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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01034761
Other study ID # 132454
Secondary ID
Status Completed
Phase N/A
First received December 15, 2009
Last updated March 7, 2015
Start date April 2013
Est. completion date June 2013

Study information

Verified date March 2015
Source Baystate Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Introduction:

The Beers list identifies medications that should be avoided in persons 65 years or older because they are ineffective, pose an unnecessarily high risk, or a safer alternative is available. In a recent study, we found a high rate of prescribing of Beers list medications to hospitalized patients. At Baystate, 41% of medical patients received at least one Beers list drug classified as "high severity," meaning it carried a high risk for an adverse drug reaction, while 5% received 3 or more. Some Beers drugs have been associated with delirium and falls. When compared to Baystate patients who did not receive a high severity medication, those who did had an increased risk of mortality (7.8% vs. 5.2%), longer length of stay (5.5 days vs. 3.9 days) and higher costs ($11,240 vs. 6243).

Specific Aims:

1. Quantify the impact of synchronous electronic alerts on physician prescribing of high-severity Beers' list drugs to hospitalized patients over the age of 65 years.

2. Compare physician reactions to each drug-specific alert

Project Description:

We will develop a series of clinical alerts in CIS, Baystate's computerized provider order entry system, to reduce the use of potentially inappropriate medications among hospitalized elders. We will randomize providers to electronic alerts or usual care. Whenever a provider randomized to alerts attempts to place an order for a high-risk medication on the Beers list and the intended recipient is over 65 years of age, a synchronous alert (i.e. a "pop-up") will inform the physician about the risks associated with the medication and will propose safer alternatives.

We will collect data on physician ordering and patient outcomes comparing the number of Beers list prescriptions from providers receiving electronic alerts to those not receiving alerts. Our anticipated outcome is a decrease in inappropriate prescribing during the period when the electronic alerts are activated. Other potential outcomes include decrease in length of stay and a decrease in falls.


Recruitment information / eligibility

Status Completed
Enrollment 719
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Hospitalized patients with Age > 65

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Pop-up alert
Pop-up alert in the electronic medical record whenever the provider enters an order for a specified high risk medication from the Beers list.

Locations

Country Name City State
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of elderly patients who receive a specified high-risk medication from the Beer's list. Earlier of hospital stay or end of study Yes
Secondary The average number of specified high risk medications prescribed per patient. Earlier of hospital stay or end of study Yes
Secondary Restraint use Earlier of hospital stay or end of study Yes
Secondary Falls Earlier of hospital stay or end of study Yes
Secondary Length of stay Earlier of hospital stay or end of study No
Secondary Total Cost Earlier of hospital stay or end of study No
Secondary Discharge status 6 months No
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