Study protocol for an economic evaluation and budget impact of implementation strategies to support routine provision of antenatal care for gestational weight gain: a stepped-wedge cluster trial.

BACKGROUND: Antenatal clinical practice guidelines recommend routine assessment of weight and provision of advice on recommended weight gain during pregnancy and referral to additional services when appropriate. However, there are barriers to clinicians adopting such best-practice guidelines. Effective, cost-effective, and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised. This paper describes the protocol for evaluating the efficiency and affordability of implementation strategies compared to the usual practice in public antenatal services. METHOD: The prospective trial-based economic evaluation will identify, measure, and value key resource and outcome impacts arising from the implementation strategies compared with usual practice. The evaluation will comprise of (i) costing, (ii) 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 (iii) cost-effectiveness analysis, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for gestational weight gain consistent with the guideline recommendations. Affordability will be evaluated using (iv) budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fund-holders. DISCUSSION: Together with the findings from the effectiveness trial, the outcomes of this economic evaluation will inform future healthcare policy, investment allocation, and research regarding the implementation of antenatal care to support healthy gestational weight gain. TRIAL REGISTRATION: Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12621000054819 (22/01/2021) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380680&isReview=true .

How cost-effective is nutrition care delivered in primary healthcare settings? A systematic review of trial-based economic evaluations.

CONTEXT: Nutrition care is an effective lifestyle intervention for the treatment and prevention of many noncommunicable diseases. Primary care is a high-value setting in which to provide nutrition care. OBJECTIVE: The objective of this review was to evaluate the cost-effectiveness of nutrition care interventions provided in primary care settings. DATA SOURCES: Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Central Register of Controlled Trials, EconLit, and the National Health Service Economic Evaluation Database (NHS EED) were searched from inception to May 2021. DATA EXTRACTION: Data extraction was guided by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) reporting guidelines. Randomized trials of nutrition interventions in primary care settings were included in the analysis if incremental cost-effectiveness ratios were reported. The main outcome variable incremental cost-effectiveness ratios (ICERs) and reported interpretations were used to categorize interventions by the cost-effectiveness plane quadrant. RESULTS: Of 6837 articles identified, 10 were included (representing 9 studies). Eight of the 9 included studies found nutrition care in primary care settings to be more costly and more effective than usual care. High study heterogeneity limited further conclusions. CONCLUSION: Nutrition care in primary care settings is effective, though it requires investment; it should, therefore, be considered in primary care planning. Further studies are needed to evaluate the long-term cost-effectiveness of providing nutrition care in primary care settings. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42020201146.

Cost, cost-consequence and cost-effectiveness evaluation of a practice change intervention to increase routine provision of antenatal care addressing maternal alcohol consumption.

BACKGROUND: Implementation of antenatal clinical guideline recommendations for addressing maternal alcohol consumption is sub-optimal. There is a complete absence of evidence of the cost and cost-effectiveness of delivering practice change interventions addressing maternal alcohol consumption amongst women accessing maternity services. The study sought to determine the cost, cost-consequence and cost-effectiveness of developing and delivering a multi-strategy practice change intervention in three sectors of a health district in New South Wales, Australia. METHODS: The trial-based economic analyses compared the costs and outcomes of the intervention to usual care over the 35-month period of the stepped-wedge trial. A health service provider perspective was selected to focus on the cost of delivering the practice change intervention, rather than the cost of delivering antenatal care itself. All costs are reported in Australian dollars ($AUD, 2019). Univariate and probabilistic sensitivity analyses assessed the effect of variation in intervention effect and costs. RESULTS: The total cost of delivering the practice change intervention across all three sectors was $367,646, of which $40,871 (11%) were development costs and $326,774 (89%) were delivery costs. Labour costs comprised 70% of the total intervention delivery cost. A single practice change strategy, 'educational meetings and educational materials' contributed 65% of the delivery cost. Based on the trial's primary efficacy outcome, the incremental cost effectiveness ratio was calculated to be $32,570 (95% CI: $32,566-$36,340) per percent increase in receipt of guideline recommended care. Based on the number of women attending the maternity services during the trial period, the average incremental cost per woman who received all guideline elements was $591 (Range: $329 - $940) . The average cost of the intervention per eligible clinician was $993 (Range: $640-$1928). CONCLUSION: The intervention was more effective than usual care, at an increased cost. Healthcare funders' willingness to pay for this incremental effect is unknown. However, the strategic investment in systems change is expected to improve the efficiency of the practice change intervention over time. Given the positive trial findings, further research and monitoring is required to assess the sustainability of intervention effectiveness and whether economies of scale, or reduced costs of intervention delivery can be achieved without impact on outcomes. TRIAL REGISTRATION: The trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

A systematic review of economic evaluations of antenatal nutrition and alcohol interventions and their associated implementation interventions.

CONTEXT: Improving maternal nutrition and promoting alcohol abstinence during pregnancy are key to reducing subsequent economic and social impacts. However, antenatal nutrition and alcohol interventions are underused, partly because economic evidence to support investment is limited. OBJECTIVE: The purpose of this systematic literature review was to assess the extent to which economic evaluations have been applied to antenatal public health interventions, and implementation strategies addressing maternal nutrition and alcohol intake. DATA SOURCES: Two separate systematic reviews were conducted to address the 2 stated aims. Both reviews adhered to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The searches were conducted using the following databases: Medline, EMBASE, Cochrane, EconLit, CINAHL, and the National Health Service Economic Evaluation Database, accompanied by a handsearch of gray literature. DATA EXTRACTION: Review 1 returned 9599 records after duplicates were removed, from which 12 economic evaluations were included. Review 2 returned 136 records after duplicates were removed, with none eligible for inclusion. The articles included in review 1 comprised 10 economic evaluations of nutrition interventions and 2 evaluations of alcohol interventions. DATA ANALYSIS: Methodological quality was assessed using the Drummond 10-point quality checklist. Methodological quality was high, with variation in reporting practices and predominance of modeled evaluations. RESULTS: Antenatal nutrition and alcohol interventions offer value for money and have potential to considerably reduce healthcare costs. No evidence regarding intervention implementation cost was identified. CONCLUSION: The current evidence base has important gaps that limit its value to decision makers. Incorporating health economic principles and methods into health promotion interventions will inform decisions about how to derive value from investment in healthcare.

Economic evaluation of a web-based menu planning intervention to improve childcare service adherence with dietary guidelines.

BACKGROUND: Despite the known benefits of healthy eating in childhood, few Australian childcare services provide food that is consistent with dietary guidelines. The effectiveness of a web-based menu planning intervention to increase childcare service provision of healthy foods and decrease provision of discretionary foods in long day-care services in Australia was assessed in a randomised controlled trial. Here we consider the costs, consequences, cost-effectiveness and budget impact of the intervention using data collected within the trial. METHODS: The prospective trial-based economic evaluation involved 54 childcare services across New South Wales (NSW), Australia. Services were randomised to a 12-month intervention or usual care. The intervention involved access to a web-based menu planning and decision support tool and online resources. Effectiveness measures included mean number of food groups, overall menu and individual food group compliance with dietary guidelines, and mean servings of food groups at 12 months. Costs (reported in $AUD, 2017/18) were evaluated from both health sector and societal perspectives. The direct cost to support uptake of the intervention was calculated, as were costs to each childcare service. The incremental cost of the intervention was calculated as the net difference in the cost to undertake menu planning and review plus the direct cost of the intervention. Incremental cost-effectiveness ratios (ICERs) including uncertainty intervals were estimated for differences in costs and effects between intervention and control groups. A relative value index was calculated to determine overall value for money. RESULTS: Over the 12 months of the trial, we calculated a difference in cost between usual practice and intervention groups of - $482 (95% UI - $859, - $56). While the measured increase in menu and food group compliance within the trial did not reach statistical significance, there were significant improvements in mean servings of fruit and discretionary food, represented in the cost-consequence analysis. The calculated relative value index of 1.1 suggests that the intervention returns acceptable value for money for the outcomes generated. CONCLUSION: Compared to usual practice, web-based programmes may offer an efficient and sustainable alternative for childcare services to improve the provision of healthy foods to children in their care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616000974404.

Maternal Diet Quality, Body Mass Index and Resource Use in the Perinatal Period: An Observational Study.

The impact of pre-pregnancy obesity and maternal diet quality on the use of healthcare resources during the perinatal period is underexplored. We assessed the effects of body mass index (BMI) and diet quality on the use of healthcare resources, to identify whether maternal diet quality may be effectively targeted to reduce antenatal heath care resource use, independent of women's BMI. Cross-sectional data and inpatient medical records were gathered from pregnant women attending publicly funded antenatal outpatient clinics in Newcastle, Australia. Dietary intake was self-reported, using the Australian Eating Survey (AES) food frequency questionnaire, and diet quality was quantified from the AES subscale, the Australian Recommended Food Score (ARFS). Mean pre-pregnancy BMI was 28.8 kg/m2 (range: 14.7 kg/m2-64 kg/m2). Mean ARFS was 28.8 (SD = 13.1). Higher BMI was associated with increased odds of caesarean delivery; women in obese class II (35.0-39.9 kg/m2) had significantly higher odds of caesarean delivery compared to women of normal weight, (OR = 2.13, 95% CI 1.03 to 4.39; p = 0.04). Using Australian Refined Diagnosis Related Group categories for birth admission, the average cost of the birth admission was $1348 more for women in the obese class II, and $1952 more for women in the obese class III, compared to women in a normal BMI weight class. Higher ARFS was associated with a small statistically significant reduction in maternal length of stay (RR = 1.24, 95% CI 1.00, 1.54; p = 0.05). There was no evidence of an association between ARFS and mode of delivery or "midwifery-in-the-home-visits".

Do the Dietary Intakes of Pregnant Women Attending Public Hospital Antenatal Clinics Align with Australian Guide to Healthy Eating Recommendations?

The maternal diet influences the long-term health status of both mother and offspring. The current study aimed to compare dietary intakes of pregnant women compared to food and nutrient recommendations in the Australian Guide to Healthy Eating (AGHE) and Nutrient Reference Values (NRVs). Usual dietary intake was assessed in a sample of women in their 3rd trimester of pregnancy attending antenatal outpatient clinics at John Hunter Hospital, Newcastle, New South Wales (NSW). Dietary intake was measured using the Australian Eating Survey, a validated, semi-quantitative 120-item food frequency questionnaire. Daily food group servings and nutrient intakes were compared to AGHE and NRV targets. Of 534 women participating, none met the AGHE recommendations for all food groups. Highest adherence was for fruit serves (38%), and lowest for breads and cereals (0.6%). Only four women met the pregnancy NRVs for folate, iron, calcium, zinc and fibre from food alone. Current dietary intakes of Australian women during pregnancy do not align with national nutrition guidelines. This highlights the importance of routine vitamin and mineral supplementation during pregnancy, as intakes from diet alone may commonly be inadequate. Future revisions of dietary guidelines and pregnancy nutrition recommendations should consider current dietary patterns. Pregnant women currently need more support to optimise food and nutrient intakes.

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.

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.

Economic Evaluations of Stepped Models of Care for Depression and Anxiety and Associated Implementation Strategies: A Review of Empiric Studies.

Since the mid-2000s stepped care, a model of integrated healthcare delivery, has been promoted for offering accessible, effective and efficient services for individuals with mental health conditions. However, adoption of the model has not been widespread warranting additional investment by way of implementation strategies to encourage uptake. These strategies also require funding and their value for money should be assessed to inform decision making and practice. We conducted a review to better understand the extent to which the cost-effectiveness of stepped care has been evaluated (review i) and also to investigate whether economic evaluation has been applied to implementation strategies of stepped care services for anxiety and depression in developed (high income) countries and to chart their methods and outcomes (review ii). The searches were conducted in six electronic databases, grey literature and relevant journals. The search strategies returned two papers for reviews (i) and a single paper for review (ii). Despite stepped care models of integrated mental health service provision being promoted as optimal, there is limited knowledge surrounding the real-world cost-effectiveness of their application and clearly a need for good quality economic evaluations of integrated care that comply with international guidelines of good practice. There is even less information pertaining to the cost-effectiveness and budget impact of strategies designed to increase the uptake of these models.