Clinical trial NCT05218343: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potentially Inappropriate Medications
Keywords: Electronic Health Records
Hospital Medication Systems
Geriatrics
Pharmacy
Electronic Prescribing
High-risk drugs
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: New York City Health and Hospitals Corporation
First posted: 2022-02-01
Enrollment: 8640
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- none

Primary outcomes:
measure: Prescription rate of modified default dose for eight high-risk drugs
timeFrame: 24 weeks
Secondary outcomes:
measure: Drug-specific prescription rate
timeFrame: 24 weeks
measure: Mean per-patient dose
timeFrame: 24 weeks
measure: Rate of inpatient falls
timeFrame: 24 weeks
measure: Rate of 30-day readmissions
timeFrame: 30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed
measure: Length of hospital stay
timeFrame: 24 weeks
measure: Cost of hospital stay
timeFrame: 24 weeks
measure: Spillover effects to patients aged <65
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Health+Hospitals
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jashvant Poeran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: