Trial Review

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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] 287093 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295610 0
Transient Ischemic Attack 295612 0
Medication adherence 295613 0
Adverse Drug Events 295614 0
Condition category
Condition code
Stroke 295889 295889 0 0
Ischaemic
Public Health 295890 295890 0 0
Health promotion/education
Stroke 296105 296105 0 0
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] 292336 0
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] 295565 0
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] 295565 0
3 months after discharge
Secondary outcome [1] 315861 0
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] 315861 0
12 months after discharge
Secondary outcome [2] 315912 0
Timeliness of having a prescription written for ongoing supply of medications (using PBS claims data)
Timepoint [2] 315912 0
At 3 months and 12 months after discharge
Secondary outcome [3] 315913 0
Self-reported medication adherence (measured using the Medication Adherence Questionnaire (MAQ))
Timepoint [3] 315913 0
At 3 months and 12 months post discharge
Secondary outcome [4] 315914 0
Self-report of organising ongoing supply of medications obtained at telephone interview
Timepoint [4] 315914 0
At 3 months and 12 months after discharge
Secondary outcome [5] 315915 0
Self-report at telephone interview of medication taking behaviour in response to perceived medication related adverse events.
Timepoint [5] 315915 0
At 3 months and 12 months post discharge
Secondary outcome [6] 315916 0
Medication related adverse events identified by self-report at telephone interview or readmission identified from patient hospital records
Timepoint [6] 315916 0
At 3 months and 12 months after discharge
Secondary outcome [7] 315917 0
Readmission and/or Stroke and/or MI identified by self-report at telephone interview or readmission identified from hospital records
Timepoint [7] 315917 0
At 3 months or 12 months post discharge
Secondary outcome [8] 315918 0
Self-report of Blood Pressure results at telephone interview
Timepoint [8] 315918 0
At 3 months and 12 months after discharge
Secondary outcome [9] 315919 0
Self-report of Cholesterol levels at telephone interview
Timepoint [9] 315919 0
At 3 months and 12 months post discharge
Secondary outcome [10] 315920 0
Changes from baseline in self-report of quality of life using EQ-5D-5L
Timepoint [10] 315920 0
At 3 months and 12 months after discharge compared to baseline before discharge.
Secondary outcome [11] 315921 0
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] 315921 0
At 3 months and 12 months after discharge
Secondary outcome [12] 315922 0
Changes from baseline in illness (stroke) perception using Brief-Illness Perception Questionnaire (Brief-IPQ)
Timepoint [12] 315922 0
At 3 months and 12 months
Secondary outcome [13] 315923 0
Changes from Baseline in Belief about medications for stroke prevention using Beliefs about Medications Questionnaire –Specific (BMQ-specific)
Timepoint [13] 315923 0
At 3 and 12 months after discharge
Secondary outcome [14] 315924 0
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] 315924 0
At 3 and 12 months after discharge
Secondary outcome [15] 315925 0
The ratio of incremental cost to incremental benefit (measured as improved adherence and/or quality-adjusted life years).
Timepoint [15] 315925 0
At 3 and 12 months after discharge
Secondary outcome [16] 316849 0
Self-report at telephone interview of communication to prescriber in response to perceived medication related adverse events.
Timepoint [16] 316849 0
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?
No
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] 4061 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 9987 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 291666 0
University
Name [1] 291666 0
School of Pharmacy
University of Queensland
Country [1] 291666 0
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] 290340 0
Individual
Name [1] 290340 0
Neil Cottrell
Address [1] 290340 0
School of Pharmacy
University of Queensland
20 Cornwall St
Woolloongabba 4102
Queensland
Country [1] 290340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293196 0
Metro South Health HREC
Ethics committee address [1] 293196 0
Ethics committee country [1] 293196 0
Australia
Date submitted for ethics approval [1] 293196 0
13/08/2015
Approval date [1] 293196 0
29/09/2015
Ethics approval number [1] 293196 0
HREC/15/QPAH/531
Ethics committee name [2] 293197 0
The University of Queensland Institutional HREC
Ethics committee address [2] 293197 0
Ethics committee country [2] 293197 0
Australia
Date submitted for ethics approval [2] 293197 0
25/09/2015
Approval date [2] 293197 0
13/10/2015
Ethics approval number [2] 293197 0
2015001612

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

Contacts
Principal investigator
Name 58810 0
Mrs Judith Coombes
Address 58810 0
Pharmacy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4102
Country 58810 0
Australia
Phone 58810 0
+61 07 31762020
Fax 58810 0
+61 07 3176 2800
Email 58810 0
[email protected]
Contact person for public queries
Name 58811 0
Judith Coombes
Address 58811 0
Pharmacy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4102
Country 58811 0
Australia
Phone 58811 0
+ 61 07 3176 2020
Fax 58811 0
+61 07 3176 2800
Email 58811 0
[email protected]
Contact person for scientific queries
Name 58812 0
Neil Cottrell
Address 58812 0
School of Pharmacy
University of Queensland
20 Cornwall St
Woolloongabba
QLD 4102
Country 58812 0
Australia
Phone 58812 0
+ 61 07 33461900
Fax 58812 0
Email 58812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant Consent did not include individual data sharing


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2147Study 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
SourceTitleYear of PublicationDOI
EmbaseUse of a patient-centred educational exchange (PCEE) to improve patient's self-management of medicines after a stroke: A randomised controlled trial study protocol.2018https://dx.doi.org/10.1136/bmjopen-2018-022225
N.B. These documents automatically identified may not have been verified by the study sponsor.