Out-of-Hospital Cardiac ArrestNCT02527473
Improving Bystander CPR Quality Through Dispatcher-assisted Basic Life Support Education Program
A study testing Dispatcher-Assisted Basic Life Support CPR Education in people with Out-of-Hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Seoul National University Hospital.
Trial summary
In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS) education program through a simulation experiment. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- Dispatcher-Assisted Basic Life Support CPR Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Aug 2015
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female Seoul residents aged between 35-65 years who are primarily a stay-at-home housewife without regular income OR
- Elderly Seoul residents who are older than 65 years old
Who cannot join
- No prior CPR training
About this study
In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS) education program through a simulation experiment.
This study aims to determine whether the new DA-BLS program for possible home bystanders is associated with improved CPR quality. We expect home bystanders who were trained with new DA-BLS education program to show better compliance with CPR instructions given by dispatcher via telephone along with improved CPR quality.
Read the detailed description
Bystander cardiopulmonary resuscitation (CPR) is a crucial component of survival after out-of hospital cardiac arrest (OHCA). Not only the rate of bystander CPR has been associated with higher OHCA survival rate, but the quality of bystander CPR as measured by proportion of correct chest compression and earlier administration has been highly indicative of positive outcomes as well.
However, bystander CPR rates have been reported to be low in many communities due to low access to CPR training. To address this, among many attempts to improve OHCA survival, enhancing bystander CPR rate and quality through dispatcher-assisted CPR (DA-CPR) to the right target group may be an effective and promising approach.
In DA-CPR, the dispatcher on the emergency line provides CPR instruction over the phone. Over-the-telephone CPR instruction was intended to primarily benefit bystanders who have little or no training, but studies have shown that it can also benefit trained bystanders who are in panic in emergency situations to prompt CPR administration. Trained bystanders who received dispatcher assistance during CPR also showed improved CPR quality.
Previous studies reported that 50-81% of OHCA occurs at home. However, the outcome in private homes was very poor compared to outside private home including public places. One possible reason of such lower survival rate may be that the current CPR education programs for home bystanders are inefficient in properly educating home bystanders to provide quality CPR to the patient. In other words, despite the reported benefits of DA-CPR in both trained and untrained bystanders, performing bystander CPR according to phone instruction provided by the dispatcher may not be easy to follow for certain home bystanders such as women and elderly.
According to a recent analysis of 2012 National OHCA Registry, outcomes after OHCA were significantly lower (adjusted odds ratio; 0.36, 95% confidence intervals; 0.18-0.71) in patients who received home bystander CPR with dispatcher assistance than in patients who received either public or who received home bystander CPR without dispatcher assistance. These results suggest that home bystander CPR with dispatcher assistance did not improve the outcomes due to low compliance of CPR instruction and low CPR performance quality by home bystanders. Considering that the in-home OHCA patients are less likely to receive bystander CPR, there needs a new approach to optimize the low compliance rate and CPR quality in possible home bystanders.
- Being tested
- Dispatcher-Assisted Basic Life Support CPR Education
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dispatcher-Assisted Basic Life Support CPR EducationOther
The training program focuses on working in a team with a dispatcher, re-enacting all steps during an emergency call from recognition of cardiac arrest to performing CPR.
The one hour training session is split into four parts:
- Video self-instruction manikin practice (30 min), including a brief introduction to AED.
- Practice in pairs (15 min): Role-playing a simulated emergency scenario as the dispatcher and the rescuer
- Debriefing (15 min): Questions, answers and reflection
- Homework: Information leaflet handed out including at-home tasks such as operating the speakerphone function on the layperson's own phone
| Study group | Role | What they receive |
|---|---|---|
| Standard Education Group | No intervention | Control group will receive standard basic life support training for one hour. |
| HEROS Group | Experimental | HEROS group will receive the dispatcher-assisted basic life support training that includes standardized video-based CPR education, interactive role-playing with the dispatcher as well as group discussion for one hour. Receives: Other: Dispatcher-Assisted Basic Life Support CPR Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total no flow time at 6 months
Measured: Baseline and 6 months
Secondary outcomes (1)
Change of proportion of correct chest compression at 6 months
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Do Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527473
- Sponsor's protocol ID
- SNUH-EM-2014-2498
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bystander CPR Quality Through Dispatcher-assisted Basic Life Support Education Program
- ClinicalTrials.gov ID
- NCT02527473
- Acronym / sponsor ID
- SNUH-EM-2014-2498
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 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.
In an attempt to enhance OHCA survival by increasing bystander CPR rate, this study will assess the effectiveness of the new basic life support with dispatch assistance (DA-BLS) education program through a simulation experiment.
This study aims to determine whether the new DA-BLS program for possible home bystanders is associated with improved CPR quality. We expect home bystanders who were trained with new DA-BLS education program to show better compliance with CPR instructions given by dispatcher via telephone along with improved CPR quality.
Detailed description
Bystander cardiopulmonary resuscitation (CPR) is a crucial component of survival after out-of hospital cardiac arrest (OHCA). Not only the rate of bystander CPR has been associated with higher OHCA survival rate, but the quality of bystander CPR as measured by proportion of correct chest compression and earlier administration has been highly indicative of positive outcomes as well.
However, bystander CPR rates have been reported to be low in many communities due to low access to CPR training. To address this, among many attempts to improve OHCA survival, enhancing bystander CPR rate and quality through dispatcher-assisted CPR (DA-CPR) to the right target group may be an effective and promising approach.
In DA-CPR, the dispatcher on the emergency line provides CPR instruction over the phone. Over-the-telephone CPR instruction was intended to primarily benefit bystanders who have little or no training, but studies have shown that it can also benefit trained bystanders who are in panic in emergency situations to prompt CPR administration. Trained bystanders who received dispatcher assistance during CPR also showed improved CPR quality.
Previous studies reported that 50-81% of OHCA occurs at home. However, the outcome in private homes was very poor compared to outside private home including public places. One possible reason of such lower survival rate may be that the current CPR education programs for home bystanders are inefficient in properly educating home bystanders to provide quality CPR to the patient. In other words, despite the reported benefits of DA-CPR in both trained and untrained bystanders, performing bystander CPR according to phone instruction provided by the dispatcher may not be easy to follow for certain home bystanders such as women and elderly.
According to a recent analysis of 2012 National OHCA Registry, outcomes after OHCA were significantly lower (adjusted odds ratio; 0.36, 95% confidence intervals; 0.18-0.71) in patients who received home bystander CPR with dispatcher assistance than in patients who received either public or who received home bystander CPR without dispatcher assistance. These results suggest that home bystander CPR with dispatcher assistance did not improve the outcomes due to low compliance of CPR instruction and low CPR performance quality by home bystanders. Considering that the in-home OHCA patients are less likely to receive bystander CPR, there needs a new approach to optimize the low compliance rate and CPR quality in possible home bystanders.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Education Group | No intervention | –Control group will receive standard basic life support training for one hour. |
| HEROS Group | Experimental | Other: Dispatcher-Assisted Basic Life Support CPR EducationHEROS group will receive the dispatcher-assisted basic life support training that includes standardized video-based CPR education, interactive role-playing with the dispatcher as well as group discussion for one hour. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female Seoul residents aged between 35-65 years who are primarily a stay-at-home housewife without regular income OR
- Elderly Seoul residents who are older than 65 years old
Key exclusion criteria (1 listed)
- No prior CPR training
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 |
|---|---|---|
| Dispatcher-Assisted Basic Life Support CPR EducationThe training program focuses on working in a team with a dispatcher, re-enacting all steps during an emergency call from recognition of cardiac arrest to performing CPR. The one hour training session is split into four parts: 1. Video self-instruction manikin practice (30 min), including a brief introduction to AED. 2. Practice in pairs (15 min): Role-playing a simulated emergency scenario as the dispatcher and the rescuer 3. Debriefing (15 min): Questions, answers and reflection 4. Homework: Information leaflet handed out including at-home tasks such as operating the speakerphone function on the layperson's own phone | Other | HEROS Group |
Primary outcome
Change of total no flow time at 6 months
Time frame: Baseline and 6 months
1 secondary outcome
Change of proportion of correct chest compression at 6 months
Time frame: Baseline and 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 19 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dispatcher-Assisted Basic Life Support CPR Education in people with Out-of-Hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Seoul National University Hospital.
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 2 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 19 Aug 2015. 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?
Change of total no flow time at 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2015.