Dataset Information

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

ABSTRACT:

Background

Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, reporting acceptability of the system changes to staff, as well as aids and hindrances to implementation and normalization of this complex intervention.

Methods

Process evaluation was used to complement an effectiveness study. Interviews with maternity and smoking cessation services staff and observations of training were undertaken. Normalization Process Theory (NPT) was used to frame the interview guides and analysis. NPT is an empirically-derived theory, developed by sociologists, that uses four concepts to understand the process of routinising new practices.

Results

Staff interviews took place across eight National Health Service trusts at a time of widespread restructuring in smoking cessation services. Principally interviewees worked in maternity (n = 63) and smoking cessation services (n = 35). Five main themes, identified inductively, influenced the implementation: 1) initial preparedness of the organisations; 2) staff training; 3) managing partnership working; 4) resources; 5) review and planning for sustainability.

Conclusions

NPT was used to show that the babyClear© package was acceptable to staff in a range of organisations. Illustrated in Themes 1, 2 & 3, staff welcomed ways to approach pregnant women about their smoking, without damaging their professional relationship with them. Predicated on producing individual behaviour change in women, the intervention does this largely through reorganising and standardising healthcare systems that are required to implement best practice guidelines. Changing organisational systems requires belief and commitment from staff, so that they set up and maintain practical adjustments to their practice and are reflective about adapting themselves and the work context as new challenges are encountered. The ongoing challenge is to identify and maintain the elements of the intervention package which are essential for its effectiveness and how to tailor them to local circumstances and resources without compromising its core ingredients.

SUBMITTER: Jones S

PROVIDER: S-EPMC6509824 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

Jones Susan S Hamilton Sharon S Bell Ruth R Araújo-Soares Vera V Glinianaia Svetlana V SV Milne Eugene M G EMG White Martin M Willmore Martyn M Shucksmith Janet J

BMC health services research 20190509 1

<h4>Background</h4>Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, ...[more]

PMID: 31072363

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Project description:BACKGROUND:There is a well-recognized need for greater use of theory to address research translational gaps. Normalization Process Theory (NPT) provides a set of sociological tools to understand and explain the social processes through which new or modified practices of thinking, enacting, and organizing work are implemented, embedded, and integrated in healthcare and other organizational settings. This review of NPT offers readers the opportunity to observe how, and in what areas, a particular theoretical approach to implementation is being used. In this article we review the literature on NPT in order to understand what interventions NPT is being used to analyze, how NPT is being operationalized, and the reported benefits, if any, of using NPT. METHODS:Using a framework analysis approach, we conducted a qualitative systematic review of peer-reviewed literature using NPT. We searched 12 electronic databases and all citations linked to six key NPT development papers. Grey literature/unpublished studies were not sought. Limitations of English language, healthcare setting and year of publication 2006 to June 2012 were set. RESULTS:Twenty-nine articles met the inclusion criteria; in the main, NPT is being applied to qualitatively analyze a diverse range of complex interventions, many beyond its original field of e-health and telehealth. The NPT constructs have high stability across settings and, notwithstanding challenges in applying NPT in terms of managing overlaps between constructs, there is evidence that it is a beneficial heuristic device to explain and guide implementation processes. CONCLUSIONS:NPT offers a generalizable framework that can be applied across contexts with opportunities for incremental knowledge gain over time and an explicit framework for analysis, which can explain and potentially shape implementation processes. This is the first review of NPT in use and it generates an impetus for further and extended use of NPT. We recommend that in future NPT research, authors should explicate their rationale for choosing NPT as their theoretical framework and, where possible, involve multiple stakeholders including service users to enable analysis of implementation from a range of perspectives.

Project description:Background Smoking during pregnancy has serious consequences for maternal and child health. An intervention package to embed National Institute for Health and Care Excellence guidance (babyClear©) was delivered across maternity and stop smoking services (SSS) within an English region, to support pregnant women to stop smoking. We aimed to ascertain acceptability among pregnant smokers receiving the intervention. Methods Pregnant smokers who received the intervention and participated in the study were interviewed, first at around 16?weeks of pregnancy (n?=?17) and again several weeks later (n?=?8) or postpartum (n?=?3). Interview schedules were informed by Normalization Process Theory (NPT) and Theoretical Domains Framework; interviews were audio-recorded, transcribed and analysed thematically, using the Framework method and NPT. Findings are grouped according to the four NPT concepts. Results Coherence: Carbon monoxide monitoring appeared to make sense; women were motivated to quit by being monitored. Cognitive participation: When linked to a professional discourse of caring and concern, some women were prompted to engage with the SS message. Women were more guarded in their reaction to initial contact from the SSS; reporting attending appointments successfully, or in some cases, experiencing problems that decreased engagement and made quitting harder. Collective action: Where women continued to smoke or failed to attend SSS appointments, an extra intervention was delivered, the Risk Perception Tool (RPT), which often prompted pregnant women to act. Reflexive monitoring: Most women accepted the need for a hard-hitting approach (RPT) and, while it distressed them at the time, they claimed they were subsequently grateful for it. SSS intervention post-RPT was seen as supportive, partly because it often involved home visits. Aspects of family inclusion in babyClear© were reported as beneficial. In Trusts where women experienced services as less focused on prioritising the stop smoking message, less well integrated or reported maternity staff as less adept at delivering the RPT, women found babyClear© less acceptable overall. Conclusions The babyClear© package was acceptable to pregnant smokers interviewed during and shortly after pregnancy and, in some cases, to promote quitting. However, some contexts were more optimal than others, leading to variation in acceptability overall.

Project description:BackgroundFor successful implementation of an innovation within a complex adaptive system, we need to understand the ways that implementation processes and their contexts shape each other. To do this, we need to explore the work people do to make sense of an innovation and integrate it into their workflow and the contextual elements that impact implementation. Combining Normalization Process Theory (NPT) with the Consolidated Framework for Implementation Research (CFIR) offers an approach to achieve this. NPT is an implementation process theory that explains how changes in the way people think about and use an innovation occurs, while CFIR is a framework that categorizes and describes contextual determinants across five domains that influence implementation. We demonstrate through a case example from our prior research how we integrated NPT and CFIR to inform the development of the interview guide, coding manual, and analysis of the findings.MethodsIn collaboration with our stakeholders, we selected NPT and CFIR to study the implementation process and co-developed an interview guide to elicit responses that would illuminate concepts from both. We conducted, audio-recorded, and transcribed 28 interviews with various professionals involved with the implementation. Based on independent coding of select transcripts and team discussion comparing, clarifying, and crystallizing codes, we developed a coding manual integrating CFIR and NPT constructs. We applied the integrated codes to all interview transcripts.ResultsOur findings highlight how integrating CFIR domains with NPT mechanisms adds explanatory strength to the analysis of implementation processes, with particular implications for practical strategies to facilitate implementation. Multiple coding across both theoretical frames captured the entanglement of process and context. Integrating NPT and CFIR enriched understandings of how interactions between implementation processes and contextual determinants shaped each other during implementation.ConclusionThe integration of NPT and CFIR provides guidance to identify and explore complex entangled interactions between agents, processes, and contextual conditions within and beyond organizations to embed innovations into routine practices. Nuanced understandings gained through this approach moves understandings beyond descriptions of determinants to explain how change occurs or not during implementation. Mechanism-based explanations illuminate concrete practical strategies to support implementation.

Project description:IntroductionSuccessful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated.MethodsDescriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample.ResultsWe obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n?=?413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI?=?0.95, TLI?=?0.93, RMSEA?=?0.08, SRMR?=?0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, ??=?0.71); Collective Action (7 items, ??=?0.78); Cognitive Participation (4 items, ??=?0.81); Reflexive Monitoring (5 items, ??=?0.65). The normalisation scale overall, was highly reliable (20 items, ??=?0.89).ConclusionsThe NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Project description:Following several pilot projects, in 2020, the Department for Education (DfE) in England committed funding of £220M p. a to its Holiday Activities and Food (HAF) programme to support all 153 upper-tier local authorities, comprising City Councils, County Councils and Metropolitan Borough Councils, to provide an activity and food programme for children who are in receipt of means-tested free school meals. In this study, qualitative interviews were conducted with representatives from three Local Authorities in the North East of England who were responsible for overseeing the implementation and delivery of HAF programmes in their Local Authority area to examine how the summer HAF programme was implemented during summer 2021. Interviews were conducted with eight participants prior to the implementation of the HAF programme, and four interviews were conducted after the programme had been delivered. Using a directed content analysis approach, an interpretative framework was co-developed, based on the four constructs (and selected sub-constructs) of Normalization Process Theory. This framework guided data coding. The analysis aimed to identify and understand the barriers and opportunities in relation to HAF implementation within local authorities. Participants did not perceive HAF as a totally new initiative as many had either commissioned or delivered holiday clubs in the past. However, the increased scale and scope of HAF was perceived as highly complex, involving multiple local authority departments and stakeholders. Nonetheless, HAF funding enabled local authorities to improve the quality and reach of their holiday programmes. Strong networks and good communication between all stakeholders supported successful delivery, despite tight delivery timescales. However, the rigidity of some of the DfE guidance was a barrier for some providers, particularly the recommended delivery model of 4 h a day, 4 days a week for 4 weeks, with many individual holiday clubs struggling to meet this level of delivery, and local authority leads interpreting the guidance at a club level rather than an individual child access level. Furthermore, participants considered the HAF eligibility criteria too restrictive. Many councils were developing long-term plans for HAF delivery, integrated into planning across several departments, and all local authorities were actively seeking ways to engage with and embed HAF within local communities.

Project description:BackgroundSuicide rates continue to rise across the United States, galvanizing the need for increased suicide prevention and intervention efforts. The Zero Suicide (ZS) model was developed in response to this need and highlights four key clinical functions of high-quality health care for patients at risk of suicide. The goal of this quality improvement study was to understand how six large health care systems operationalized practices to support these functions-identification, engagement, treatment and care transitions.MethodsUsing a key informant interview guide and data collection template, researchers who were embedded in each health care system cataloged and summarized current and future practices supporting ZS, including, (1) the function addressed; (2) a description of practice intent and mechanism of intervention; (3) the target patient population and service setting; (4) when/how the practice was (or will be) implemented; and (5) whether/how the practice was documented and/or measured. Normalization process theory (NPT), an implementation evaluation framework, was applied to help understand how ZS had been operationalized in routine clinical practices and, specifically, what ZS practices were described by key informants (coherence), the current state of norms/conventions supporting these practices (cognitive participation), how health care teams performed these practices (collective action), and whether/how practices were measured when they occurred (reflexive monitoring).ResultsThe most well-defined and consistently measured ZS practices (current and future) focused on the identification of patients at high risk of suicide. Stakeholders also described numerous engagement and treatment practices, and some practices intended to support care transitions. However, few engagement and transition practices were systematically measured, and few treatment practices were designed specifically for patients at risk of suicide.ConclusionsThe findings from this study will support large-scale evaluation of the effectiveness of ZS implementation and inform recommendations for implementation of high-quality suicide-related care in health care systems nationwide.

Project description:Background'Cascade training' or 'train-the-trainers' has been widely utilised in the dissemination of information and expertise in health and social care, but with little examination of the work required for optimal delivery. National suicide prevention strategies commonly include such training initiatives.MethodsA qualitative study to characterise the work, according to the concepts of Normalization Process Theory, required to disseminate STORM, a model of suicide prevention training across Scotland, and then implement it within organisations. This utilised a cascade style 'train-the trainers' intervention delivered as part of the Choose Life suicide prevention strategy in Scotland during 2008-11. Semi-structured interviews were carried out with 19 training facilitators, 30 of their group participants within organisations and 11 local managers within health boards in Scotland.ResultsCrucial to the process of a cascade training approach to implementing suicide prevention within an organisation was the multi-layered activity of constructing coherence of the intervention at every level in order to prevent dilution of the training. This necessitated collaborative work within and between groups of actors- managers, facilitators and participants. Where facilitators were effectively engaged in their role, confident in their ability to train, supported by supervision and possessed the leadership skills to engage both with participants and their local context to deliver training, there was evidence of both successful delivery and embedding within the organisation. However, there was little systematic evidence of institutional level appraisal- crucial to truly implementing a novel intervention within the system - despite efforts at local managerial engagement.ConclusionsSuccessful cascade or train-the-trainer implementation of an intervention requires extensive collaborative work to take place between and within groups of actors at all levels of an organization from those working at policy level to the 'coalface'. A priori application of Normalization Process Theory, to specify aims and goals for the necessary work to be carried out between different groups of actors, would assist in embedding a novel working practice at all levels. Future national training strategies for suicide prevention should address what is required to establish a flourishing culture of high-quality skills acquisition and development within healthcare organisations.

Project description:BackgroundCOVID-19 necessitated the rapid implementation and uptake of virtual health care; however, virtual care's potential role remains unclear in the urgent care setting. In December 2020, the first virtual emergency department (ED) in the Greater Toronto Area was piloted at Sunnybrook Health Sciences Centre by connecting patients to emergency physicians through an online portal.ObjectiveThis study aims to understand whether and how ED physicians were able to integrate a virtual ED alongside in-person operations.MethodsWe conducted semistructured interviews with ED physicians guided by the Normalization Process Theory (NPT). The NPT provides a framework to understand how individuals and teams navigate the process of embedding new models of care as part of normal practice. All physicians who had worked within the virtual ED model were invited to participate. Data were analyzed using a combination of inductive and deductive techniques informed by the NPT.ResultsA total of 14 physicians were interviewed. Participant experiences were categorized into 1 of 2 groups: 1 group moved to normalize the virtual ED in practice, while the other described barriers to routine adoption. These groups differed in their perception of the patient benefits as well as the perceived role in the virtual ED. The group that normalized the virtual ED model saw value for patients (coherence) and was motivated by patient satisfaction witnessed (reflexive monitoring) at the end of the virtual appointment. By contrast, the other group did not find virtual ED work reflective of the perceived role of urgent care (cognitive participation) and felt their skills as ED physicians were underutilized. The limited ability to examine patients and a sense that patient issues were not fully resolved at the end of the virtual appointment caused frustration among the second group.ConclusionsAs further digital integration within the health care system occurs, it will be essential to support the evolution of staff skill sets to ensure physicians are satisfied with the care they are providing to their patients, while also ensuring the technology and process are efficient.

Project description:BACKGROUND:Many countries are engaged in primary care reforms to support older adults who are living longer in the community. Health Teams Advancing Patient Experience: Strengthening Quality [Health TAPESTRY] is a primary care intervention aimed at supporting older adults that involves trained volunteers, interprofessional teams, technology, and system navigation. This paper examines implementation of Health TAPESTRY in relation to interprofessional teamwork including volunteers. METHODS:This study applied Normalization Process Theory (NPT) and used a descriptive qualitative approach [1] embedded in a mixed-methods, pragmatic randomized controlled trial. It was situated in two primary care practice sites in a large urban setting in Ontario, Canada. Focus groups and interviews were conducted with primary care providers, clinical managers, administrative assistants, volunteers, and a volunteer coordinator. Data was collected at 4?months (June-July 2015) and 12?months (February-March 2016) after intervention start-up. Patients were interviewed at the end of the six-month intervention. Field notes were taken at weekly huddle meetings. RESULTS:Overall, 84 participants were included in 17 focus groups and 13 interviews; 24 field notes were collected. Themes were organized under four NPT constructs of implementation: 1) Coherence- (making sense/understanding of the program's purpose/value) generating comprehensive assessments of older adults; strengthening health promotion, disease prevention, and self-management; enhancing patient-focused care; strengthening interprofessional care delivery; improving coordination of health and community services. 2) Cognitive Participation- (enrolment/buy-in) tackling new ways of working; attaining role clarity. 3) Collective Action- (enactment/operationalizing) changing team processes; reconfiguring resources. 4) Reflective Monitoring- (appraisal) improving teamwork and collaboration; reconfiguring roles and processes. CONCLUSIONS:This study contributes key strategies for effective implementation of interventions involving interprofessional primary care teams. Findings indicate that regular communication among all team members, the development of procedures and/or protocols to support team processes, and ongoing review and feedback are critical to implementation of innovations involving primary care teams. TRIAL REGISTRATION:ClinicalTrials.gov, no. NCT02283723 November 5, 2014. Prospectively registered.

Dataset Information

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

Background

Methods

Results

Conclusions

Publications

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

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