Tobacco Cessation CompetenceBTI studentsNCT06564766
Effectiveness of Debriefing After a Short Training on Brief Tobacco Intervention for Nursing Students: A Randomized Clinical Trial
A study testing Debriefing in people with Tobacco Cessation Competence, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Background:** Brief tobacco intervention (BTI) is a key component in addressing the tobacco pandemic. The WHO recommends incorporating specific training on tobacco dependence and cessation into the curricula of health professionals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation Competence
- What is being tested?
- Debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 24 Jan 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria were being enrolled in the second-year course \"Foundations of Community Nursing,\" where BTI training is provided, and agreeing to participate in the study.
Who cannot join
- Nothing
Trial locations and contacts
1 site in 1 country.
About this study
- Background:** Brief tobacco intervention (BTI) is a key component in addressing the tobacco pandemic. The WHO recommends incorporating specific training on tobacco dependence and cessation into the curricula of health professionals. In studies published on smoking cessation training for nursing students, debriefing is used as a key tool.
- Objectives:** To determine the effectiveness of debriefing following an objective evaluation of BTI training in nursing students and to assess its impact at 3 and 9 months.
- Design:** Randomized controlled clinical trial with block randomization to evaluate the debriefing intervention versus no debriefing, with follow-up measurements taken five times over a period of 9 months.
- Participants:** The study was conducted with second-year nursing students at the University of Murcia, Spain, during the 2021-2023 academic years.
- Methods:** Both the experimental group (EG) and the control group (CG) received BTI training according to the 5 As and 5 Rs model in a brief 2.5-hour format in groups of 13-16 students. The data collection protocol was similar in both the EG and CG, with 5 measurements taken, always following the viewing of the 3 problem-solving videos and evaluating learning through the BTI-St®. The baseline measurement was taken before the BTI training (T0), followed by another measurement after students in both groups received BTI training in primary care (T1). Subsequently, in the experimental group, an expert instructor conducted a structured debriefing of approximately 10-15 minutes for each clinical scenario, while the control group received no additional intervention. At the end of the first day, all participants viewed the videos and completed the tool again (T2). At three and nine months, students viewed the videos and measurements were taken at T3 and T4, respectively. A two-factor repeated measures ANOVA was used to analyze intra-subject and inter-subject differences.
Read the detailed description
Method of Measurement
To assess changes in learning related to brief tobacco intervention (BTI) among nursing students, the Brief Tobacco Intervention BTI-St© tool was used, employing the standardized patient videos previously described. This instrument is based on a criterion-referenced test or competency test model, allowing for an objective evaluation of student performance in BTI and the identification of learning deficiencies. It is presented as an algorithm comprising 23 dichotomous items organized according to the 5As and 5Rs model, and it has demonstrated adequate validity and reliability (Ramos-Morcillo et al., 2022). Students are required to watch a video-recorded clinical scenario and indicate whether the criteria for brief smoking cessation intervention are met. Responses are scored against the gold standard defined in the validation of the scenarios, with item scores ranging from 0 (incorrect) to 1 (correct). The total maximum score for the presented scenarios ranges from 0 to 1 point if the student correctly answers all the items.
- Conditions
- Tobacco Cessation Competence
- Being tested
- Debriefing
- Keywords
- tobacco, cessation, brief intervention, nursing education, competence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebriefingOther
In the experimental group, an expert instructor conducted a structured debriefing lasting about 10-15 minutes for each clinical scenario, while in the control group, no additional intervention was provided.
The debriefing used in this study has the following characteristics: brief (≤ 15 minutes), educator present, educator experienced in debriefing, focused on healthcare management or decision-making, and used the Plus-Delta method, where participants are asked to reflect on the simulation event and assess their performance by identifying what went well and areas for improvement.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Both groups (EG and CG) received BTI training in a short 2.5-hour format in groups of 13-16 students. The content included: 1) general information and epidemiology of smoking, 2) passive smoking, 3) evidence of the effectiveness of tobacco interventions, and 4) the approach to smoking cessation in Primary Care as proposed by the WHO using the 5 As and 5 Rs model to help patients quit smoking (World Health Organization, 2014). This model outlines the five main steps of the 5 As (Ask, Advise, Assess, Assist, and Arrange) for providing brief intervention in primary care settings and the 5 Rs (Relevance, Risks, Rewards, Roadblocks, and Repetition) to address with smokers who are not yet ready to quit. |
| Experimental group | Experimental | Not described Receives: Other: Debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
brief tobacco intervention competence
To assess changes in learning brief tobacco intervention (BTI) skills among nursing students, the Brief Tobacco Intervention BTI-St© tool was used, utilizing the previously described videos of standardized patients. This tool is based on a criterion-referenced test or competency test model, allowing for an objective evaluation of students' performance in BTI and the identification of learning deficiencies. It is presented as an algorithm comprising 23 dichotomous items organized according to the 5As and 5Rs model, and it has demonstrated adequate validity and reliability (Ramos-Morcillo et al., 2022). Students are required to watch a recorded clinical scenario and then indicate whether or not the criteria for brief intervention to quit smoking are met. Their responses are corrected against the gold standard defined in the validation of the scenarios, with item scores ranging from 0 (incorrect) to 1 (correct). The total maximum score for the scenarios ranges from 0 to 1 point.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Feb 2021
- Primary completion31 May 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Cessation CompetenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA RUZAFA MARTINEZ, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564766
- Sponsor's protocol ID
- 1968/2018
- Acronym
- BTI students
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi SH, Kim YH. Effects of Smoking Cessation Intervention Education Program Based on Blended Learning among Nursing Students in South Korea. Osong Public Health Res Perspect. 2018 Aug;9(4):185-191. doi: 10.24171/j.phrp.2018.9.4.07.
PubMed 30159224
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Debriefing After a Short Training on Brief Tobacco Intervention for Nursing Students: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06564766
- Acronym / sponsor ID
- BTI students / 1968/2018
- Conditions
- Tobacco Cessation Competence
- Keywords
- tobacco, cessation, brief intervention, nursing education, competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 21 Aug 2024 (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.
- Background:** Brief tobacco intervention (BTI) is a key component in addressing the tobacco pandemic. The WHO recommends incorporating specific training on tobacco dependence and cessation into the curricula of health professionals. In studies published on smoking cessation training for nursing students, debriefing is used as a key tool.
- Objectives:** To determine the effectiveness of debriefing following an objective evaluation of BTI training in nursing students and to assess its impact at 3 and 9 months.
- Design:** Randomized controlled clinical trial with block randomization to evaluate the debriefing intervention versus no debriefing, with follow-up measurements taken five times over a period of 9 months.
- Participants:** The study was conducted with second-year nursing students at the University of Murcia, Spain, during the 2021-2023 academic years.
- Methods:** Both the experimental group (EG) and the control group (CG) received BTI training according to the 5 As and 5 Rs model in a brief 2.5-hour format in groups of 13-16 students. The data collection protocol was similar in both the EG and CG, with 5 measurements taken, always following the viewing of the 3 problem-solving videos and evaluating learning through the BTI-St®. The baseline measurement was taken before the BTI training (T0), followed by another measurement after students in both groups received BTI training in primary care (T1). Subsequently, in the experimental group, an expert instructor conducted a structured debriefing of approximately 10-15 minutes for each clinical scenario, while the control group received no additional intervention. At the end of the first day, all participants viewed the videos and completed the tool again (T2). At three and nine months, students viewed the videos and measurements were taken at T3 and T4, respectively. A two-factor repeated measures ANOVA was used to analyze intra-subject and inter-subject differences.
Detailed description
Method of Measurement
To assess changes in learning related to brief tobacco intervention (BTI) among nursing students, the Brief Tobacco Intervention BTI-St© tool was used, employing the standardized patient videos previously described. This instrument is based on a criterion-referenced test or competency test model, allowing for an objective evaluation of student performance in BTI and the identification of learning deficiencies. It is presented as an algorithm comprising 23 dichotomous items organized according to the 5As and 5Rs model, and it has demonstrated adequate validity and reliability (Ramos-Morcillo et al., 2022). Students are required to watch a video-recorded clinical scenario and indicate whether the criteria for brief smoking cessation intervention are met. Responses are scored against the gold standard defined in the validation of the scenarios, with item scores ranging from 0 (incorrect) to 1 (correct). The total maximum score for the presented scenarios ranges from 0 to 1 point if the student correctly answers all the items.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Both groups (EG and CG) received BTI training in a short 2.5-hour format in groups of 13-16 students. The content included: 1) general information and epidemiology of smoking, 2) passive smoking, 3) evidence of the effectiveness of tobacco interventions, and 4) the approach to smoking cessation in Primary Care as proposed by the WHO using the 5 As and 5 Rs model to help patients quit smoking (World Health Organization, 2014). This model outlines the five main steps of the 5 As (Ask, Advise, Assess, Assist, and Arrange) for providing brief intervention in primary care settings and the 5 Rs (Relevance, Risks, Rewards, Roadblocks, and Repetition) to address with smokers who are not yet ready to quit. |
| Experimental group | Experimental | Other: Debriefing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were being enrolled in the second-year course \"Foundations of Community Nursing,\" where BTI training is provided, and agreeing to participate in the study.
Key exclusion criteria (1 listed)
- Nothing
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 |
|---|---|---|
| DebriefingIn the experimental group, an expert instructor conducted a structured debriefing lasting about 10-15 minutes for each clinical scenario, while in the control group, no additional intervention was provided. The debriefing used in this study has the following characteristics: brief (≤ 15 minutes), educator present, educator experienced in debriefing, focused on healthcare management or decision-making, and used the Plus-Delta method, where participants are asked to reflect on the simulation event and assess their performance by identifying what went well and areas for improvement. | Other | Experimental group |
Primary outcome
brief tobacco intervention competence
Time frame: 12 months
To assess changes in learning brief tobacco intervention (BTI) skills among nursing students, the Brief Tobacco Intervention BTI-St© tool was used, utilizing the previously described videos of standardized patients. This tool is based on a criterion-referenced test or competency test model, allowing for an objective evaluation of students' performance in BTI and the identification of learning deficiencies. It is presented as an algorithm comprising 23 dichotomous items organized according to the 5As and 5Rs model, and it has demonstrated adequate validity and reliability (Ramos-Morcillo et al., 2022). Students are required to watch a recorded clinical scenario and then indicate whether or not the criteria for brief intervention to quit smoking are met. Their responses are corrected against the gold standard defined in the validation of the scenarios, with item scores ranging from 0 (incorrect) to 1 (correct). The total maximum score for the scenarios ranges from 0 to 1 point.
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 21 Aug 2024.
- Background: PubMed 30159224Choi SH, Kim YH. Effects of Smoking Cessation Intervention Education Program Based on Blended Learning among Nursing Students in South Korea. Osong Public Health Res Perspect. 2018 Aug;9(4):185-191. doi: 10.24171/j.phrp.2018.9.4.07.
- Individual participant dataSharing planned: No
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 testing Debriefing in people with Tobacco Cessation Competence, run by Universidad de Murcia at 1 site in Spain.
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 21 Aug 2024. 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 Spain. 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?
brief tobacco intervention competence (time frame: 12 months). 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 NCT06564766, which also lists 1 linked publication.
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 21 Aug 2024.