ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

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]

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]

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]

Six and twelve months post-discharge for an acute coronary syndrome hospital admission.

Secondary outcome [1]

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]

6 and 12 months post-discharge

Secondary outcome [2]

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]

6 and 12 months post-discharge.

Secondary outcome [3]

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]

2 and 12 months post-discharge

Secondary outcome [4]

All-cause mortality

Timepoint [4]

6 and 12 months post-discharge.

Secondary outcome [5]

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]

6 and 12 months post-discharge

Secondary outcome [6]

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]

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?

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]

7000

Recruitment postcode(s) [2]

7250

Recruitment postcode(s) [3]

7320

Funding & Sponsors

Funding source category [1]

University

Name [1]

IRGS, University of Tasmania, Sandy Bay Campus

Address [1]

Churchill Ave, University of Tasmania, Sandy Bay Campus, Tasmania 7001

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Royal Hobart Hospital

Address [1]

Argyle St, Hobart, Tasmania 7000

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Launceston General Hospital

Address [2]

Charles St, Launceston, Tasmania, 7250

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health and Medical Human Research Ethics Committee

Ethics committee address [1]

Private Bag 1, Research House, Churchill Avenue, University of Tasmania, Sandy Bay Campus, Tasmania 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2011

Approval date [1]

29/07/2011

Ethics approval number [1]

H11821

Summary

Brief summary

Can home medicine reviews improve health outcomes when directed at patients after acute coronary syndrome.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Gregory Peterson

Address

Private Bag 26 School of Pharmacy University of Tasmania Sandy Bay 7001

Country

Australia

Phone

+61 3 62262195

Fax

[email protected]

Contact person for public queries

Name

Daniel Bernal

Address

Private Bag 26, School of Pharmacy, University of Tasmania, Sandy Bay, 7001

Country

Australia

Phone

+61 3 6226 8535

Fax

[email protected]

Contact person for scientific queries

Name

Daniel Bernal

Address

Private Bag 26, School of Pharmacy, University of Tasmania, Sandy Bay, 7001

Country

Australia

Phone

+61 3 6226 8535

Fax

[email protected]

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

Source	Title	Year of Publication	DOI
Dimensions AI	Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial	2012	https://doi.org/10.1186/1745-6215-13-30

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically