IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

BACKGROUND: Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP2ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care. METHODS: IMP2ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP2ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP2ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation. DISCUSSION: The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2 December 2019.

Experiences of cancer immunotherapy with immune checkpoint inhibitors (ExCIm)-insights of people affected by cancer and healthcare professionals: a qualitative study protocol.

INTRODUCTION: There is a global interest in cancer immunotherapy. Clinical trials have found that one group, immune checkpoint inhibitors (ICIs), has demonstrated clinical benefits across various cancers. However, research focused on the experiences of people affected by cancer who have undergone this treatment using qualitative methodology is currently limited. Moreover, little is known about the experiences and education needs of the healthcare staff supporting the people receiving these immunotherapies. This study therefore seeks to explore the experiences of using ICIs by both the people affected by cancer and the healthcare professionals who support those people, and use the findings to make recommendations for ICI supportive care guidance development, cancer immunotherapy education materials for healthcare professionals, cancer policy and further research. METHODS AND ANALYSIS: Patient participants (n=up to 30) will be recruited within the UK. The sample will incorporate a range of perspectives, sociodemographic factors, diagnoses and ICI treatments, yet share some common experiences. Healthcare professionals (n=up to 15) involved in supporting people receiving immunotherapy will also be recruited from across the UK. Data will be generated through in-depth, semistructured interviews. Reflexive thematic analysis will be used to obtain thorough understanding of individual's perspectives on, and experiences of, immunotherapy. Study dates are as follows: December 2019-March 2022. ETHICS AND DISSEMINATION: The research will be performed in accordance with the UK Policy for Health and Social Care Research and Cardiff University's Research Integrity and Governance Code of Practice (2018). The study received ethical approval from the West Midlands and Black Country Research Ethics Committee in October 2019. Health Research Authority and Health and Care Research Wales approvals were confirmed in December 2019. All participants will provide informed consent. Findings will be published in peer-reviewed journals, non-academic platforms, the Macmillan Cancer Support website, disseminated at relevant national and international conferences and presented via a webinar. The study is listed on the National Institute for Health Research (NIHR) Clinical Research Network Central Portfolio.