SmokingNCT03818360
Deliver an Evidence-based Smoking Cessation Intervention for Smokers Attending A&E Departments in Hong Kong
A study testing an evidence-based smoking cessation intervention comprising brief advice plus active referrals in people with Smoking and Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This project aims to deliver an evidence-based smoking cessation intervention comprising the provision of brief cessation advice to smokers attending emergency departments and active referral to existing smoking cessation services. The objectives are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Evidence-Based Nursing
- What is being tested?
- an evidence-based smoking cessation intervention comprising brief advice plus active referrals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,603 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Aug 2019to 28 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Healthcare professionals employed in the emergency departments of various hospitals under the Hospital Authority
- Smokers attending emergency departments who are triaged as semi-urgent (level 4) or non-urgent (level 5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of an Evidence-based Smoking Cessation Intervention Comprising Brief Advice Plus Active Referrals for Smokers Attending Emergency Departments in Hong Kong
This project aims to deliver an evidence-based smoking cessation intervention comprising the provision of brief cessation advice to smokers attending emergency departments and active referral to existing smoking cessation services. The objectives are as follows:
- To promote this evidence-based project to emergency departments in various hospitals under the Hospital Authority
- To construct a network with non-governmental organisations (NGOs) to provide smoking cessation services
- To train healthcare professionals to use the AWARD model to deliver brief cessation advice to smokers
- To deliver brief cessation advice via healthcare professionals and actively refer smokers to existing smoking cessation services.
Read the detailed description
Smoking exerts harmful effects on nearly every organ of the body and is considered responsible for 7 million deaths worldwide every year.1 Despite a decrease in the prevalence of daily cigarette smoking from 23.3% in 1982 to 10.0% in 2017, 615,000 daily smokers2 remain in Hong Kong, where 400,000 hospitalisations per year are attributable to smoking.3 These statistics cannot be overlooked or undervalued.
The provision of medical attention to smokers in physical discomfort who visit accident and emergency departments (AEDs) could be an excellent teachable model, as it provides an invaluable opportunity to encourage smoking cessation. Smokers who consult physicians in an emergency setting are more likely to adopt better health-related behaviours. According to the Hospital Authority,4 approximately 2 million people visit AEDs in Hong Kong each year; of them, 68% are triaged as semi-urgent (level 4) or non-urgent (level 5). The average waiting time for a medical consultation varies among AEDs but generally exceeds 30 min for triage level 4 and 1-2 h for level 5. These wait times represent a golden opportunity in which healthcare professionals could advise smokers to quit and provide information about available smoking cessation programmes.4 However, cigarette smoking is addictive, and cessation is a difficult process associated with a high rate of relapse, particularly among smokers with a high level of nicotine dependency.5 According to the latest Hong Kong Thematic Household Survey, 31.2% of participating cigarette smokers had tried but failed to quit smoking.2 Therefore, an innovative intervention is needed and should be evaluated with the intent to enhance its effectiveness and potential for implementation in clinical settings. Based on the health needs of the community, we propose that such a smoking cessation strategy should combine different components, such as the administration of brief advice by healthcare professionals and the provision of referrals and follow-up boosters by community smoking cessation services, to achieve a larger intervention effect.
Most existing cessation programmes, including stage-matched interventions6 and motivational interviews,7 generally require implementation periods exceeding 30 minutes. Previous reviews have indicated that a comprehensive intervention might more effectively promote smoking cessation, compared to brief advice.8-10 However, the provision of a comprehensive smoking cessation intervention is not feasible in the busy clinical settings of Hong Kong. Indeed, healthcare professionals most commonly cite a lack of time as the reason for their inability to help patients with smoking cessation; specifically, these professionals are very busy and cannot spare even a few extra minutes.11 Other barriers to assistance include a lack of training and experience, lack of confidence in the effectiveness of the interventions and deficiencies in or a lack of incentives, support or requirements from hospital management regarding the implementation of these programmes. Moreover, our previous smoking cessation projects in an outpatient clinical setting revealed that many patients were too impatient to participate in a long intervention, while others expressed a reluctance to participate because of concerns that they might miss or experience delays in their medical consultations or other medical procedures.11-13 Nevertheless, although a brief intervention is more feasible in a clinical setting, it may be too brief and inadequate to have a significant effect on smokers.12,13 Moreover, the effectiveness of some brief interventions for smokers which focus mainly on providing self-help materials is undermined by a failure to offer or arrange any follow-up.9 Evidence indicates that smoking cessation services, including telephone quitlines, are an effective means of supporting smoking cessation efforts.14 However, these services are generally poorly utilised, with a usage rate of 23.2% among smokers in Hong Kong.2 Therefore, the combination of brief cessation advice plus referrals for smokers to utilise existing smoking cessation services in Hong Kong may comprise an alternative strategy that could enhance the effects of intervention, particularly for patients requiring additional counselling.
Interventions will include:
- Use of brief smoking cessation interventions by healthcare professionals
- Self-determination intervention for smoking cessation (i.e., immediate or progressive cessation with the ultimate goal of completion over an acceptable period)
- Active referral
Service targets
Phase I: To promote our project to the emergency departments of hospitals under the Hospital Authority.
Phrase II: To recruit healthcare professionals from participating emergency departments to attend a half-day training workshop.
Phrase III: To provide brief smoking cessation advices by healthcare professionals to smokers who attend emergency departments and actively refer them to existing smoking cessation services
- Being tested
- an evidence-based smoking cessation intervention comprising brief advice plus active referrals
- Keywords
- Smoking cessation intervention, Evidence-based, Brief advice, Active referrals, Emergency departments
- Medical subject headings
- Smoking, Smoking Cessation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an evidence-based smoking cessation intervention comprising brief advice plus active referralsBehavioural
The trained healthcare professionals will be encouraged to deliver brief smoking cessation advice based on the AWARD model to smokers who attend emergency departments and are triaged as semi-urgent or non-urgent. The trained healthcare professionals will ask the smokers their smoking history, then deliver the warning message to the smokers. If the smokers refuse to quit immediately, the trained healthcare professionals will advise them to reduce the number of cigarettes smoked per day, with the goal of complete cessation within 6 months. The healthcare professionals will then actively refer smokers to the chosen service provider within 1 week of recruitment. Smokers will receive proactive telephone calls from the service providers, receive a leaflet about the health-related hazards of smoking and benefits of quitting, and a pocket-sized information card containing brief information about the existing smoking cessation services in Hong Kong.
| Study group | Role | What they receive |
|---|---|---|
| Smokers attending A&E | Experimental | Receive an evidence-based smoking cessation intervention comprising brief advice plus active referrals for smokers attending emergency departments in Hong Kong. Receives: Behavioral: an evidence-based smoking cessation intervention comprising brief advice plus active referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated abstinence of smokers at the 6-month follow-up
The self-reported quitters at the 6-month follow-up will be invited to participate in a biochemical validation (measurement of exhaled [CO] and salivary cotinine level). The criteria for validated abstinence are an exhaled CO level of less than 4 ppm and a saliva cotinine level of less than 10 ng/ml.
Measured: at the 6-month follow-up
Secondary outcomes (5)
Biochemically validated abstinence of smokers at the 12-month follow-up
The self-reported quitters at the 12-month follow-up will be invited to participate in a biochemical validation (measurement of exhaled [CO] and salivary cotinine level). The criteria for validated abstinence are an exhaled CO level of less than 4 ppm and a saliva cotinine level of less than 10 ng/ml.
Measured: at the 12-month follow-up
Self-reported 7-day point prevalence of abstinence at the 6-month follow-up
Smokers will be asked to report self-reported 7-day point prevalence of abstinence at the 6-month follow-up
Measured: at the 6-month follow-up
Self-reported 7-day point prevalence of abstinence at the 12-month follow-up
Smokers will be asked to report self-reported 7-day point prevalence of abstinence at the 12-month follow-up
Measured: at the 12-month follow-up
Self-reported reduction of ≥ 50% in cigarette consumption at the 6-month follow-up
Smokers will be asked to report self-reported reduction of ≥ 50% in cigarette consumption at the 6-month follow-up
Measured: at the 6-month follow-up
Self-reported reduction of ≥ 50% in cigarette consumption at the 12-month follow-up
Smokers will be asked to report self-reported reduction of ≥ 50% in cigarette consumption at the 12-month follow-up
Measured: at the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start13 Aug 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818360
- Sponsor's protocol ID
- UW 19-032
- Status last verified
- Aug 2023
- First submitted
- 23 Jan 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
Publications
Li HCW, Xia W, Li L, Chen H, Ho LLK, Cheung KY, Xiao S, Chan YC, Chung OKJ. Evidence-based brief cessation advice plus active referral for emergency department patients who smoke: a single-arm, real-world clinical trial. BMC Med. 2025 Nov 27;23(1):714. doi: 10.1186/s12916-025-04534-9.
PubMed 41310683
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Evidence-based Smoking Cessation Intervention Comprising Brief Advice Plus Active Referrals for Smokers Attending Emergency Departments in Hong Kong
- ClinicalTrials.gov ID
- NCT03818360
- Acronym / sponsor ID
- UW 19-032
- Keywords
- Smoking cessation intervention, Evidence-based, Brief advice, Active referrals, Emergency departments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,603 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 28 Jan 2019 (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.
This project aims to deliver an evidence-based smoking cessation intervention comprising the provision of brief cessation advice to smokers attending emergency departments and active referral to existing smoking cessation services. The objectives are as follows:
- To promote this evidence-based project to emergency departments in various hospitals under the Hospital Authority
- To construct a network with non-governmental organisations (NGOs) to provide smoking cessation services
- To train healthcare professionals to use the AWARD model to deliver brief cessation advice to smokers
- To deliver brief cessation advice via healthcare professionals and actively refer smokers to existing smoking cessation services.
Detailed description
Smoking exerts harmful effects on nearly every organ of the body and is considered responsible for 7 million deaths worldwide every year.1 Despite a decrease in the prevalence of daily cigarette smoking from 23.3% in 1982 to 10.0% in 2017, 615,000 daily smokers2 remain in Hong Kong, where 400,000 hospitalisations per year are attributable to smoking.3 These statistics cannot be overlooked or undervalued.
The provision of medical attention to smokers in physical discomfort who visit accident and emergency departments (AEDs) could be an excellent teachable model, as it provides an invaluable opportunity to encourage smoking cessation. Smokers who consult physicians in an emergency setting are more likely to adopt better health-related behaviours. According to the Hospital Authority,4 approximately 2 million people visit AEDs in Hong Kong each year; of them, 68% are triaged as semi-urgent (level 4) or non-urgent (level 5). The average waiting time for a medical consultation varies among AEDs but generally exceeds 30 min for triage level 4 and 1-2 h for level 5. These wait times represent a golden opportunity in which healthcare professionals could advise smokers to quit and provide information about available smoking cessation programmes.4 However, cigarette smoking is addictive, and cessation is a difficult process associated with a high rate of relapse, particularly among smokers with a high level of nicotine dependency.5 According to the latest Hong Kong Thematic Household Survey, 31.2% of participating cigarette smokers had tried but failed to quit smoking.2 Therefore, an innovative intervention is needed and should be evaluated with the intent to enhance its effectiveness and potential for implementation in clinical settings. Based on the health needs of the community, we propose that such a smoking cessation strategy should combine different components, such as the administration of brief advice by healthcare professionals and the provision of referrals and follow-up boosters by community smoking cessation services, to achieve a larger intervention effect.
Most existing cessation programmes, including stage-matched interventions6 and motivational interviews,7 generally require implementation periods exceeding 30 minutes. Previous reviews have indicated that a comprehensive intervention might more effectively promote smoking cessation, compared to brief advice.8-10 However, the provision of a comprehensive smoking cessation intervention is not feasible in the busy clinical settings of Hong Kong. Indeed, healthcare professionals most commonly cite a lack of time as the reason for their inability to help patients with smoking cessation; specifically, these professionals are very busy and cannot spare even a few extra minutes.11 Other barriers to assistance include a lack of training and experience, lack of confidence in the effectiveness of the interventions and deficiencies in or a lack of incentives, support or requirements from hospital management regarding the implementation of these programmes. Moreover, our previous smoking cessation projects in an outpatient clinical setting revealed that many patients were too impatient to participate in a long intervention, while others expressed a reluctance to participate because of concerns that they might miss or experience delays in their medical consultations or other medical procedures.11-13 Nevertheless, although a brief intervention is more feasible in a clinical setting, it may be too brief and inadequate to have a significant effect on smokers.12,13 Moreover, the effectiveness of some brief interventions for smokers which focus mainly on providing self-help materials is undermined by a failure to offer or arrange any follow-up.9 Evidence indicates that smoking cessation services, including telephone quitlines, are an effective means of supporting smoking cessation efforts.14 However, these services are generally poorly utilised, with a usage rate of 23.2% among smokers in Hong Kong.2 Therefore, the combination of brief cessation advice plus referrals for smokers to utilise existing smoking cessation services in Hong Kong may comprise an alternative strategy that could enhance the effects of intervention, particularly for patients requiring additional counselling.
Interventions will include:
- Use of brief smoking cessation interventions by healthcare professionals
- Self-determination intervention for smoking cessation (i.e., immediate or progressive cessation with the ultimate goal of completion over an acceptable period)
- Active referral
Service targets
Phase I: To promote our project to the emergency departments of hospitals under the Hospital Authority.
Phrase II: To recruit healthcare professionals from participating emergency departments to attend a half-day training workshop.
Phrase III: To provide brief smoking cessation advices by healthcare professionals to smokers who attend emergency departments and actively refer them to existing smoking cessation services
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers attending A&E | Experimental | Behavioral: an evidence-based smoking cessation intervention comprising brief advice plus active referralsReceive an evidence-based smoking cessation intervention comprising brief advice plus active referrals for smokers attending emergency departments in Hong Kong. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| an evidence-based smoking cessation intervention comprising brief advice plus active referralsThe trained healthcare professionals will be encouraged to deliver brief smoking cessation advice based on the AWARD model to smokers who attend emergency departments and are triaged as semi-urgent or non-urgent. The trained healthcare professionals will ask the smokers their smoking history, then deliver the warning message to the smokers. If the smokers refuse to quit immediately, the trained healthcare professionals will advise them to reduce the number of cigarettes smoked per day, with the goal of complete cessation within 6 months. The healthcare professionals will then actively refer smokers to the chosen service provider within 1 week of recruitment. Smokers will receive proactive telephone calls from the service providers, receive a leaflet about the health-related hazards of smoking and benefits of quitting, and a pocket-sized information card containing brief information about the existing smoking cessation services in Hong Kong. | Behavioural | Smokers attending A&E |
Primary outcome
Biochemically validated abstinence of smokers at the 6-month follow-up
Time frame: at the 6-month follow-up
The self-reported quitters at the 6-month follow-up will be invited to participate in a biochemical validation (measurement of exhaled [CO] and salivary cotinine level). The criteria for validated abstinence are an exhaled CO level of less than 4 ppm and a saliva cotinine level of less than 10 ng/ml.
5 secondary outcomes
Biochemically validated abstinence of smokers at the 12-month follow-up
Time frame: at the 12-month follow-up
Self-reported 7-day point prevalence of abstinence at the 6-month follow-up
Time frame: at the 6-month follow-up
Self-reported 7-day point prevalence of abstinence at the 12-month follow-up
Time frame: at the 12-month follow-up
Self-reported reduction of ≥ 50% in cigarette consumption at the 6-month follow-up
Time frame: at the 6-month follow-up
Self-reported reduction of ≥ 50% in cigarette consumption at the 12-month follow-up
Time frame: at the 12-month follow-up
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 3 Aug 2023.
- Derived from this study: PubMed 41310683Li HCW, Xia W, Li L, Chen H, Ho LLK, Cheung KY, Xiao S, Chan YC, Chung OKJ. Evidence-based brief cessation advice plus active referral for emergency department patients who smoke: a single-arm, real-world clinical trial. BMC Med. 2025 Nov 27;23(1):714. doi: 10.1186/s12916-025-04534-9.
- Individual participant dataSharing planned: Yes. The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
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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.
Ho Cheung William Li, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an evidence-based smoking cessation intervention comprising brief advice plus active referrals in people with Smoking and Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Aug 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 Hong Kong. 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?
Biochemically validated abstinence of smokers at the 6-month follow-up (time frame: at the 6-month follow-up). 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 NCT03818360, 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 3 Aug 2023.