Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions

Background: Interventions to change behaviour have substantial potential to impact positively on individual and overall public health. Despite an increasing focus on health behaviour change intervention research, interventions do not always have the desired effect on outcomes, while others have diluted effects once implemented into real-life settings. There is little investment into understanding how or why such interventions work or do not work. Methodological inadequacies of trials of behavioural interventions have been previously suggested as a barrier to the quality and advancement of behavioural research, with intervention fidelity acknowledged as a key area for improvement. However, there is much ambiguity regarding the terminology and conceptualisation of intervention fidelity and a lack of practical guidance regarding how to address it sufficiently, particularly within trials of complex behavioural interventions. Objectives: This article outlines specific issues concerning intervention fidelity within trials of health behaviour change interventions and suggests practical considerations and specific recommendations for researchers, with examples from the literature presented. Conclusions: Recommendations pertain to (1) clarifying how fidelity is defined and conceptualised, (2) considering fidelity beyond intervention delivery, (3) considering strategies to both enhance and assess fidelity, (4) making use of existing frameworks and guidance, (5) considering the quality and comprehensiveness of fidelity assessment strategies, (6) considering the balance between fidelity and adaptation and (7) reporting the use of fidelity enhancement and assessment strategies and their results. Suggestions for future research to improve our understanding of, and ability to, address fidelity in behaviour change interventions are also provided

Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial.

Objectives: We developed a complex intervention called DECIDE (ComputeriseD dECisIonal support for suboptimally controlleD typE 2 Diabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact of DECIDE.Design: A pilot cluster randomised controlled trial. Setting Conducted in 14 practices in Irish General Practice. Participants The DECIDE intervention was targeted at GPs. They applied DECIDE to patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ≥70 mmol/mol and/or blood pressure ≥150/95 mmHg.Intervention: The intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care. Control practices delivered usual care. Primary and secondary outcome measures Feasibility and acceptability was determined using thematic analysis of semi-structured interviews with GPs, combined with data from the DECIDE website. Clinical outcomes included HbA1c, medication intensification, blood pressure and lipids.Results: We recruited 14 practices and 134 patients. At 4-month follow-up, all practices and 114 patients were followed up. GPs reported finding decision support helpful navigating increasingly complex medication algorithms. However, the majority of GPs believed that the target patient group had poor engagement with GP and hospital services for a range of reasons. At follow-up, there was no difference in glycaemic control (-3.6 mmol/mol (95% CI -11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services. Continuation criteria supported proceeding to a definitive randomised trial with some modifications.Conclusion: The DECIDE study was feasible and acceptable to GPs but wider impacts on glycaemic and blood pressure control need to be considered for this patient population going forward. Trial registration number: ISRCTN69498919</div

Parental experiences and perceptions of infant complementary feeding: a qualitative evidence synthesis

Background Interventions to prevent childhood obesity increasingly focus on infant feeding, but demonstrate inconsistent effects. A comprehensive qualitative evidence synthesis is essential to better understand feeding behaviours and inform intervention development. The aim of this study is to synthesize evidence on perceptions and experiences of infant feeding and complementary feeding recommendations. Methods Databases CINAHL, EMBASE, MEDLINE, PsycINFO, Academic Search Complete, SocIndex and Maternity and Infant Care were searched from inception to May 2017. Eligible studies examined parents' experiences of complementary feeding of children

Sexual counselling for patients with cardiovascular disease: protocol for a pilot study of the CHARMS sexual counselling intervention.

Introduction Sexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland.Methods and analysis This is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via questionnaires and interviews.Ethics and dissemination This study is approved by the Research Ethics Committee (REC) of the National University of Ireland, Galway. Findings will be disseminated to cardiac rehabilitation staff, patients/partners and relevant policymakers via appropriate publications and presentations

A collaborative approach to developing sustainable behaviour change interventions for childhood obesity prevention: Development of the Choosing Healthy Eating for Infant Health (CHErIsH) intervention and implementation strategy

Objectives and Design There is growing recognition of the need for effective behaviour change interventions to prevent chronic diseases that are feasible and sustainable and can be implemented within routine health care systems. Focusing on implementation from the outset of intervention development, and incorporating multiple stakeholder perspectives to achieve this, is therefore essential. This study explores the development of the Choosing Healthy Eating for Infant Health (CHErIsH) childhood obesity prevention intervention and implementation strategy to improve infant feeding behaviours. Methods Five qualitative and quantitative evidence syntheses, two primary qualitative studies, and formal/informal consultations were conducted with practice, policy, research, and parent stakeholders. The Behaviour Change Wheel was used to guide the integration of findings. Results The CHErIsH intervention targets parent‐level behaviour change and comprises (1) brief verbal messages and (2) trustworthy resources, to be delivered by health care professionals (HCPs) during routine infant vaccination visits. The implementation strategy targets HCP‐level behaviour change and comprises (1) a local opinion leader, (2) incentivized training, (3) HCP resources and educational materials, (4) electronic delivery prompts, (5) awareness‐raising across all primary care HCPs, and (6) local technical support. Conclusions This study provides a rigorous example of the development of an evidence‐based intervention aimed at improving parental infant feeding behaviours, alongside an evidence‐based behaviour change strategy to facilitate implementation and sustainability in primary care. This approach demonstrates how to systematically incorporate multiple stakeholder perspectives with existing literature and move from multiple evidence sources to clearly specified intervention components for both the intervention and implementation strategy

The CHARMS pilot study: a multi-method assessment of the feasibility of a sexual counselling implementation intervention in cardiac rehabilitation in Ireland

Background: Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland. Methods: The CHARMS intervention, consisting of awareness training and skills development for staff, and education and support for patients, was implemented in two CR centres. Following a repeated measures design, quantitative and qualitative feasibility, fidelity, cost, and outcome data were collected from staff and patients at baseline (T1, pre-intervention), at 3 months post-baseline (T2, post-intervention), and at 6 months post-baseline (T3, postintervention). Data were organised according to a 14-point reporting framework of methodological issues that should be examined in pilot and feasibility studies. To inform a future definitive trial, potential solutions to identified feasibility issues were generated using the ADePT process for decision-making after pilot and feasibility trials. Results: Most elements of the study protocol were executed smoothly, and intervention implementation was successful. Patients’ (N = 42) responses to the intervention were positive. The reporting framework and the ADePT process facilitated the identification of two overarching feasibility problems, as well as solutions to be implemented in a definitive trial: (1) a high level of patient attrition in the pilot study, to be addressed through the use of financial incentives, reducing the length of the patient questionnaire, and providing a telephone survey option; and (2) negative staff perceptions, to be addressed through an augmented staff intervention, reframing ‘sexual counselling’ as ‘sexual education and support’ to fit with professional role perceptions, and reviewing all intervention terminology with a CR staff member to ensure acceptability. Conclusions: This article reports the successful piloting of a novel sexual counselling implementation intervention in cardiac rehabilitation. The utilisation of an extended reporting framework and the ADePT process facilitated the identification of adaptations necessary to ensure the feasibility of a definitive trial, thereby maximising methodological transparency

Choosing healthy eating for infant health (CHErIsH) study: protocol for a feasibility study

Introduction Childhood obesity is a public health challenge. There is evidence for associations between parents’ feeding behaviours and childhood obesity risk. Primary care provides a unique opportunity for delivery of infant feeding interventions for childhood obesity prevention. Implementation strategies are needed to support infant feeding intervention delivery. The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP)-level implementation strategy to support delivery. Methods and analysis This protocol provides a description of a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with an embedded process evaluation and economic evaluation. Intervention participants will be parents of infants aged ≤6 weeks at recruitment, attending a participating HCP in a primary care practice. The intervention will be delivered at the infant’s 2, 4, 6, 12 and 13month vaccination visits and involves brief verbal infant feeding messages and additional resources, including a leaflet, magnet, infant bib and sign-posting to an information website. The implementation strategy encompasses a local opinion leader, HCP training delivered prior to intervention delivery, electronic delivery prompts and additional resources, including a training manual, poster and support from the research team. An embedded mixed-methods process evaluation will examine the acceptability and feasibility of the intervention, the implementation strategy and study processes including data collection. Qualitative interviews will explore parent and HCP experiences and perspectives of delivery and receipt of the intervention and implementation strategy. Self-report surveys will examine fidelity of delivery and receipt, and acceptability, suitability and comprehensiveness of the intervention, implementation strategy and study processes. Data from electronic delivery prompts will also be collected to examine implementation of the intervention. A cost–outcome description will be conducted to measure costs of the intervention and the implementation strategy. Ethics and dissemination This study received approval from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Study findings will be disseminated via peer-reviewed publications and conference presentations

Enhancing the translation of health behaviour change research into practice: a selective conceptual review of the synergy between implementation science and health psychology

Health psychology is at the forefront of developing and disseminating evidence, theories, and methods that have improved the understanding of health behaviour change. However, current dissemination approaches may be insufficient for promoting broader application and impact of this evidence to benefit the health of patients and the public. Nevertheless, behaviour change theory/methods typically directed towards health behaviours are now used in implementation science to understand and support behaviour change in individuals at different health system levels whose own behaviour impacts delivering evidence based health behaviour change interventions. Despite contributing to implementation science, health psychology is perhaps doing less to draw from it. A redoubled focus on implementation science in health psychology could provide novel prospects for enhancing the impact of health behaviour change evidence. We report a Health Psychology Review-specific review-of-reviews of trials of health behaviour change interventions published from inception to April 2020. We identified 34 reviews and assessed whether implementation readiness of behaviour change interventions was discussed. We then narratively review how implementation science has integrated theory/methods from health psychology and related discipline. Finally, we demonstrate how greater synergy between implementation science and health psychology could promote greater follow-through on advances made in the science of health behaviour change