Improving the safety and continuity of medicines management at care transitions

Conditions

Heart failure Circulatory System

Catherine Powell, Hanif Ismail, Liz Breen, Beth Fylan, Sarah Alderson et al. (22 authors)

BMC Health Services Research2024-10-09

Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot

Lauren Moreau, Ivana Holloway, Beth Fylan, Suzanne Hartley, Bonnie Cundill et al. (18 authors)

BMJ Open2022-04-013 citations

10.1136/bmjopen-2021-054274

Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial

Catherine Powell, Liz Breen, Beth Fylan, Hanif Ismail, Sarah Alderson et al. (9 authors)

BMJ Open2020-11-019 citations

10.1136/bmjopen-2020-040493

Interventions

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 Interv

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
All-cause mortality and heart failure rehospitalisation; Timepoint(s): 12 months from discharge	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed