed in Phase 1 across the MPN during Phase 2
and 3 to review late deaths occurring on the NBU (those ≥ 3 days
post-natal age) to identify modifiable factors occurring during
the NBU stay. TCR audit reports will be collated as part of MPN
activities and aggregate reports generated on modifiable factors
from across the 11 hospitals. Pooled data will be used to describe
the nature and frequency of modifiable factors across hospitals.
Study sites: This work will include all 11 MPN hospitals. Study
populations: Hospitals will be asked to review late post-natal deaths
(those ≥ 3 days post-natal age at time of death) each month
(noting that the Ministry of Health expects all neonatal deaths to
be reviewed). Data collection procedure: Deidentified data will be
collected from hospitals’ structured neonatal TCR audit reports.
We aim to collect data on 250 cases as the basis for a report
summarizing findings from all hospitals.
3. How do important process of care quality indicators and mortality change over the period of MPN participation
Building on Phase 1 and the earlier establishment of the
information system we will track and develop feedback systems
on quality of practices such as feed prescribing, monitoring
(e.g. assessment with pulse oximetry) and mortality outcomes
and progressively use this to focus hospital teams’ attention on
their performance in providing quality care and achieving good
survival outcomes. We will aim to further drive local learning on
how to improve care through online and MPN meetings between
hospitals and promote the use of the information from locally
conducted neonatal TCR audits that identify factors that can be
modified to improve outcomes.
Study sites: This work will include all 11 MPN hospitals. Study
populations & sampling: We will examine medical records for all
NBU admissions in Phases 1, 2 and 3 and especially those meeting
criteria of being a vulnerable baby (either preterm birth (<37 weeks
gestation) or low birth weight (<2500g). Data collection procedure:
All NBU records from which routine de-identified data are
currently being captured and we will use the quality indicators
developed (e.g. on feeding practices and correct antibiotic use)
to provide monthly mortality reports and three monthly summary
reports on quality of care indicators. We will track the change
in aggregate and hospital specific performance and mortality
outcomes over time.
4. What is the optimum approach for risk adjustment of neonatal mortality so that variations in case-mix and case-severity can
be accounted for when evaluating temporal trends in inpatient neonatal mortality
We will build on prior work undertaken in a single Kenyan hospital
to develop two candidate prognostic scores for neonatal mortality
and use data already captured to undertake external validation
and improvement of these modelling approaches.
The aim will be to develop a prognostic scoring approach that can
be applied at individual patient level that enables us to undertake
risk adjustment when tracking the long-term trends in survival
outcomes in response to the MPN intervention.
Study sites: This work will include all 11 MPN hospitals. Study
populations & sampling: We will use existing data on over 30,000
NBU to validate / revise a preferred prognostic model and then
use this model to provide risk-adjusted estimates of mortality each
month for the 11 sites for a total of 36 months across Phases 1,
2 and 3. These data will enable us to say with greater certainty
whether NBU mortality rates are declining over the period of
intervention and potentially in which sub-populations.
5. How do senior doctors and nurses’ social ties influence the performance of frontline staff and evolve within the MPN influenced
by face to face and online interaction
Building on work to develop and implement the communications
training we will progress to examine the relationships between
medical and nursing staff within and between hospitals. This
work will be informed by conduct of a realist review of social MPN
analyses conducted on hospital staff and based on this proceed
to empiric work involving in-depth interviews (IDIs) with senior
hospital staff, small group discussions with frontline workers and
family members, and episodes of non-participant observation
of everyday practices. The aims of this data collection will be to
explore changes in how MPN participants perceive their roles,
their teamwork, the practices they employ to improve neonatal
and family centred care and how these may all be mediated by
the creation or strengthening of social ties resulting from MPN
participation.
Study sites: Medical and nursing leads from all 11 MPN hospitals’
NBUs will be eligible for IDI and four hospitals representing
maximum variation in performance on quality indicators
being tracked will be identified for further IDI and small group
discussions. In these four purposefully selected hospitals, non-
participant observation will be conducted and front-line staff and
family members will be invited for small group discussions based
on convenience sampling but employing inclusion criteria to ensure
diversity in respondents (e.g. based on age, qualification (for staff),
gender and education (for family members) The aim is to conduct
two small group discussions with staff (total four to six people) and
families per site.
6. How does information being produced by the MPN reach senior advisory and advocacy group members and how may it be
influential in fostering MPN growth and wider health system improvement
The MoH Technical Group of Experts is expected to meet three
times monthly in Phases 2 and 3. In the last 3 months of Phase
3 IDI will be conducted with group members and key wider
stakeholders. We will explore their opinions on the value of the
information being created by the MPN, their experience of their
work as a group, and how such information might be used in
the wider health system context to promote improved NBU
care. Activities or reports have been of value in helping support
decision making.
This work will focus on the national level and at the level of county
administrations where these have hospitals included in the MPN. In
Phase 3 IDI will be conducted with members of the MoH Technical
Group of Experts (n = 6 - 8), health care policy makers, key donor
partner personnel (e.g. UNICEF, WHO) and selected senior county
and hospital managers (total n = 6 - 10). Sampling procedures:
Sampling will be purposeful with a snowballing approach used to
identify relevant interviewees in national or county government,
hospital management or donor organisations.
7. How can better performance measurement be integrated into national information systems to sustain improvement
We have conducted with the MoH (Informatics Division) a careful
appraisal of existing neonatal data collection approaches within
the national DHIS2 system revealing considerable weaknesses 110.
We will draw on prior work 38 to use consensus development
methods to develop a core set of preferred neonatal quality and
outcome indicators for use at national level. We will follow this
with use of human centred co-design approaches to improve
the process of neonatal data capture and the DHIS2 tools that
support it to enable long-term, large scale tracking of neonatal
care and outcomes embedded in the national DHIS2.
This work will be conducted at the national level with the Ministry
of Health and its Neonatal and Child Health Unit and its Informatics
Division. A stakeholder meeting, linking to one of the proposed
MPN meetings, will be held to review and suggest revisions to
the current information procedures and tools. Draft quality and
outcome indicators developed will be refined and agreed with
key stakeholders though the Ministry of Health Technical Group
of Experts. Based on this process we will revise existing paper
tools and online DHIS2 data capture tools employing co-design
workshops and ‘walk-throughs’ with health records information
officers and clinicians to develop minimal viable products (MVPs)
for initial testing. We will progress these MVPs so they can be
incorporated into the DHIS2 system and potentially extend this by
enabling distributed data capture through mobile applications.

TCR, team based case review; MPN, multi-professional network; NBU, newborn unit; IDI, in-depth interview; MoH, Ministry of Health; MVP, minimal viable product.