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Completed

NCT Number: NCT04272671

De-prescribing Program to Evaluate Falls in Older Adults

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.

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Key information

Conditions

Opioid-related Disorders Benzodiazepine-Related Disorders Chemically-Induced Disorders Falls Injury Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

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 EHR to evaluate impact of the intervention on de-prescribing opioids and BZDs.

Primary outcomes

  1. Changes in Opioid and/or BZD use

    Time frame: 1 year pre-intervention, 1 year post intervention

    Changes in opioid use will be measured using milligram morphine equivalents per day and benzodiazepine use will be measure using lorazepam or diazepam equivalents per day

Secondary outcomes

  1. Frequency of Falls

    Time frame: 1 year pre-intervention, 1 year post intervention

    evaluating the educational impact on opioid and BZD deprescribing in relation to falls looking at the rate of falls 1 year per-intervention and the rate at completion of the study

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Implementation of a De-prescribing Medication Program to Evaluate Falls in Older Adults

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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