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BackgroundNational audits aim to reduce variations in quality by stimulating quality improvement. However, varying provider engagement with audit data means that this is not being realised.AimThe aim of the study was to develop and evaluate a quality dashboard (i.e. QualDash) to support clinical teams’ and managers’ use of national audit data.DesignThe study was a realist evaluation and biography of artefacts study.SettingThe study involved five NHS acute trusts.Methods and resultsIn phase 1, we developed a theory of national audits through interviews. Data use was supported by data access, audit staff skilled to produce data visualisations, data timeliness and quality, and the importance of perceived metrics. Data were mainly used by clinical teams. Organisational-level staff questioned the legitimacy of national audits. In phase 2, QualDash was co-designed and the QualDash theory was developed. QualDash provides interactive customisable visualisations to enable the exploration of relationships between variables. Locating QualDash on site servers gave users control of data upload frequency. In phase 3, we developed an adoption strategy through focus groups. ‘Champions’, awareness-raising through e-bulletins and demonstrations, and quick reference tools were agreed. In phase 4, we tested the QualDash theory using a mixed-methods evaluation. Constraints on use were metric configurations that did not match users’ expectations, affecting champions’ willingness to promote QualDash, and limited computing resources. Easy customisability supported use. The greatest use was where data use was previously constrained. In these contexts, report preparation time was reduced and efforts to improve data quality were supported, although the interrupted time series analysis did not show improved data quality. Twenty-three questionnaires were returned, revealing positive perceptions of ease of use and usefulness. In phase 5, the feasibility of conducting a cluster randomised controlled trial of QualDash was assessed. Interviews were undertaken to understand how QualDash could be revised to support a region-wide Gold Command. Requirements included multiple real-time data sources and functionality to help to identify priorities.ConclusionsAudits seeking to widen engagement may find the following strategies beneficial: involving a range of professional groups in choosing metrics;real-time reporting;presenting ‘headline’ metrics important to organisational-level staff;using routinely collected clinical data to populate data fields;and dashboards that help staff to explore and report audit data. Those designing dashboards may find it beneficial to include the following: ‘at a glance’ visualisation of key metrics;visualisations configured in line with existing visualisations that teams use, with clear labelling;functionality that supports the creation of reports and presentations;the ability to explore relationships between variables and drill down to look at subgroups;and low requirements for computing resources. Organisations introducing a dashboard may find the following strategies beneficial: clinical champion to promote use;testing with real data by audit staff;establishing routines for integrating use into work practices;involving audit staff in adoption activities;and allowing customisation.LimitationsThe COVID-19 pandemic stopped phase 4 data collection, limiting our ability to further test and refine the QualDash theory. Questionnaire results should be treated with caution because of the small, possibly biased, sample. Control sites for the interrupted time series analysis were not possible because of research and development delays. One intervention site did not submit data. Limited uptake meant that assessing the impact on more measures was not appropriate.Future workThe extent to which national audit dashboards are used and the strategies national audits use to encourage uptake, a realist review of the impact of dashboards, and rigorous evaluations of the impact of dashboards and the effectiveness of adoption strategies should be explored.Study registrationThis study is registered as ISRCTN18289782.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research;Vol. 10, No. 12. See the NIHR Journals Library website for further project information.
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BACKGROUND: Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. This study aims to establish key trial parameters, assess the acceptability of the intervention and the extent to which it can be delivered with fidelity, and to demonstrate "proof of principle" regarding its efficacy on primary and process outcomes. METHODS: The ACTION intervention includes an individual 1:1 ACT session followed by three group sessions involving 8-10 women and two practitioner psychologists. Participants are also provided with access to a website containing evidence-based methods for self-managing side-effects. The ACT sessions were adapted during the COVID-19 pandemic to be remotely delivered via video conferencing software. To evaluate the feasibility and acceptability of this intervention, a multi-site, exploratory, two-arm, individually randomised external pilot trial with a nested qualitative study will be undertaken. Eighty women with early stage breast cancer prescribed adjuvant endocrine therapy will be randomised (1:1) to receive treatment as usual or treatment as usual plus the ACTION intervention. The planned future primary outcome is medication adherence assessed by the ASK-12 measure. Progression to a phase III RCT will be based on criteria related to recruitment and follow-up rates, acceptability to patients, competency and fidelity of delivery, and proof of principle for change in medication adherence. DISCUSSION: This external pilot trial will be used to ascertain the feasibility of undertaking a future phase III RCT to definitively evaluate an ACT-based intervention to support medication taking behaviour and quality of life in women with early stage breast cancer on adjuvant endocrine therapy. TRIAL REGISTRATION: ISRCTN: 12027752. Registered 24 December 2020, https://doi.org/10.1186/ISRCTN12027752.
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OBJECTIVES: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. SETTING: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. PARTICIPANTS AND OUTCOME MEASURES: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists' attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings. ETHICS AND DISSEMINATION: Approval obtained through the East Midlands-Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads. TRIAL REGISTRATION NUMBER: ISRCTN12464275.