Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Counseling and Nicotine replacement (CN) (Behavioral); Counseling, Nicotine replacement and Bupropion (CNB) (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: ZonMw: The Netherlands Organisation for Health Research and Development

Official(s) and/or principal investigator(s):
Annelies E Jacobs, PHD, Study Chair, Affiliation: Radboud University

Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.

Results: Baseline analyses revealed the 22. 5% was willing to quit smoking within 1 month, another 31. 4% was willing to quit within six months. Greater motivation to quit smoking was positively associated with greater COPD symptom severity. After six months' follow-up more patients in the intervention group (CN: 16. 0%, CNB: 13. 3%) self-reported to have stopped smoking compared to patients receiving UC (8. 8%) (bivariate comparison between UC-CN and UC-CNB yielded significant differences in these quit rates (p's<.05)). After twelve months these figures hardly changed (CN: 14. 4%; CNB: 14. 5%; UC: 7. 4%). Biochemical verification (urine cotinine) of the self-reports dramatically lowered the quit rates (CN: 8. 6%; CNB: 8. 3%; UC: 4. 1%). Thus, addition of bupropion-SR to the program did not increase the effectiveness of the intervention, therefore in subsequent analysis the two intervention groups were treated as one. The self-reported 12 months' quit rates were 7. 4% in usual care versus 14. 5% in the intervention (p<.05); after biochemical verification quit rates decreased to 4. 1% and 8. 5% respectively (p>.05). Less severe dyspnoea complaints and having had telephone counseling by the practice assistant predicted success.

Conclusion: A great part of smoking patients with COPD is willing to quit smoking withing six months. Patients suffering from more severe COPD symptoms had greater motivation than patients experiencing less burden from the disease. Application of the moderate intensive intervention in routine general practice doubled the quit rates but yielded small effects. The program has potential to improve the treatment for patients with COPD and might be more successful if the quit attempt is supported by extra symptom medication. As the addition of bupropion-SR was only used by a minority its effectiveness in routine care could not be proven. Telephone follow-up counseling seems a useful support aid.

Official title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Primary outcome: Smoking cessation (point prevalence, both self reported as biochemical verified)

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

- Current smoking

- Suffering from COPD according to the GP's diagnosis

- In command of the Dutch language.

Exclusion Criteria:

- Too ill

- Under control of a chest physician

- Serious physical or psychological comorbidity

Radboud University Nijmegen Medical Centre, Nijmegen 6500HB, Netherlands

Starting date: March 2000
Ending date: December 2003
Last updated: February 25, 2008