Reimbursement for smoking cessation treatment
| ISRCTN | ISRCTN55212198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55212198 |
| Protocol serial number | NTR104; STIVORO and the Dutch Asthma Foundation 3.4.03.28 |
| Sponsor | CAPHRI research institute, University Maastricht (Netherlands) |
| Funders | Dutch Asthma Foundation (Netherlands), STIVORO (Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 10/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Kaper
Scientific
Scientific
Care and Public Health Research Institute (CAPHRI), Maastricht University
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882420 |
|---|---|
| janneke.kaper@hag.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Random consent design |
| Secondary study design | Randomised controlled trial |
| Scientific title | (Added 18/08/09) The (cost)-effectiveness of reimbursement for smoking cessation treatment |
| Study objectives | Reimbursement for smoking cessation treatment will increase the use of the treatment and the number of quit attempts. The increased use of smoking cessation treatment by reimbursement will result into increased prolonged abstinence. |
| Ethics approval(s) | Approved by the Medical Ethics Committee of the Trimbos Institute in Utrecht, The Netherlands (May 2005). |
| Health condition(s) or problem(s) studied | Smoking cessation |
| Intervention | For a period of 6 months, smokers in the intervention group had the opportunity to apply for reimbursement for SCT. They received a leaflet with a description of the SCTs for which reimbursement was available, and information on how to receive the reimbursement. Smokers in the intervention group could receive full reimbursement for pharmacological treatment (bupropion and NRT (chewing gum, patch, tablet, sublingual tablet and inhaler)), behavioural counselling (written advice, telephone or face to face counselling) or a combination. To receive reimbursement, they had to send the receipt and two statements of personal contact with a health care professional (general practitioner, general practice nurse, physician, psychologist or health community worker) to the health insurance company. Before the study started, all the health care professionals in the study region were informed about the study. No limit was set on the number of applications for reimbursement. In the control, no reimbursement or information about smoking cessation treatment was offered. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome measure of the reimbursement study was continuous abstinence from smoking. Continuous abstinence was defined as not having smoked for at least seven days preceding the 6-month and 12-month questionnaire and not having relapsed between both questionnaires. After the 6-month and 12-month questionnaire, quitters were contacted to make an appointment for biochemical validation of their smoking status. |
| Key secondary outcome measure(s) |
Secondary outcomes were the use of smoking cessation treatment, the number of quit attempts that were undertaken, and the cost-effectiveness of reimbursement was assessed. |
| Completion date | 01/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1266 |
| Key inclusion criteria | We included smokers of at least 18 years old and healthcare insured by health insurance company "De Friesland Zorgverzekeraar". Participants did not have to be motivated to quit smoking. |
| Key exclusion criteria | Only one smoker per household was allowed to participate. |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 01/05/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Care and Public Health Research Institute (CAPHRI), Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2005 | Yes | No | |
| Results article | results on cost effectiveness | 01/07/2006 | Yes | No | |
| Results article | results on sustained abstinence | 01/11/2006 | Yes | No |
