scholarly journals Evaluating an enhanced quality improvement intervention in maternity units: PReCePT trial protocol

2021 ◽  
Vol 10 (2) ◽  
pp. e001204
Author(s):  
Hannah Edwards ◽  
Maria Theresa Redaniel ◽  
Brent Opmeer ◽  
Tim Peters ◽  
Ruta Margelyte ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Quality Improvement ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Quality Improvement Intervention ◽  
Research Database ◽  
National Guidance ◽  
Registration Number ◽  
Randomised Controlled ◽  
Term Labour

The UK’s National Institute for Health and Care Excellence Preterm labour and birth guideline recommends use of magnesium sulfate (MgSO4) in deliveries below 30 weeks’ gestation to prevent cerebral palsy and other neurological problems associated with preterm delivery. Despite national guidance, the uptake of MgSO4 administration in eligible women has been slow. National Health Service England has rolled out the PReCePT (PRevention of Cerebral Palsy in Pre-Term labour) quality improvement (QI) toolkit to increase uptake of MgSO4 in preterm deliveries. The toolkit is designed to increase maternity staff knowledge about MgSO4 and provides training and practical tools to help staff consider use in eligible women. The PReCePT trial compares the effectiveness of two different methods of implementing the QI toolkit (standard versus enhanced support). The standard support arm (control) receives the QI toolkit and regional-level support for a midwife/obstetric ‘champion’. The enhanced support arm (intervention) receives this plus additional clinical backfill funding and unit-level QI microcoaching. It is funded by The Health Foundation. This is a cluster randomised controlled trial designed to include 48 maternity units randomised (2:1 ratio) to standard or enhanced support. Units are eligible for inclusion if they have 10 or more preterm (<30 weeks’ gestation) deliveries annually and MgSO4 uptake of 70% or less. Randomisation is stratified by previous level of MgSO4 uptake. The QI intervention is implemented over 9 months. All units are followed up for a further 9 months. Blinding is not possible due to the nature of the intervention. The primary outcome is the proportion of MgSO4 uptake among eligible women at follow-up, adjusting for uptake before implementation of the toolkit. The effectiveness of the intervention will be assessed using weighted linear regression on data from the National Neonatal Research Database. Semistructured qualitative staff interviews will inform understanding of the process and outcomes. Economic evaluation will describe total costs and cost-effectiveness.Trial registration number SRCTN 40938673.

scholarly journals Evaluating the impact of an enhanced support implementation of the PReCePT (PRevention of Cerebral palsy in Pre-Term labour) quality improvement toolkit to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisabilities: study protocol for a cluster randomized controlled trial

2020 ◽  
Author(s):  
Hannah B Edwards ◽  
Maria Theresa Redaniel ◽  
Brent Opmeer ◽  
Tim J Peters ◽  
Ruta Margelyte ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Quality Improvement ◽  
Magnesium Sulphate ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Research Database ◽  
Randomised Controlled ◽  
The Impact ◽  
Standard Support ◽  
Support Model

The UKs National Institute for Health and Care Excellence (NICE) Preterm labour and birth guideline recommends use of magnesium sulphate (MgSO4) in deliveries below 30 weeks gestation to prevent cerebral palsy and other neurological problems associated with preterm delivery. Despite national guidance, the uptake of MgSO4 administration in eligible women has been slow. NHS England has rolled out the PReCePT Quality Improvement (QI) toolkit to increase uptake of MgSO4 in preterm deliveries. The toolkit is designed to increase maternity staff knowledge about MgSO4 and provides training and practical tools to help staff consider use in eligible women. The PReCePT trial will evaluate the effectiveness of an enhanced support model of implementing the QI toolkit, compared with the standard support model. The standard support arm (control) receives the QI toolkit and regional-level support for a midwife/obstetric champion. The enhanced support arm (intervention) receives this plus additional clinical backfill funding and unit-level QI micro-coaching. This is a cluster randomised controlled trial designed to include 48 maternity units randomised (2:1 ratio) to standard or enhanced support. Units are eligible for inclusion if they have ten or more pre-term (<30 weeks gestation) deliveries annually and MgSO4 uptake of 70% or less. Randomisation is stratified by previous level of MgSO4 uptake. The QI intervention is implemented over nine months. All units are followed up for a further nine months. Blinding is not possible due to the nature of the intervention. The primary outcome is the proportion of MgSO4 uptake amongst eligible women at follow-up, adjusting for uptake before implementation of the toolkit. The effectiveness of the intervention will be assessed using weighted linear regression on data from the National Neonatal Research Database. Semi-structured qualitative staff interviews will inform understanding of the process and outcomes. Economic evaluation will describe total costs and cost-effectiveness.

scholarly journals Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006226 ◽  
Author(s):  
Jemimah Ride ◽  
Heather Rowe ◽  
Karen Wynter ◽  
Jane Fisher ◽  
Paula Lorgelly
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Health Problems ◽  
Human Research Ethics ◽  
Registration Number ◽  
Randomised Controlled ◽  
First Time

IntroductionPostnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers.Methods and analysisThe evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial.Ethics and disseminationApproval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012.Trial registration numberThe trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796).

scholarly journals Discontinuing Inappropriate Medication in Nursing Home Residents (DIM-NHR Study): protocol of a cluster randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006082 ◽  
Author(s):  
Hans Wouters ◽  
Elise H Quik ◽  
Froukje Boersma ◽  
Peder Nygård ◽  
Judith Bosman ◽  
...  
Keyword(s):  
Nursing Home ◽  
Controlled Trial ◽  
Elderly Care ◽  
Inappropriate Medication ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Care Physician ◽  
Registration Number ◽  
Randomised Controlled

IntroductionNursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents’ quality of life. The objective of the ‘Discontinuing Inappropriate Medication in Nursing Home Residents’ (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication.MethodsA cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4 months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient’s elderly care physician in collaboration with a pharmacist.AnalysisPrimary outcomes—the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes—undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness.Ethics and disseminationParticipant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed.Trial registration numberThis study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095)

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