A deprescribing medication program to evaluate falls in older adults: methods for a randomized pragmatic clinical trial

BACKGROUND: Opioids and benzodiazepines (BZDs) are some of the most commonly prescribed medications that contribute to falls in older adults. These medications are challenging to appropriately prescribe and monitor, with little guidance on safe prescribing of these medications for older patients. Only a handful of small studies have evaluated whether reducing opioid and BZD use through deprescribing has a positive impact on outcomes. Leveraging the strengths of a large health system, we evaluated the impact of a targeted consultant pharmacist intervention to deprescribe opioids and BZDs for older adults seen in primary care practices in North Carolina. METHODS: We developed a toolkit and process for deprescribing opioids and BZDs in older adults based on a literature review and guidance from an interprofessional team of pharmacists, geriatricians, and investigators. A total of fifteen primary care practices have been randomized to receive the targeted consultant pharmacist service (n = 8) or usual care (n = 7). The intervention consists of several components: (1) weekly automated reports to identify chronic users of opioids and BZDs, (2) clinical pharmacist medication review, and (3) recommendations for deprescribing and/or alternate therapies routed to prescribers through the electronic health record. We will collect data for all patients presenting one of the primary care clinics who meet the criteria for chronic use of opioids and/or BZDs, based on their prescription order history. We will use the year prior to evaluate baseline medication exposures using morphine milligram equivalents (MMEs) and diazepam milligram equivalents (DMEs). In the year following the intervention, we will evaluate changes in medication exposures and medication discontinuations between control and intervention clinics. Incident falls will be evaluated as a secondary outcome. To date, the study has enrolled 914 chronic opioid users and 1048 chronic BZD users. We anticipate that we will have 80% power to detect a 30% reduction in MMEs or DMEs. DISCUSSION: This clinic randomized pragmatic trial will contribute valuable evidence regarding the impact of pharmacist interventions to reduce falls in older adults through deprescribing of opioids and BZDs in primary care settings. TRIAL REGISTRATION: Clinicaltrials.govNCT04272671. Registered on February 17, 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06164-5.