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

Hospital Universitario San Ignacio

Status: Completed

Conditions: Risk Behavior

Treatments: Behavioral: brief counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03521622

2018/07

Details and patient eligibility

About

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

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups, including a placebo group

brief counseling interventions

Experimental group

Description:

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.

Treatment:

Behavioral: brief counseling

Control group

Placebo Comparator group

Description:

written informative material about healthy lifestyles

Treatment:

Behavioral: brief counseling