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

Study Overview
=================
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

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

Conditions
-----------------
Potentially Inappropriate Medications

Intervention / Treatment
-----------------
* Behavioral: EHR-based nudge interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a patient must be hospitalized 65-years old or older receive one of the targeted medications Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This cluster randomized crossover (CRXO) trial involves 10 sites in an urban health system: five clinics will start the trial under the intervention/control during a first time period (T1) then will switch to intervention/control status (T2). The primary outcome is prescription rate of a lower default dose for 8 high-risk drugs. Other inputs used for trial design were: baseline rate of prescriptions meeting the geriatric standard (sources: local data, Geriatrics At Your Fingertips), within-period intraclass correlation coefficient (ICC, correlation between two randomly chosen observations in the same cluster), cluster autocorrelation (ratio of between-period ICC to within-period ICC), and coefficient of variation of cluster sizes (required when unequal sample size per cluster is expected). The aim is for ≥80% power to detect a ≥50% increase in prescriptions meeting the geriatric standard; this is based on previous studies and on the researchers' preliminary data on Trazodone.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No change in default dose or frequency selected for the eight targeted drugs | |
| Experimental: Intervention<br>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<br>* Change/introduction of default drug and frequency during electronic prescribing of high-risk drugs for a patient aged ≥65 years<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic Health Records, Hospital Medication Systems, Geriatrics, Pharmacy, Electronic Prescribing, High-risk drugs