Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic

A Pilot Randomized Controlled Trial: Effectiveness of Brief Smoking Cessation Counselling in Pre-Anaesthesia Assessment Clinic (PAAC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking ( Cigarette)
• Intervention / Treatment: Procedure: Nurse-led AWARD brief smoking cessation counselling with active referral and tailored perioperative booklet in the pre-anaesthetic assessment clinic; Procedure: Usual pre-anaesthetic care without structured smoking cessation

Detailed Description

This is a pilot, two-arm, parallel-group, assessor-blinded randomized controlled trial conducted in the nurse-led Pre-anaesthetic Assessment Clinics of Pok Oi Hospital, targeting adult elective surgical patients who are current smokers and attend for pre-operative evaluation. The trial is designed primarily to assess feasibility, acceptability, and preliminary effectiveness of a brief, perioperative nurse-delivered smoking cessation intervention using the AWARD model (Ask, Warn, Advise, Refer, Do-it-again) integrated into routine pre-anaesthetic assessment workflow. It will generate key operational parameters (e.g., recruitment and retention rates, intervention fidelity, data completeness, contamination risk) and effect size estimates needed to design and power a future definitive trial.

After screening at the pre-anaesthetic assessment clinic, eligible smokers (carbon monoxide ≥4 ppm in exhaled breath and self-reported smoking in the past 7 days) who provide informed consent will complete a baseline self-administered questionnaire capturing smoking history (e.g., daily cigarette consumption, years of smoking, previous quit attempts), readiness to quit, perceived importance and confidence, psychosocial variables (social support, depression/anxiety, alcohol use), and sociodemographic data. They will then be randomized 1:1 using a computer-generated sequence with allocation concealment maintained by serially numbered, opaque, sealed envelopes opened only after consent. Due to the nature of the intervention, participants and counsellor nurses cannot be blinded, but outcome assessors, data collectors on the day of surgery, and statistical analysts will remain masked to group allocation until primary analyses are completed.

Participants allocated to the intervention arm will attend the Nurse Pre-Anaesthetic Assessment Clinic, where trained perioperative nurses deliver a single, structured 3-5-minute AWARD-based counselling session focused on the perioperative risks of continued smoking and the benefits of short-term cessation before surgery. The counselling is supported by objective feedback from exhaled carbon monoxide measurement, a tailored perioperative smoking cessation booklet specifically developed and content-validated with anaesthetist input, and an active referral process to the hospital's smoking cessation service (i.e., direct arrangement or linkage rather than passive provision of contact details). The "Do-it-again" component includes reinforcement of cessation messages on the day of surgery and a planned follow-up contact approximately one month after surgery to assess sustained abstinence and provide additional brief support as required. Intervention fidelity is promoted through a structured training program for perioperative nurses (covering the AWARD protocol, perioperative smoking risk education, motivational interviewing techniques, and use of CO monitoring), competency assessment before enrolment starts, and ongoing supervision and case-review meetings during the trial.

Control arm participants will receive usual pre-anaesthetic care, consisting of consultation with surgeons and anaesthetists without exposure to the nurse-led smoking cessation clinic. In this pathway, smoking advice, if offered, is unstructured and not guided by a standardized protocol; patients typically receive only the generic hospital smoking cessation leaflet and referral occurs at the discretion of individual clinicians without a formal active referral mechanism. This design allows the trial to compare the added value of a structured, nurse-delivered behavioural intervention plus active referral against the current standard of care in the same institutional setting.

The primary efficacy endpoint is 7-day point prevalence smoking abstinence on the day of surgery, verified biochemically by exhaled carbon monoxide (with a pre-specified cut-off indicating abstinence) and a salivary cotinine rapid test. Secondary endpoints include reductions in daily cigarette consumption between baseline and day of surgery, 1-month post-operative abstinence status, patient-reported satisfaction with the smoking cessation support received, and early post-operative complication rates within 30 days classified using a standardized surgical complication grading system. An independent operating theatre nurse, blinded to group allocation, will collect perioperative outcome data and biochemical validation measures on the day of surgery; post-operative complications will be extracted from electronic medical records by blinded researchers; and 1-month smoking status and satisfaction will be obtained via telephone follow-up.

Quantitative analyses for this pilot will be primarily descriptive, focusing on estimation rather than hypothesis testing. Feasibility outcomes (recruitment rate, retention, adherence to the AWARD protocol, completeness of outcome data) will be summarized with proportions and confidence intervals. Between-group comparisons of abstinence and complication rates will use appropriate categorical tests and regression models to provide preliminary effect size estimates and adjusted risk or odds ratios controlling for important covariates such as age, sex, baseline smoking intensity, and comorbidities. Continuous secondary outcomes (e.g., change in cigarettes per day) will be analyzed using parametric or non-parametric methods depending on distributional assumptions. These results will inform refinement of eligibility criteria, intervention delivery logistics, and sample size calculations for a subsequent adequately powered multicentre trial.

Overall, this detailed design embeds a standardized, scalable, nurse-led smoking cessation strategy directly into pre-operative assessment, tests its operational practicality in a real-world perioperative pathway, and explores its potential to improve short-term abstinence and surgical risk profiles in a high-risk smoker population.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsz Ling Chim; Phone Number: 852 57978026; Email: ctl374@ha.org.hk

Study Locations

• Hong Kong
  • Yuen Long, Hong Kong, 000
    • Anaesthesia and Operating Theatre Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led AWARD brief smoking cessation counselling plus active referral and tailored perioperative; 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; 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.
Active Comparator: Usual pre-anaesthetic care without structured smoking cessation counselling; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery	The average number of cigarettes smoked per day at surgery day and 4 weeks post -surgery among those who have not achieved complete abstinence. Self-reported daily cigarette consumption (percentage reduction compared to baseline).	on the surgery day and 4 weeks post -surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of major postoperative complications	The rate of major postoperative complications (e.g., pneumonia, wound infection, cardiovascular events) within 30 days post-surgery, as data will be extracted from electronic medical records (Clinical Data Analysis and Reporting System (CDARS)).	within 30 days post-surgery,
Patient Satisfaction	Patient Satisfaction Mean score on a 5-point Likert scale assessing satisfaction with smoking cessation support received, administered via questionnaire at 1 month's post-surgery. Mean score on a 5-point Likert scale for patient satisfaction with smoking cessation support (range 1-5, where higher scores indicate better satisfaction). Assesses satisfaction with the counselling service, leaflet content, and overall care.	1 month's post-surgery

Collaborators and Investigators

• Sponsor: Pok Oi Hospital

Publications and helpful links

General Publications

• 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
• 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.
• 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.
• 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.
• 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.
• Rice, V. H., et al. (2020). "Nursing interventions for smoking cessation: Evidence from a Cochrane Review." Cochrane Database of Systematic Reviews, (12), CD001188.
• 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
• 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.
• 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
• Centers for Disease Control and Prevention (CDC). (2022). "The impact of smoking on surgical outcomes." Retrieved from CDC website.
• 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
• American Nurses Association (ANA). (2021). "Nurses' role in tobacco cessation and surgical outcomes." Retrieved from ANA website.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative smoking cessation; Elective surgical patients who smoke; Nurse-led brief intervention; AWARD smoking cessation model; Pre-anaesthetic assessment clinic; Randomized controlled pilot trial; Carbon monoxide breath testing; Salivary cotinine validation; Postoperative pulmonary and wound complications; Perioperative nurse smoke cessation counselling
• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Smoking; Tobacco Use; Cigarette Smoking
• Other Study ID Numbers: PokOiH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No