ArrhythmiaNCT02529176
Trial of a Best-Practice Alert in the Electronic Medical Record to Reduce Unnecessary Telemetry Monitoring
A study testing Best-practice alert in people with Arrhythmia, run by University of California, San Francisco.
Trial summary
This is a randomized trial of a best-practice alert delivered via the electronic medical record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Best-practice alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident or attending physician on the Medicine service during the six month trial period.
Who cannot join
- None
About this study
Official title: Randomized Trial of a Best-Practice Alert in the Electronic Medical Record to Reduce Unnecessary Telemetry Monitoring
This is a randomized trial of a best-practice alert delivered via the electronic medical record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month period. The alert notifies physicians that their order for continuous cardiac monitoring (telemetry) for a given patient has exceeded the duration recommended by national guidelines and offers them the opportunity to discontinue monitoring if they feel it is clinically appropriate. Physicians will be randomized to either receive the BPA or not, with the anticipation that physicians in the intervention arm will discontinue unnecessary telemetry.
Read the detailed description
Physicians often order continuous cardiac monitoring (telemetry) for their patients in the hospital. Telemetry provides real-time heart rate and rhythm monitoring and can be useful for detecting arrhythmias and evaluating the response to cardiac therapies. Leads on the patient's chest detect the electrical signature of the heartbeat, relay the information to a box in the patient's shirt pocket, and this box relays the signal in real-time to a control room where technicians monitor for abnormalities. If a technician notes an abnormality he or she will contact the appropriate provider. Currently, physicians can order telemetry at UCSF Medical Center with or without providing an indication for its use. In addition, telemetry remains active until the provider discontinues it or the patient leaves the hospital. Studies at UCSF and hospitals nationwide demonstrate that telemetry is overused. Physicians either order it without a valid indication or they do not remember to discontinue it when the indication is no longer valid. Guidelines published by the American Heart Association provide clarity regarding what clinical conditions warrant telemetry and for how long. However, numerous studies demonstrate that physicians do not faithfully follow these guidelines. This led the American Board of Internal Medicine Foundation to urge physicians in Hospital Medicine to develop protocols governing the use of telemetry outside of the intensive care unit in a 2013 campaign called Choosing Wisely.
The harms of telemetry overuse are myriad: 1) Frequent false or unimportant alarms lead to alarm fatigue and studies have documented patient harm when subsequent real alarms were ignored. False alarms also often necessitate a visit to the patient by the nurse and this distracts the nurse from other patients, 2) Monitoring patients without an active cardiac condition often reveals clinically unimportant abnormalities that obligate physicians to work them up, just by virtue of having seen them on monitor. The work-up then results in unnecessary cost and anxiety, 3) Leads on the patient's chest often fall off with movement and have to be replaced by the nurse. This discourages patients from getting more exercise while they are hospitalized, which is a risk factor for muscle atrophy, and getting enough sleep, which is a risk factor for delirium, 4) Telemetry is not available for all hospital beds at UCSF and even units where it is available have limitations for the types of arrhythmias they can monitor. Thus, telemetry monitoring for a patient who does not need it can prevent another patient from having timely access to a monitor-capable bed.
In order to reduce unnecessary telemetry use, we propose to use a best-practice alert (BPA) delivered to physicians by the electronic medical record (Apex). We propose to study this BPA in a randomized trial. Physicians on the Medicine service would be randomized to either receive the BPA on their patients or not during a six month study period. We would examine both groups for the following outcomes: physician response to the alert, total hours of telemetry used, number of rapid response activations for arrhythmic events, and number of code blue events.
- Conditions
- Arrhythmia
- Being tested
- Best-practice alert
- Keywords
- telemetry, cardiac monitoring
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best-practice alertBehavioural
Also called BPA
The best-practice alert notifies physicians that their patient's telemetry monitoring duration has exceeded national guidelines and gives the physician the option to: discontinue monitoring if they feel it is clinically appropriate, dismiss the alert, or re-alert in four hours.
| Study group | Role | What they receive |
|---|---|---|
| Best-practice alert | Experimental | Receive the best-practice alert (BPA) during the course of their clinical work in the electronic medical record. Receives: Behavioral: Best-practice alert |
| No alert | No intervention | Physicians will receive no best-practice alert from the electronic medical record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of cardiac monitoring across all patients cared for by the physicians in the study.
Measured: Over the course of the six month trial
Secondary outcomes (1)
Code blue and rapid response rates in the hospital
Measured: During the six month trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Najafi, MD, University of California, San Francisco
- Investigators
- Nader Najafi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529176
- Sponsor's protocol ID
- BPA818
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2015
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
PubMed 7484840Najafi N, Auerbach A. Use and outcomes of telemetry monitoring on a medicine service. Arch Intern Med. 2012 Sep 24;172(17):1349-50. doi: 10.1001/archinternmed.2012.3163. No abstract available.
PubMed 22892708Benjamin EM, Klugman RA, Luckmann R, Fairchild DG, Abookire SA. Impact of cardiac telemetry on patient safety and cost. Am J Manag Care. 2013 Jun 1;19(6):e225-32.
PubMed 23844751Dressler R, Dryer MM, Coletti C, Mahoney D, Doorey AJ. Altering overuse of cardiac telemetry in non-intensive care unit settings by hardwiring the use of American Heart Association guidelines. JAMA Intern Med. 2014 Nov;174(11):1852-4. doi: 10.1001/jamainternmed.2014.4491. No abstract available.
PubMed 25243419Najafi N, Cucina R, Pierre B, Khanna R. Assessment of a Targeted Electronic Health Record Intervention to Reduce Telemetry Duration: A Cluster-Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):11-15. doi: 10.1001/jamainternmed.2018.5859.
PubMed 30535345
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Best-Practice Alert in the Electronic Medical Record to Reduce Unnecessary Telemetry Monitoring
- ClinicalTrials.gov ID
- NCT02529176
- Acronym / sponsor ID
- BPA818
- Conditions
- Arrhythmia
- Keywords
- telemetry, cardiac monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Aug 2015 (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.
This is a randomized trial of a best-practice alert delivered via the electronic medical record (Apex) to physicians on the Medicine service at UCSF Medical Center over a six month period. The alert notifies physicians that their order for continuous cardiac monitoring (telemetry) for a given patient has exceeded the duration recommended by national guidelines and offers them the opportunity to discontinue monitoring if they feel it is clinically appropriate. Physicians will be randomized to either receive the BPA or not, with the anticipation that physicians in the intervention arm will discontinue unnecessary telemetry.
Detailed description
Physicians often order continuous cardiac monitoring (telemetry) for their patients in the hospital. Telemetry provides real-time heart rate and rhythm monitoring and can be useful for detecting arrhythmias and evaluating the response to cardiac therapies. Leads on the patient's chest detect the electrical signature of the heartbeat, relay the information to a box in the patient's shirt pocket, and this box relays the signal in real-time to a control room where technicians monitor for abnormalities. If a technician notes an abnormality he or she will contact the appropriate provider. Currently, physicians can order telemetry at UCSF Medical Center with or without providing an indication for its use. In addition, telemetry remains active until the provider discontinues it or the patient leaves the hospital. Studies at UCSF and hospitals nationwide demonstrate that telemetry is overused. Physicians either order it without a valid indication or they do not remember to discontinue it when the indication is no longer valid. Guidelines published by the American Heart Association provide clarity regarding what clinical conditions warrant telemetry and for how long. However, numerous studies demonstrate that physicians do not faithfully follow these guidelines. This led the American Board of Internal Medicine Foundation to urge physicians in Hospital Medicine to develop protocols governing the use of telemetry outside of the intensive care unit in a 2013 campaign called Choosing Wisely.
The harms of telemetry overuse are myriad: 1) Frequent false or unimportant alarms lead to alarm fatigue and studies have documented patient harm when subsequent real alarms were ignored. False alarms also often necessitate a visit to the patient by the nurse and this distracts the nurse from other patients, 2) Monitoring patients without an active cardiac condition often reveals clinically unimportant abnormalities that obligate physicians to work them up, just by virtue of having seen them on monitor. The work-up then results in unnecessary cost and anxiety, 3) Leads on the patient's chest often fall off with movement and have to be replaced by the nurse. This discourages patients from getting more exercise while they are hospitalized, which is a risk factor for muscle atrophy, and getting enough sleep, which is a risk factor for delirium, 4) Telemetry is not available for all hospital beds at UCSF and even units where it is available have limitations for the types of arrhythmias they can monitor. Thus, telemetry monitoring for a patient who does not need it can prevent another patient from having timely access to a monitor-capable bed.
In order to reduce unnecessary telemetry use, we propose to use a best-practice alert (BPA) delivered to physicians by the electronic medical record (Apex). We propose to study this BPA in a randomized trial. Physicians on the Medicine service would be randomized to either receive the BPA on their patients or not during a six month study period. We would examine both groups for the following outcomes: physician response to the alert, total hours of telemetry used, number of rapid response activations for arrhythmic events, and number of code blue events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best-practice alert | Experimental | Behavioral: Best-practice alertReceive the best-practice alert (BPA) during the course of their clinical work in the electronic medical record. |
| No alert | No intervention | –Physicians will receive no best-practice alert from the electronic medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident or attending physician on the Medicine service during the six month trial period.
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 |
|---|---|---|
| Best-practice alertAlso: BPAThe best-practice alert notifies physicians that their patient's telemetry monitoring duration has exceeded national guidelines and gives the physician the option to: discontinue monitoring if they feel it is clinically appropriate, dismiss the alert, or re-alert in four hours. | Behavioural | Best-practice alert |
Primary outcome
Duration of cardiac monitoring across all patients cared for by the physicians in the study.
Time frame: Over the course of the six month trial
1 secondary outcome
Code blue and rapid response rates in the hospital
Time frame: During the six month trial period
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 14 Nov 2019.
- Background: PubMed 7484840Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
- Background: PubMed 22892708Najafi N, Auerbach A. Use and outcomes of telemetry monitoring on a medicine service. Arch Intern Med. 2012 Sep 24;172(17):1349-50. doi: 10.1001/archinternmed.2012.3163. No abstract available.
- Background: PubMed 23844751Benjamin EM, Klugman RA, Luckmann R, Fairchild DG, Abookire SA. Impact of cardiac telemetry on patient safety and cost. Am J Manag Care. 2013 Jun 1;19(6):e225-32.
- Background: PubMed 25243419Dressler R, Dryer MM, Coletti C, Mahoney D, Doorey AJ. Altering overuse of cardiac telemetry in non-intensive care unit settings by hardwiring the use of American Heart Association guidelines. JAMA Intern Med. 2014 Nov;174(11):1852-4. doi: 10.1001/jamainternmed.2014.4491. No abstract available.
- Derived from this study: PubMed 30535345Najafi N, Cucina R, Pierre B, Khanna R. Assessment of a Targeted Electronic Health Record Intervention to Reduce Telemetry Duration: A Cluster-Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):11-15. doi: 10.1001/jamainternmed.2018.5859.
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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.
Nader Najafi, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Best-practice alert in people with Arrhythmia, run by University of California, San Francisco.
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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of cardiac monitoring across all patients cared for by the physicians in the study. (time frame: Over the course of the six month trial). 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 NCT02529176, which also lists 5 linked publications.
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 14 Nov 2019.