An implementation intervention to increase the routine provision of antenatal care addressing gestational weight gain: study protocol for a stepped-wedge cluster trial

Background Weight gain during pregnancy that is outside of recommended levels is associated with a range of adverse outcomes for the mother and child, including gestational diabetes, pre-eclampsia, preterm birth, and obesity. Internationally, 60–80% of pregnant women report gaining weight outside of recommended levels. While guideline recommendations and RCT evidence support the provision of antenatal care that supports healthy gestational weight gain, less than 10% of health professionals routinely weigh pregnant women; discuss weight gain, diet, and physical activity; and provide a referral for additional support. This study aims to determine the effectiveness of an implementation intervention in increasing the provision of recommended gestational weight gain care by maternity services. Methods A stepped-wedge controlled trial, with a staggered implementation intervention, will be conducted across maternity services in three health sectors in New South Wales, Australia. The implementation intervention will consist of evidence-based, locally-tailored strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training, and monitoring and feedback. Primary outcome measures will be the proportion of women who report receiving (i) assessment of gestational weight gain; (ii) advice on gestational weight gain, dietary intake, and physical activity; and (iii) offer of referral to a telephone coaching service or local dietetics service. Measurement of outcomes will occur via telephone interviews with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost, cost-consequence, cost-effectiveness, and budget impact of the implementation intervention. Receipt of all care elements, acceptance of referral, weight gain during pregnancy, diet quality, and physical activity will be measured as secondary outcomes. Process measures including acceptability, adoption, fidelity, and reach will be reported. Discussion This will be the first controlled trial to evaluate the effectiveness of a implementation intervention in improving antenatal care that addresses gestational weight gain. The findings will inform decision-making by maternity services and policy agencies and, if the intervention is demonstrated to be effective, could be applied at scale to benefit the health of women and children across Australia and internationally. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12621000054819. Registered on 22 January 2021

Physical Activity Coaching Implementation Among Physiotherapists and SCI Peer Mentors: Behavioural Determinants and Effects

Background: The most profound drop in physical activity among people with spinal cord injury (SCI) is observed in the months following discharge from rehabilitation. The ProACTIVE SCI intervention has previously demonstrated large-sized effects on physical activity among people with SCI in the community setting. If implemented successfully during the transition from hospital to community setting, this intervention may help improve physical activity at a critical, yet understudied, timepoint for people with SCI. The purpose of this study is to evaluate the effects of an implementation intervention on physical activity coaching behaviour and its determinants to inform future adaptation of the intervention for sustained implementation.Methods: This study employed a single group, pre-post design. The Knowledge to Action Framework supplemented by the Quality Implementation Framework were used to engage end-users in adapting the intervention and implementation process. The implementation intervention consisted of training (instructions, demonstration, behavioural practice, feedback), provision of educational resources, the addition of a physical activity prompt in patient discharge forms, and engagement of champions. The determinants of physical activity coaching were evaluated using a survey based on the Theoretical Domains Framework (TDF), administered before and immediately following training. Paired two-tailed t-tests were conducted to detect a significant within-subject effect over time on physical activity coaching determinants.Results: A total of ten participants attended training and completed the TDF survey. No significant differences were observed in any of the current physical activity coaching behaviours evaluated during the training period. However, participants reported significant improvements in physical activity coaching behavioural determinants including knowledge, skills, beliefs about capabilities, environmental context and resources, social influences, behavioural regulation, and memory, attention and decision processes (ps<0.05).Conclusions: Improvements in determinants signal the potential for changes in physical activity coaching behaviour. Determinant scores that remained low will be targeted to inform the ongoing adaptation of the implementation intervention. This study serves as an example of using the TDF, the Knowledge to Action Framework, and the Quality Implementation Framework to guide adaptation and implementation of an intervention.Trial Registration: U.S. National Library of Medicine, NCT04493606. Registered 29 July 2020, https://clinicaltrials.gov/ct2/show/NCT04493606

Feasibility of a pharmacy-led intervention to de-implement non-guideline-concordant proton pump inhibitor use

Background Proton pump inhibitors (PPIs) are among the most prescribed medications and are often used unnecessarily. PPIs are used for the treatment of heartburn and acid-related disorders. Emerging evidence indicates that PPIs are associated with serious adverse events, such as increased risk of Clostridioides difficile infection. In this study, we designed and piloted a PPI de-implementation intervention among hospitalized non-intensive care unit patients. Methods Using the Systems Engineering Initiative for Patient Safety (SEIPS) model as the framework, we developed an intervention with input from providers and patients. On a bi-weekly basis, a trainee pharmacist reviewed a random sample of eligible patients’ charts to assess if PPI prescriptions were guideline-concordant; a recommendation to de-implement non-guideline-concordant PPI therapy was sent when applicable. We used convergent parallel mixed-methods design to evaluate the feasibility and outcomes of the intervention. Results During the study period (September 2019 to August 2020), 2171 patients with an active PPI prescription were admitted. We randomly selected 155 patient charts for review. The mean age of patients was 70.9 ± 9 years, 97.4% were male, and 35% were on PPIs for ≥5 years. The average time (minutes) needed to complete the intervention was as follows: 5 to assess if the PPI was guideline-concordant, 5 to provide patient education, and 7 to follow-up with patients post-discharge. After intervention initiation, the week-to-week mean number of PPI prescriptions decreased by 0.5 (S<0.0001). Barriers and facilitators spanned the 5 elements of the SEIPS model and included factors such as providers’ perception that PPIs are low priority medications and patients’ willingness to make changes to their PPI therapy if needed, respectively. Ready access to pharmacists was another frequently reported facilitator to guideline-concordant PPI. Providers recommended a PPI de-implementation intervention that is specific and tells them exactly what they need to do with a PPI treatment. Conclusion In a busy inpatient setting, we developed a feasible way to assess PPI therapy, de-implement non-guideline-concordant PPI use, and provide follow-up to assess any unintended consequences. We documented barriers, facilitators, and provider recommendations that should be considered before implementing such an intervention on a large scale.

A pilot randomised controlled trial of a web-based implementation intervention to increase child intake of fruit and vegetables within childcare centres

Background As dietary behaviours developed during early childhood are known to track into adulthood, interventions that aim to improve child nutrition at a population level are recommended. Whilst early childhood education and care (ECEC) is a promising setting for interventions targeting children’s nutrition behaviours, previous interventions have largely used high intensity, face-to-face approaches, limiting their reach, implementation and potential impact at a population level. Web-based modalities represent a promising means of supporting the delivery of childcare-based interventions whilst overcoming challenges of previous approaches; however, the feasibility of using such modalities to support implementation is largely unknown. As such, this study sought to collect feasibility and pilot data to inform the design of a web-based intervention together with health promotion officer support within childcare centres. Child dietary intake will also be assessed to provide an estimate of the impact of the implementation intervention. Methods A superiority cluster randomised controlled trial with repeat cross-sectional data collection employing an effectiveness-implementation type-II hybrid design will be conducted with childcare centres within the Hunter New England region of New South Wales, Australia. Type-II hybrid designs provide the opportunity to assess intervention efficacy whilst piloting the feasibility of the implementation strategies. Centres allocated to the intervention group will receive access to a web-based program together with health promotion officer support to implement targeted healthy eating practices to improve child diet in care. A number of outcomes will be assessed to inform the feasibility to conduct a larger trial, including childcare centre and parent recruitment and consent rates for each component of data collection, uptake of the implementation strategies, acceptability of the intervention and implementation strategies, appropriateness of the implementation strategies and the contextual factors influencing implementation. Discussion This study will provide high-quality evidence regarding the potential feasibility of a web-based intervention and the impact of healthy eating practices on child diet in care. Web-based modalities provide a promising approach for population-wide implementation support to childcare centres given their potential reach and consistency with existing infrastructure. Trial registration Prospectively registered with Australian New Zealand Clinical Trial Registry (ACTRN12619001158156).

Getting to implementation: a protocol for a Hybrid III stepped wedge cluster randomized evaluation of using data-driven implementation strategies to improve cirrhosis care for Veterans

Background Cirrhosis is a rapidly increasing cause of global mortality. To improve cirrhosis care, the Veterans Health Administration (VHA) developed the Hepatic Innovation Team (HIT) Collaborative to support VA Medical Centers (VAMCs) to deliver evidence-based cirrhosis care. This randomized HIT program evaluation aims to develop and assess a novel approach for choosing and applying implementation strategies to improve the quality of cirrhosis care. Methods Evaluation aims are to (1) empirically determine which combinations of implementation strategies are associated with successful implementation of evidence-based practices (EBPs) for Veterans with cirrhosis, (2) manualize these “data-driven” implementation strategies, and (3) assess the effectiveness of data-driven implementation strategies in increasing cirrhosis EBP uptake. Aim 1 will include an online survey of all VAMCs’ use of 73 implementations strategies to improve cirrhosis care, as defined by the Expert Recommendations for Implementing Change taxonomy. Traditional statistical as well as configurational comparative methods will both be employed to determine which combinations of implementation strategies are associated with site-level adherence to EBPs for cirrhosis. In aim 2, semi-structured interviews with high-performing VAMCs will be conducted to operationalize successful implementation strategies for cirrhosis care. These data will be used to inform the creation of a step-by-step guide to tailoring and applying the implementation strategies identified in aim 1. In aim 3, this manualized implementation intervention will be assessed using a hybrid type III stepped-wedge cluster randomized design. This evaluation will be conducted in 12 VAMCs, with four VAMCs crossing from control to intervention every 6 months, in order to assess the effectiveness of using data-driven implementation strategies to improve guideline-concordant cirrhosis care. Discussion Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care. This evaluation will provide implementation support tools that can be applied to enhance the implementation of other evidence-based practices. Trial registration This project was registered at ClinicalTrials.Gov (NCT04178096) on 4/29/20.

Effectiveness of a Theory- and Web-Based Adaptive Implementation Intervention on Nurses’ and Nursing Students’ Intentions to Provide Brief Counseling: Protocol for a Randomized Controlled Trial

Background Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by nurses is difficult due to contextual and practitioner-level factors impeding nurses’ motivation and intentions to provide brief counseling (eg, unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Theory-based implementation interventions could address these practitioner-level factors and support evidence-based practice in the context of brief counseling. Web-based, adaptive e-learning (electronic learning) programs are a novel type of implementation intervention that could address the limitations of current brief counseling training programs, such as accessibility and personalization. Objective This paper presents a study protocol for evaluating the effectiveness of the E_MOTIVA implementation intervention—a theory- and web-based adaptive e-learning program—to increase nurses’ and nursing students’ intentions to provide brief counseling for smoking, an unbalanced diet, and medication nonadherence. Methods A two-group, single-blind, randomized controlled trial will be conducted with nurses and nursing students enrolled in a Bachelor of Science in Nursing program in Quebec, Canada. Participants in the experimental group will be allocated to the E_MOTIVA intervention—a theory- and web-based adaptive e-learning program—while participants in the active control group will be allocated to the E_MOTIVB intervention, a knowledge- and web-based standardized e-learning program. The E_MOTIVA intervention was designed to influence the constructs of the Theory of Planned Behavior (eg, attitude, subjective norms, and perceived behavioral control) in the context of brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess participants’ cognitive load and engagement related to e-learning. Participants will complete the Brief Counseling Nursing Practices Questionnaire–Abridged Version at baseline and follow-up. All study measures will be completed online. Results The study is ongoing. The results of the study will provide answers to the primary hypothesis (H1) that experimental group participants will demonstrate a greater change in the score of intentions to provide brief counseling between baseline (–T1) and follow-up (T4). Secondary hypotheses include greater improvements in scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling in the experimental group between baseline and follow-up. We also anticipate lower intrinsic and extrinsic cognitive loads (H8, H9), higher germane cognitive load (H10), and higher engagement (H11, H12) in the experimental group. Conclusions This study will be among the first in evaluating a novel type of implementation intervention, a theory- and web-based adaptive e-learning program, in nurses and nursing students. This type of intervention has the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing. Trial Registration ISRCTN Registry ISRCTN32603572; http://www.isrctn.com/ISRCTN32603572 International Registered Report Identifier (IRRID) PRR1-10.2196/18894