NCT04272671

De-prescribing Program to Evaluate Falls in Older Adults

Completed NA Last updated 5 January 2022

What this trial tests

NA trial testing Educational Intervention in Opioid-Related Disorders in 15 participants. Completed in 1 October 2021.

Timeline

26 February 2020

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	15
Start date	26 February 2020
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Educational Intervention

Conditions studied

• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
• Benzodiazepine-Related Disorders — all drugs for Benzodiazepine-Related Disorders →
• Falls Injury — all drugs for Falls Injury →

Sponsor

University of North Carolina, Chapel Hill

Who can join

65 and older, any sex, with Opioid-Related Disorders or Benzodiazepine-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-Care Prescribers' Perspectives on Deprescribing Opioids and Benzodiazepines in Older Adults.
   Niznik JD, Ferreri SP, Armistead LT, Kelley CJ, et al · · 2022 · cited 18× · PMID 35896779 · DOI 10.1007/s40266-022-00967-6
2. A deprescribing medication program to evaluate falls in older adults: methods for a randomized pragmatic clinical trial.
   Niznik J, Ferreri SP, Armistead L, Urick B, et al · · 2022 · cited 12× · PMID 35379307 · DOI 10.1186/s13063-022-06164-5
3. Patterns and disparities in prescribing of opioids and benzodiazepines for older adults in North Carolina.
   Niznik JD, Hughes T, Armistead LT, Kashyap J, et al · · 2023 · cited 6× · PMID 36779609 · DOI 10.1111/jgs.18288
4. Association of Average Daily Morphine Milligram Equivalents and Falls in Older Adult Chronic Opioid Users.
   Hwang S, Hughes TD, Niznik J, Ferreri SP. · · 2024 · cited 2× · PMID 38668088 · DOI 10.3390/pharmacy12020062
5. An EHR-based method to structure, standardize, and automate clinical documentation tasks for pharmacists to generate extractable outcomes.
   Sanders KA, Wolverton D, Stamopoulos M, Zunich R, et al · · 2023 · cited 2× · PMID 37181730 · DOI 10.1093/jamiaopen/ooad034
6. A Pharmacist Consultant Service for Deprescribing Opioids and Benzodiazepines in Older Adults: A Cluster Randomized Trial.
   Busby-Whitehead J, Ferreri SP, Niznik J, Armistead LT, et al · · 2026 · PMID 41746649 · DOI 10.1001/jamanetworkopen.2025.60581
7. Pharmacist-Led Deprescribing of Opioids and Benzodiazepines in Older Adults: Examining Implementation and Perceptions.
   Hughes TD, Sottung E, Nowak J, Sanders KA. · · 2024 · PMID 39195848 · DOI 10.3390/pharmacy12040119