Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomised trial (OPTI-SCRIPT study)
Background: Potentially inappropriate prescribing (PIP) is common and can result in increased morbidity, adverse drug events and hospitalisations. In 2007, 36% of Irish people aged 70 years or over received at least one potentially inappropriate prescription, with an associated expenditure of €45 million. This thesis documents the design, conduct, and evaluation of a cluster randomised controlled trial (RCT) in Irish primary care focused on reducing PIP in older patients (> 70 years).
Methods: The intervention development was guided by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions. Literature and information from experts were combined to define the main components of the intervention which was then tested with five GPs during the pilot and evaluated using qualitative interviews
During the OPTI-SCRIPT trial 21 practices and 196 patients were allocated to intervention (11 practices, 99 patients) or control (10 practices, 97 patients) using minimisation. Intervention participants received a multifaceted intervention incorporating academic detailing with a pharmacist, medicines review with web-based pharmaceutical treatment algorithms that provided recommended alternative treatment options, and tailored patient information leaflets. Control practices delivered usual care and received simple patient-level PIP feedback. Primary outcomes were the proportion of participants with PIP and the mean number of potentially inappropriate prescriptions per group. Secondary outcomes included drug-specific outcomes, well-being and beliefs about medication. Routinely collected national prescribing data were analysed as a contemporary national comparison.
During the mixed methods process evaluation, semi-structured interviews with participating GPs and a purposive sample of patients in the intervention group were conducted. Interviews were transcribed verbatim and the data analysed using a thematic analysis. Data were also collected from practice questionnaires, website activity and researcher logs.
Results: All 21 practices and 190 patients were followed up. At follow-up there was a statistically significant difference between groups. For patients in the intervention group, the odds of not having PIP were 3 times higher than the odds in the control group (OR 3.1 95% Cl 1.4, 6.5). The average PIP in the intervention group was also significantly lower than control (0.70 v 1.19, p=0.004). In the control group, the incidence rate for PIP was 1.42 times the incidence rate for the intervention group. The intervention had a statistically significant effect in reducing proton pump inhibitor prescribing but not on the other secondary outcomes. Exploratory analysis of national prescribing data highlighted that PIP was increasing during the study period and that the control group did not act differently to national trends.
The process evaluation highlighted that requiring GPs to be involved in patient recruitment was time consuming. GPs received a standardised academic detailing session but delivered the intervention differently. Patient information leaflets were not used at all. Participants identified important barriers and facilitators to the future effectiveness of such an intervention, with time being a barrier reported by both GPs and patients. Overall, the intervention was positively received with participants referring to the value of medication reviews to improve prescribing practices and reduce unnecessary medications in older patients.
Conclusions: The study found that a multifaceted intervention incorporating academic detailing with a pharmacist, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, but not tailored patient information leaflets, was effective in reducing PIP, particularly for proton pump inhibitors, but had no effect on other secondary outcomes. The process evaluation highlighted that the intervention was acceptable to the majority of participants.