None listed
Conditions
Brief summary
The SPACE Cluster Randomised Control Trial (RCT) will test the effect of an intervention designed to promote medicines review and support safer prescribing decisions in general practice. In New Zealand (NZ) there were 15,254 hospital admissions for adverse drug events (ADEs) in 2005. Most ADE admissions are caused by commonly prescribed drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet medications and anticoagulants, which together account for one third of ADE admissions. The single greatest predictor of adverse drug events and ‘high-risk’ prescribing is the number of medicines a person is taking. With demographic trends, there are increasing numbers of older people who are prescribed multiple medications for co-exsiting medical conditions. In NZ, approximately 10% of older people are taking ten or more regular medicines, and high-risk prescribing is common, often involving NSAIDs. We have developed the Safer Prescribing and Care for the Elderly (SPACE) intervention for NZ general practice, adapted from the successful Australian Veterans' MATES programme. The first SPACE module comprises a practice audit to identify high-risk prescribing of NSAIDs and antiplatelet medicines to ‘vulnerable’ patients (at least one existing risk factor for ADE), an outreach visit from the Primary Health Organisation (PHO) pharmacist to provide education and patient-specific feedback to general practitioners (GPs), and patient activation through a practice mail-out encouraging patients receiving ‘high-risk’ medication combinations to discuss their medicines when they next see their GP. This cluster RCT is planned to assess whether the SPACE intervention can reduce the rate of ‘high-risk’ prescribing and related ADE hospital admissions over 12 months amongst predominantly older ‘vulnerable’ patients using existing PHO infrastructure and systems in every-day NZ primary care. Methods: A cluster RCT design involving 8000 vulnerable patients from 40 practices (including 120 GPs), would be adequate to detect a 25% reduction in rate of ‘high-risk’ prescribing, allowing for a 12% loss to follow-up of patients over 12 months. Randomisation will be by practice. Significance: The prevalence of high-risk prescribing and avoidable ADE admissions, and the unnecessary cost imposed on an already stretched health system, justify greater efforts to improve the safety of prescribing in general practice. The aging population with increasing polypharmacy mean the ADE rates and costs will only increase unless we can improve the safety of prescribing in general practice. If shown to be effective, the SPACE programme could be rolled out nationally and used routinely by PHOs, with further evidence-based SPACE modules developed to support safer prescribing in general practice and minimise avoidable ADE hospital admission
Interventions
The SPACE intervention comprises a practice audit to identify people with high-risk prescribing for non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines; an one-off 15 minute outreach visit by a community pharmacist to deliver to doctors patient-specific feedback and educational material; a tick-box for doctors to indicate the action they will take in response to the feedback; a mail-out of the educational material to local community pharmacists; and, one month later, a m
The SPACE intervention comprises a practice audit to identify people with high-risk prescribing for non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines; an one-off 15 minute outreach visit by a community pharmacist to deliver to doctors patient-specific feedback and educational material; a tick-box for doctors to indicate the action they will take in response to the feedback; a mail-out of the educational material to local community pharmacists; and, one month later, a mail-out from the practice to patients identified as having high-risk prescribing containing information about their medicines and a letter encouraging them to discuss their medicines when they next see their doctor. All prescribing decisions will be made as usual by the doctor in discussion with the patient. For doctors the intervention entails the one-off 15-minute meeting with the pharmacist to go through their list of patients identified as having high-risk prescribing, and then for each patient indicating in a tick-box the intended action (‘review medicines + patient letter’, ‘review medicines + no letter', ‘no action’). The intervention does not target patients, but rather targets doctors. However, patients with high-risk prescribing that are selected by the doctor to receive a mail-out, will receive a mail-out from the practice containing a medicines information brochure and a letter encouraging the patient to talk about their medicines when they are next in at the practice seeing their doctor. Thus in summary the intervention comprises practice prescribing audit to identify patients with high-risk prescribing and generate a list of such patients for each doctor; a 15-minute one-off outreach visit by the pharmacist to go through with each doctor their list of patients identified as having high-risk prescribing; a tick-box for the doctor to select for each patient the intended action; a mail-out to selected patients. As part of the intervention, the local pharmacist will be notified of the study. The feedback to each doctor comprises their list of patients who fulfil the high-risk prescribing definition for this study; a one page summary of educational material about the safe prescribing of NSAIDs and anti-platelet medicines. This same educational material will be provided to local community pharmacists. The mail-out to patients comprises a brief letter informing patients that the practice is reviewing the prescribing of some medicines and that they (the patient) is on the medicines of interest, and encouragement to discuss their medicines when they are next in at the practice seeing their doctor. The medicines information brochure provides basic information about NSAIDs and anti-platelet medicines. The audit, feedback and tick-box occur at baseline; the pharmacist is informed at or as close as possible to baseline; the mail-out to the patient occurs at baseline (although the mail-out will take a couple of days in postal transit).
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: Patients (‘vulnerable patients’) will be included in the study if, at baseline, they fulfil one or more of the following inclusion criteria: • Gastrointestinal risk factors (and not on gastro-protective medication) - Prior peptic ulcer; 75y and older; 65y and older prescribed aspirin; Prescribed oral anticoagulant • Renal risk factors - Prescribed both renin-angiotensin system blocker and diuretic; chronic kidney disease (eGFR <60) • Cardiac risk factors - Heart failure Where patients have baseline assessments included in one study practice and then move to a second study practice before baseline assessment at the second practice, they will be included as study participants in the second practice only.
Exclusion criteria
All patients fulfilling inclusion criteria in participating practices will be included. If children fulfil the inclusion criteria they will be included. This is highly unlikely given the inclusion criteria. No children were identified in audits during the feasibility study. We see no reason to exclude children - if children are receiving high-risk prescribing then it makes sense for doctors to review their medicines as well. The intervention is designed to promote medicines review.
Outcome results
None listed