Physiologic MonitoringNCT02041858
Effect of Altered Alarm Settings on Patient Adverse Events and Alarm Signal Frequency
A study testing Altered Alarm Settings in people with Physiologic Monitoring and Alarms, run by Johns Hopkins University at 1 site in United States.
Trial summary
Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem. The problem of alarm desensitization is multifaceted and is related to a high false alarm rate, poor positive predictive value, lack of alarm standardization and the large number of medical devices with built in alarms in use… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physiologic Monitoring, Alarms
- What is being tested?
- Altered Alarm Settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: All patients who are in the Coronary Care Unit and able to provide consent during the collection time period will be considered for inclusion. This unit consists of adult patients with a primary cardiac etiology for their illness. The vast majority of these patients are either there for coronary artery disease or congestive heart failure.
Exclusion Criteria: Patients who are unable to provide consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Altered Alarm Settings on Patient Adverse Events and Alarm Signal Frequency: A Randomized Controlled Trial Feasibility Study
Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem. The problem of alarm desensitization is multifaceted and is related to a high false alarm rate, poor positive predictive value, lack of alarm standardization and the large number of medical devices with built in alarms in use today. Cardiac monitor alarms are intended to notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of physiologic monitor alarms occur on monitored units each day. As a result, practitioners are highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4% of monitor alarms are false or clinically insignificant. Alarm hazards is the number one medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care Research Institute) among the top 3 medical device hazards for the past three years (ECRI, 2011). Delivering actionable alarm information to care providers is challenging given the significant number of false alarms.
Ideally, alarms should activate for events in greatest need of clinical attention without increasing the risk of adverse patient outcomes. This is not the case with current monitoring technology which is designed for high sensitivity and low specificity. Practitioners must use clinical intuition for determining how conservatively alarms should be set to be most useful. There is no research evidence to support how best to set alarms without affecting patient outcomes.
Read more
Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that the frequency of alarm signals can be reduced by more than 50% through an altered set of alarm parameters. This reduction in alarm signals has lead to an increase awareness of alarms that do occur as well as create a quieter, healing environment for patients. Although this change was not associated with a "noticeable" increase in adverse patient events, this important outcome was not rigorously studied.
The specific aims of this pilot study is to determine if decreasing the number of alarms by using an altered set of alarm parameters has an effect on patient outcomes in an intensive care unit.
This project may have a significant impact on patient safety. A decrease in noise at the bedside may result in less distraction to caregivers and may have a positive effect on patient recovery. It is expected that the altered set of monitor default parameters will result in a decrease in audible alarms without increasing clinically significant adverse patient events.
- Conditions
- Physiologic Monitoring, Alarms
- Being tested
- Altered Alarm Settings
- Keywords
- Alarms, Physiologic Monitoring, Critical Care, Alarm fatigue, Adverse Events
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altered Alarm SettingsOther
An altered set of alarm parameter settings
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm with organizational-based alarm parameter settings |
| Altered Alarm Settings | Experimental | Altered set of alarm parameter settings. Receives: Other: Altered Alarm Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant adverse events
A variety of clinically significant events were assessed while subjects were on the protocol
Measured: 1 day
Secondary outcomes (2)
Alarm Signals
The number of alarm signals were assessed while the subject was on the protocol.
Measured: 1 day
Alarm-triggered interventions
The number and type of alarm-triggered interventions were assessed while the patient was on the protocol.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physiologic MonitoringStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julius Cuong Pham, Johns Hopkins University
- Investigators
- Julius C Pham, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041858
- Sponsor's protocol ID
- NA_00079765
- Status last verified
- Mar 2017
- First submitted
- 17 Jan 2014
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.
PubMed 22839984Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5.
PubMed 8205831Tsien CL, Fackler JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med. 1997 Apr;25(4):614-9. doi: 10.1097/00003246-199704000-00010.
PubMed 9142025Chambrin MC, Ravaux P, Calvelo-Aros D, Jaborska A, Chopin C, Boniface B. Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis. Intensive Care Med. 1999 Dec;25(12):1360-6. doi: 10.1007/s001340051082.
PubMed 10660842Atzema C, Schull MJ, Borgundvaag B, Slaughter GR, Lee CK. ALARMED: adverse events in low-risk patients with chest pain receiving continuous electrocardiographic monitoring in the emergency department. A pilot study. Am J Emerg Med. 2006 Jan;24(1):62-7. doi: 10.1016/j.ajem.2005.05.015.
PubMed 16338512Siebig S, Kuhls S, Imhoff M, Langgartner J, Reng M, Scholmerich J, Gather U, Wrede CE. Collection of annotated data in a clinical validation study for alarm algorithms in intensive care--a methodologic framework. J Crit Care. 2010 Mar;25(1):128-35. doi: 10.1016/j.jcrc.2008.09.001. Epub 2009 Jan 17.
PubMed 19327311
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Altered Alarm Settings on Patient Adverse Events and Alarm Signal Frequency: A Randomized Controlled Trial Feasibility Study
- ClinicalTrials.gov ID
- NCT02041858
- Acronym / sponsor ID
- NA_00079765
- Conditions
- Physiologic Monitoring, Alarms
- Keywords
- Alarms, Physiologic Monitoring, Critical Care, Alarm fatigue, Adverse Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2014 (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.
Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem. The problem of alarm desensitization is multifaceted and is related to a high false alarm rate, poor positive predictive value, lack of alarm standardization and the large number of medical devices with built in alarms in use today. Cardiac monitor alarms are intended to notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of physiologic monitor alarms occur on monitored units each day. As a result, practitioners are highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4% of monitor alarms are false or clinically insignificant. Alarm hazards is the number one medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care Research Institute) among the top 3 medical device hazards for the past three years (ECRI, 2011). Delivering actionable alarm information to care providers is challenging given the significant number of false alarms.
Ideally, alarms should activate for events in greatest need of clinical attention without increasing the risk of adverse patient outcomes. This is not the case with current monitoring technology which is designed for high sensitivity and low specificity. Practitioners must use clinical intuition for determining how conservatively alarms should be set to be most useful. There is no research evidence to support how best to set alarms without affecting patient outcomes.
Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that the frequency of alarm signals can be reduced by more than 50% through an altered set of alarm parameters. This reduction in alarm signals has lead to an increase awareness of alarms that do occur as well as create a quieter, healing environment for patients. Although this change was not associated with a "noticeable" increase in adverse patient events, this important outcome was not rigorously studied.
The specific aims of this pilot study is to determine if decreasing the number of alarms by using an altered set of alarm parameters has an effect on patient outcomes in an intensive care unit.
This project may have a significant impact on patient safety. A decrease in noise at the bedside may result in less distraction to caregivers and may have a positive effect on patient recovery. It is expected that the altered set of monitor default parameters will result in a decrease in audible alarms without increasing clinically significant adverse patient events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control arm with organizational-based alarm parameter settings |
| Altered Alarm Settings | Experimental | Other: Altered Alarm SettingsAltered set of alarm parameter settings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Altered Alarm SettingsAn altered set of alarm parameter settings | Other | Altered Alarm Settings |
Primary outcome
Clinically significant adverse events
Time frame: 1 day
A variety of clinically significant events were assessed while subjects were on the protocol
2 secondary outcomes
Alarm Signals
Time frame: 1 day
Alarm-triggered interventions
Time frame: 1 day
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 6 Mar 2017.
- Background: PubMed 22839984Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.
- Background: PubMed 8205831Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5.
- Background: PubMed 9142025Tsien CL, Fackler JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med. 1997 Apr;25(4):614-9. doi: 10.1097/00003246-199704000-00010.
- Background: PubMed 10660842Chambrin MC, Ravaux P, Calvelo-Aros D, Jaborska A, Chopin C, Boniface B. Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis. Intensive Care Med. 1999 Dec;25(12):1360-6. doi: 10.1007/s001340051082.
- Background: PubMed 16338512Atzema C, Schull MJ, Borgundvaag B, Slaughter GR, Lee CK. ALARMED: adverse events in low-risk patients with chest pain receiving continuous electrocardiographic monitoring in the emergency department. A pilot study. Am J Emerg Med. 2006 Jan;24(1):62-7. doi: 10.1016/j.ajem.2005.05.015.
- Background: PubMed 19327311Siebig S, Kuhls S, Imhoff M, Langgartner J, Reng M, Scholmerich J, Gather U, Wrede CE. Collection of annotated data in a clinical validation study for alarm algorithms in intensive care--a methodologic framework. J Crit Care. 2010 Mar;25(1):128-35. doi: 10.1016/j.jcrc.2008.09.001. Epub 2009 Jan 17.
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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.
Julius C Pham, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altered Alarm Settings in people with Physiologic Monitoring and Alarms, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. 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?
Clinically significant adverse events (time frame: 1 day). 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 NCT02041858, which also lists 6 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 6 Mar 2017.