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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT02529176
Study groupRoleWhat they receive
Best-practice alertExperimentalReceive the best-practice alert (BPA) during the course of their clinical work in the electronic medical record.
Receives: Behavioral: Best-practice alert
No alertNo interventionPhysicians 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.

  1. 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)
  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.

  1. First posted20 Aug 2015 (estimated)
  2. Study startDec 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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)
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 7484840
  • Najafi 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 22892708
  • Benjamin 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 23844751
  • Dressler 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 25243419
  • Najafi 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

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.

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