OPERAM was a cluster randomized controlled trial to examine the effect of optimizing drug treatment on drug-related hospital admissions in older adults with multimorbidity and polypharmacy ad- mitted to hospital.
110 clinicians were randomized to usual care or a structured pharmacotherapy optimization intervention performed at the individual patient level (2,008 patients overall). Inappropriate prescribing was very common (in 789 participants (86%) in the intervention arm). In 491 of these (62%), at least one recommendation from the optimization intervention was successfully implemented at two months. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group (hazard ratio of 0.95, 95% confidence interval 0.77 to 1.17).
In conclusion, inappropriate prescribing was found to be common in this population and the intervention was able to reduce it but this did not translate into a reduction of drug-related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimization interventions that reduce inappropriate prescribing and improve patient outcomes.
The project in selected numbers:
- 2,008 patients enrolled in 110 clusters at 4 European sites
- 13,951 completed visits or follow-up phone calls
- 1,457,464 data points in trial database
- 9,824 lines of code for data preparation and main statistical analysis
CTU Bern was involved in the planning phase of the trial and contributed to the trial design and protocol.
CTU Bern set up the study in the Webspirit database and maintained the database during the study.
Central Data Monitoring
CTU Bern monitored database entries during the course of the study and ensured data quality.
CTU Bern initiated the study in collaboration with the sponsor, coordinated monitoring activities, and performed on-site visits at selected sites.
All main analyses were done at CTU Bern.