NCT07505147

Brief Summary

The goal of this clinical trial is to evaluate whether a brief, nurse-delivered smoking cessation intervention can increase pre-operative smoking abstinence and improve perioperative outcomes among adult elective surgical patients who are current smokers. The main questions it aims to answer are: Does a perioperative nurse-delivered AWARD brief counselling intervention with active referral and a tailored perioperative smoking cessation booklet increase the 7-day point prevalence abstinence rate on the day of surgery, biochemically validated by exhaled carbon monoxide and salivary cotinine? Is this intervention feasible and acceptable in the pre-anaesthetic assessment clinic in terms of recruitment, retention, intervention fidelity, and patient compliance? Researchers will compare patients receiving the nurse-led AWARD brief counselling plus active referral and tailored perioperative booklet to patients receiving usual pre-anaesthetic care without structured smoking cessation counselling, to see if the intervention leads to higher pre-operative abstinence and signals of reduced post-operative complications. Participants will: Attend the pre-anaesthetic assessment clinic where eligibility and baseline data (e.g., smoking behavior, readiness to quit, sociodemographic information) are collected and exhaled carbon monoxide is measured. Be randomly assigned to either receive brief AWARD-model counselling with active referral and a tailored perioperative smoking cessation booklet from a trained perioperative nurse, or to continue with usual pre-anaesthetic care. Have their smoking status reassessed on the day of surgery (including repeat CO and salivary cotinine testing) and at 1-month follow-up, along with collection of post-operative complication data and patient satisfaction with the smoking cessation support.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress16%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 20, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Perioperative smoking cessationElective surgical patients who smokeNurse-led brief interventionAWARD smoking cessation modelPre-anaesthetic assessment clinicRandomized controlled pilot trialCarbon monoxide breath testingSalivary cotinine validationPostoperative pulmonary and wound complicationsPerioperative nurse smoke cessation counselling

Outcome Measures

Primary Outcomes (1)

  • Complete smoking abstinence

    A short-term Smoking Abstinence: The proportion of patients who report complete smoking abstinence (7-day point prevalence abstinence) biochemically validated by exhaled CO levels \< 6 ppm on the day of surgery and negative result of Cotinine rapid salvia test and at 4 weeks post-counseling (1-Month Sustained Cessation Rate by self- report phone survey).

    on the day of surgery and at 4 weeks post-surgery

Secondary Outcomes (1)

  • The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery

    on the surgery day and 4 weeks post -surgery

Other Outcomes (2)

  • The rate of major postoperative complications

    within 30 days post-surgery,

  • Patient Satisfaction

    1 month's post-surgery

Study Arms (2)

Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative

EXPERIMENTAL

Participants attend the Nurse Pre-Anaesthetic Assessment Clinic and receive brief nurse-delivered smoking cessation counselling using the AWARD model, plus active referral to hospital smoking cessation services and a tailored perioperative smoking cessation booklet, in addition to standard pre-anaesthetic assessment

Procedure: Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic

Usual pre-anaesthetic care without structured smoking cessation counselling

ACTIVE COMPARATOR

Participants receive usual pre-anaesthetic care from surgeons and anaesthetists without visiting the nurse-led clinic; smoking advice, if given, is unstructured and there is no standardized counselling, tailored booklet, or protocolized active referral beyond the general hospital leaflet

Procedure: Usual pre-anaesthetic care without structured smoking cessation

Interventions

This intervention is a structured, nurse-led, behavioral smoking cessation program embedded within a nurse-run Pre-Anaesthetic Assessment Clinic for elective surgical patients who smoke. It consists of a single brief counselling session (approximately 3-5 minutes) delivered by trained perioperative nurses using the standardized AWARD model (Ask, Warn, Advise, Refer, Do-it-again), with content specifically tailored to perioperative risks and benefits of quitting before surgery. During the session, nurses use exhaled carbon monoxide testing as a motivational tool, provide a perioperative-focused, tailor-made smoking cessation booklet validated by a consultant anaesthetist, and make an active referral to the hospital's smoking cessation service rather than passive signposting. Fidelity is supported through dedicated nurse training, competency assessment, and ongoing supervision, and the intervention is reinforced on the day of surgery and at 1-month follow-up.

Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative

Participants receive usual pre-anaesthetic care from surgeons and anaesthetists. Smoking advice, if given, is brief and unstructured, with no standardized counselling protocol, no tailored perioperative booklet, and no protocolised active referral beyond the routine hospital leaflet.

Usual pre-anaesthetic care without structured smoking cessation counselling

Eligibility Criteria

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

You may qualify if:

  • Adult patients (≥18 years)
  • Current smokers attending the pre-anaesthetic assessment clinic
  • Scheduled for elective surgery within 6 months

You may not qualify if:

  • Emergency surgery
  • Patients having surgery day less than 7 days
  • Cognitive impairment preventing consent
  • Patients already receiving active treatment from other smoking cessation services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthesia and Operating Theatre Services

Yuen Long, 000, Hong Kong

Location

Related Publications (12)

  • Ying, X., Freedland, K. E., Powell, L. H., Stuart, E. A., Ehrhardt, S., & Mayo-Wilson, E. (2025). Determining sample size for pilot trials: a tutorial. BMJ (Clinical research ed.), 390, e083405. https://doi.org/10.1136/bmj-2024-083405

    BACKGROUND
  • Wetterslev J, Hansen EG, Kamp-Jensen M, Roikjaer O, Kanstrup IL (2000). PaO2 during anaesthesia and years of smoking predict late postoperative hypoxaemia and complications after upper abdominal surgery in patients without preoperative cardiopulmonary dysfunction. Acta Anaesthesiol Scand ;44:9-16.

    BACKGROUND
  • Whitehead AL, Julious SA, Cooper CL, Campbell MJ. (2016). Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25(3):1057-1073. doi: 10.1177/0962280215588241.

    BACKGROUND
  • Warner, D. O., et al. (2020). "The effects of smoking cessation on surgical outcomes: A review of current evidence." Mayo Clinic Proceedings, 95(2), 393-402.

    BACKGROUND
  • Siddiqui, M., et al. (2021). "Short-term smoking cessation interventions and their impact on surgical complications: A meta-analysis." Journal of Perioperative Nursing, 34(3), 221-229.

    BACKGROUND
  • Rice, V. H., et al. (2020). "Nursing interventions for smoking cessation: Evidence from a Cochrane Review." Cochrane Database of Systematic Reviews, (12), CD001188.

    BACKGROUND
  • Ng CS, Yu CWS, Leung L, et al. (2024). Economic costs of tobacco-related diseases in Hong Kong in 2021. Tobacco Control Published Online First: . doi: 10.1136/tc-2024-058817

    BACKGROUND
  • Moore, R. A., et al. (2020). "Smoking cessation before surgery and its impact on postoperative outcomes: A systematic review." Cochrane Database of Systematic Reviews, (8), CD012852.

    BACKGROUND
  • K. Andrews, P. Bale, J. Chu, A. Cramer, P. Aveyard (2006). A randomized controlled trial to assess the effectiveness of a letter from a consultant surgeon in causing smokers to stop smoking pre-operatively. Elsevier Public Health 120, 356-358

    BACKGROUND
  • Centers for Disease Control and Prevention (CDC). (2022). "The impact of smoking on surgical outcomes." Retrieved from CDC website.

    BACKGROUND
  • Bissett, K., Ascenzi. J., & Whalen, M. (2025). Johns Hopkins evidence-based practice for nurses and healthcare professionals: Model and guidelines. 5th ed. Sigma Theta Tau International

    BACKGROUND
  • American Nurses Association (ANA). (2021). "Nurses' role in tobacco cessation and surgical outcomes." Retrieved from ANA website.

    BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Central Study Contacts

Tsz Ling Chim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Nurse Consultant

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations