ElderlyNCT01034761
Using Clinical Alerts to Decrease Inappropriate Medication Prescribing
A study testing Pop-up alert in people with Elderly, run by Baystate Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Pop-up alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 719 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized patients with Age > 65
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Using Clinical Alerts in a Computerized Provider Order Entry System to Decrease Inappropriate Medication Prescribing Among Hospitalized Elders
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).
Read more
Specific Aims:
- 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.
- 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.
- Conditions
- Elderly
- Being tested
- Pop-up alert
- Keywords
- Electronic prescribing, Inappropriate medications, Patient safety, Elderly patients in the hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pop-up alertBehavioural
Pop-up alert in the electronic medical record whenever the provider enters an order for a specified high risk medication from the Beers list.
| Study group | Role | What they receive |
|---|---|---|
| Pop-up alerts | Experimental | Providers will receive pop-up alerts in the electronic medical record when prescribing one of the specified medications from the Beers list. Receives: Behavioral: Pop-up alert |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of elderly patients who receive a specified high-risk medication from the Beer's list.
Measured: Earlier of hospital stay or end of study
Secondary outcomes (6)
The average number of specified high risk medications prescribed per patient.
Measured: Earlier of hospital stay or end of study
Restraint use
Measured: Earlier of hospital stay or end of study
Falls
Measured: Earlier of hospital stay or end of study
Length of stay
Measured: Earlier of hospital stay or end of study
Total Cost
Measured: Earlier of hospital stay or end of study
Discharge status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Canty, MD, Baystate Medical Center
- Investigators
- Linda J Canty, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034761
- Sponsor's protocol ID
- 132454
- Status last verified
- Mar 2015
- First submitted
- 15 Dec 2009
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cole JA, Goncalves-Bradley DC, Alqahtani M, Barry HE, Cadogan C, Rankin A, Patterson SM, Kerse N, Cardwell CR, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2023 Oct 11;10(10):CD008165. doi: 10.1002/14651858.CD008165.pub5.
PubMed 37818791
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Clinical Alerts in a Computerized Provider Order Entry System to Decrease Inappropriate Medication Prescribing Among Hospitalized Elders
- ClinicalTrials.gov ID
- NCT01034761
- Acronym / sponsor ID
- 132454
- Conditions
- Elderly
- Keywords
- Electronic prescribing, Inappropriate medications, Patient safety, Elderly patients in the hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pop-up alerts | Experimental | Behavioral: Pop-up alertProviders will receive pop-up alerts in the electronic medical record when prescribing one of the specified medications from the Beers list. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with Age > 65
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pop-up alertPop-up alert in the electronic medical record whenever the provider enters an order for a specified high risk medication from the Beers list. | Behavioural | Pop-up alerts |
Primary outcome
The percentage of elderly patients who receive a specified high-risk medication from the Beer's list.
Time frame: Earlier of hospital stay or end of study
6 secondary outcomes
The average number of specified high risk medications prescribed per patient.
Time frame: Earlier of hospital stay or end of study
Restraint use
Time frame: Earlier of hospital stay or end of study
Falls
Time frame: Earlier of hospital stay or end of study
Length of stay
Time frame: Earlier of hospital stay or end of study
Total Cost
Time frame: Earlier of hospital stay or end of study
Discharge status
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 37818791Cole JA, Goncalves-Bradley DC, Alqahtani M, Barry HE, Cadogan C, Rankin A, Patterson SM, Kerse N, Cardwell CR, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2023 Oct 11;10(10):CD008165. doi: 10.1002/14651858.CD008165.pub5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J Canty, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pop-up alert in people with Elderly, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of elderly patients who receive a specified high-risk medication from the Beer's list. (time frame: Earlier of hospital stay or end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.