A practice change intervention to improve antenatal care addressing alcohol consumption by women during pregnancy: research protocol for a randomised stepped-wedge cluster trial

Abstract Background Antenatal clinical practice guidelines recommend routine assessment of women’s alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to the usual practice in an implementation trial. Methods The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. A budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise (i) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (ii) cost-effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with the guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fundholders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care. Discussion Uptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12617000882325. Registered on 16 June 2017

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Protocol for an economic evaluation and budget impact assessment of a randomised, stepped-wedge controlled trial for practice change support to increase routine provision of antenatal care for maternal alcohol consumption

10.21203/rs.3.rs-49050/v1 ◽

2020 ◽

Author(s):

Penny Reeves ◽

Zoe Szewczyk ◽

Melanie Kingsland ◽

Emma Doherty ◽

Elizabeth Elliott ◽

...

Keyword(s):

Economic Evaluation ◽

Alcohol Consumption ◽

Impact Assessment ◽

Budget Impact ◽

Cost Effective ◽

Practice Change ◽

Stepped Wedge ◽

Usual Practice ◽

Maternal Alcohol Consumption ◽

Implementation Trial

Abstract Background Antenatal clinical practice guidelines recommend routine assessment of women’s alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefit of guidelines are realized through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to usual practice in an implementation trial. Methods The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. Budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise: (i) a cost-consequence analyses, where a score card approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial; and (ii) a cost effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fund-holders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care. Discussion Uptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses.

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PD.01 Stepped wedge cluster trial to evaluate training to community midwives to improve membrane sweeping to reduce induction of labour

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2014-306576.230 ◽

2014 ◽

Vol 99 (Suppl 1) ◽

pp. A80.3-A82 ◽

Cited By ~ 1

Author(s):

S Kenyon ◽

S Dann ◽

P Clarke ◽

A Hogan ◽

D Jenkinson ◽

...

Keyword(s):

Induction Of Labour ◽

Stepped Wedge ◽

Cluster Trial ◽

Community Midwives

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Alcohol Consumption for People Admitted in French Emergency Departments: A Protocol for a Multi-Center Cluster Trial

Journal of Addiction Research & Therapy ◽

10.4172/2155-6105.1000250 ◽

2015 ◽

Vol 06 (04) ◽

Author(s):

De Chazeron I ◽

Guelon T

Keyword(s):

Alcohol Consumption ◽

Emergency Departments ◽

Cluster Trial

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Antenatal care for alcohol consumption during pregnancy: pregnant women’s reported receipt of care and associated characteristics

BMC Pregnancy and Childbirth ◽

10.1186/s12884-019-2436-y ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 4

Author(s):

Emma Doherty ◽

John Wiggers ◽

Luke Wolfenden ◽

Amy E. Anderson ◽

Kristy Crooks ◽

...

Keyword(s):

Alcohol Consumption ◽

Antenatal Care

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Does a multidisciplinary nutritional intervention prevent nutritional decline in hospital patients? A stepped wedge randomised cluster trial

e-SPEN Journal ◽

10.1016/j.clnme.2014.01.002 ◽

2014 ◽

Vol 9 (2) ◽

pp. e84-e90 ◽

Cited By ~ 10

Author(s):

Timothy J. Schultz ◽

Alison L. Kitson ◽

Stijn Soenen ◽

Leslye Long ◽

Alison Shanks ◽

...

Keyword(s):

Nutritional Intervention ◽

Stepped Wedge ◽

Cluster Trial ◽

Hospital Patients

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Implementation strategies to improve preconception and antenatal care for tobacco smoking, alcohol consumption and weight management: a systematic review protocol

Systematic Reviews ◽

10.1186/s13643-019-1193-3 ◽

2019 ◽

Vol 8 (1) ◽

Author(s):

Emma Doherty ◽

Melanie Kingsland ◽

Luke Wolfenden ◽

John Wiggers ◽

Julia Dray ◽

...

Keyword(s):

Risk Factors ◽

Systematic Review ◽

Alcohol Consumption ◽

Antenatal Care ◽

Weight Management ◽

Tobacco Smoking ◽

Implementation Strategy ◽

Implementation Strategies ◽

Modifiable Risk Factors ◽

Cochrane Central Register

Abstract Background Despite existing best practice care recommendations for addressing tobacco smoking, alcohol consumption and weight management in preconception and antenatal care, such recommendations are often not implemented into routine practice. Effective strategies that target known barriers to implementation are key to reducing this evidence to practice gap. The aim of this review is to synthesise the evidence on the effectiveness of implementation strategies in improving the provision of preconception and antenatal care for these modifiable risk factors. Methods Randomised and non-randomised study designs will be eligible for inclusion if they have a parallel control group. We will include studies that either compare an implementation strategy to usual practice or compare two or more strategies. Participants may include any health service providing preconception or antenatal care to women and/or the health professionals working within such a service. The primary outcome will be any measure of the effectiveness of implementation strategies to improve preconception and/or antenatal care for tobacco smoking, alcohol consumption and/or weight management (including care to improve nutrition and/or physical activity). Secondary outcomes will include the effect of the implementation strategy on women’s modifiable risk factors, estimates of absolute costs or cost-effectiveness and any reported unintentional consequences. Eligible studies will be identified via searching Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Maternity and Infant Care, CINAHL, ProQuest Dissertations and Theses and other sources (e.g. contacting experts in the field). Study selection, data extraction and risk of bias will be assessed independently by two review authors and differences resolved by a third reviewer. If data permits, we will conduct fixed-effects or random-effects meta-analysis where appropriate. If studies do not report the same outcome or there is significant heterogeneity, results will be summarised narratively. Discussion This review will identify which implementation strategies are effective in improving the routine provision of preconception and antenatal care for tobacco smoking, alcohol consumption and weight management. Such a review will be of interest to service providers, policy makers and implementation researchers seeking to improve women’s modifiable risk factors in preconception and antenatal care settings. Systematic review registration PROSPERO CRD42019131691

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