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Trial registered on ANZCTR

Registration number

ACTRN12615000888561

Ethics application status

Approved

Date submitted

29/07/2015

Date registered

25/08/2015

Date last updated

5/02/2021

Date data sharing statement initially provided

30/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A conversation with patients about medications after a stroke

Scientific title

In patients admitted for a stroke or TIA does a patient centred education exchange added to usual care versus usual care improve self-management of medications (defined as organising ongoing supply of medications, medication taking behaviour/adherence, and monitoring and reporting of perceived adverse effects)?

Secondary ID [1]

None

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Transient Ischemic Attack

Medication adherence

Adverse Drug Events

Condition category

Condition code

Stroke

Ischaemic

Public Health

Health promotion/education

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention comprises two patient centred educational exchange sessions (based on social marketing/academic detailing principals) conducted by the research pharmacist; one session is conducted face to face before discharge and one by telephone approximately ten days after discharge.
The first part of the sessions has structured questions from previously validated questionnaires to identify patients’ beliefs about their stroke in general (using the brief-Illness Perception Questionnaire (brief- IPQ)) and medications in particular(using the Beliefs about Medicine questionnaire specific (BMQ-specific) to identify necessity and concern beliefs. There is also an opportunity for the patient to self-report their previous medication taking behavior (using the Medication Adherence Questionnaire (MAQ)) of the medications of interest.
The identified concerns (which can be barriers) and necessities (which can be enablers) identified from the validated questionnaires are taken into account and can be referred to in a brief personalised conversation using a two sided single page document given to the participant (the detailing tool) to outline each of up to three (stroke prevention) medications the patient is taking and the delivery of four a-priori key messages. This expected to take a total of twenty to thirty minutes both for the face to face session and for the telephone follow-up session.

Intervention code [1]

Behaviour

Comparator / control treatment

Usual care
Usual care includes admission to a stroke specific ward, multidisciplinary care by the stroke team, education using National Stroke Foundation materials by the stroke nurse, clinical pharmacy services provided by the ward pharmacist and discharge advice provided by the medical staff. Usual care provided by the ward pharmacist includes medication history taking and reconciliation, medication review during the admission, discharge reconciliation, provision of a medication list at discharge and medication counselling at discharge.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is adherence measured by the proportion of days covered (PDC) over the three months after discharge, using prescription refill data (obtained from the pharmaceutical benefits scheme (PBS)) for the combination of all three classes of medications (antithrombotic, antihypertensive and lipid lowering medications)prescribed.

Timepoint [1]

3 months after discharge

Secondary outcome [1]

Adherence measured by the proportion of days covered (PDC) over the twelve months after discharge, using prescription refill data for the combination of three classes of medications (antithrombotic, antihypertensive and lipid lowering medications)prescribed.

Timepoint [1]

12 months after discharge

Secondary outcome [2]

Timeliness of having a prescription written for ongoing supply of medications (using PBS claims data)

Timepoint [2]

At 3 months and 12 months after discharge

Secondary outcome [3]

Self-reported medication adherence (measured using the Medication Adherence Questionnaire (MAQ))

Timepoint [3]

At 3 months and 12 months post discharge

Secondary outcome [4]

Self-report of organising ongoing supply of medications obtained at telephone interview

Timepoint [4]

At 3 months and 12 months after discharge

Secondary outcome [5]

Self-report at telephone interview of medication taking behaviour in response to perceived medication related adverse events.

Timepoint [5]

At 3 months and 12 months post discharge

Secondary outcome [6]

Medication related adverse events identified by self-report at telephone interview or readmission identified from patient hospital records

Timepoint [6]

At 3 months and 12 months after discharge

Secondary outcome [7]

Readmission and/or Stroke and/or MI identified by self-report at telephone interview or readmission identified from hospital records

Timepoint [7]

At 3 months or 12 months post discharge

Secondary outcome [8]

Self-report of Blood Pressure results at telephone interview

Timepoint [8]

At 3 months and 12 months after discharge

Secondary outcome [9]

Self-report of Cholesterol levels at telephone interview

Timepoint [9]

At 3 months and 12 months post discharge

Secondary outcome [10]

Changes from baseline in self-report of quality of life using EQ-5D-5L

Timepoint [10]

At 3 months and 12 months after discharge compared to baseline before discharge.

Secondary outcome [11]

Knowledge defined by the ability to identify each of the three medications/classes they have been prescribed for stroke prevention including a lay description of the indication and their dose instructions at telephone interview

Timepoint [11]

At 3 months and 12 months after discharge

Secondary outcome [12]

Changes from baseline in illness (stroke) perception using Brief-Illness Perception Questionnaire (Brief-IPQ)

Timepoint [12]

At 3 months and 12 months

Secondary outcome [13]

Changes from Baseline in Belief about medications for stroke prevention using Beliefs about Medications Questionnaire –Specific (BMQ-specific)

Timepoint [13]

At 3 and 12 months after discharge

Secondary outcome [14]

Comparative cost of the PCEE intervention as compared to usual care, from a health system perspective. Any impact of the PCEE on health-resource use (e.g. medication use, GP visits, hospital readmissions) will be considered when estimating costs.

Timepoint [14]

At 3 and 12 months after discharge

Secondary outcome [15]

The ratio of incremental cost to incremental benefit (measured as improved adherence and/or quality-adjusted life years).

Timepoint [15]

At 3 and 12 months after discharge

Secondary outcome [16]

Self-report at telephone interview of communication to prescriber in response to perceived medication related adverse events.

Timepoint [16]

At 3 and 12 months

Eligibility

Key inclusion criteria

aged 18 years or older,
have been admitted under the “Medical Stroke Unit” or "Medical Admission and Planning Unit" at Princess Alexandra Hospital, with a principal diagnosis of Stroke or TIA,
planned to be discharged to their home.
patient manages their medication,
patient has a Mental Status Questionnaire (MSQ) score of 10/10 on the Neurological Observation Chart
the patient is able to provide consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those patients planned for discharge to a residential care facility (eg a nursing or residential care home) where a staff member is responsible for the patients’ medication administration
those unable to complete the questionnaire (even) with assistance (this may be due to language difficulties or cognitive impairment)
those who do not wish to take part.

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)

After the patient has consented to the study they will be allocated to either the intervention or control group. The allocation will be concealed by sealed opaque envelopes stored in the clinical trials office of the pharmacy department.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation code will be a computer generated four block randomisation code Random order generation used Sealed Envelope Ltd. 2015. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 17 Jul 2015].

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size- The primary outcome is adherence measured by the proportion of days covered (PDC) over the three months after discharge, using prescription refill data for three classes of medications (antithrombotic, antihypertensive and lipid lowering medications).
The sample size calculation used the criterion for significance (alpha) set at 0.05 and the power (beta) at 80%. It is proposed that the intervention will result in a 7% improvement in adherence compared to standard care. This difference of 7% was selected as reasonable; because an effect of this magnitude has been shown with secondary prevention medications used for cardiovascular diseases and has been linked to a clinical difference. An effect size of 0.54 (0.07/0.13) was selected using results from a study conducted with participants discharged on similar medications after a diagnosis of acute coronary syndrome. A sample size of 55 in each arm is required for effect size of 0.54, We allowed for a slighter larger pooled standard deviation of 0.15 (effect size 0.7/.15= 0.47) requiring a sample size of 73 . Allowing the addition of 15% for using a nonparametric test due to skewed data and assuming attrition rates of approximately 10% we would need to enroll at least 92 participants for each group; we propose to include 100 participants in each arm.

Data entry and analyses will be performed using Microsoft Excel 'Registered Trademark' and SPSS Statistics 22 'Registered Trademark'. Demographic data and baseline characteristics in the intervention and control groups will be compared using summary statistics. Comparative analysis will be conducted to compare outcomes and changes in outcomes over baseline to 3 months and baseline to 12 months.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/12/2015

Actual

21/12/2015

Date of last participant enrolment

Anticipated

30/05/2018

Actual

10/04/2018

Date of last data collection

Anticipated

30/11/2019

Actual

13/05/2020

Sample size

Target

200

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Pharmacy
University of Queensland

Address [1]

20 Cornwall St
Woolloongabba
QLD 4102

Country [1]

Australia

Primary sponsor type

Individual

Name

Judith Coombes

Address

Pharmacy Department
Princess Alexandra Hospital
Ipswich Hospital
Woolloongabba
QLD
4102

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Neil Cottrell

Address [1]

School of Pharmacy
University of Queensland
20 Cornwall St
Woolloongabba 4102
Queensland

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health HREC

Ethics committee address [1]

PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/08/2015

Approval date [1]

29/09/2015

Ethics approval number [1]

HREC/15/QPAH/531

Ethics committee name [2]

The University of Queensland Institutional HREC

Ethics committee address [2]

University of Queensland
Cumbrae-Stewart Building
Research Rd
Brisbane 
QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

25/09/2015

Approval date [2]

13/10/2015

Ethics approval number [2]

2015001612

Summary

Brief summary

Medications recommended to reduce the risk of a subsequent stroke are prescribed after a stroke or Transient Ischemic event (TIA). To gain most benefit, patients need to be able to self-manage these medications. That is; to organize continued supply of these medications with their general practitioner and community pharmacy, to take them as agreed with the prescriber and to be able to communicate any unwanted effects they may experience.
The primary aim of this study is to determine if a “patient centred educational exchange” added to usual care improves adherence to prescribed medications for secondary prevention for stroke patients compared with usual care.
We have a number of secondary aims to investigate the further impact of this relationship based model of information exchange on sustaining adherence, self-reported medication taking behaviour, clinical outcomes, quality of life, changes in knowledge, beliefs towards medicines and illness and to determine the cost of the model.
Patients who have been admitted to the Stroke Unit, Princess Alexandra Hospital, with a diagnosis of stroke or TIA and who are being discharged back to their own home will be approached to participate in this study.
Participation in this project will involve completing a questionnaire on three or four occasions. 
The first will be before the participant is discharged from hospital, the second will take place over the telephone about 3 months after discharge and the third over telephone at 12 months after discharge. The questionnaire will take about fifteen minutes to complete. The questionnaire contains questions related to the participant’s quality of life, the participant’s views of stroke, the participant’s view and opinion of their medicines prescribed to reduce the risk of stroke and questions on the way the participant takes their stroke prevention medications. The telephone interviews will also ask questions about GP and Hospital visits, perceived medication related problems, Blood Pressure and Cholesterol results if known.   
About half of the participants in this study will be chosen (by randomisation) to have a longer interview with the researcher before discharge from hospital. This will be a conversation about the participants’ stroke medications. These participants will also be contacted by telephone approximately ten days after discharge from hospital. The telephone call will involve the same questionnaire, a conversation about their stroke medications and an opportunity to follow-up on any questions the participants’ may have about their medicines.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Judith Coombes

Address

Pharmacy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4102

Country

Australia

Phone

+61 07 31762020

Fax

+61 07 3176 2800

judith.coombes@health.qld.gov.au

Contact person for public queries

Name

Judith Coombes

Address

Pharmacy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4102

Country

Australia

Phone

+ 61 07 3176 2020

Fax

+61 07 3176 2800

judith.coombes@health.qld.gov.au

Contact person for scientific queries

Name

Neil Cottrell

Address

School of Pharmacy
University of Queensland
20 Cornwall St
Woolloongabba
QLD 4102

Country

Australia

Phone

+ 61 07 33461900

Fax

n.cottrell@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Participant Consent did not include individual data sharing

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2147	Study protocol		https://bmjopen.bmj.com/content/8/8/e022225

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
Embase	Use of a patient-centred educational exchange (PCEE) to improve patient's self-management of medicines after a stroke: A randomised controlled trial study protocol.	2018	https://dx.doi.org/10.1136/bmjopen-2018-022225

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

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