Condition category
Circulatory System
Date applied
12/03/2018
Date assigned
11/04/2018
Last edited
11/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes