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

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

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

Study Overview

• Status: Completed
• Conditions: Potentially Inappropriate Medications
• Intervention / Treatment: Behavioral: EHR-based "nudge" interventions

• Study Type: Interventional
• Enrollment (Actual): 8640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10013
      • NYC Health+Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No change in default dose or frequency selected for the eight targeted drugs
Experimental: Intervention; The first option a prescriber sees when prescribing any of eight high-risk drugs for elderly hospitalized patients will be modified; the first frequency option a prescriber sees will be modified as well. Providers retain the ability to prescribe any dose or frequency.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean per-patient dose	Mean per-patient dose of the relevant individual high-risk drugs.	24 weeks
Rate of inpatient falls	Inpatient falls (with and without injury)	24 weeks
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
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
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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: NYC Health + Hospitals
• Investigators: Principal Investigator: Jashvant Poeran, MD, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Geriatrics; Electronic Health Records; Pharmacy; Hospital Medication Systems; Electronic Prescribing; High-risk drugs
• Other Study ID Numbers: GCO-21-0383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing IPD was not something including in the IRB application process. Only aggregated data will be disseminated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No