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

Abstract

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

Patterns and disparities in prescribing of opioids and benzodiazepines for older adults in North Carolina

“…Analyses were conducted using pre‐intervention data from a randomized pragmatic trial funded by the Centers for Disease Control and Prevention (registered at http://clinicaltrials.gov [NCT04272671]). The objective of that trial was to evaluate the effectiveness of pharmacist‐initiated deprescribing recommendations to primary care prescribers for patients aged ≥65 years old who were at risk for falls due to chronic opioid and/or BZD use 13 . Practices were part of the UNC Physician Network of the UNC Health System, a large public academic medical center.…”

“…We extracted data on prescription orders to identify patients who were chronic users of opioids and BZDs based on preliminary analyses 13 . Prescription orders included those that originated from a provider at one of the 15 clinics.…”

“…Overall clinic population n = 25,120 evaluate the effectiveness of pharmacist-initiated deprescribing recommendations to primary care prescribers for patients aged ≥65 years old who were at risk for falls due to chronic opioid and/or BZD use. 13 Practices were part of the UNC Physician Network of the UNC Health System, a large public academic medical center. Practices were located in 14 of the 100 counties throughout NC, of which 78 are considered rural.…”

“…We extracted data on prescription orders to identify patients who were chronic users of opioids and BZDs based on preliminary analyses. 13 Prescription orders included those that originated from a provider at one of the 15 clinics. Chronic opioid use was defined as having at least four prescription orders in the prior year with at least one in the last 90 days.…”

An EHR-based method to structure, standardize, and automate clinical documentation tasks for pharmacists to generate extractable outcomes

“…The application of preset phrases and dropdowns described below was part of an ongoing pragmatic randomized study of a pharmacist intervention to deprescribe opioids and benzodiazepines (BZDs) for older adults seen in primary care practices in North Carolina (registered at clinicaltrials.gov [NCT04272671]). 15 Briefly, the objective of the study was to evaluate the effectiveness of a clinical pharmacist intervention to identify patients aged ≥65 years old at risk for falls, based on chronic opioid and/or BZD use, and subsequently provide targeted deprescribing recommendations to primary care prescribers to help initiate tapering plans. A medication tapering plan or “taper” helps a patient to safely discontinue a medication to reduce the risk of withdrawal symptoms from dependency and adverse outcomes after a medication is deprescribed by a provider.…”