NCT07505147

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Pok Oi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Smoking ( Cigarette)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: Hong Kong