NCT06564766

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

August 19, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

tobaccocessationbrief interventionnursing educationcompetence

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (2)

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

Interventions

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.

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Nothing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Health Sciences Campus.

Murcia, 30120, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30159224BACKGROUND

MeSH Terms

Interventions

Crisis Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

February 15, 2021

Primary Completion

May 31, 2023

Study Completion

January 24, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations