Inclusion criteria

Participants recruited to this study must be aged 18 years or older, have been admitted to the MSU or the MAPU with a principal diagnosis of stroke or TIA, and are planned to be discharged to their home.

The participant should be expecting to manage their own medication after discharge home, have a documented Mental Status Questionnaire (MSQ)33 score of 10/10 at the time of recruitment and be able to provide consent. The consent form requires the researcher to sign a declaration saying that they have given a verbal explanation of the research project, its procedures and risks, and believe that the participant has understood that explanation. This means the participant is unlikely to have severe problems with verbal communication.

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 patients who have been planned for a rehabilitation period of greater than 1 month as they will be having weekly education sessions, those with an MSQ <10, unable to complete the questionnaire (even) with assistance (this may be due to language difficulties or cognitive impairment) and those who do not provide consent. Those who are excluded will receive standard care, which includes education, without incurring any disadvantage.

Allocation/randomisation

The allocation of participants to control or intervention will be concealed until the participant has been consented to reduce allocation bias. After the participant has consented to the study, the research pharmacist will contact the clinical trials pharmacist, who is not involved in the study and who will identify the allocation, one to one, to either the intervention or control group. The allocation will be previously determined using a computer-generated four block randomisation code using Sealed Envelope.34 The allocation will be concealed by placing the allocation in sealed opaque envelopes stored in the clinical trials office of the pharmacy department.

Once the participant is allocated, the researcher will no longer be blinded to participant’s allocation. The reason the researcher will no longer be blinded is that the researcher will conduct the intervention and follow-up calls.

Sample size

The primary outcome is adherence measured by the proportion of days covered (PDC) (defined as the days of medication supplies when the medications were collected divided by the days in the time interval) over the 3 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 with 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 diseases35 36 and has been linked to a clinical difference.37 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.36 A sample size of 55 in each arm is required for effect size of 0.54. We allowed for a slighter larger pooled SD of 0.15 (effect size 0.7/0.15=0.47) requiring a sample size of n=73. Adherence data are likely to be skewed38 and so will not fulfil the requirements for a parametric test. Lehmann and D’Abrera39 suggest the addition of 15% more participants (n=84) when planning to use non-parametric tests such as the Mann-Whitney U test. Assuming attrition rates of approximately 10%, we would need to enrol at least 92 participants for each group; we propose to include 100 participants in each arm. It is predicted that approximately two participants will be recruited per week, estimating a 2-year recruitment period. The first participant was recruited on the 18 December 2015 and the study will be ongoing until April 2019.

Usual care

Usual care includes admission to a stroke-specific ward, multidisciplinary care by the stroke team, education using Stroke Foundation-Australia materials by the stroke nurse,40 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 list41 and medication counselling at discharge.

Intervention: PCEE

The intervention consists of two sessions, one which will take place at the patients’ bedside before the usual pharmacist discharge counselling and the second which will be conducted over the telephone at least 10 days after discharge. These sessions are additional to and designed to integrate with usual care. The PCEE is structured with an introduction, conversation and conclusion.

The session begins with an ‘introduction’ phase establishing credibility ‘I am a pharmacist with an interest in patients taking medication to reduce the risk of stroke.’ Next, the clinical pharmacist will give the opportunity to the patient to ask a question. ‘What one thing would you most like to discuss about medications you have been prescribed since your stroke/TIA?’ There is an opportunity to answer this question before moving on.

The session will then move into the ‘conversation’ using previously validated questionnaires to identify patients’ perceptions, beliefs and concerns about their stroke in general (using the Brief-Illness Perception Questionnaire (Brief-IPQ)24 and medications in particular (using the Beliefs about Medicine Questionnaire specific (BMQ-specific).25 There is also an opportunity for the patient to self-report their previous medication taking behaviour for the medications of interest (using the Medication Adherence Questionnaire (MAQ).26 The identified barriers and enablers will be used to personalise the conversation. A double-sided single page document will be personalised and given to the participant (the detailing tool). The detailing tool contains an infographic to help illustrate the discussion about the stroke prevention medications the patient has been prescribed on one side, and four a priori key messages on the other side (see online supplementary file 2. infographic example).

The four key messages are: ‘Know about your medications prescribed to reduce risk of stroke’, ‘Organise ongoing supply of your medications’, ‘Continue to take these medications as agreed with your doctors’ and ‘Report any new symptoms or concerns to your doctor’.

In the final phase, ‘conclusion’, items identified to be discussed when the clinical pharmacist telephones the patient will be listed.

To provide an opportunity for ‘follow-up’ and reinforcement of key messages, the intervention is designed to include two sessions. The clinical pharmacist will arrange to telephone the participant at least 10 days after discharge to ask them the same questions and to talk about their medications.

It is hypothesised that patients in the intervention group will be influenced to organise ongoing supply of their medications and take their medications as prescribed. In addition, it is hoped that if they identify that they are experiencing unwanted effects from a medication(s), they will not keep taking medication(s) long term, rather discuss their concerns with their doctor.

Behavioural measures

Behavioural measures look at things the participant has done. In this study visiting the doctor and having their medication dispensed is observer collected.47 48 Pharmaceutical claims data can provide an objective, non-invasive measure of adherence and has been used in many drug trials and in a number of studies similar to this one. A range of methods for use of claims data to measure medication possession ratios and PDC have been described to assess an individuals’ medication adherence.38 47–50

The PDC is defined as the days of medication supplies when the medications were collected divided by the days in the time interval. This can be averaged over the total (eg, a 90-day interval), or to be more reflective of medication exposure, a shorter interval can be measured and added together (eg, in Australia most medications for chronic diseases are supplied at approximately 1-month intervals). The PDC calculated using multiple short intervals49 50 can more accurately account for gaps in supply or extra medication supplies. The example shown in figure 1 adapted from Bijlsma et al 49 and Bryson et al 50 shows how the adherence over three lots of 30-day intervals can be calculated using the gaps in supply for three patients obtaining 30-day supplies. The calculation used is: Proportion of 90 days covered=(90 –total of days not covered in each 30-day interval)/90×100.

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Figure 1

Examples of proportion of days covered calculated using multiple 30-day intervals.

Patient 1 obtained medications on the day of discharge, 30 days later and then had a gap of 5 days before the third supply. Patient 1 PDC=[(30+0)+(30+0)+(30−5)]/90×100=94%.

Patient 2 obtained the first supply 5 days before discharge, these were not used until the day of discharge so although the second supply was obtained 10 days after the first supply, there was only a 5-day gap in supply for the patient. Five days of tablets remaining from the second supply were used in the third interval. The third supply was obtained after a 10-day gap. Patient 2 PDC=[(30+5–5)+(30−5)+(30+5–10)]/90×100=89%.

Patient 3 obtained medications on the day of discharge, 20 days later and then had a gap of 40 days before the third supply. Patient 3 PDC= [(30+0)+(30+10–10)+(30−30)]/90×100=67%.

In this study the days covered in each dispensing interval will be calculated for up to three different medications (antithrombotic, antihypertensive, lipid-lowering medication) dependant on the medication plan at discharge. These will then be expressed as a mean (across the up to three medications) percentage and analysed as a continuous variable.

Self-reported behavioural measures in this study include self-report of medication adherence using the MAQ,26 organising an ongoing medication supply and action taken if they experience adverse effects from their medication. The MAQ is a well-validated scale, previously used in many clinical conditions.51

Affective cognitive outcomes

Affective cognitive outcomes include measures of what the participant knows and how they feel, these are usually self-reported.

In this study, the affective cognitive group includes metrics such as knowledge and understanding regarding name, type and dose of medications, participants knowing their BP reading or cholesterol level, participants’ perceptions of their illness and beliefs about their medications. Participant perceptions of their stroke will be evaluated using the adapted-Brief IPQ at baseline, 3 and 12 months. Beliefs about antithrombotic, antihypertensive and lipid-lowering medications will be evaluated using the BMQ-specific at baseline, 3 months and 12 months. Changes in these may be able to be used to explain changes in other measures for example adherence.46

Health outcomes

In this study, we will evaluate patient self-reported clinical measures (BP and Cholesterol), readmissions, subsequent stroke or MI, adverse drug reactions and quality of life.

Medication-related adverse events will be identified by patient self-report using probe questions adapted from a previously validated trigger tool52 at 3 months and 12 months for each medication class of interest. Medication-related adverse events will also be collected from any readmission notes at 3 months and 12 months postdischarge.

Quality of life will be measured using EQ-5D-5L42 before discharge (baseline), 3 months and 12 months. This tool (EQ-5D-5L) has previously been used in stroke research.53

Economic outcomes

Economic outcomes will be determined from the health service perspective using an incremental cost-effectiveness ratio (ICER). The ICER indicates the difference between the intervention and control cost (time and resources costed) per the difference in QALYs determined using the quality of life measure EQ-5D-5L. Time taken to deliver the PCEE sessions (intervention group only) will be recorded on the interview schedule at both the bedside (before discharge) and telephone follow-up (7–10 days post discharge) sessions and costed using standard pharmacist salary rates. Any impact of the intervention on health resource use (eg, medication use, hospital readmissions) will be considered when estimating costs. Patient interview using EQ-5D-5L will be conducted before discharge (baseline), at 3 months and 12 months. Uncertainty in the estimated ICER will be evaluated using non-parametric bootstrapping techniques.

Adverse event reporting and quality assurance

This study involves completing a questionnaire and discussing stroke medications through one face-to-face interview and three follow-up telephone calls for the intervention group. The control group will complete one face-to-face interview and two follow-up telephone calls. It is possible that during either the face-to-face interview or one of the telephone interviews, the participant identifies a medication-related issue. Although this is unlikely to be as a result of the study, the researcher may still have concerns over the patients’ safety. If the researcher has concerns requiring immediate intervention, the patients’ doctor will be contacted. In the case of the face-to-face interview in the hospital that will be a medical member of the treating team. In the case of the telephone interview that will be the patients’ general practitioner.

This is an RCT where data on adverse drug reactions and events including stroke and readmission will be collected. It is possible that differences can be determined between the two groups before the recruitment period is complete. A data safety monitoring committee (consisting of an independent medical doctor—clinical pharmacologist and pharmacist—Drug Use Evaluation Pharmacist) has been established to analyse the adverse events every 6 months with responsibility to terminate recruitment into the study early if necessary.

This RCT will provide evidence about the effect of a PCEE on patient adherence, self-reported medication-taking behaviour, clinical outcomes, quality of life, changes in knowledge and beliefs towards medicines and illness. It is expected that communication of results will inform an evidence-based approach to communication with patients about medication-taking behaviour related to stroke prevention. Communication of results of this study will seek to impact on the practice of health practitioners and consumers interested in patient medicine-taking behaviour and those interested in secondary prevention of stroke.