Primary objectiveThis study will serve as a pre-test of three strategies for GPs to opportunistically advice adolescents not to initiate or to quit smoking. The primary objective of the study is to assess the acceptability and feasibility of theseā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet van toepassing; primair preventief onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acceptability
Adolescents* evaluation of the strategy as assessed by a questionnaires at T1
(immediately after consultation) and T2 (two week follow-up):
- Condition 1: whether they found the advice clear, useful and relevant; what
they particularly liked and disliked about the advice; whether they had given
thought to the advice and how;
- Condition 2: condition 1 + how relevant they found the information and images
regarding harmful consequences of smoking; what they particularly liked and
disliked about the information and images; whether there was sufficient
information or not enough (applies also for the images); whether the
information covered the right topics and was new for them; whether they had
given thought to the information and images and how
- Condition 3: condition 1 + how relevant they found the information on
specific situations which may be difficult to refuse an offer of a cigarette;
what they particularly liked and disliked about the information and formulating
an action plan; whether there was enough information or not enough; whether
they formulated an action plan (if applicable, why not); whether they had used
their action plan (T2) or were planning to use it in the future (T1 and
T2).
GPs* evaluation of the strategy as assessed by a questionnaire
post-intervention:
- How easy the strategy was;
- How effective they found it;
- How it could be improved;
- If they will continue to use the strategy.
Feasibility:
- The proportion of GPs approached and agreed to participate
- The proportion of adolescents approached and included into the study
- Subjects* response rates to the follow-up questionnaires
- Duration of intervention
Secondary outcome
Adolescent*s behavioural attributes (T0, T1 & T2):
- Intention to refrain from or to quit smoking
- Attitude towards smoking
- Perceived risk of smoking
- Social norm
- Perceived self-efficacy to resist smoking
GP-adolescent interaction:
- Video-recordings of consultation (random sample)
Adolescent*s socio-demographic characteristics (T0):
- Gender
- Age
- Educational level
Other measures:
- If parents were present during consultation (T1)
- Action plans (T1 condition 3)
Background summary
Background
Active smoking during adolescence has potential harmful effects on later
social, emotional, and physical well-being. Extensive research shows a link
between youth tobacco use and an increased health risk, including respiratory
problems, coronary heart disease and cancer in later adulthood. In the
Netherlands, most children in primary school and the early years of secondary
school show a healthy behavioural lifestyle; the prevalence of young daily
smokers is relatively low between the ages of 10 and 15 (0%-10%). However,
among adolescents aged 16 to 19 year the prevalence increases to 12%-27%.
Moreover, the majority of Dutch teenagers in this age range has experimented
with cigarette smoking (50-61%) and around one in every three teenagers
indicates having smoked in the previous four weeks (26%-35%). Therefore, this
period is crucial in the development of regular smoking behaviours. Moreover,
90% of the adult smokers start with smoking during adolescence, which indicates
the importance of tobacco control interventions during adolescence.
General practice and smoking cessation intervention
General practice provides an unique setting to inform adolescents about the
risks of smoking, motivate them to quit or not to start smoking and to offer
quit smoking support. In general, current guidelines recommend GPs to
proactively ask patients about their smoking behaviour, provide tailored
information about risks, and to create and maintain records on the patients*
current smoking status which allow GPs to address the patients* smoking status
regularly in the future (NHG-Standaard Stoppen met roken). GPs are subsequently
recommended to provide pharmacological and behavioural support to smokers who
are motivated to quit or to refer them to a skilled practice nurse who
provides quit smoking cessation. However, no guidelines for the treatment of
tobacco use by adolescents are currently available in general practice.
Tobacco control among adolescents
Reducing the prevalence of smoking among adolescents can occur by two means: 1)
increasing the number of adolescents who give up smoking, and 2) decreasing the
number of adolescents who initiate smoking. In the last decade, several tobacco
control strategies are developed and used in school-based intervention studies
which resulted in a reduced smoking initiation rate among adolescents. However,
adolescents who already regularly smoke are also interested in quitting; study
findings show a lifetime cessation attempt prevalence of 71% among these young
smokers. Yet, high relapse rates are common in this age group and studies show
that adolescents* plans for quitting are often relatively vague and far in the
future. Since adolescents indicate that they want to discuss their smoking
behaviour with their healthcare provider, GPs could play a key role in tobacco
use prevention among adolescents. Moreover, recent studies urge efforts to
increase the proportion of physicians who screen and counsel adolescents about
unhealthy behaviour, including smoking behaviour.
GP advice for smoking cessation
A meta-analysis of 17 studies has shown that a single tailored advise of a
physician has small but significant effects on quit rates compared to no advice
among adult smokers. It is however unknown if these effects are also present
among adolescent smokers. A recent study showed that adolescents who had tried
to quit smoking in the past 12 months were two times more likely to report
having been asked about smoking or advised to quit by a healthcare
professional. Therefore, it can be suggested that routinely providing such
minimal interventions in general practice has beneficial effects on adolescent
smoking abstinence and initiation.
Action plans
Recent years, multiple school-based tobacco prevention interventions aimed to
increase skills among adolescents to resist social influences that encourage
smoking. An often used strategy learns adolescents how to refuse the offer of a
cigarette in potential difficult situations by forming simple *if-then* plans,
also called action plans or implementation intentions. This planning strategy
is show to be effective within school-based settings and reduces smoking
initiation rates to 0% compared to a control condition in which 6% of the
adolescents initiated smoking. In addition, this strategy is shown to increase
abstinence rates among smokers to 19% compared to abstinence rates of only 2%
in a control condition.
Threatening health messages
Other tobacco control interventions focus on increasing the perceived risks of
adolescents with regard of the harmful consequences of smoking. Such
interventions often include threatening health messages or images to increase
the adolescent*s perceived risk with regard to the harmful consequences of
smoking. It is shown that adolescents rate this strategy as effective in
preventing them from smoking, especially in a younger adolescents. For this
reason, it is suggested that threatening health warnings or images may play an
important role in preventing smoking initiation among adolescents.
Study objective
Primary objective
This study will serve as a pre-test of three strategies for GPs to
opportunistically advice adolescents not to initiate or to quit smoking. The
primary objective of the study is to assess the acceptability and feasibility
of these strategies as evaluated by GPs and adolescents.
Secondary objectives
The secondary objective of the study is to explore the short-term effectiveness
of the proposed GP strategies on adolescent*s attitude towards smoking,
perceived self-efficacy to refrain from smoking, and on adolescent*s intention
to refrain from or to quit smoking.
It is hypothesized that all three strategies will lead to a more positive
attitude towards smoking, perceived self-efficacy and a higher intention of
adolescents to refrain from or to quit smoking. Yet, based on promising
results of previous school-based interventions among adolescents, it is
hypothesized that adolescents who form action plans with help of their GP will
report the highest intention to refrain from or to start smoking compared to
the other two strategies.
Study design
This study will serve as a pre-test of three GP strategies aimed at tobacco use
prevention among adolescents. The results of this study will be used to refine
the potential most effective, acceptable and feasible strategy and to proceed
with a pragmatic (cluster) randomized controlled trial to examine the long-term
effectiveness of this strategy. The present study is built out of two parts, a
quantitative and qualitative part.
Quantitative part
The first part of the study will consist of a quasi-experimental, pre-post
study. This study will consist of three conditions in which GPs will routinely
implement one of three strategies during consultations with adolescents aged 12
to 19 years. The three strategies correspond to current GP guidelines for
smoking cessation care (condition 1 and 2) or are proven effective in a
school-based setting (condition 3). The three strategies are aimed to routinely
identify the smoking status of adolescents and to create awareness among the
adolescents about potential harmful consequences of smoking and peer pressure
with regard to initiating smoking.In each condition, the participating GP will
implement one of three strategies in all consultations with adolescents during
a period of three months. Because the present study will serve as a pre-test of
these strategies, GPs will not be randomized and no control group will be
included in the study. Yet, the first condition in which GPs will only provide
the adolescent with a single advice will serve as a reference group. Figure 1
present the flow chart of the study.
Qualitative part
GPs who participate in the above-mentioned study will be asked to video-tape a
sample of consultations with adolescents. The video-recordings will be used to
assess the delivery of the strategies. Analyses of the communication will be
used to provide more insight in the interaction between GPs and adolescent
patients during the consultations. These insights may provide practical tools
for GPs on how unsolicited conversations about smoking with adolescents may be
best introduced and which reactions of adolescents can be anticipated
Intervention
The three tobacco control strategies will focus on routinely implementing tasks
of GPs as outlined in the current guideline for the treatment of tobacco use of
the Dutch College of General Practitioners (NHG-Standaard Stoppen met roken).
Since recent studies have suggested that these tasks should be limited to
asking about smoking, advising to quit and arranging follow-up support (*A-A-A
approach*), the strategies outlined in the present study will follow this
suggestion. Overall, GPs will identify the subjects* smoking status, inform the
about risks of smoking or potential difficult situation to refuse a cigarette
and advise to quit or not to start smoking. If the adolescents smokes, GPs will
refer him/her to a practice nurse or to external smoking cessation support, as
outlined in current GP guidelines.
Condition 1
During the intervention period, GPs in this condition will ask the subject
about his/her attitude about smoking and provides a short advice. The smoking
status will be registered in the electronic patient medical record by the GP
regardless of the subjects* reason of consultation. Depending on the smoking
status of the subject the following scenario*s may occur within this condition:
Subject is a regular smoker (smokes at least once a week):
The GP advises to quit smoking, tailored to relevant characteristics of the
subject.
Subject is a non-smoker, but has previously (tried to) smoke(d) at least once :
The GP advises not to initiate smoking or experiment with smoking anymore in
the future. The advice will be tailored to relevant characteristics of the
subject.
Subject is a non-smoker and has never smoked before:
The GP praises for not having smoked and advises not to initiate or experiment
with smoking in the future, tailored to relevant characteristics of the subject.
Condition 2
Alike condition 1, GPs in this condition will assess and register the smoking
status of the subject and provide a tailored advice based on the subject*s
smoking status (see: condition 1). In addition, the GP in this condition
discusses the potential harmful short- and long term consequences of smoking,
using graphic images of these harmful consequences (see: appendix 1). These
images are planned to be used as pictorial warnings on cigarette packages in
the European Union.
Condition 3
Alike condition 1, GPs* in this condition will assess and register the smoking
status of the subject and provides tailored advice based on the smoking status
(see: condition 1). Subsequently, the GP will provide information about
specific situations which may be difficult to refuse an offer of a cigarette
(school break, party, etc.). In addition, the GP will suggest that an a priori
action plan on how to refuse a cigarette in such situations can be very
helpful. The GP instructs the subject to formulate an action plan using a
questionnaire in the waiting room.
All three conditions
The parents (or relevant others) of the subject may also be present during the
intervention. Although the smoking status of the parents is likely to be
discussed as well, the GP will focus on the smoking behaviour of the subject.
Study burden and risks
This study is carried out in minors because the research questions specifically
relate to adolescents aged 12 to 19 years. Participation entails minimal
burden; adolescents complete three questionnaires (pre, post, and follow-up).
The risks of participating in the study are negligible; the tobacco control
strategies are part of current evidence-based healthcare.
Hippocratespad 21
Leiden 2333 ZD
NL
Hippocratespad 21
Leiden 2333 ZD
NL
Listed location countries
Age
Inclusion criteria
- Aged 12 to 19 (birth year 2001 to 1994)
- Willing to participate in study procedures
- Visiting the participating GP during the intervention period
- Able to read and write the Dutch language
Exclusion criteria
- Poor cognitive function
- Mental disorder
- Substance dependence
- Illiteracy
- If parents of minor subjects (aged 12 to 17 years) raise objections
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47714.058.14 |