Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

COPD Clinical Trial

Official title:

Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294905
• Other study ID #: 945-16-104
• Status: Terminated
• Phase: N/A
• First received: February 21, 2006
• Last updated: September 22, 2010
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates a large scale implementation strategy in a 2-armed community intervention trial. The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.

Description:

COPD is an increasing cause of death and morbidity and smoking is its primary cause. Professional smoking cessation treatment is very cost-effective and therefore recommended by national guidelines. A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The incremental cost-effectiveness ratio (ICER) was Euro 1012 showing that the protocol was cost-effective. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates an implementation strategy in a 2-armed community intervention trial. General practices (N=150, 2700 smoking patients with COPD) will be randomly allocated to the intervention or control condition. In the control condition the usual dissemination strategy of distributing guidelines and subsequent products through the professional channels (journals, postgraduate education) will take place. In the intervention condition a multifaceted implementation strategy wil be executed aimed at support of the general practice team (outreach education by a facilitator, support for detecting smoking patients with COPD, provision of patient education materials, help desk/website, telephone and e-mail reminders). The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures. Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months. Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients. A process analysis and evaluations by patients and professionals are an integral part of the study. A cost-effectiveness analysis taking a health care sector perspective will be performed and will show the expected costs per practice and an incremental cost-effectiveness ratio (ICER). The study will last 34 months, the intervention period will take 18 months per practice.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2700
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• COPD

• Smoking

• Age 40 years or over

Exclusion Criteria:

• Under control of lung specialist

• Not Dutch-speaking

• Serious physical of psychiatric comorbidity

• Under 40 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Implementation of a combined smoking cessation strategy

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research (WOK)	117 KWAZO, Postbus 9101	6500 Hb

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Hilberink SR, Jacobs JE, Bottema BJ, de Vries H, Grol RP. Smoking cessation in patients with COPD in daily general practice (SMOCC): six months' results. Prev Med. 2005 Nov-Dec;41(5-6):822-7. Epub 2005 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months
Secondary	Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients

External Links

•   Site of the Centre for Quality of Care Research (WOK)