Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CE 18-004 | Other Identifier | UNC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention Arm | Experimental | The intervention arm will receive educational material that enhances the standard of care for deprescribing opioids and BZDs. |
|
| Ususal Care (Control Arm) | No Intervention | Control group will receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefanie Ferreri | University of North Carolina, Chapel Hill | Principal Investigator |
| Jan Busby-Whitehead | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41746649 | Derived | Busby-Whitehead J, Ferreri SP, Niznik J, Armistead LT, Hughes T, Zhao L, Urick BY, Preisser JS, Larson C, Roberts E, Foushee L, Haddad Y. A Pharmacist Consultant Service for Deprescribing Opioids and Benzodiazepines in Older Adults: A Cluster Randomized Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2560581. doi: 10.1001/jamanetworkopen.2025.60581. | |
| 35379307 |
Not provided
Not provided
Deidentified individual data that supports the results will be shared beginning 12 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Made available for 12-36 months following the publication of the primary manuscript from the trial.
Contact study primary investigator at stefanie_ferreri@unc.edu
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
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.
Not provided
Not provided
As this is a pragmatic design, there will be no blinding for this study.
Not provided
|
| 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. |
| D011314 | Preventive Health Services |