ClinicalTrials.Veeva

Menu

De-prescribing Program to Evaluate Falls in Older Adults

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Opioid-Related Disorders
Benzodiazepine-Related Disorders
Falls Injury

Treatments

Other: Educational Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04272671
18-2920
CE 18-004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Educational Intervention Arm
Experimental group
Description:
The intervention arm will receive educational material that enhances the standard of care for deprescribing opioids and BZDs.
Treatment:
Other: Educational Intervention
Ususal Care (Control Arm)
No Intervention group
Description:
Control group will receive standard of care

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems