Smoking CessationCESARNCT05461066
Cost-effectiveness of a Tobacco Cessation Care Service in the Community Pharmacy
A study testing CESAR training in people with Smoking Cessation and Pharmacist-Patient Relations, run by Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Pharmacist-Patient Relations
- What is being tested?
- CESAR training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- cognitive impairment
- drug uses
- pregnancy or lactation.
About this study
Official title: Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up
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.
- Conditions
- Smoking Cessation, Pharmacist-Patient Relations
- Being tested
- CESAR training
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CESAR trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Smoking cessation intervention in community pharmacies Receives: Behavioral: CESAR training |
| Control | Active comparator | Usual care of smoking cessation in community pharmacies Receives: Behavioral: CESAR training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Dichotomicus variable (yes/no)
Measured: Before/after the intervention (1 year)
Quality of Life (EuroQOL-5D)
Measured with EuroQOL-5D
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461066
- Sponsor's protocol ID
- EPA-13-16
- Acronym
- CESAR
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Gomez Martinez JC, Gaztelurrutia Lavesa L, Mendoza Barbero A, Plaza Zamora J, Lage Pinon M, Aguilo Juanola M, Climent Catala M, de Andres Dirube A, Garcia Moreno L, Jaraiz Magarinos I, Moral Ajado M, Sanchez Marcos N. Smoking cessation intervention in the community pharmacy: Cost-effectiveness of a non-randomized cluster-controlled trial at 12-months' follow-up. Res Social Adm Pharm. 2024 Jan;20(1):19-27. doi: 10.1016/j.sapharm.2023.09.003. Epub 2023 Sep 7.
PubMed 37704533
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation Care Service in the Community Pharmacy: Cost-effectiveness of a Non-randomized Cluster-controlled Trial at 12-months' Follow-up
- ClinicalTrials.gov ID
- NCT05461066
- Acronym / sponsor ID
- CESAR / EPA-13-16
- Conditions
- Smoking Cessation, Pharmacist-Patient Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Sociedad Espanola de Farmacia Clinica, Familiar y ComunitariaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CESAR trainingSmoking cessation intervention in community pharmacies |
| Control | Active comparator | Behavioral: CESAR trainingUsual care of smoking cessation in community pharmacies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- cognitive impairment
- drug uses
- pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CESAR trainingIntervention 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. | Behavioural | Control, Intervention |
Primary outcome
Smoking cessation
Time frame: Before/after the intervention (1 year)
Dichotomicus variable (yes/no)
Quality of Life (EuroQOL-5D)
Time frame: 1 year
Measured with EuroQOL-5D
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Derived from this study: PubMed 37704533Gomez Martinez JC, Gaztelurrutia Lavesa L, Mendoza Barbero A, Plaza Zamora J, Lage Pinon M, Aguilo Juanola M, Climent Catala M, de Andres Dirube A, Garcia Moreno L, Jaraiz Magarinos I, Moral Ajado M, Sanchez Marcos N. Smoking cessation intervention in the community pharmacy: Cost-effectiveness of a non-randomized cluster-controlled trial at 12-months' follow-up. Res Social Adm Pharm. 2024 Jan;20(1):19-27. doi: 10.1016/j.sapharm.2023.09.003. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CESAR training in people with Smoking Cessation and Pharmacist-Patient Relations, run by Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: Before/after the intervention (1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.