None listed
Conditions
Brief summary
In Australia, one in three people have high blood pressure (BP). Most people who are taking medicine for their BP, still have a BP above 140/90mmHg). Pharmacists can help take care of BP because people visit them for medicine, and they know how to educate patients. Our research found that education from doctors is not always the same, and online resources are not easy to understand. Because of this, we are running a study where pharmacists will measure BP and deliver care to patients. Participants will be: - Adults aged 18-70 years - Taking up to 3 BP medicines for at least 3 months - Have BP >140/90 mmHg Pharmacies will have study pamphlets on show to tell people about the study. Pharmacists will check if people are eligible when they collect their BP medicine. People who meet the criteria above will have their BP measured by a pharmacist. If their BP is high, they will give consent and fill out a health survey. A computer will then randomly assign them to the treatment or control group. What is the intervention? The control group will get normal care. The treatment group will: 1. Participate in a structured education session by trained pharmacists. 2. Independently use a standardised co-designed education package to support self-management of BP, called the ‘BP Toolkit’. The education by pharmacists will be: 1. A brief check of the participant’s BP and other heart medicines. 2. Shared decision-making with the patient to set goals to look after their BP. These goals may be sticking to medicine regimens, home BP measurement, or lifestyle behaviours, such as diet. 3. Introduction to the BP Toolkit to help people look after their BP.
Interventions
The multi-modal intervention will be delivered once only- at the time the participant is screened, consented, and randomised in the pharmacy.
The intervention involves
1) delivery of a structured education session ('Hypertension MedsCheck') by pharmacists when the patient presents for anti-hypertensive medication with uncontrolled BP (greater than or equal to140/90 mmHg) measured at pharmacy and
2) independent use of a standardised co-designed education package to support self-management of b
The multi-modal intervention will be delivered once only- at the time the participant is screened, consented, and randomised in the pharmacy. The intervention involves 1) delivery of a structured education session ('Hypertension MedsCheck') by pharmacists when the patient presents for anti-hypertensive medication with uncontrolled BP (greater than or equal to140/90 mmHg) measured at pharmacy and 2) independent use of a standardised co-designed education package to support self-management of blood pressure, called the ’BP Toolkit’. Intervention participants will receive a brief medication review modelled off the MedsCheck program, a structured clinical pharmacy service funded by the Australian Government through the Pharmacy Programs Administrator, This session will involve a 20-minute face-to-face consultation where a registered pharmacist will review a participant’s blood pressure and cardiovascular medication regimen and develop a medication profile and action plan. The focus is on education and self-management, identifying medication-related problems, improving medication use, and providing education on best practices. The education session delivered by pharmacists will include: 1) Brief medication review: review of the participants cardiovascular medications. 2) Action-planning: The pharmacist will work with the participant to develop a personalised plan and set realistic 6-month goals. This session will include identifying and setting goals in relation to one or more of the following management practices: medication adherence, lifestyle (e.g., diet and exercise), exploration of additional heart disease risk factors, or scheduling regular blood pressure checks and/or home blood pressure measurement. Pharmacists and participants will be encouraged to set 3-5 goals in the SMART format, as is recommended during a standard MedsCheck (Specific, Measurable, Achievable, Relevant, Time-bound). Based on the medication review, action-planning session and the participant’s blood pressure readings; the pharmacist will also provide recommendations for when the participant should be reviewed by their general practitioner. Participants will be provided with a copy of the action-plan and will be encouraged to take it with them to see their general practitioner. 3) Introduction and brief demonstration of the BP Toolkit to support ongoing engagement for blood pressure management and to ensure participants are comfortable navigating and utilising the website. The BP Toolkit is a standardised co-designed educational package of evidence-based recommendations for patients to self-monitor blood pressure and navigate blood pressure management activities, including guidance to obtain an accurate blood pressure device; instructions to measure blood pressure at home; resources to record and report blood pressure to healthcare providers, including prompts to visit a general practitioner, and lifestyle and medication advice. The pharmacist will demonstrate and guide participants through the BP Toolkit website, providing a comprehensive overview that includes an introduction to the site, instructions on navigation, and a demonstration of its key features and functionalities. Personalised guidance will be offered based on each participant’s identified issues as outlined in their individual action plans. Participants will also be shown how to access and use the website independently and will be encouraged to explore and utilise the BP Toolkit at their own discretion following the session. After the face-to-face intervention, each participant will be emailed a copy of their personalised action plan and signed consent form, a link to the BP Toolkit website, and information on how to contact the research team. Usability data will be collected from the BP Toolkit website, including the number of logins, time spent on the website and within each topic, and the use of interactive features such as storing blood pressure readings and downloading website resources. 4) Follow-up: As is recommended for a standard MedsCheck, pharmacists will be recommended to communicate the patient’s action-plan with the prescribing general practitioner and informing them about the trial. It is recommended that this communication provide a summary of the study, including tailored recommendations and goals established during the structured education session, as well as any necessary follow-up actions, reinforcing the key points covered during the session. Pharmacists may choose how they wish to communicate with general practitioners (such as via phone, email or fax). Six months following randomisation and intervention delivery, participants will return to the pharmacy for a follow-up visit. During this visit, their blood pressure will be measured, and they will complete an online questionnaire to assess whether they have achieved the goals outlined in their personalised action plan.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adult participants (aged 18-70 years) who visit the pharmacy for dispensing of their anti-hypertensive medication for the purpose of BP management and uncontrolled BP, defined as unobserved pharmacy-measured BP of equal to or greater than 140/90 mmHg. Eligible participants must have been on BP medication for at least three months and be taking no more than three different classes of BP medications, including single-pill combinations.
Exclusion criteria
People who have had a change in antihypertensive medications within the past 6 months. People who are currently pregnant, planning a pregnancy and/or breastfeeding will be excluded from the study due to the distinct nature of BP management during pregnancy and the postpartum period. BP regulation in pregnant individuals requires specialised care and protocols that differ from the general population. People who live with someone who is already enrolled in the study. People who have a severe co-existing medical condition and/or a planned major cardiovascular procedure in the next 6-months that would impede or prevent engagement in the intervention e.g., dementia, terminal illness or Transcatheter Aortic Valve Implantation, or who are already participating in another health and/or medicine related clinical trial or who are unable to give consent will also be excluded. For safety reasons, people will also be excluded if they are found at the time of assessment in pharmacy to have an average systolic BP equal to or greater than180 mmHg and/or diastolic BP equal to or greater than 110 mmHg.
Outcome results
None listed