Effectiveness of Counseling Interventions to Modify Risk Behaviors in Patients at the Hospital San Ignacio. (EFICO)

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

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

Study Overview

• Status: Completed
• Conditions: Risk Behavior
• Intervention / Treatment: Behavioral: brief counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Distrito Capital
    • Bogotá, Distrito Capital, Colombia
      • Hospital Universitario de San Ignacio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brief counseling interventions; For smoking patients the brief intervention is 5 As model for motivated patients and 5Rs for not motivated patients. For risky alcohol drinkers the brief intervention is simple advise for motivated patients and brief intervention for not motivated patients.	Behavioral: brief counseling; Brief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention
Placebo Comparator: Control group; written informative material about healthy lifestyles	Behavioral: brief counseling; Brief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the level of progress in the stage of behavioral change	Stages of change of Prochaska and DiClemente	one and three months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of smokers and risky alcohol drinker	proportion of smokers and risky alcohol drinker in each arm of the study	one and three months after the intervention

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio
• Collaborators: Pontificia Universidad Javeriana
• Investigators: Principal Investigator: Luz H Alba, MD, Hospital San Ignacio

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: counseling; tobacco; behavioral therapy; alcohol drinking
• Other Study ID Numbers: 2018/07

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