- Understand the experiences and perceptions of healthcare practitioners, and patients aged over 75 years in relation to direct oral anticoagulants (DOACs) for non valvular atrial fibrillation (AF)
- Determine the influence of local policy and pathway design on prescribing behavior, use and monitoring of DOACs
- Undertake a systematic review and meta-synthesis of qualitative literature in order to provide a current evidence synthesis of patient and practitioner perspectives on the prescription of anticoagulants for patients aged over 75 years with one or more co-morbidities.
- Explore healthcare professional perceptions of DOAC prescribing guidance for patients over 75 years with co-morbidities
- Explore the views and experiences of patients aged over 75 years with co-morbidities prescribed DOACs
- Identify the scale and pattern of overall oral anticoagulant prescribing over time, and in different primary care settings stratified by location of practices (inner city or sub-urban) and patients’ socio-demographic characteristics.
- To develop a monitoring plan for older patients on DOACs championed via community pharmacy
- To provide training and resources for community and practice based pharmacists to improve patient safety, reduce harm and avoid hospital admissions due to adverse drug events associated with DOACs
- To improve communication and counselling provided to patients and carers by pharmacists who are strategically placed to provide expert advice on safe medicines use
A qualitative (rather than quantitative) methodology is more appropriate in exploring perceptions and behaviours relating to complex DOAC prescribing decisions in older adults with co-morbidities. However, this study does include a quantitative element to provide contextual descriptive data of the larger city wide trends in oral anticoagulant prescribing which in addition will inform the sampling framework for qualitative data collection. There is no survey instrument which would specifically address this research question.
Stage 1: Patient and Public Involvement (PPI).
Preliminary PPI work was undertaken by the researcher regarding perspectives on anticoagulation with DOACs for stroke prevention. This took place between February – March 2017 with: an elderly patient with NVAF, three GPs; a Public Health Officer from Sheffield City Council; a Medicine Optimisation Pharmacist from the NHS Sheffield CCG. Further PPI work was undertaken by the researcher with a presentation to the lay Cardiovascular Panel at the Northern General Hospital on the 12th of April 2017 to discuss the rationale, design, lay protocol, recruitment and sampling method. They provided input into the project title and highlighted potential outputs for this research including how information about DOACs is currently conveyed to patients and how this could be improved. This process helped refine the aims and objectives of this research and overall study design including recruitment strategies for patients and practitioners.
The PPI group provided contact details of the local Atrial Fibrillation Support Group, a further lay audience, where a project plan will be shared with the aim of dissemination, enhancing the researcher’s knowledge and vice versa. The PPI group confirmed that the research was feasible, important and relevant and expressed a keen interest to provide further support. Members have agreed to join the steering group for support throughout the project to inform the design, feasibility, acceptability and help identify potential dissemination partners.
Stage 2: Systematic Review and Narrative Metasynthesis
Build upon existing literature review, using systematic searches to address the research question and develop a narrative meta-synthesis of qualitative research relevant to the prescribing and management of oral anticoagulants (OAC) in patients over 75 years, with non valvular atrial fibrillation (NVAF) and one or more co-morbidities. Five databases (CINAHL, MEDLINE, Embase, PsycINFO and Web of Science) will be searched using pre-defined inclusion and exclusion criteria. This work will be submitted for conference presentation and publication in a peer-reviewed journal. It will provide the first comprehensive account of the problems associated with high-risk (OAC) prescribing in people with co-morbidities, and will inform a topic guide for semi-structured interviews in Stage 4.
Stage 3: A Descriptive Evaluation of Current Guidelines, Care Pathways and prescribing trends for the Initiation and Management of DOACs
Clinical guidelines, current prescribing protocols, description of local factors that influence the initiation of DOACs (e.g hospital vs primary care initiation, formularies), and subsequent care pathways will be mapped, facilitated by my membership of the multidisciplinary atrial fibrillation working group in Sheffield. I will use these care pathways to explore issues that influence prescribing, and patterns of prescribing behaviour. I will draw comparisons to determine variations in these factors.
Use of routinely available secondary data (index of deprivation (IMD), age profile, training status, practice size, Quality and Outcomes Framework (QoF) prevalence and prescribing data) from Sheffield GP practices and the CCG will inform my sampling framework for the qualitative interviews in Phase 4.
A routine population data set (CCG and Public Health) already in use to audit trends in AF prescribing and quality assurance of stroke prevention within Sheffield will be used to investigate trends of DOACs versus warfarin prescription by age and co-morbidities with expert support to inform the necessary searches and statistical analyses. This stage of the project will provide new data on the prescription patterns of DOAC in Sheffield and rich setting descriptors for the research study. I will compare my findings with national data, where available.
Stage 4: Recruitment and Semi-structured Interviews with Patients and Healthcare Providers
An interview topic guide (informed by Stages 1 – 3) will be presented to my PPI and Academic Steering Group and I will receive feedback in terms of content. Research Ethics and governance application are already in preparation for submission at this stage.
GP practices will be recruited through adoption by the NIHR Yorkshire and Humber Primary Care Clinical Research Network (C. Mitchell has NIHR Chief Investigator status) and through supervisory panel and university department networks. There is funding to support practice based recruitment cost within the budget including funds for practitioner time. Practices will be approached and invited to participate. A purposive sampling strategy will be used to identify between 5-10 GP surgeries reflecting a diverse variation including size of practice, training or non-training status, socio-dermographic location of the practice within the Yorkshire and Humber region.
Patients with AF, aged ≥75 (with a past or present drug history of a DOAC) will be recruited through the identified GP practices (about 3-5 per Practice). These patients will have one or more of: hypertension, chronic kidney disease, ischaemic heart disease, congestive heart failure, previous stroke/transient ischaemic attack or vascular disease and/ or be on ten or more medications. I will recruit patients who are ambulant to their GP surgery and as well as housebound patients.
A purposive sampling strategy will be used to obtain diverse patient representation in terms of ethnicity, sex, socio-economic status and age and to identify important common patterns across the sample. Practice support costs have been allocated to protect time for a practice healthcare practitioner to screen the list of eligible patients according to defined inclusion and exclusion criteria. The eligible participants will be invited to participate by postal invitation letter and information leaflet with a return envelope and reply slip with contact details and a consent form for the researcher to contact the patient if they are interested in discussing participation in the study.
Following informed consent, I will conduct semi-structured interviews with 25-30 patients. Interviewing will continue to data saturation (usually achieved in similar studies at 25-30 patients). A minimum number of interviews and will be conducted for the initial analysis sample and a further number that generate no new ideas will be used to specify theoretical saturation of the main concepts.
The semi-structured interviews will explore the patient and healthcare practitioners experiences of the acceptability, adherence and side effects of DOACS. I will explore the patient’s views of being prescribed DOAC for stroke prevention, and will establish the quality of information communicated to the patient when the drug is first prescribed and subsequently managed. Patients will be offered the opportunity to be interviewed in their own homes or (if possible) or at their GP surgery. Appropriate Safe Working procedures will be adhered to at all times.
The healthcare professionals involved in prescribing, dispensing and monitoring DOACs for the participating patients will also be interviewed: GPs; Community or Practice-based Pharmacist; Nurses (practice or community if the patient is housebound). In particular, perceptions of the role of the community and practice based pharmacists in these often-complex decisions will be examined.
Consent from healthcare professionals will be sought following patient consent but before interview to avoid missing data.
The aim of interviewing the healthcare professionals is to understand reasons why anticoagulant therapy is initiated or not, and the challenges of decision making when prescribing DOACs to adults aged over 75 years, with co-morbidities and polypharmacy. This research enquiry will enable me to understand differences in how DOACs are prescribed across a large city, and will identify common factors that inhibit, or promote, decision-making around DOAC prescription. It may also allow the researcher to explore if concerns over DOAC prescription are truly informed, or if the reputation of these types of drugs is a barrier per se.
The researcher will also investigate how age, gender, frailty, and sociodemographic indices influence drug prescription trends. The health professional interviews will be conducted at the relevant GP surgery and in community pharmacies attended by the patients interviewed.
Qualitative Data Analysis
Interview data will be recorded, transcribed verbatim, and organised using NVivo11 software. Thematic analysis will be undertaken using constant comparative methods with independent verification of emergent themes to triangulate data. The final thematic framework will be presented to my Steering Group. The theoretical framework for analysis will be ‘person-centered care’. All work will be subject to ethical approval and will follow data sharing governance.
The researcher will present emergent themes to the PPI group in order to obtain lay feedback and explore consensus on the emergent themes. Four different GP practices will be identified through purposive sampling based upon GP practice location, size of practice and training status. The researcher will use focus groups to feedback emergent themes from the individual patient and professional interviews in order to gather consensus and shared experiences of re-prescription of DOAC following episodes of gastrointestinal bleeding, intracerebral hemorrhage or anaemia. The researcher will also ask focus group members to discuss patient safety concerns and the benefits and limitations of current monitoring systems for DOACs.
The proposed research will provide new insights into the reasons behind the choice of prescribed oral anticoagulants, confidence in making this choice, and the influencing factors that might guide a physician to prescribing one medication over another. Through the field work and patient-public involvement activity, the researcher has already engaged in deep discussion with patients with atrial fibrillation, members of the Sheffield Clinical Commissioning Group (CCG), pharmacists and GPs to explore issues of importance of the topic and feasibility of conduct of the proposed study design.
Themes around prescribing risk, safety, and pragmatism have consistently emerged, and have reinforced research findings on the topic of primary care high-risk prescribing. The aim of the research is to provide patient and practitioner orientated guidelines for primary healthcare professionals on the prescription of high-risk medication for preventive therapy in elderly patients. The research will also inform policy on implementing NICE guidance on person centred care in prescribing decisions for people with co-morbidities, a high priority for the National Health Service.