Catherine O’Donnell

A qualitative systematic review of studies using the normalization process theory to research implementation processes

BackgroundThere 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.MethodsUsing 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 Grey literature/unpublished studies were not sought.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.ResultsTwenty-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.ConclusionsNPT 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.

Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies

BackgroundNumerous types of digital health interventions (DHIs) are available to patients and the public but many factors affect their ability to engage and enrol in them. This systematic review aims to identify and synthesise the qualitative literature on barriers and facilitators to engagement and recruitment to DHIs to inform future implementation efforts.MethodsPubMed, MEDLINE, CINAHL, Embase, Scopus and the ACM Digital Library were searched for English language qualitative studies from 2000 – 2015 that discussed factors affecting engagement and enrolment in a range of DHIs (e.g. ‘telemedicine’, ‘mobile applications’, ‘personal health record’, ‘social networking’). Text mining and additional search strategies were used to identify 1,448 records. Two reviewers independently carried out paper screening, quality assessment, data extraction and analysis. Data was analysed using framework synthesis, informed by Normalization Process Theory, and Burden of Treatment Theory helped conceptualise the interpretation of results.ResultsNineteen publications were included in the review. Four overarching themes that affect patient and public engagement and enrolment in DHIs emerged; 1) personal agency and motivation; 2) personal life and values; 3) the engagement and recruitment approach; and 4) the quality of the DHI. The review also summarises engagement and recruitment strategies used. A preliminary DIgital Health EnGagement MOdel (DIEGO) was developed to highlight the key processes involved. Existing knowledge gaps are identified and a number of recommendations made for future research. Study limitations include English language publications and exclusion of grey literature.ConclusionThis review summarises and highlights the complexity of digital health engagement and recruitment processes and outlines issues that need to be addressed before patients and the public commit to digital health and it can be implemented effectively. More work is needed to create successful engagement strategies and better quality digital solutions that are personalised where possible and to gain clinical accreditation and endorsement when appropriate. More investment is also needed to improve computer literacy and ensure technologies are accessible and affordable for those who wish to sign up to them.Systematic review registrationInternational Prospective Register of Systematic Reviews CRD42015029846

From theory to 'measurement' in complex interventions: Methodological lessons from the development of an e-health normalisation instrument

BackgroundAlthough empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field.MethodsA 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals.ResultsThe developed instrument was pre-tested in two professional samples (N = 46; N = 231). Ratings of items representing normalisation ‘processes’ were significantly related to staff members’ perceptions of whether or not e-health had become ‘routine’. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts.ConclusionsTo develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.

Health-care access for migrants in Europe

Migration is a reality of today’s world, with over one billion migrants worldwide. While many choose to move voluntarily, others are forced to migrate due to economic reasons or to flee war, conflict, or persecution. Such migrants often find themselves in precarious and marginalized situations—particularly asylum seekers, refugees, and undocumented or irregular migrants. While often viewed as a single group, the legal status and entitlements of these three groups are different. This has implications for their ability to access health care; in addition, rights and entitlements vary across the 28 countries of the European Union and across different parts of national health systems. The lack of entitlement to receive care, including primary and secondary care, is a significant barrier for many asylum seekers and refugees and an even greater barrier for undocumented migrants. Other barriers include different health profiles and awareness of chronic disease risk amongst migrants; awareness of the organization of health systems in host countries; and language and communication. The use of professional interpreters can help to overcome communication barriers, but entitlement to free interpreting services is highly variable. Host countries need to consider how to ensure their health systems are “migrant-friendly”: solutions include provision of professional interpreters; ensuring that health care staff are aware of migrants’ rights to access health care; and increasing knowledge of migrants in relation to the organization of the health care system in their host country and how to access care, for example through the use of patient navigators. However, perhaps one of the greatest facilitators for migrants will be a more favorable political situation, which stops demonizing people who are forced to migrate due to situations out of their control.

REsearch into implementation STrategies to support patients of different ORigins and language background in a variety of European primary care settings (RESTORE): study protocol

BackgroundThe implementation of guidelines and training initiatives to support communication in cross-cultural primary care consultations is ad hoc across a range of international settings with negative consequences particularly for migrants. This situation reflects a well-documented translational gap between evidence and practice and is part of the wider problem of implementing guidelines and the broader range of professional educational and quality interventions in routine practice. In this paper, we describe our use of a contemporary social theory, Normalization Process Theory and participatory research methodology—Participatory Learning and Action—to investigate and support implementation of such guidelines and training initiatives in routine practice.MethodsThis is a qualitative case study, using multiple primary care sites across Europe. Purposive and maximum variation sampling approaches will be used to identify and recruit stakeholders—migrant service users, general practitioners, primary care nurses, practice managers and administrative staff, interpreters, cultural mediators, service planners, and policy makers. We are conducting a mapping exercise to identify relevant guidelines and training initiatives. We will then initiate a PLA-brokered dialogue with stakeholders around Normalization Process Theory’s four constructs—coherence, cognitive participation, collective action, and reflexive monitoring. Through this, we will enable stakeholders in each setting to select a single guideline or training initiative for implementation in their local setting. We will prospectively investigate and support the implementation journeys for the five selected interventions. Data will be generated using a Participatory Learning and Action approach to interviews and focus groups. Data analysis will follow the principles of thematic analysis, will occur in iterative cycles throughout the project and will involve participatory co-analysis with key stakeholders to enhance the authenticity and veracity of findings.DiscussionThis research employs a unique combination of Normalization Process Theory and Participatory Learning and Action, which will provide a novel approach to the analysis of implementation journeys. The findings will advance knowledge in the field of implementation science because we are using and testing theoretical and methodological approaches so that we can critically appraise their scope to mediate barriers and improve the implementation processes.

Exploring public perspectives on e-health: findings from two citizen juries.

Background  Interest and investment in e‐health continue to grow world‐wide, but there remains relatively little engagement with the public on this subject, despite calls for more public involvement in health‐care planning.

Reducing the health care burden for marginalised migrants: The potential role for primary care in Europe

There is a growing interest in the health of migrants worldwide. Migrants, particularly those in marginalised situations, face significant barriers and inequities in entitlement and access to high quality health care. This study aimed to explore the potential role of primary care in mitigating such barriers and identify ways in which health care policies and systems can influence the ability of primary care to meet the needs of vulnerable and marginalised migrants. The study compared routinely available country-level data on health system structure and financing, policy support for language and communication, and barriers and facilitators to health care access reported in the published literature. These were then mapped to a framework of primary care systems to identify where the key features mitigating or amplifying barriers to access lay. Reflecting on the data generated, we argue that culturally-sensitive primary care can play a key role in delivering accessible, high-quality care to migrants in vulnerable situations. Policymakers and practitioners need to appreciate that both individual patient capacity, and the way health care systems are configured and funded, can constrain access to care and have a negative impact on the quality of care that practitioners can provide to such populations. Strategies to address these issues, from the level of policy through to practice, are urgently needed.

Can we quantify harm in general practice records? An assessment of precision and power using computer simulation

BackgroundEstimating harm rates for specific patient populations and detecting significant changes in them over time are essential if patient safety in general practice is to be improved. Clinical record review (CRR) is arguably the most suitable method for these purposes, but the optimal values and combinations of its parameters (such as numbers of records and practices) remain unknown. Our aims were to: 1. Determine and quantify CRR parameters; 2. Assess the precision and power of feasible CRR scenarios; and 3. Quantify the minimum requirements for adequate precision and acceptable power.MethodWe explored precision and power of CRR scenarios using Monte Carlo simulation. A range of parameter values were combined in 864 different CRR scenarios, with 1000 random data sets generated for each, and harm rates were estimated and tested for change over time by fitting a generalised linear model with a Poisson response.ResultsCRR scenarios with ≥100 detected harm incidents had harm rate estimates with acceptable precision. Harm reductions of 20% or ≥50% were detected with adequate power by those CRR scenarios with at least 100 and 500 harm incidents respectively. The number of detected harm incidents was dependent on the baseline harm rate multiplied by: the period of time reviewed in each record; number of records reviewed per practice; number of practices who reviewed records; and the number of times each record was reviewed.ConclusionWe developed a simple formula to calculate the minimum values of CRR parameters required to achieve adequate precision and acceptable power when monitoring harm rates. Our findings have practical implications for health care decision-makers, leaders and researchers aiming to measure and reduce harm at regional or national level.

Healthcare for migrants, participatory health research and implementation science—better health policy and practice through inclusion. The RESTORE project

Abstract Background: This is a time of unprecedented mobility across the globe. Healthcare systems need to adapt to ensure that primary care is culturally and linguistically appropriate for migrants. Evidence-based guidelines and training interventions for cultural competence and the use of professional interpreters are available across European healthcare settings. However, in real-world practice migrants and their healthcare providers ‘get by’ with a range of informal and inadequate strategies. RESTORE is an EU FP7 funded project, which is designed to address this translational gap. Objectives: The objective of RESTORE is to investigate and support the implementation of guidelines and training initiatives to support communication in cross-cultural consultations in selected European primary care settings. Design: RESTORE is a qualitative, participatory health project running from 2011–2015. It uses a novel combination of normalization process theory and participatory learning and action research to follow and shape the implementation journeys of relevant guidelines and training initiatives. Research teams in Ireland, England, the Netherlands, Austria and Greece are conducting similar parallel qualitative case study fieldwork, with a complementary health policy analysis led by Scotland. In each setting, key stakeholders, including migrants, are involved in participatory data generation and analysis. Expected results: RESTORE will provide knowledge about the levers and barriers to the implementation of guidelines and training initiatives in European healthcare settings and about successful, transferrable strategies to overcome identified barriers. RESTORE will elucidate the role of policy in shaping these implementation journeys; generate recommendations for European policy driving the development of culturally and linguistically appropriate healthcare systems.

Developing a preliminary ‘never event’ list for general practice using consensus-building methods

Background The ‘never event’ concept has been implemented in many acute hospital settings to help prevent serious patient safety incidents. Benefits include increasing awareness of highly important patient safety risks among the healthcare workforce, promoting proactive implementation of preventive measures, and facilitating incident reporting. Aim To develop a preliminary list of never events for general practice. Design and setting Application of a range of consensus-building methods in Scottish and UK general practices. Method A total of 345 general practice team members suggested potential never events. Next, ‘informed’ staff (n =15) developed criteria for defining never events and applied the criteria to create a list of candidate never events. Finally, UK primary care patient safety ‘experts’ (n = 17) reviewed, refined, and validated a preliminary list via a modified Delphi group and by completing a content validity index exercise. Results There were 721 written suggestions received as potential never events. Thematic categorisation reduced this to 38. Five criteria specific to general practice were developed and applied to produce 11 candidate never events. The expert group endorsed a preliminary list of 10 items with a content validity index (CVI) score of >80%. Conclusion A preliminary list of never events was developed for general practice through practitioner experience and consensus-building methods. This is an important first step to determine the potential value of the never event concept in this setting. It is now intended to undertake further testing of this preliminary list to assess its acceptability, feasibility, and potential usefulness as a safety improvement intervention.