Skip to main content
OpenTrials
Completed

NCT Number: NCT05461066

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CESAR training

Behavioral

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.

Primary outcomes

  1. Smoking cessation

    Time frame: Before/after the intervention (1 year)

    Dichotomicus variable (yes/no)

  2. Quality of Life (EuroQOL-5D)

    Time frame: 1 year

    Measured with EuroQOL-5D

  3. Cost-effectiveness

    Time frame: 1 year

    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.

  4. Cost-utility

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria

Other

Registry information

Official study title

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

Acronym: CESAR

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.