Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy

Smoking Cessation Clinical Trial

— CESAR  

Official title:

Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461066
• Other study ID #: EPA-13-16
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2022
• Source: Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was a non-randomized controlled trial of 12-months' follow-up with 182 Spanish community pharmacists. Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours. The control group received the usual care. Data were self-reported and collected in a computerized health registration system. Outcomes were smoking cessation and quality of life (EuroQOL-5D) collected at baseline, 6 months', and 12 months' follow-up. Cost data were collected for the study period and included direct health costs, sick leave, and intervention costs. Smoking cessation was analysed through logistic regression models. Generalized linear models were carried out for quality-adjusted life year costs. Incremental cost-effectiveness ratios (ICERs) and cost-utility ratios (RCUI) were calculated. Sensitivity analyses were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smoker over 18 years old
• consent to participate
• presence at the community pharmacy for one of three reasons (a) a medical prescription for a treatment to stop smoking, (b) a consultation about how to stop smoking, (c) asking if he/she smokes when he/she consults for associated symptoms or harm.

Exclusion Criteria:

• cognitive impairment
• drug uses
• pregnancy or lactation.

Related Conditions & MeSH terms

• Pharmacist-Patient Relations
• Smoking Cessation

Intervention

Behavioral:
• CESAR training
Intervention community pharmacists received the CESAR training to improve their smoking cessation services, consisting of an initial interview and follow-up visits to identify obstacles and reinforce behaviours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation	Dichotomicus variable (yes/no)	Before/after the intervention (1 year)
Primary	Quality of Life (EuroQOL-5D)	Measured with EuroQOL-5D	1 year
Primary	Cost-effectiveness	In cost-effectiveness, the deterministic Incremental Cost Effectiveness Ratio (ICER) is the coefficient resulting from dividing the difference between groups in costs by the difference in probability between groups that an additional patient will cease their smoking history.	1 year
Primary	Cost-utility	For the cost-utility, the Deterministic Incremental Cost-Utility Ratio (ICUR) is the coefficient resulting from dividing the difference between groups in costs by the difference between groups in quality-adjusted life years.	1 year