Clinical trial NCT03521622: Effectiveness of Counseling Interventions to Modify Risk Behaviors in Patients at the Hospital San Ignacio.
Official title: Effectiveness of Counseling Interventions to Modify the Stage of Behavioral Change in Risk Behaviors (Smoking and Risky Alcohol Consumption) of Patient's Candidates for Surgery at the Hospital San Ignacio. Bogotá-Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Keywords: counseling
behavioral therapy
tobacco
alcohol drinking
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
First posted: 2018-05-11
Enrollment: 440
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Bogotá-Colombia

Detailed description: Objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Design: controlled clinical trial with random assignment Population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the Hospital Universitario de San Ignacio. Interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. Measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. The level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. Expected duration: 28 months. Financing: Hospital Universitario de San Ignacio and Pontificia Universidad Javeriana. Ethical aspects: the study is adjusted to international and national standards for research projects. Under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.

Eligibility criteria: Inclusion Criteria:

* candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms.
* Current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and AUDIT score between 8-15 points)
* patients with contact information
* Patients that want to participate

Exclusion Criteria:

* People who are being treated for smoking cessation or decreased consumption of alcohol.
* People with diseases that compromise their ability to understand information or their ability to verbal communication
* Patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco
* Patients in action or maintenance stages of behavioral change against their risk factor

Primary outcomes:
measure: the level of progress in the stage of behavioral change
timeFrame: one and three months after the intervention
Secondary outcomes:
measure: proportion of smokers and risky alcohol drinker
timeFrame: one and three months after the intervention
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital Universitario de San Ignacio
state: Distrito Capital
Study officials:
affiliation: Hospital San Ignacio
name: Luz H Alba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingrid A, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of brief counselling in a hospital setting for smoking cessation and risky alcohol drinking reduction: randomised clinical trial protocol. Rev Colomb Psiquiatr (Engl Ed). 2022 Apr-Jun;51(2):146-152. doi: 10.1016/j.rcpeng.2020.06.003. Epub 2022 Jun 16. English, Spanish.
citation: Almonacid I, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of Brief Counseling in a Hospital Setting for Smoking Cessation and Risky Alcohol Drinking Reduction: Randomized Clinical Trial Protocol. Rev Colomb Psiquiatr (Engl Ed). 2020 Nov 12:S0034-7450(20)30085-8. doi: 10.1016/j.rcp.2020.06.005. Online ahead of print. English, Spanish.