The Impact of Brief Motivational Counseling for Smoking Cessation in an Italian Emergency Department: a Randomized Controlled Trial

NCT04107753 | Completed

• 1 other identifier: CE 93/16
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Smoke is still a significant Public Health problem. The Emergency Departments (EDs) could be the ideal setting to set up smoke cessation interventions (high prevalence of smoking patient compared to the general population). The structured brief counseling 5As based (ask, advice, asses, assist, arrange) is an effective Public Health intervention when performed by the General Practitioners. Still not clear is its feasibility and effectiveness in the ED setting. Aim of the study. To assess the feasibility and effectiveness of the 5As based counselling in the University ED of Novara compared to the "usual care".

Conditions

Smoking Habit

Outcome Measures

Primary Outcomes (1)

• Point prevalence of tobacco-free patients assessment

  Those who did not smoke in the last 7 days; dichotomous variable: yes/no. Better outcome: yes. Investigated by the ad-hoc telephone administrated questionnaire.

  At 12 months from the intervention

Secondary Outcomes (5)

• Point prevalence of tobacco-free patients assessment

  At 6 months from the intervention

• Continuous abstinence during the last 3 months assessment

  At 12 months from the intervention

• Decrease of at least 50% in daily tobacco use in the past 7 days with respect to baseline

  At 12 months from the intervention

• Transition in motivational stages

  At 12 months from the intervention

• Quit attempts number.

  At 12 months from the intervention

Study Arms (2)

Intervention: Brief counseling based on the 5As model

EXPERIMENTAL

The intervention group received a brief counseling based on the 5As model. It mainly consists of the following steps: ask, advice, asses, assist, arrange. It is performed by the nurse who take clinical care of the patient. The patients receive an information card about the Smoke cessation center's (CTT) and the patients who agree are contacted by the CTT's staff.

Behavioral: Brief counseling based on the 5As model

Control group

NO INTERVENTION

No other intervention than the "usual care" (range between the not mentioning the subject at all, to a general advice to quit without bringing any evidence or any structured counseling).

Interventions

Brief counseling based on the 5As model BEHAVIORAL

It is a structured brief counselling perfomed by nurse who takes clinical care of the patient and it is performed as follow: 1. ASK: every patient should be asked whether he/she is or is not a smoker; 2. ADVICE: the patient is advised to quit in a strong, clear and personalized way; 3. ASSESS: the patient is asked if he/she would like to quit and the strenght of his/her dependence is assessed. 4. ASSIST: The smoker interested in quitting are assisted in their attempts, for example by helping them to define a quit date, by advising them about strategies against withdrawal symptoms and by providing them information material; patients are asked whether they want to be contacted by the CTT. 5. ARRANGE: this step is only addressed to the patients who have started a treatment in the CTT and is expected to prevent or treat eventual relapses.

Intervention: Brief counseling based on the 5As model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-statement as "current smokers" (at least one cigarette per day) during the triage interview;
• age ≥ 18;
• priority code urgency (yellow code) or deferrable urgency (green code) or non-urgency (white code);
• provision of an informed consent.

You may not qualify if:

• priority code emergency (red code);
• altered mental status or history of psychiatric illness;
• inability to understand either written or oral Italian;
• patient already in treatment or follow-up for tobacco addiction;
• patient allocated to a nurse who has not been trained in counseling and does not participate to the study;
• informed consent denied

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead
• Lega Italiana per la Lotta contro i Tumori: collaborator

Study Sites (1)

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Novara, 28100, Italy

Location

Related Publications (6)

• Foulds J. Strategies for smoking cessation. Br Med Bull. 1996 Jan;52(1):157-73. doi: 10.1093/oxfordjournals.bmb.a011523.

  PMID: 8746304 BACKGROUND

• Gorini G, Carreras G, Giordano L, Anghinoni E, Iossa A, Coppo A, Talassi F, Galavotti M, Chellini E; SPRINT Working Group. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial. BMC Public Health. 2012 Sep 5;12:740. doi: 10.1186/1471-2458-12-740.

  PMID: 22950883 BACKGROUND

• Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2002;(3):CD001292. doi: 10.1002/14651858.CD001292.

  PMID: 12137623 BACKGROUND

• McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.

  PMID: 12729175 BACKGROUND

• Patrick DL, Cheadle A, Thompson DC, Diehr P, Koepsell T, Kinne S. The validity of self-reported smoking: a review and meta-analysis. Am J Public Health. 1994 Jul;84(7):1086-93. doi: 10.2105/ajph.84.7.1086.

  PMID: 8017530 BACKGROUND

• Virtanen SE, Zeebari Z, Rohyo I, Galanti MR. Evaluation of a brief counseling for tobacco cessation in dental clinics among Swedish smokers and snus users. A cluster randomized controlled trial (the FRITT study). Prev Med. 2015 Jan;70:26-32. doi: 10.1016/j.ypmed.2014.11.005. Epub 2014 Nov 18.

  PMID: 25445335 BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know in which group they were randomized
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients in whom the inclusion criteria are met are asked by the triage nurses if they are smokers. Those patients are then asked by the triage nurses if they want to participate in the study; those who consent are randomized in the control or intervention group. The triage window of the software currently used for clinical care management in the ED (PsNet, Hi. Tech Spa) has been equiped in such a way that, for patients who agree to participate in the study, is casually print one of the two symbols on the informative consent paper given to patient in the end of the triage procedure.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: April 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: July 28, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

IT (1)