None listed
Conditions
Brief summary
Dose administration aids (DAAs) facilitate ease of administration by packaging multiple tablets together by date and time, thereby reducing unintentional non-adherence and medication errors. Use of reminder packaging has been shown to improve adherence by 11% measured by pill count. However, barriers to DAA use remain including cost, limited GP involvement in the initiation process, lack of patient understanding and lack of randomised controlled trials of DAAs in Australia. The PAX Pilot study will determine if a coordinated strategy of delivering cardiovascular drug therapy via dose administration aids can effectively increase prescription possession ratio compared to usual care. The study will test the hypothesis that the use of dose administration aids will increase adherence and therefore, increase prescription possession ratio, among people with greater than equal to 5 medications compared to usual care.
Interventions
INTERVENTION: Letter to patients inviting them to receive a home-delivered dose administration aid.
This will be an 8 month pilot study designed as a “trial within cohort” (TwiC) randomised controlled trial (RCT). The TWiC design involves embedding a RCT within an established cohort (general practice in this case) to test the effectiveness of an intervention under pragmatic patient care environments, and to utilise information routinely collected in an existing cohort. The key difference compar
INTERVENTION: Letter to patients inviting them to receive a home-delivered dose administration aid. This will be an 8 month pilot study designed as a “trial within cohort” (TwiC) randomised controlled trial (RCT). The TWiC design involves embedding a RCT within an established cohort (general practice in this case) to test the effectiveness of an intervention under pragmatic patient care environments, and to utilise information routinely collected in an existing cohort. The key difference compared to a standard RCT is that a patient subset is randomly selected to be offered the study intervention, with the outcomes of this subset compared to the remaining eligible patients in the cohort who receive usual care (i.e. control). In this way much more realistic and generalisable results are obtained, while maintaining randomisation. Patients on greater than equal to five medications will be identified in the medical records of participating GPs, at least one of which must be a cardiovascular medication. A GP and Study Coordinator will screen electronic medical records of potentially eligible participants using the inclusion and exclusion criteria. Eligible participants will be randomised to the intervention (i.e. a patient directed invitation letter from the GP) or control arms. Participants in the intervention arm (N is equal to 100 patients) will be sent a letter from the GP inviting them to try using a Dose Administration Aid (DAA), such as a Doseaid sachet. Those randomised to the control arm will not receive a letter and will form the standard care group. Participants, who have received the letter and decide to take up the DoseAid offer, will contact the research team. A research team member will then contact them, providing further education, allowing them to seek clarification and obtaining verbal consent for the trial. The GP will prescribe the participants’ usual medications and provide the script to the local Pharmacy. The Pharmacy will then provide education to participants as required and consent them for a DoseAid as per usual care processes. DoseAid is a Queensland based company, licensed by the Therapeutic Goods Administration and is GMP-compliant. DoseAid will supply the medications and sort them into individually-labelled sachets with easy tear packaging by day, dose and time. These sachets are then rolled up in chronological date and time order. DoseAid will send the sachets to the Pharmacy and the latter will directly mail the sachets to participants in the intervention group. Participants will receive their DoseAid sachets monthly for 8 months. Prescription Possession Ratio (PPR) will be measured at 8 months to monitor adherence. PPR is defined as the percentage of time that an individual has a valid prescription script according to practice prescription records in a given observation period.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant inclusion criteria: 1. Community dwelling adults aged greater than equal to 18 years old 2. Prescribed at least 5 medicines, with at least 1 cardiovascular indication which includes medications for coronary artery disease, stroke, peripheral vascular disease, hypertension, hypercholesterolaemia, diabetes, arrhythmias, heart failure and valvular heart disease. Broadly this includes Pharmaceutical Benefits Scheme Anatomical Therapeutic Chemical Classifications A10, B01, B02, C01-C10. 3. Stable medical conditions and stable medications for at least 6 months prior to enrolment 4. Ability to give informed consent Site selection criteria: Primary care practices using electronic health records that have the ability to generate practice-level reports of the target population and have regular data extractions performed via MedicineInsight or network processes.
Exclusion criteria
Participant exclusion criteria: 1. Responsible primary care or other responsible physician believes it is not appropriate for the patient to participate in the study. 2. A medical illness, which in the view of the treating physician, has an anticipated life expectancy of less than 8 months. 3. Patients using any other dose administration aid (e.g. webster pack, automated devices) 4. Patients with physical disabilities precluding use of the DoseAid (e.g. tearing the sachets) and without a carer to assist them. 5. Patients with significant cognitive or psychiatric conditions precluding informed consent and use of DoseAid
Outcome results
None listed