Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process (DISCO-SET)

Smoking Cessation Clinical Trial

— DISCO-SET  

Official title:

Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833933
• Other study ID #: 35RC21_9742_DISCO-SET
• Status: Completed
• Start date: April 7, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: November 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.

Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.

Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.

The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.

The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Active smoker patient at inclusion in the DISCO study,

• No objection to participate in the study,

• Patient still followed in the active file of general practitioners' offices (GP).

• Patient's telephone and postal details available

Exclusion Criteria:

• Patient not physically or mentally able to complete the phone survey,

• Patient deceased,

• Patient not reachable despite 5 phone calls and message left on answering machine.

• Patient under curatorship, guardianship or safeguard of justice

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive
• Smoking Cessation

Intervention

Other:
• Phone survey about smoking cessation process since intervention in DISCO trial
We will conduct a phone survey at 2 years follow-up with a random sample of smoking patients at inclusion in DISCO trial, to know the evolution of their smoking habits, the quit attempts since the intervention and the modalities of these attempts.

Locations

Country	Name	City	State
France	Emmanuelle FOURE-AMELOT	Bédée	Bretagne
France	Béatrice NEGARET	Breteil	Bretagne
France	Lucie DELATTE	Janzé	Bretagne
France	Marie BROSSET	Miniac-Morvan	Bretagne
France	Antoine MOUTEL	Redon	Bretagne
France	Anna JARNO-JOSSE	Rennes	Bretagne
France	Hoël CHARBONNEL	Rennes	Bretagne
France	Romain NIFENECKER	Rennes	Bretagne
France	Jean-Philippe DUGUEY	Saint-Malo	Bretagne
France	Laurent LENOBLE	Sulniac	Bretagne
France	Lucie MURGALE	Talensac	Bretagne
France	Marieke SALACROUP	Tremblay	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of smoking patients with at least 1 episode of smoking cessation attempts of at least 28 days since inclusion in the DISCO study.		2 years
Secondary	Smoking cessation of at least 7 days	Number of patients with smoking cessation of at least 7 days in patients who had quit smoking by the day of the survey, since inclusion in DISCO study	2 years
Secondary	Smoking cessation of at least 28 days	Number of patients with smoking cessation of at least 28 days in patients who had quit smoking by the day of the survey, since inclusion in DISCO study	2 years
Secondary	Smoking cessation of at least 6 months	Number of patients with smoking cessation of at least 6 months in patients who had quit smoking by the day of the survey, since inclusion in DISCO study	2 years
Secondary	Smoking cessation attempts of 7 days	Number of patients with smoking cessation attempts of 7 days in active smoking patients at the day of the survey, since inclusion in DISCO	2 years
Secondary	Smoking cessation attempts of 28 days	Number of patients with smoking cessation attempts of 28 days in active smoking patients at the day of the survey, since inclusion in DISCO	2 years
Secondary	Smoking cessation attempts of 6 months	Number of patients with smoking cessation attempts of 6 months in active smoking patients at the day of the survey, since inclusion in DISCO	2 years
Secondary	Cumulative duration (days) of smoking cessation attempts since inclusion in DISCO study		2 years
Secondary	Change in daily tobacco consumption in cigarettes per day, compared to the consumption reported at inclusion in DISCO		2 years
Secondary	Change in daily tobacco consumption in cigarettes per day at least 50% on the day of the survey, compared to the consumption reported at inclusion in DISCO		2 years
Secondary	Percentage of patients who made their first smoking cessation attempt in their life since their inclusion in the DISCO study		2 years
Secondary	Percentage of patients who used each kind of heath professionnal aid and material cessation aid since their inclusion in the DISCO study		2 years
Secondary	Percentage of patients who have discussed smoking with their general practitioner and number of consultations where this was discussed since their inclusion in the DISCO study		2 years
Secondary	Percentage of general practitioners still in practice, available for this study and who have not changed their patient base		2 years
Secondary	Percentage of patients included with completed questionnaires in the sample of 120 patients, with percentage of refusals to participate, incomplete questionnaires and non-responders		2 years
Secondary	Average number of calls per patient before inclusion and per patient included with completed questionnaire		2 years
Secondary	Average number of trips per practitioners and per number of patients included in each practitioners		2 years