Safer Prescribing and Care for the Elderly (SPACE): a cluster randomised controlled trial in general practice

Abstract

BackgroundSafer prescribing in general practice may help to decrease preventable adverse drug events (ADE) and related hospitalisations.AimTo test effect of SPACE on high-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines and related hospitalisations.Design & settingPragmatic cluster randomised controlled trial in general practice. Participants were patients at increased risk of ADEs from NSAIDs and/or antiplatelet medicines at baseline. SPACE comprises automated search to generate for each general practitioner (GP)a list of patients with high-risk prescribing; pharmacist outreach to provide education and one-on-one review of list with GP; and automated letter inviting patients to seek medication review with their GP.MethodPrimary outcome was difference in high-risk prescribing of NSAIDs and/or antiplatelet medicines at 6 months; secondary outcomes included high-risk prescribing for gastrointestinal, renal or cardiac ADEs separately; 12-month outcomes; and related ADE hospitalisations.ResultsWe recruited 39 practices with 205 GPs and 191,593 patients including 21,877 (11.4%) participants, 1,479 (6.8%) with high-risk prescribing. High-risk prescribing improved in both groups at 6 and 12 months compared with baseline. At 6 months, there was no significant difference between groups (OR: 0.99 (0.87, 1.13)) although SPACE improved more for gastrointestinal ADEs (0.81 (0.68, 0.96)). At 12 months, the control group improved more (OR: 1.29 (1.11, 1.49)). There was no significant difference for related hospitalisations.ConclusionFurther work is needed to identify scalable interventions that support safer prescribing in general practice. The use of automated search and feedback plus letter to patient warrants further exploration.

Process evaluation of the Safer Prescribing and Care for the Elderly (SPACE) cluster randomised controlled trial in New Zealand general practice

“…This process evaluation used mixed methods to help understand implementation of the SPACE intervention in general practice and the limited effect of the intervention, adding to the knowledge gained from the pilot study and qualitative interviews. [3][4][5] Recruitment into the trial was challenging. Time pressures and poor remuneration remain major barriers to GPs participating in research, but it was also bad timing that a non-trial safer prescribing initiative targeting the same prescribing topic was introduced at the same time.…”

“…The SPACE trial was conducted in 39 general practices with 21 867 participants identified as at increased risk of experiencing gastrointestinal, renal or cardiac ADEs from nonsteroidal anti-inflammatory or anti-platelet medications at baseline, of whom 1479 (6.8%) had received high-risk prescribing. 3 Of the 39 practices, 20 were allocated to the intervention group, including 100 GPs and 613 participants with high-risk prescribing at baseline. All practices had electronic medical records and used practice management systems compatible with the trial system for a remote electronic search of the practice database.…”

“…1,2 The Safer Prescribing and Care for the Elderly (SPACE) cluster randomised controlled trial was conducted in New Zealand general practice from 2018 to 2020 to investigate the effect of the SPACE intervention on high-risk prescribing of non-steroidal antiinflammatory and/or antiplatelet medicines and related hospitalisations. 3 High-risk prescribing places patients at increased risk of ADEs. SPACE is a complex intervention involving: (i) an automated search of practice records to identify and generate for each general practitioner (GP) a list of patients with high-risk prescribing for the prescribing topic; outreach visit from pharmacist to deliver: (ii) group education to GPs (30-60 min) and (iii) one-on-one feedback with each GP (15-30 min); (iv) tick-box for GPs to indicate an intended action for each patient in their list (Letter; No letter but possible change and/or discussion with patient when next in; No action); and (v) letter from a GP to selected patients inviting them to discuss their medicines when they are next in (Supplementary Table S1).…”

“…SPACE is a complex intervention involving: (i) an automated search of practice records to identify and generate for each general practitioner (GP) a list of patients with high-risk prescribing for the prescribing topic; outreach visit from pharmacist to deliver: (ii) group education to GPs (30-60 min) and (iii) one-on-one feedback with each GP (15-30 min); (iv) tick-box for GPs to indicate an intended action for each patient in their list (Letter; No letter but possible change and/or discussion with patient when next in; No action); and (v) letter from a GP to selected patients inviting them to discuss their medicines when they are next in (Supplementary Table S1). 3 All GPs who attended the one-on-one session with the study pharmacist received a NZ$100 gift voucher. The trial found that SPACE decreased high-risk prescribing for gastrointestinal ADEs at 6 months, primarily by increasing proton-pump inhibitor protection, but did not decrease highrisk prescribing for ardiovascular or renal ADEs.…”

“…The detailed methods and results have been published previously. [3][4][5] Process evaluations are recommended to understand how and why an intervention has or has not worked, and to help understand variation in responses and discrepancies between expected and observed effect. 6,7 Process evaluations can help to understand whether an intervention was implemented and delivered in the way that was intended and reasons for variation, and can outline contextual influences on effectiveness to inform future intervention development and implementation.…”