Intensive CareNCT05692375
Impact of the Save the Shame! Game on Advanced Life Support Knowledge
A study of Intensive Care, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
Trial summary
Gamification, listed by the European Resuscitation Council (ERC) as a learning process in its 2021 guidelines, is a new digital innovation tool that brings added value towards motivation that seems to reuse time in a creative way. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2022to 1 Oct 2022
- 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
Who may be able to join
- to be a nurse or a physician,
- to provide care in a intensive care unit of the identified hospital center (cirurgical, cardiothoracic, coronary, medical or trauma)
Who cannot join
- be any other health professional
- providing care in settings other than intensive care settings
- absence of informed consent
- belonging to the invited group of experts
- participation in the instrument design pre-test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Save the Shame! Game on Advanced Life Support Knowledge of Nurses and Physicians in Intensive Care Medicine Settings, a Pilot Randomized Study
Gamification, listed by the European Resuscitation Council (ERC) as a learning process in its 2021 guidelines, is a new digital innovation tool that brings added value towards motivation that seems to reuse time in a creative way. The aim of this study is to evaluate the impact of the game "Save the shame!" on advanced life support (ALS) knowledge of nurses and physicians in intensive care medicine settings. This is a cross-sectional study following a mixed methodology. In its preliminary phase it follows a qualitative and exploratory methodology, with application of the E-Delphi technique for creation and validation of the "Save the shame! game and validation of the ALS knowledge test. The study subsequently follows the experimental methodology. The investigators expect to confirm the hypothesis that the game "Save the Shame!" has a positive impact on the skills training of health professionals in intensive care medicine settings in a Portuguese hospital center.
Read the detailed description
Study Design The investigators developed an experimental approach, where randomization in sample identification was ensured and where a control group was present, favoring a strongest level of contribution to the evidence. This is a cross-sectional study with quantitative data collection following a Randomized Controlled Trial (RCT) design.
In order to carry out the proposed experimental study, it was necessary to create two essential elements in this process: the "Save the Same!" game and the ALS knowledge assessment test, which constitutes a data collection instrument necessary to test the research hypotheses.
Arms, Groups, and Interventions The population was defined as nurses and physicians of the intensive care units of a Portuguese hospital center (N=275). The inclusion criteria were, to be a nurse or a physician, to provide care in a intensive care unit of the identified hospital center (cirurgical, cardiothoracic, coronary, medical or trauma). On the other hand, the exclusion criteria were, be any other health professional, providing care in settings other than intensive care settings, absence of informed consent, belonging to the invited group of experts, participation in the instrument design pre-test.
Participants were invited via institutional email and data was collected through the access of on-line platforms.
The experimental group was asked to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform. The control group neither used nor had access to the game. Afterwards both groups performed the ALS knowledge assessment test. It is a test with 20 multiple choice questions each scored as right (0.5 points) or wrong (0 points).
The sample was stratified in order to eliminate "professional group" variable. This was a protocol update at made at 10th of March
- Conditions
- Intensive Care
- Being tested
- Invitation to play the game "Save the shame!"
- Keywords
- healthcare, gamification, education, advanced life support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to play the game "Save the shame!"Other
The experimental group was asked to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform . The control group neither used nor had access to the game. Afterwards both groups performed the ALS knowledge assessment test. It is a test with 20 multiple choice questions each scored as right (0.5 points) or wrong (0 points).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will be inveted to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform . Receives: Other: Invitation to play the game "Save the shame!" |
| Control | No intervention | The control group neither used nor had access to the game. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score at the advanced life support knowledge assessment test
The minimun score at the scale is 0 and the maximum is 100, were 100 means the best result.
It was applied through an online application, facilitating the participation of the guests and providing the automatic transcription of the results. The platform registration was carried out in a coded manner, thus ensuring the anonymity of the participants.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jun 2022
- Primary completion10 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators developed an experimental approach, where we ensured randomization in sample identification and where a control group was present, favoring a strongest level of contribution to the evidence. This is a cross-sectional study with quantitative data collection following a Randomized Controlled Trial (RCT) design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Sponsor type
- Other government
- Collaborators
- University of Minho
- Responsible party
- Principal investigator, Sara Santos Ribeiro, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692375
- Sponsor's protocol ID
- 01
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Save the Shame! Game on Advanced Life Support Knowledge of Nurses and Physicians in Intensive Care Medicine Settings, a Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT05692375
- Acronym / sponsor ID
- 01
- Conditions
- Intensive Care
- Keywords
- healthcare, gamification, education, advanced life support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Other government
- Collaborators
- University of Minho
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 20 Jan 2023 (actual)
- 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.
Gamification, listed by the European Resuscitation Council (ERC) as a learning process in its 2021 guidelines, is a new digital innovation tool that brings added value towards motivation that seems to reuse time in a creative way. The aim of this study is to evaluate the impact of the game "Save the shame!" on advanced life support (ALS) knowledge of nurses and physicians in intensive care medicine settings. This is a cross-sectional study following a mixed methodology. In its preliminary phase it follows a qualitative and exploratory methodology, with application of the E-Delphi technique for creation and validation of the "Save the shame! game and validation of the ALS knowledge test. The study subsequently follows the experimental methodology. The investigators expect to confirm the hypothesis that the game "Save the Shame!" has a positive impact on the skills training of health professionals in intensive care medicine settings in a Portuguese hospital center.
Detailed description
Study Design The investigators developed an experimental approach, where randomization in sample identification was ensured and where a control group was present, favoring a strongest level of contribution to the evidence. This is a cross-sectional study with quantitative data collection following a Randomized Controlled Trial (RCT) design.
In order to carry out the proposed experimental study, it was necessary to create two essential elements in this process: the "Save the Same!" game and the ALS knowledge assessment test, which constitutes a data collection instrument necessary to test the research hypotheses.
Arms, Groups, and Interventions The population was defined as nurses and physicians of the intensive care units of a Portuguese hospital center (N=275). The inclusion criteria were, to be a nurse or a physician, to provide care in a intensive care unit of the identified hospital center (cirurgical, cardiothoracic, coronary, medical or trauma). On the other hand, the exclusion criteria were, be any other health professional, providing care in settings other than intensive care settings, absence of informed consent, belonging to the invited group of experts, participation in the instrument design pre-test.
Participants were invited via institutional email and data was collected through the access of on-line platforms.
The experimental group was asked to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform. The control group neither used nor had access to the game. Afterwards both groups performed the ALS knowledge assessment test. It is a test with 20 multiple choice questions each scored as right (0.5 points) or wrong (0 points).
The sample was stratified in order to eliminate "professional group" variable. This was a protocol update at made at 10th of March
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators developed an experimental approach, where we ensured randomization in sample identification and where a control group was present, favoring a strongest level of contribution to the evidence. This is a cross-sectional study with quantitative data collection following a Randomized Controlled Trial (RCT) design.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Invitation to play the game "Save the shame!"The experimental group will be inveted to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform . |
| Control | No intervention | –The control group neither used nor had access to the game. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- to be a nurse or a physician,
- to provide care in a intensive care unit of the identified hospital center (cirurgical, cardiothoracic, coronary, medical or trauma)
Key exclusion criteria (5 listed)
- be any other health professional
- providing care in settings other than intensive care settings
- absence of informed consent
- belonging to the invited group of experts
- participation in the instrument design pre-test
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 |
|---|---|---|
| Invitation to play the game "Save the shame!"The experimental group was asked to use the game. Two weeks were defined as the time to use the game. The use of the game can be seen by the coded digital record on its digital platform . The control group neither used nor had access to the game. Afterwards both groups performed the ALS knowledge assessment test. It is a test with 20 multiple choice questions each scored as right (0.5 points) or wrong (0 points). | Other | Experimental |
Primary outcome
The score at the advanced life support knowledge assessment test
Time frame: 3 weeks
The minimun score at the scale is 0 and the maximum is 100, were 100 means the best result. It was applied through an online application, facilitating the participation of the guests and providing the automatic transcription of the results. The platform registration was carried out in a coded manner, thus ensuring the anonymity of the participants.
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 31 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intensive Care, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
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 5 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 31 Mar 2023. 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 Portugal. 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 score at the advanced life support knowledge assessment test (time frame: 3 weeks). 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 31 Mar 2023.