Assessing the Effect of the Facilitated Implementation of a Co-designed Newborn Clinical Audit Tool on Overcoming the Modifiable Factors in the Feeding Practices of Low Birth Weight Newborns: a Mixed Methods Study
Abstract
Background
Prematurity and its complications account for the majority of the deaths during the newborn period in
sub-Saharan Africa. The majority of these deaths are from preventable causes, indicating poor quality of
in-hospital care. Clinical audits are proven to be an important quality improvement intervention that
enable health workers to reflect on their practice and identify and act on modifiable gaps in the care
provided to the small and sick newborns. The challenge however lies in the implementation strategy
used that can be flexible enough to identify the requirements of an individual setting and adapt to them.
Facilitation utilises such an approach and has proved to be effective for implementing complex
interventions.
Study objective: To design and introduce the use of a newborn audit tool and its implementation guide
to reduce the time to regain birth weight of LBW newborns through improved feeding practices in
County Hospitals in Kenya.
Study methods
Study design: A quasi-experimental study design of the implementation science format that uses a
mixed methods approach.
Study methods: The study was conducted in six hospitals that are part of a Clinical Information Network.
These included Pumwani Maternity Referral Hospital (PMRH), Kenyatta National Hospital (KNH), Mama
Lucy Kibaki Hospital, Kiambu County Referral Hospital, Thika Level 5 Hospital and Machakos Level 5
Hospital. The study population included two arms; the health workers who were involved in the audit
meetings and the low birth weight and very low birth weight newborns who were used to evaluate the
outcomes. The co-design of a newborn clinical audit tool and audit implementation guide using a threestep
Human Centred Design (HCD) approach. The three steps included; (1) understanding the context,
the users and the available audit tools, (2) the cognitive walkthrough where the prototype audit tool
was taken through several cycles of reviewing with users on real cases in KNH and PMRH newborn units
and refining it based on their feedback, and (3) usability testing where the final prototype tool and the
implementation guide were tested in two high volume newborn units to determine their usability.
The integrated Promoting Action on Research Implementation in Health Sciences (iPARIHS) framework
was used as the conceptual framework to guide the implementation of the final audit tool and
implementation guide in four hospitals using facilitation as a strategy with the intended recipients in
their contextual setting. The four hospitals were randomly assigned to experimental and control arms
and facilitation was used as an implementation strategy in the experiment arm. The secondary outcome
of interest was the effect of facilitation on mortality of the LBW newborn. Evaluation of the effect of
facilitation was done using a mixed methods approach. A controlled before and after (CBA) study was
used to evaluate the effect of facilitation on improving newborn feeding practices and subsequently,
reducing their time to regain birth weight. Participant observation was used to understand why and how
facilitation worked or did not work.
Data analysis: Clinical characteristics were summarised descriptively. The inferential statistics used a
competing risk survival analysis as the univariate analysis to estimate the probability of regaining birth
weight with death as the competing risk. A Cox proportional cause-specific hazard regression analysis
was used for the multivariable analysis. Qualitative data were managed on NVivo 12 software and
thematic analysis was used for the qualitative analysis.
Results
Quantitative results: I included a total of 2956 low birth weight (LBW) (1500 – 2499g) and very low birth
weight (VLBW) (1000 – 1499g) newborns from both study arms throughout the study period. The
cumulative incidence function (CIF) curves showed that the probability of regaining birth weight
compared to death was comparable between experimental (facilitation) and control study arms (non
facilitated sites) and across the study periods. There was, however, a significant difference in overall
mortality between the experiment and control hospitals in the post-intervention period with the
probability of death peaking at 13% (95% CI 0.1 – 0.16) in the control arm compared to 6.6% (95% CI
0.04 – 0.09) in the experiment arm. The cause-specific hazard regression demonstrated no difference in
the hazard of regaining birth weight in the experiment arm compared to the control arm (HR 0.95, p =
0.75) after adjusting for all the covariates. There was, however, a significant decrease in the hazard of
death among the newborns in the experiment arm compared to the control arm (HR 0.64, p = 0.019).
Qualitative results: The factors supporting the implementation of the newborn clinical audit tool using
facilitation included: Leadership with a dynamic mindset, ownership of the clinical audit, availability of
infrastructure and the interrelatedness of the departments. The barriers included: Limited leadership
support, resistance to change in how clinical audits were conducted, lack of a shared vision, power
dynamics revealing team-based hierarchies, infrastructural constraints, hindrances to effective feed and
fluid management and slow organizational adoption of digital technology.
Conclusion
Facilitation as an implementation strategy recognizes the complex, unpredictable and non-linear
relationship between an innovation, the recipients and context making it an effect implementation
strategy for the clinical audit. Facilitation was effective in enabling more use of audit processes.
However, I observed no difference in the primary outcome but did observe a difference in mortality that
likely requires further investigation.
Publisher
University of Nairobi
Rights
Attribution-NonCommercial-NoDerivs 3.0 United StatesUsage Rights
http://creativecommons.org/licenses/by-nc-nd/3.0/us/Collections
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