ISCOMAT
Research type
Research Study
Full title
Improving the safety and continuity of medicines management at care transitions
IRAS ID
231431
Contact name
Christopher P Gale
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN66212970
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
Research Summary
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 – especially when medicines have been started or changed in hospital.
This cluster randomised controlled trial is the final stage in a programme of four work packages, which has been developed to help the way patients are supported with their medicines, and also aims to improve the way medical professionals work together to offer good standards of care to patients when they transition from hospital to home. The study will involve patients with heart failure – chosen because they need a number of medicines. Also, some of these medicines need careful monitoring. We will be comparing a Medicines at Transition Intervention (MaTI) with Treatment as Usual (TAU).
We aim to recruit 2100 participants across 42 ‘clusters’, who will be randomised on a 1:1 basis to one of two study arms. Participants will be aged 18 and have a confirmed primary diagnosis of heart failure (with evidence of at least moderate left ventricular systolic dysfunction (via echocardiogram) within the last 5 years).
Since this is a cluster randomised controlled trial, consent to deliver the intervention is given by the NHS Trust, and patients will be asked for their consent for data collection purposes only. Data collection will be in the form of patient-completed questionnaires (at four timepoints over 12-months post-registration), and data collection from routine data providers (this includes NHS Digital, GP records, Office for National Statistics, and the National Heart Failure Audit).
The primary outcome for the study is all-cause mortality and heart failure rehospitalisation, measured 12 months from registration in to the study. There are a number of secondary outcomes and an embedded process evaluation, and economic evaluation.Summary of Results
Introduction
ISCOMAT is a series of interlinked work packages which aim to help the way patients are supported with their medicines. This may contribute to improving their health through helping them better understand their medicines. It also aims to improve the way medical professionals work together to offer good standards of care to patients when they leave hospital. The programme has designed and tested a complex intervention (Medicines at Transitions Intervention) – co-designed with patients and clinicians – to make best use of medicines and reduce harm through effective medicines management for heart failure patients from hospital discharge and into primary care.
The ISCOMAT intervention “Medicines at Transitions Intervention” (MaTI) is designed to improve the use of prescribed medicines when patients move from one setting to another, including reducing harm from medicines. ISCOMAT is a cluster randomised controlled trial to evaluate the effect and cost effectiveness of the intervention, in conjunction with a rigorous process evaluation.The ISCOMAT trial is currently in the analysis stage and full trial results will be available via open-access (NIHR Journals Library) when published.
Methods
ISCOMAT is a pragamatic multicentre cluster-randomised trial (cRCT) that aimed to recruit a target of 42 cardiology services (sites) randomised on a 1:1 basis either to implement the MaTI or to continue with treatment as usual (TAU). We aimed to recruit 50 participants from each site (total 2100 participants) over approximately 12 months.Heart Failure patients were identified by staff in the cardiology service and screened for consent to data collection. Consenting patients were registered and outcomes assessments undertaken at 2- and 6- weeks post-discharge, 3 and 12 months post-registration. Data was collected on training, implementation and delivery of the MaTI in sites so randomised. We collected all outcome measures in both trial arms and used routine data sources to capture some outcome data where appropriate. These methods allow us to 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 being registered on the study.
In an embedded process evaluation we undertook observations of training and practice, and conducted interviews with a sample of participants and staff within the cardiology services: to gain insight and understanding of intervention implementation, and configuration of services.
We also looked at how much the toolkit costs to put into action in an embedded health economics study. This study will develop an economic model the aim of which will be to assess the long-term cost-effectiveness of the intervention, compared with treatment as usual.
Trial update
44 cardiology services (sites) were randomised. Of these, 43 sites (23 control, 20 intervention) opened to recruitment (one site withdrew prior to open).During the COVID-19 pandemic, the trial paused recruitment and subsequently closed following discussions with the trial steering committee and the National Institute for Health Research (NIHR) on 28/07/2020.
Recruitment was 78% to target (1641/2100) at the time trial closed to recruitment. Return rates for self-reported questionnaires vary by time point and range from 46%-56% of all registered participants. The return rates of the questionnaires sent range from 61%-67%.
Results of the trial are not yet complete and will be available via open access upon publication.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0017
Date of REC Opinion
31 Jan 2018
REC opinion
Favourable Opinion