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

This study has been terminated.
(recruitment of patients did not reach sufficient numbers)
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00294905
First received: February 21, 2006
Last updated: September 22, 2010
Last verified: February 2007
  Purpose

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.


Condition Intervention
COPD
Behavioral: Implementation of a combined smoking cessation strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months

Secondary Outcome Measures:
  • Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients

Estimated Enrollment: 2700
Study Start Date: March 2006
Estimated Study Completion Date: June 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294905

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research (WOK)
117 KWAZO, Postbus 9101, 6500 Hb, Netherlands, Nijmegen
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: R. Grol, PhD Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00294905     History of Changes
Other Study ID Numbers: 945-16-104
Study First Received: February 21, 2006
Last Updated: September 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
COPD
smoking cessation
implementation
patient counseling
general practice

ClinicalTrials.gov processed this record on October 23, 2014