Title: Improving the safety and continuity of medicines management at care transitions (ISCOMAT)
Funder: Department of Health and Social Care

Abstract: Background Avoidable harm associated with medicines is widespread - particularly at care transitions. Unintended discrepancies in patients medicines after hospital discharge affect more than half of patients. The elderly and those taking multiple medicines are at particular risk and those with heart failure need attention if proven benefits in delayed disease progression and reduced mortality are to be realised. Our completed systematic review of approaches to improve continuity of medicines management at transitions found that patient support and improved healthcare professional communication can reduce risk but effective models for implementation are lacking. There were few multicentre studies, and few measured or showed benefits in health or clinical outcomes. Most interventions focused on the hospital with little patient involvement in their design. Our programme will develop and test a co-designed, theory-based, and fully costed complex intervention for patients with heart failure incorporating learning from existing good practice. In parallel we will measure the effect of this intervention through a novel data linkage process across the patient pathway. Aim To design and test a complex intervention to make best use of medicines and reduce harm through effective medicines management for heart failure patients from hospital discharge and into primary care. Objectives &bull; Map and evaluate current medicines management pathways across care transitions &bull; Devise an underlying data linkage and data collection exercise to measure the effect of the proposed intervention &bull; Synthesise these data to develop a model of best practice that can contribute to a multi-disciplinary intervention &bull; Based on a co-design process, develop a complex intervention, referred to as a Medicines at Transitions Toolkit (MaTT) &bull; Assess the intervention for usability and acceptability, establish an effective implementation process, and determine the feasibility of data collection for economic evaluation &bull; Evaluate the effect and cost effectiveness of the intervention in a multi-centre cluster-randomised trial, in conjunction with a rigorous process evaluation Research Plan The four work packages, involve three regions (Yorkshire & Humber, the North West, and the North East). WP1 (mth 1-15) is a systems analysis using mixed methods to map and evaluate the cardiology medicines management pathway in four health economies from discharge through to primary care. In parallel, a data linkage exercise will demonstrate tracking of medicines and collection of outcome measures. WP2a & 2b (mth 6-15): 2a is a patient-led, experience-based co-design (EBCD) process to address patient information and staff training needs at care transitions. In WP2b, after user-testing specific informational tools, intervention modelling informed by behavior change theory and using COM-B, will combine the EBCD and WP1 outputs with the findings of our updated systematic review. WP3 (month 16-24) is a mixed method feasibility study with 30 patients across three health economies to establish the optimum implementation process for the intervention, assess usability and acceptability, identify implementation barriers and facilitators, and test our proposed data collection methods. We have specified progression criteria which we will need to meet to proceed to the full trial. WP3 will also pilot data collection for the economic evaluation. WP4 (month 16-68) is a 1:1 randomised, controlled cluster trial (WP4a) incorporating a comprehensive economic evaluation, and a process evaluation (WP4b). We will recruit 50 patients with HF over 12 months from cardiology ward(s) in each of 42 acute NHS trusts across our three regions (n=2100 patients). Assuming an estimated ICC of 0.01 and allowing for 15% patient attrition we will achieve 80% power at 5% significance level. An internal pilot will ensure an acceptable recruitment rate. A mixed method process evaluation will examine the effect of organisational context and setting, and how the intervention is best implemented. Projected outputs &bull; Medicines At Transitions Toolkit (MaTT) &bull; MaTT staff training module &bull; Data linkage algorithm for evaluation of medicines management in a (cardiology) patient pathway Publications will include &bull; Multi-centre systems analysis of existing cardiology medicine management pathways &bull; Development and implementation of a data linkage algorithm for (cardiology) medicines management across transitions &bull; Use of a modified EBCD process to develop a complex intervention &bull; Effect of an intervention to improve the safety and continuity of medicines management at care transitions (ISCOMAT): a cluster RCT &bull; Cost effectiveness an intervention to improve the safety and continuity of medicines management at care transitions Dissemination events Dissemination will be maximised by close involvement of stakeholders in each of the study settings, the external advisory group, TPP and NICOR. We will hold a twice yearly conference, supported by the Yorkshire and Humber Improvement Academy (JW). We will also develop an open access ISCOMAT website with twitter feeds to post progress reports and receive feedback. Benefits to patients and NHS Effective medicines management reduces preventable harm, and is essential in a climate of austerity. Our outputs will be, with modifications, transferable to other patient groups who have long term conditions, frequent hospital readmissions and polypharmacy.

Lay abstract: Making the use of medicines as safe and effective as possible are priorities for patients and healthcare providers. When a patient moves (e.g. from hospital to home) medicine problems are common and planned changes are not always followed through. Patients particularly at risk are those with long-term illnesses taking several medicines &ndash; especially when medicines have been started or changed in hospital. We aim to improve the use of prescribed medicines when patients move from one setting to another, including reducing harm from medicines. We will study patients with heart failure &ndash; chosen because they need a number of medicines. Also, some of these medicines need careful monitoring - making sure doses are increased gradually to the level where they work best. We will work closely with patients and healthcare staff to fully understand what happens now when patients move between hospitals and their own home. We will then use this understanding to develop and test ways of improving how medicines are used. First, we will look at how patients medicines are managed at discharge &ndash; and then after discharge - in four areas of England. We will do this by watching what happens to patients and also by interviewing patients and staff in hospitals, doctors surgeries and local pharmacies. We will also look at the key documents used by patients and staff. From this we will identify examples of good practice. We will then bring together groups of patients and staff in each area to hear about our findings and those from previous research and to come up with ideas about what might work best in the future. We will use all this information to produce a toolkit which contains the things staff and patients need to make good practice happen. We cannot predict exactly what needs to be in the toolkit. However, our work so far suggests it is likely to include a medicines information pack for patients, a staff training module, and a structured follow-up medicines check at the local pharmacy after leaving hospital. This toolkit will be tested in a trial ( randomised controlled trial ) across 42 healthcare districts. We will measure the impact of the intervention by checking whether patients have had any serious health problems and whether three important medicines for heart failure are still being prescribed 12 months after leaving hospital. We will also look at how much the toolkit costs to put into action and how well it fits into local practice. This means that if it is shown to work, we will know how to spread its use across the country.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR