Intervention for Smoking Cessation in Pre-Surgical Patients.

Hospital Universitari Vall d'Hebron Research Institute232 enrolled

Overview

The goal of this clinical trial is to assess efficacy of an intensive pre-surgical intervention to quit smoking in smoking patients who will be operated on implant orthopedic surgery or general and urological surgery. The main question\[s\] it aims to answer are: * Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to a brief intervention * Evaluate the implementation of this protocol. Participants will be randomized to 2 intervention groups (patients programmed for protesic implant orthopedic surgery in the first group, and general and urological surgery) and 2 control groups (stratified in the same manner as the intervention groups), and will be monitored through telematic check ups via phone calls.

1. Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit. 2. Subjects in the intensive intervention group will be sent to a specialized Preventive Medicine consult for smoking cessation, completing 6 visits (2 before surgical intervention, 4 visits withint the following 12 months). Subjects in the control group will receive brief advice on quitting smoking through a phone call the the same day randomization is performed. Both groups will receive follow up calls at months 1, 3, 6, and 12, after surgical intervetion. All patients will have their smoking habits evaluated and the relevant data about the surgical intervention collected the day of the intervention. 3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary. 4. Data entry and quality control of the database will be performed periodically for the duration of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Interventions

Intensive intervention for smoking cessationBEHAVIORAL

Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.

Brief intervention for smoking cessationBEHAVIORAL

Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must 18 years old or older, and be able to consent. * Surgery programmed for at least 4 weeks after inclusion in the study. * Smokers Exclusion Criteria: * Pregnancy * Already under treatment for smoking cessation * Inability to consent due to cognitive impairment or language barrier. * Non-primary knee or hip replacement surgery * Participation in any study that forbids use of nicotine substitution therapy (dermal, oral)

Outcomes

Primary Outcomes

Tobacco use

Change in self reported tobacco use (smoking)

Time frame: Evaluated at 1, 3, 6, and 12 months after surgical intervention

Secondary Outcomes

Changes in concentration of exhaled CO measured with a CO-oximeter

A patient will be considered as an active tobacco user if more than 6 of carboxyhemoglobin particles per million are found through the use of a CO-oximeter