Clinical trial NCT04272671: De-prescribing Program to Evaluate Falls in Older Adults
Official title: Implementation of a De-prescribing Medication Program to Evaluate Falls in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Benzodiazepine-Related Disorders
Falls Injury
Keywords: De-Prescribing
Falls in Older Adults
Benzodiazepines
Opioid
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-02-17
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial uses a cluster-randomized pragmatic design wherein clinics are randomized into intervention and control, and all patients receiving care from those clinics are categorized into intervention or control based on their clinic's participation.
Primary purpose: PREVENTION

Brief summary: Purpose: The proposed study will implement and evaluate the effect of an opioid and benzodiazepine (BZD) de-prescribing intervention on falls risk in older adults.

Participants: Outpatient clinics with older adult patients, healthcare providers, older adult patients

Procedures (methods): In this proposed study, there will be 10 primary care clinics randomly assigned to the intervention arm and 10 primary care clinics randomly assigned to the control arm. In the first phase of this study, patient and provider focus groups will be used to inform the development of the intervention which will be tested during the active trial phase. The intervention has the following components: 1) alerts given to providers to identify patients taking opioids or benzodiazepines (BZD) and therefore at risk for falls; 2) educational materials to inform providers on best practices for de-prescribing opioids and BZDs in patients at risk; and 3) recommendations on de-prescribing provided by a consultant pharmacist. Impact of the intervention will be evaluated using pre-post surveys evaluating changes in providers' knowledge, confidence, and skills as well as information from the electronic health record (EHR) to evaluate impact of the intervention on de-prescribing opioids and BZDs.

Detailed description: Falls among older adults is costly and dangerous. Observational studies show consistent associations between falls and certain medications. It is widely accepted that falls-related morbidity and mortality could be reduced if systems were in place to identify falls risks and intervene to reduce the risks identified. In this study, health care professionals (HCPs) within UNC outpatient clinics will be alerted to patients on high-risk medications and provide team-based interventions to maximize the success of falls education and medication deprescribing.

This deprescribing intervention will focus specifically on opioids and benzodiazepines (BZDs) in patients 65 years of age and older since these medications have high susceptibility to negative cognitive effects in older adults and contribute to a higher risk of falls. This study will identify factors affecting the adoption, effective implementation, and maintenance of a deprescribing program focused on opioids and BZDs with the intent of reducing falls.

Eligibility criteria: Inclusion Criteria:

* UNC HealthCare clinic providing primary care services
* age at least 65 years old
* taking at least one chronic opioid or one chronic benzodiazepine medication

Exclusion Criteria:

* Clinics that do not provided primary care services
* Patients who exhibit signs of cognitive impairment or speech/hearing deficits that make obtaining informed consent and completing data collection activities difficult
* Patients undergoing active cancer treatment, receiving hospice care, or living in a skilled nursing facility
* Non-English speaking patients will be excluded from participating in the patient focus group.
* Participants who do not wish to be audio-recorded during focus group

Primary outcomes:
measure: Changes in Opioid and/or BZD use
timeFrame: 1 year pre-intervention, 1 year post intervention
Secondary outcomes:
measure: Frequency of Falls
timeFrame: 1 year pre-intervention, 1 year post intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stefanie Ferreri
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Jan Busby-Whitehead
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niznik J, Ferreri SP, Armistead L, Urick B, Vest MH, Zhao L, Hughes T, McBride JM, Busby-Whitehead J. A deprescribing medication program to evaluate falls in older adults: methods for a randomized pragmatic clinical trial. Trials. 2022 Apr 4;23(1):256. doi: 10.1186/s13063-022-06164-5.