NCT03818360

Brief 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. 1.To promote this evidence-based project to emergency departments in various hospitals under the Hospital Authority
  2. 2.To construct a network with non-governmental organisations (NGOs) to provide smoking cessation services
  3. 3.To train healthcare professionals to use the AWARD model to deliver brief cessation advice to smokers
  4. 4.To deliver brief cessation advice via healthcare professionals and actively refer smokers to existing smoking cessation services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,603

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

August 13, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3.5 years

First QC Date

January 23, 2019

Last Update Submit

August 1, 2023

Conditions

Keywords

Smoking cessation interventionEvidence-basedBrief adviceActive referralsEmergency departments

Outcome Measures

Primary Outcomes (1)

  • 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.

    at the 6-month follow-up

Secondary Outcomes (5)

  • Biochemically validated abstinence of smokers at the 12-month follow-up

    at the 12-month follow-up

  • Self-reported 7-day point prevalence of abstinence at the 6-month follow-up

    at the 6-month follow-up

  • Self-reported 7-day point prevalence of abstinence at the 12-month follow-up

    at the 12-month follow-up

  • Self-reported reduction of ≥ 50% in cigarette consumption at the 6-month follow-up

    at the 6-month follow-up

  • Self-reported reduction of ≥ 50% in cigarette consumption at the 12-month follow-up

    at the 12-month follow-up

Other Outcomes (28)

  • Number of emergency departments participated at the end of recruitment

    at 10 months

  • Knowledge of the risk of smoking in trained healthcare professionals before the training workshops

    baseline

  • Knowledge of the risk of smoking in trained healthcare professionals at the end of the training workshops

    up to 1 week

  • +25 more other outcomes

Study Arms (1)

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.

Behavioral: an evidence-based smoking cessation intervention comprising brief advice plus active referrals

Interventions

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.

Smokers attending A&E

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SmokingSmoking CessationEmergencies

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ho Cheung William Li, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 28, 2019

Study Start

August 13, 2019

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

Time Frame
After the project is completed and the results of the project has been published.
Access Criteria
Request could be sent to Principal Investigator

Locations