F17
Conditions
Interventions
Group 1: All participating general practitioners and health care assistants will receive training on the trial protocol and procedures as well as a very brief (two pages) handout with an overview of t
Sponsors
Institut für Allgemeinmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: currently smoking 10 or more cigarettes per day
Exclusion criteria
Exclusion criteria: terminally ill, pregnant/breastfeeding; moderate-to-severe cognitive impairment; contra-indications for the use of any smoking cessation pharmacotherapy; insufficient command of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary scientific objective is to assess, in the context of brief GP advice to stop smoking according to the ABC method, whether offering full reimbursement of the costs for smoking cessation pharmacotherapy compared with no reimbursement (i.e., current care as usual) increases abstinence from smoking after 12 weeks in smoking patients consulting their GP. Patients from both the intervention and control groups will fill out a questionnaire in their GP practice at baseline and at 12-week follow-up. The questionnaire items are based on an ongoing national survey on the use of tobacco in the German population (Deutsche Befragung zum Rauchverhalten, DEBRA: www.debra-study.info). Furthermore, patients will verify their tobacco abstinence with an exhaled carbon monoxide test using a reliable and valid handheld tool (each practice will be equipped with a Bedfont piCO Smokelyzer). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary scientific objectives are to assess whether brief GP advice and free pharmacotherapy increase the rate at which patients make an attempt to quit smoking, use and adhere to pharmacotherapy or other methods to aid their quit attempt, report any adverse or serious adverse events and changes in health-related quality of life between baseline and 12-week follow-up. The questionnaire items are based on an ongoing national survey on the use of tobacco in the German population (Deutsche Befragung zum Rauchverhalten, DEBRA: www.debra-study.info). We also have a network objective, i.e., we want to demonstrate the practicability and feasibility of conducting trials within the NRW-GPRN and identify unforeseen problems that could compromise the quality or flow of such studies. We, therefore, plan to conduct a mixed-methods process evaluation. For the process evaluation, we will conduct separate qualitative focus group interviews with 6-8 GP-HCA dyads (2 groups) and 12-16 patients (2 groups) regarding relevant topics of study participation. For the process validation, we will also take all existing study data into account, such as data on recruitment (e.g., participation rate), use of software (REDCap) to collect patient data online in GP practices, training success of GPs in e-learning, and performance of surveys (e.g., missing data). | — |
Countries
Germany
Contacts
Public ContactDaniel Kotz
Institut für Allgemeinmedizin
Outcome results
None listed