An Intuitive, Non-intrusive, Approach to Reduce Patient Harm From Inappropriate Dosing of High-risk Drugs in Older Adult Patients Across an Urban Safety Net Hospital System

Not Applicable

Completed

• Conditions: Potentially Inappropriate Medications

• Registration Number: NCT05218343
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This study will assess whether a modification in the default dose and frequency (the first option a provider sees) during electronic prescribing of a high-risk drug can impact prescribing behavior and subsequent changes in average dose for the targeted high-risk drug, when prescribed to a hospitalized patient aged ≥65 years. In this cluster randomized crossover (CRXO) trial we will randomize a non-intrusive "nudge" intervention, which involves modifying the default dose for high-risk drugs when prescribed electronically to hospitalized patients aged ≥65 years. The CRXO trial involves 10 sites in an urban health system: five sites will start the trial under the intervention/control during a first time period (T1) after which they switch intervention/control status (T2). The primary outcome is prescription rate of a lower default dose (i.e. the geriatric standard) for 8 high-risk drugs. This study will inform the effectiveness of EHR-based "nudge" interventions to reduce inappropriate prescribing of high-risk drugs for elderly patients.

Analyses ongoing, expected to finalize spring 2023

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Study Start: 2022-02-16
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8640

Inclusion Criteria

• a patient must be hospitalized
• 65-years old or older
• receive one of the targeted medications

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Prescription rate of modified default dose for eight high-risk drugs	24 weeks	Rate at which the modified default dose (geriatric standard) and frequency for eight high-risk drugs are prescribed.

Secondary Outcome Measures

Name	Time	Method
Drug-specific prescription rate	24 weeks	Drug-specific prescription rate of the modified default dose for each of the eight high-risk medications and type of order (frequency/type of order).
Mean per-patient dose	24 weeks	Mean per-patient dose of the relevant individual high-risk drugs.
Rate of 30-day readmissions	30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed	30-day readmission rates for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Length of hospital stay	24 weeks	Duration of hospitalization in days for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Cost of hospital stay	24 weeks	Cost of hospitalization in USD for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Spillover effects to patients aged <65	24 weeks	The rate of prescriptions of the newly defaulted (geriatric) dose for any of the eight high-risk drugs among patients aged \<65 years.
Rate of inpatient falls	24 weeks	Inpatient falls (with and without injury)

Trial Locations

Locations (2)

NYC Health+Hospitals; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States