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

Potentially Inappropriate Medications Clinical Trial

Official title:

Modifying Default Dosing During Electronic Prescribing to Impact Prescribing of High-risk Drugs in Hospitalized Elderly Patients: A Cluster Randomized Controlled Trial With Crossover

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218343
• Other study ID #: GCO-21-0383
• Status: Completed
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: August 2, 2022

Study information

• Verified date: March 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8640
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• a patient must be hospitalized

• 65-years old or older

• receive one of the targeted medications

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Potentially Inappropriate Medications

Intervention

Behavioral:
• EHR-based "nudge" interventions
Change/introduction of default drug and frequency during electronic prescribing of high-risk drugs for a patient aged =65 years

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYC Health+Hospitals	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	NYC Health + Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription rate of modified default dose for eight high-risk drugs	Rate at which the modified default dose (geriatric standard) and frequency for eight high-risk drugs are prescribed.	24 weeks
Secondary	Drug-specific prescription rate	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).	24 weeks
Secondary	Mean per-patient dose	Mean per-patient dose of the relevant individual high-risk drugs.	24 weeks
Secondary	Rate of inpatient falls	Inpatient falls (with and without injury)	24 weeks
Secondary	Rate of 30-day readmissions	30-day readmission rates for patients aged =65 years who received any of the eight high-risk drugs during their hospitalization.	30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed
Secondary	Length of hospital stay	Duration of hospitalization in days for patients aged =65 years who received any of the eight high-risk drugs during their hospitalization.	24 weeks
Secondary	Cost of hospital stay	Cost of hospitalization in USD for patients aged =65 years who received any of the eight high-risk drugs during their hospitalization.	24 weeks
Secondary	Spillover effects to patients aged <65	The rate of prescriptions of the newly defaulted (geriatric) dose for any of the eight high-risk drugs among patients aged <65 years.	24 weeks