De-prescribing Program to Evaluate Falls in Older Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-Related Disorders, Benzodiazepine-Related Disorders, Falls Injury

Intervention / Treatment
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* Other: Educational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention Arm<br>The intervention arm will receive educational material that enhances the standard of care for deprescribing opioids and BZDs. | Other: Educational Intervention<br>* 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.<br>|
| No Intervention: Ususal Care (Control Arm)<br>Control group will receive standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Opioid and/or BZD use | 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 | 1 year pre-intervention, 1 year post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Falls | 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 | 1 year pre-intervention, 1 year post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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De-Prescribing, Falls in Older Adults, Benzodiazepines, Opioid