Clinical trial NCT05538065: NUDGE-EHR Replication Trial at Mass General Brigham
Official title: Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Benzodiazepine Sedative Adverse Reaction
Anticholinergic Adverse Reaction
Adverse Drug Event
Keywords: Benzodiazepine
Sedative hypnotic
Overprescribing
Anticholinergic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2022-09-13
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.

Detailed description: This is a cluster randomized control trial (RCT) to evaluate whether newly designed EHR-based tools designed using behavioral principles reduce inappropriate prescribing and adverse outcomes among older adults. This study will be conducted in outpatient primary care practices at Mass General Brigham (MGB), specifically Massachusetts General Hospital. MGB has a fully functional EHR, EpicCare, that supports computerized ordering of medications. MGB is comprised of 150 outpatient practices with over 1,800 physicians.

In this trial, approximately 190 primary care providers at MGH will be randomized to receive usual care or an active intervention. Providers randomized to one of the 2 selected treatment arms will receive an EHR tool to guide their care of eligible patients. They will be followed for 12 months. Providers randomized to usual care will receive no newly-designed EHR tool. Providers will receive these EHR tools for their patients who meet the following criteria: 1) older adults (aged 65 years or more), and 2) who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic or have been prescribed at least one active orders of at least 90 pills of two different anticholinergics in the last 180 days.

Eligibility criteria: Inclusion Criteria:

* Primary care provider at Mass General Brigham

Providers will receive these EHR tools for their patients who meet the following criteria:

1. older adults (aged 65 years or more)
2. who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic in the last 180 days.

Outcomes will be measured on the patient level.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Inappropriate Prescribing
timeFrame: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant
Secondary outcomes:
measure: Quantity of High-risk Medication Prescribed
timeFrame: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant
measure: Cumulative Lorazepam Milligram Equivalents Prescribed
timeFrame: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: