Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000452998
Ethics application status
Approved
Date submitted
3/05/2011
Date registered
3/05/2011
Date last updated
11/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Medication Reviews ReDirected (MedReDi): Acute Coronary Syndrome as an Indication for Home Medicine Review, a Randomised Controlled Trial
Scientific title
In acute coronary syndrome patients discharged from hospital, does a home medicine review increase the percentage of patients taking all four guideline-recommended medications compared to usual care?
Secondary ID [1] 260099 0
nil
Universal Trial Number (UTN)
U1111-1121-1394
Trial acronym
MedReDi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary prevention of acute coronary syndrome 265775 0
Condition category
Condition code
Cardiovascular 265930 265930 0 0
Coronary heart disease
Public Health 265931 265931 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home Medicine Review - a service provided by specifically trained pharmacists on request from a patient's GP. Following GP referral, the patient's community pharmacist selects an accredited pharmacist to complete the review and passes on the referral. The accredited pharmacist visits the patient, preferably in their home and discusses their current methods for managing their medication. From this visit, the accredited pharmacist compiles a report for the GP, detailing the patient's actual list of medications at their home and how they were taking them as well as any recommendations for improvement of the medication regimen. In this trial we will be using acute coronary syndrome as a referral trigger for this process. This process should occur at or near two months post-discharge. In this trial the accredited pharmacists completing the reviews will be given additional training and a brief assessment quiz on evidence-based management of acute coronary syndrome (ACS) and how to include this into an ACS-specific home medicine review. If an accredited pharmacist is not available or not willing to undertake the education then a study pharmacist who has also undergone the training package will complete the review.
Intervention code [1] 264516 0
Other interventions
Comparator / control treatment
Standard/usual care that is given post-discharge to all patients admited for the treatment of acute coronary syndromes. This often includes specialist cardiology appointments and cardiac rehabilitation. Patient adherence to standard/usual care may vary significantly.
Control group
Active

Outcomes
Primary outcome [1] 266685 0
The proportion of patients taking all four classes of Australian National Heart Foundation guideline-recommended medications at six and twelve months post-discharge from an acute coronary syndrome hospital admission. The four medication classes include: antithrombotics (aspirin/clopidogrel/prasugrel); ACE inhibitors or ARB's; beta blockers; statins. The Medication Possession Ratio (MPR) assessed by collecting community pharmacy dispensing records will be the primary measure for this outcome with an MPR of 80 to 120% accepted as the adherence cut-offs. The Morisky Questionnaire will be the secondary measure if MPR recrods are incomplete.
Timepoint [1] 266685 0
Six and twelve months post-discharge for an acute coronary syndrome hospital admission.
Secondary outcome [1] 276189 0
median number of hospital admissions. Assessed by scheduled checking of the hospital inpatient management system. This is a statewide system and hence will allow the assessment of all patients from one site.
Timepoint [1] 276189 0
6 and 12 months post-discharge
Secondary outcome [2] 276190 0
median length of hospital stay in days per readmission. Assessed by scheduled checking of the hospital inpatient management system. This is a statewide system and hence will allow the assessment of all patients from one site.
Timepoint [2] 276190 0
6 and 12 months post-discharge.
Secondary outcome [3] 276191 0
Seattle Angina Questionnaire as a cardiac-specific quality of life measure and the Euroqol EQ5D and as general health quality of life measure.
Timepoint [3] 276191 0
2 and 12 months post-discharge
Secondary outcome [4] 276192 0
All-cause mortality
Timepoint [4] 276192 0
6 and 12 months post-discharge.
Secondary outcome [5] 295489 0
Cardiac Rehabilitation completion rates. Cardiac rehabilitation rates will be assessed by checking administrative records for the two cardiac rehabilitation programmes at the two trial sites.
Timepoint [5] 295489 0
6 and 12 months post-discharge
Secondary outcome [6] 295490 0
Smoking cessation rates. Smoking cessation rates will be assessed by questionnaire (Do you smoke cigarettes? Yes/No) and nicotine dependence is assessed as a part of this using the Fagerstrom Nicotine Dependence Test.
Timepoint [6] 295490 0
6 and 12 months post-discharge

Eligibility
Key inclusion criteria
Any patients admited with a diagnosis of acute coronary syndrome or equivalent event, including: unstable angina, non-ST elevation AMI, ST elevation AMI, AMI, or heart attack.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive decline to the extent that it may prevent ability to obtain informed consent directly from the patient. Palliative patients with a life expectancy less than 18 months. Discharge destination other than "home". Non-Medicare eligible patients, eg. international patients.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by computerised concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/03/2012
Actual
25/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
465
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3970 0
7000
Recruitment postcode(s) [2] 3971 0
7250
Recruitment postcode(s) [3] 3972 0
7320

Funding & Sponsors
Funding source category [1] 265004 0
University
Name [1] 265004 0
IRGS, University of Tasmania, Sandy Bay Campus
Country [1] 265004 0
Australia
Primary sponsor type
University
Name
Unit for Medication Outcomes Research and Education, School of Pharmacy, University of Tasmania, Sandy Bay
Address
Churchill Ave, Sandy Bay, Tasmania 7001
Country
Australia
Secondary sponsor category [1] 264101 0
None
Name [1] 264101 0
Address [1] 264101 0
Country [1] 264101 0
Other collaborator category [1] 251978 0
Hospital
Name [1] 251978 0
Royal Hobart Hospital
Address [1] 251978 0
Argyle St, Hobart, Tasmania 7000
Country [1] 251978 0
Australia
Other collaborator category [2] 260783 0
Hospital
Name [2] 260783 0
Launceston General Hospital
Address [2] 260783 0
Charles St, Launceston, Tasmania, 7250
Country [2] 260783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266977 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 266977 0
Ethics committee country [1] 266977 0
Australia
Date submitted for ethics approval [1] 266977 0
09/05/2011
Approval date [1] 266977 0
29/07/2011
Ethics approval number [1] 266977 0
H11821

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32563 0
Prof Gregory Peterson
Address 32563 0
Private Bag 26 School of Pharmacy University of Tasmania Sandy Bay 7001
Country 32563 0
Australia
Phone 32563 0
+61 3 62262195
Fax 32563 0
Email 32563 0
G.Peterson@utas.edu.au
Contact person for public queries
Name 15810 0
Daniel Bernal
Address 15810 0
Private Bag 26, School of Pharmacy, University of Tasmania, Sandy Bay, 7001
Country 15810 0
Australia
Phone 15810 0
+61 3 6226 8535
Fax 15810 0
Email 15810 0
ddbernal@utas.edu.au
Contact person for scientific queries
Name 6738 0
Daniel Bernal
Address 6738 0
Private Bag 26, School of Pharmacy, University of Tasmania, Sandy Bay, 7001
Country 6738 0
Australia
Phone 6738 0
+61 3 6226 8535
Fax 6738 0
Email 6738 0
ddbernal@utas.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIHome medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial2012https://doi.org/10.1186/1745-6215-13-30
N.B. These documents automatically identified may not have been verified by the study sponsor.