NCT04272671

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

February 13, 2020

Last Update Submit

January 3, 2022

Conditions

Opioid-Related DisordersBenzodiazepine-Related DisordersFalls Injury

Keywords

De-PrescribingFalls in Older AdultsBenzodiazepinesOpioid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Frequency of Falls

    1 year pre-intervention, 1 year post intervention

Study Arms (2)

Educational Intervention Arm

EXPERIMENTAL

The intervention arm will receive educational material that enhances the standard of care for deprescribing opioids and BZDs.

Other: Educational Intervention

Ususal Care (Control Arm)

NO INTERVENTION

Control group will receive standard of care

Interventions

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.

Educational Intervention Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • UNC HealthCare clinic providing primary care services
  • age at least 65 years old
  • taking at least one chronic opioid or one chronic benzodiazepine medication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 35379307DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Stefanie Ferreri

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Jan Busby-Whitehead

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
As this is a pragmatic design, there will be no blinding for this study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

February 26, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Made available for 12-36 months following the publication of the primary manuscript from the trial.
Access Criteria
Contact study primary investigator at stefanie\ ferreri@unc.edu

Locations

US(1)