Aging Clinical Trial - NUDGE-EHR Replication Trial at Mass General Brigham

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Adverse Drug Event
Aging
Anticholinergic Adverse Reaction
Benzodiazepine Sedative Adverse Reaction
Drug-Related Side Effects and Adverse Reactions

Clinical Trial Details

NCT number	NCT05538065
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 10, 2022
Completion date	April 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Recruiting	`NCT06032065` - SMART Exercise for PAD	Phase 3
Active, not recruiting	`NCT05293730` - Trial of the Impact of the Electronic Frailty Integrated With Social Needs	N/A
Recruiting	`NCT03932162` - Gene Expression Changes In Young and Geriatric Skin	Early Phase 1
Completed	`NCT04064528` - Effects of Age on Amino Acid Delivery to Tendon	N/A
Active, not recruiting	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT06029920` - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment	N/A
Recruiting	`NCT05543980` - Leg Heat Therapy in Elderly Individuals	Phase 2
Recruiting	`NCT05566938` - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Not yet recruiting	`NCT06071130` - Emotion, Aging, and Decision Making	N/A
Enrolling by invitation	`NCT04641663` - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)	N/A
Completed	`NCT04088006` - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity	N/A
Completed	`NCT03695081` - Patient Pathway Pharmacist - Optimal Drug-related Care	N/A
Recruiting	`NCT05424263` - Acetate and Age-associated Arterial Dysfunction	Phase 2
Completed	`NCT05601713` - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling	N/A
Completed	`NCT04551339` - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19	N/A
Recruiting	`NCT04997577` - Speech Perception and High Cognitive Demand	N/A
Completed	`NCT05922475` - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training	N/A
Completed	`NCT04015479` - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NUDGE-EHR Replication Trial at Mass General Brigham — NUDGE-EHR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms