Plain English Summary
Background and study aims
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 study 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.
Who can participate?
Patients aged 18 and over with heart failure
What does the study involve?
Participating NHS centres are randomly allocated to either receive the Medicines at Transition Intervention (MaTI) or continue with treatment as usual. The MaTI includes online training about discharge management, patient held information, enhanced communication between hospital and the patients’ community pharmacists, and increased engagement of community pharmacists with patient care after discharge. Data is collected using patient-completed questionnaires (at four timepoints over 12 months), and from routine data providers (this includes NHS Digital, GP records, Office for National Statistics, and the National Heart Failure Audit). All-cause mortality (death) and heart failure rehospitalisation are measured after 12 months.
What are the possible benefits and risks of participating?
This research is an opportunity to enhance patient care through providing additional information and support about medicines. Patients who participate may benefit in the long term through the improvement of medicines management systems that supplies and helps them use their medicines. They will also have the opportunity to share their experiences of their healthcare. There will be few risks for participants in this research project owing to the study aims and design.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
January 2017 to October 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Lauren Moreau
l.a.moreau@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lauren Moreau
ORCID ID
Contact details
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 343 7588
l.a.moreau@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
37060
Study information
Scientific title
Improving the safety and continuity of medicines management at care transitions
Acronym
ISCOMAT
Study hypothesis
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.
Ethics approval
HRA REC - Yorkshire and the Humber – Bradford Leeds, 01/03/2018, ref: 18/YH/0017
Study design
Randomised; Interventional; Design type: Prevention, Process of Care, Education or Self-Management, Complex Intervention
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease
Intervention
The aim is to recruit 2100 participants across 42 ‘clusters’, who will be randomised using an automated randomisation service on a 1:1 allocation to either implement the Medicines at Transition Intervention (MaTI), or continue with treatment as usual (TAU).
The MATI consists of the following inputs:
1. Online training to secondary care cardiology, Community Pharmacy and primary care staff about discharge management
2. Patient held information
3. Enhanced communication between hospital and the patients’ community pharmacists
4. Increased engagement of community pharmacists with patient care after discharge
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).
Intervention type
Other
Phase
Drug names
Primary outcome measures
All-cause mortality and heart failure rehospitalisation; Timepoint(s): 12 months from discharge
Secondary outcome measures
Key secondary endpoint:
Still being prescribed at least one of the medications in each of the following three groups at 12 months:
1. ACE Inhibitor (ACEI); Angiotensin II Receptor Blocker (ARB); Salcubitril/Valsartan
2. Beta blocker; Ivabradine
3. Mineralocorticoid Receptor Antagonist (MRA)
*For patients with contraindications to any of the three groups, the endpoint will be derived with respect to the groups that are indicated (e.g. a patient prescribed an ACEI and a beta blocker, but not an MRA, at 12 months will have achieved the endpoint if MRAs are contraindicated).
Other secondary endpoints:
1. The individual components of the primary endpoint, regarded as time-to-event endpoints, namely:
1.1. Time to all-cause mortality
1.2. Time to heart-failure-related rehospitalisation
2. Length of time on guideline recommended (and indicated as above*) cardiovascular medications
3. Patient understanding of their medicines, measured by a 10-point Likert scale in the Patient Experience Survey at 2 and 6 weeks and 12 months post-registration
4. Patient satisfaction with medicines related care, measured by a 10-point Likert scale in the Patient Experience Survey at 2 and 6 weeks and 12 months post-registration
5. Quality-adjusted life years, measured by the EQ-5D-3L at baseline, 3 months and 12 months
6. Days alive and out of hospital, defined as the number of days in the year (365 days) beginning the day after registration that the patient spends alive and not in hospital
7. Time to all-cause hospitalisation and time to CV-related hospitalisation in the 12 months from registration
8. Cause-specific deaths
Overall trial start date
01/01/2017
Overall trial end date
31/10/2021
Reason abandoned
Eligibility
Participant inclusion criteria
1. Admitted or transferred to a ward participating in the ISCOMAT trial
2. Heart failure with evidence of at least moderate left ventricular systolic dysfunction confirmed (via echocardiogram) within the last 5 years
3. Aged 18 years or over at time of admission to hospital
4. Planned discharged from recruiting hospital to their home (defined by usual place of residence) or a care home
5. Planned discharge to within geographical area of that cluster
6. Capacity to provide Informed Consent
7. Provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 2100; UK Sample Size: 2100
Participant exclusion criteria
NHS Trusts meeting any of the following exclusion criteria will not be eligible for inclusion:
1. Already providing medicines management deemed to be sufficiently similar to the MaTI intervention
Patients meeting any of the following exclusion criteria will not be eligible for inclusion:
1. Patients in a terminal phase of illness / end of life care pathway who are not expected to survive beyond 6 weeks from date of discharge
2. Patients who are already participating in the ISCOMAT study (for example, patients who have been re-admitted)
Recruitment start date
01/05/2018
Recruitment end date
30/04/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
Bradford Teaching Hospitals NHS Foundation Trust
Sponsor details
Research Management & Support Office
Bradford Institute for Health Research
BRADFORD
BD9 6RJ
United Kingdom
+44 (0)1274 38 2575
jane.dennison@bthft.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0514-20009
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists will publish their work in high quality academic and professional journals. Longstanding and ongoing engagement with stakeholders will provide a direct pathway to impact for the outputs of this research. The Patient-Led Steering Group will inform the dissemination strategy and its members will play an active role in the format and content of academic papers (specifically patient implications) and will present at local, regional and national conferences and meetings.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary