Opioid-Related DisordersNCT04272671
De-prescribing Program to Evaluate Falls in Older Adults
A study testing Educational Intervention in people with Opioid-Related Disorders and Benzodiazepine-Related Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Benzodiazepine-Related Disorders, Falls Injury
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- UNC HealthCare clinic providing primary care services
- age at least 65 years old
- taking at least one chronic opioid or one chronic benzodiazepine medication
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Implementation of a De-prescribing Medication 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.
Read the detailed 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.
- Being tested
- Educational Intervention
- Keywords
- De-Prescribing, Falls in Older Adults, Benzodiazepines, Opioid
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Arm | Experimental | The intervention arm will receive educational material that enhances the standard of care for deprescribing opioids and BZDs. Receives: Other: Educational Intervention |
| Ususal Care (Control Arm) | No intervention | Control group will receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year pre-intervention, 1 year post intervention
Secondary outcomes (1)
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
Measured: 1 year pre-intervention, 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Feb 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Stefanie Ferreri, Principal investigator, University of North Carolina, Chapel HillJan Busby-Whitehead, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272671
- Sponsor's protocol ID
- 18-2920
- Other IDs
- CE 18-004
- Status last verified
- Jan 2022
- First submitted
- 13 Feb 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41746649Niznik 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.
PubMed 35379307
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a De-prescribing Medication Program to Evaluate Falls in Older Adults
- ClinicalTrials.gov ID
- NCT04272671
- Acronym / sponsor ID
- 18-2920
- Keywords
- De-Prescribing, Falls in Older Adults, Benzodiazepines, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Arm | Experimental | Other: Educational InterventionThe 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- UNC HealthCare clinic providing primary care services
- age at least 65 years old
- taking at least one chronic opioid or one chronic benzodiazepine medication
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionThe 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. | Other | Educational Intervention Arm |
Primary outcome
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
1 secondary outcome
Frequency of Falls
Time frame: 1 year pre-intervention, 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 41746649Busby-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.
- Derived from this study: PubMed 35379307Niznik 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie Ferreri principal investigator
University of North Carolina, Chapel Hill
Jan Busby-Whitehead principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Opioid-Related Disorders and Benzodiazepine-Related Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Opioid and/or BZD use (time frame: 1 year pre-intervention, 1 year post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.