The coaching for smokers trial
| ISRCTN | ISRCTN38129107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38129107 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/09/2017
- Registration date
- 02/10/2017
- Last edited
- 18/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Tobacco abuse is a frequent issue in primary care, and general practitioners (GPs) play a key role in promoting smoking cessation to their patients who smoke. However, smoking is often accompanied by other harmful behavior patterns, and not all smokers are ready and willing to give up smoking. Thus, a GP focusing on smoking cessation alone might waste the opportunity to improve his patient’s health by supporting a change of another adverse habit of higher priority from the patient’s view. A “multithematic” and patient-centered coaching strategy based on shared decision making and motivational interviewing should be preferred over a mere smoking cessation approach. The health promoting program “Gesundheitscoaching-KHM” (www.gesundheitscoaching-khm.ch), developed by a group of Swiss family doctors, is based on the above principles with particular emphasis on the patients’ freedom of choice with regard to what aspect of their health-related behavior they want to address primarily. The program has already proved its practicability in a study carried out among primary care practitioners and their patients in eastern Switzerland. This present study intends to show that using “Gesundheitcoaching-KHM” with smokers among general practitioners’ patients will lead to higher overall health benefits without resulting in a reduced rate of successful smoking cessation, compared to a “monothematic” state of the art smoking cessation scheme.
Who can participate?
Primary care providers in the German-speaking part of Switzerland without any previous training in “Gesundheitscoaching-KHM”, and their cigarette smoking adult patients
What does the study involve?
The general practitioners are randomly allocated to either the intervention or the control group. The general practitioners in the intervention group then undergo a standardized teaching session involving role play with actors posing as patients (standardized patients) and covering communication skills and the use of various structured counseling tools. The control group is instructed in smoking cessation counseling and the use of smoking cessation tools only. After training, the participating general practitioners recruit cigarette smokers from their patients. The included patients undergo a variable number of individual coaching or counseling sessions with their doctors. Coaching of patients in the intervention group is conducted according to “Gesundheitscoaching-KHM” and patients in the control group receive state of the art smoking cessation counseling. Data from the patients is collected over a period of 12 months after the first session (follow up). Self-reported smoking cessation is confirmed by means of saliva cotinine tests.
What are the possible benefits and risks of participating?
The patients profit from the beneficial effects of either “Gesundheitscoachig-KHM” or of smoking cessation counseling. General practitioners receive a financial incentive. No new or untested treatment or therapy will be tried on the patients and no invasive procedures performed. Therefore, the risk for all study participants is minimal and not higher than the risk associated with established smoke cessation or other counseling-based health promoting programs.
Where is the study conducted?
Institute of Primary Care of the University of Zurich (Switzerland)
When is the study starting and how long is it expected to run for?
January 2017 to December 2021
Who is funding the study?
1. Tobacco-prevention fund TPF, c/o Federal Office of Public Health FOPH (Switzerland)
2. Institute of Primary Care, University Hospital Zurich (Switzerland)
Who is the main contact?
1. Dr. med. Stefan Neuner-Jehle MPH (scientific)
stefan.neuner-jehle@usz.ch
2. Dr Thomas Grischott (public)
thomas.grischott@usz.ch
Contact information
Scientific
Institute of Primary Care
University Hospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
| Phone | +41 (0)44 255 98 55 |
|---|---|
| stefan.neuner-jehle@usz.ch |
Public
Institute of Primary Care
UniversityHospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
 ORCID ID |
0000-0002-1564-5296 |
|---|---|
| Phone | +41 (0)44 255 98 55 |
| thomas.grischott@usz.ch |
Study information
| Study design | Single-center double-blind cluster-randomized parallel-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Efficacy of motivating short interventions for smokers in primary care: a cluster randomized controlled trial |
| Study acronym | COSMOS |
| Study hypothesis | Activating and coaching of cigarette smoking patients in general practitioners’ offices following the principles of the health-promoting program ”Gesundheitscoaching-KHM” leads to improved health-related behavior with better overall health benefits than subjecting all smoking patients to a monothematic state of the art smoke cessation scheme, without resulting in a reduced rate of successful smoke stops. |
| Ethics approval(s) | Ethics Committee of the Canton of Zurich, 23/01/2018, request no. 2017-02043 |
| Condition | Tobacco abuse and other modifiable health risk factors of smokers |
| Intervention | The general practitioners are randomly allocated to either the intervention or the control arm of the trial. Randomization on the level of physicians (= clusters) with stratification by type of doctor's office (i.e. single and group practice being the strata) will be done using a software random number generator. The general practitioners in the intervention group will be trained in coaching according to the principles of “Gesundheitscoaching-KHM”. In group training sessions of four hours involving standardized patients they will be taught how to use motivational interview techniques and validated coaching tools to explore, promote and build on their patients’ motivation and confidence to achieve a change of their modifiable health risk factors. The general practitioners in the control group will be trained in the use of a smoke cessation counseling-algorithm based on the motivation of the patient. The training will correspond in duration and structure to the training of the physicians in the intervention arm but will be different with regard to content. After training, the participating general practitioners will recruit cigarette smokers successively from their patients. The included patients will undergo a variable number of individual coaching or counseling sessions with their doctors (usually up to three). Coaching of patients in the intervention arm will be conducted according to “Gesundheitscoaching-KHM” and patients in the control arm will receive state of the art smoke cessation counseling. Data from the patients will be collected over a period of 12 months after the first session (follow up). Self-reported smoke stops will be confirmed by means of saliva cotinine tests. |
| Intervention type | Behavioural |
| Primary outcome measure | Proportion of participants with any relevant health-promoting change in either smoking behavior, body weight, physical activity, alcohol consumption, stress level, eating habits or another self-chosen health related behavioral dimension (self-declaration questionnaires; additional confirmatory saliva cotinine test after 12 months) after 1, 6 and 12 months |
| Secondary outcome measures | 1. Smoking cessation rates among patients with high intrinsic motivation to stop smoking after 1, 6, and 12 months based on self-declaration (questionnaires) and after 12 months using saliva cotinine-testing 2. Smoking cessation rates among all participants after 1, 6, and 12 months based on self-declaration (questionnaires) and after 12 months using saliva cotinine-testing 3. Reduction in number of cigarettes per day (self-declaration questionnaires) after 1, 6, and 12 months compared to baseline 4. Weight loss in units of 1 kg (self-declaration questionnaires) after 1, 6, and 12 months, compared to baseline 5. Increase in physical activity time per week in units of 5 minutes (self-declaration questionnaires) after 1, 6, and 12 months, compared to baseline 6. Reduction in number of standard drinks per week (self-declaration questionnaires) after 1, 6, and 12 months, compared to baseline, and number of alcohol-free days per week (self-declaration questionnaires) at 1, 6, and 12 months 7. Reduction in score of the 10-item Perceived Stress Scale (PSS-10, German version) after 1, 6, and 12 months, compared to baseline 8. Increase in score of translated “MedDietScore” questionnaire after 1, 6, and 12 months, compared to baseline 9. Participant’s degree of motivation and – if applicable – confidence to achieve and maintain a change in behavior (self-efficacy) (self-declaration questionnaires after each coaching/counseling session) 10. If applicable: Availability of a plan on when and how to take action (action planning) and existence of a relapse plan (coping planning) (self-declaration questionnaires after each coaching/counseling session) Parameters describing setting (e.g. characteristics of GPs’ clientele and infrastructure), process quality (e.g. training course quality), structure quality (e.g. refusal or dropout rates), and other data will be collected as covariates using questionnaires after recruitment of GPs, GP training, and the GPs’ individually last patient coachings/counselings). |
| Overall study start date | 01/01/2017 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 general practitioners (clusters) and 200 patients (target cluster size about 4) |
| Total final enrolment | 239 |
| Participant inclusion criteria | 1. Current cigarette smoker 2. Male or female of at least 18 years of age 3. Registered as patient in the recruiting physician’s patient base 4. Capable of judgement with regard to participation in the study 5. Signed informed consent after being informed |
| Participant exclusion criteria | 1. Severe general or psychiatric illness (e.g. malignancy, major depressive episode, dementia etc) 2. Inability of the participant to follow the procedures of the study due to other reasons (e.g. language problems) 3. Foreseeable change of general practitioner within one year (e.g. due to planned relocation) On the level of general practitioners previous training in “Gesundheitscoaching-KHM” disqualifies from participation in the study. |
| Recruitment start date | 01/01/2018 |
| Recruitment end date | 30/06/2020 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
Sponsor information
University/education
attn. Dr. med. Stefan Neuner-Jehle MPH
University Hospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
| Phone | +41 (0)44 255 98 55 |
|---|---|
| stefan.neuner-jehle@usz.ch | |
| Website | http://www.hausarztmedizin.uzh.ch/de.html |
"ROR" |
https://ror.org/029ma5383 |
Funders
Funder type
Government
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Zurich, Switzerland, University of Zurich, UZH
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The study protocol will be submitted for publication before completion of patient recruitment. Full study results are intended to be published in an international scientific journal from October 2019 to December 2020. |
| IPD sharing plan | Current IPD sharing statement as of 09/12/2021: Deidentified individual participant data, informed consent forms, and/or case report forms generated and/or analysed during the current study will be available for research purposes related to the trial from the sponsor-investigator Dr. med. Stefan Neuner-Jehle MPH (stefan.neuner-jehle@usz.ch) after the publication of the study results. All proposals requesting data access will need to specify an analysis plan and have approval from the Hospital Discharge Study research group before data release. Previous IPD sharing statement: The data-sharing plans for the current study are currently unknown and will be made available at a later date. All study data will be archived at the study center (Institute of Primary Care, University Hospital Zurich) for a minimum of 10 years after study completion or premature termination of the clinical trial. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/01/2019 | Yes | No | |
| Results article | 27/06/2022 | 18/07/2022 | Yes | No |
Editorial Notes
18/07/2022: Publication reference added.
08/03/2022: 90 general practitioners and 149 patients were recruited to the study so the total final enrolment number has been changed from 136 to 239.
09/12/2021: The IPD sharing statement was updated.
10/07/2020: The total final enrolment was added.
06/04/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2018 to 30/06/2020.
2. The overall trial end date has been changed from 31/12/2020 to 31/12/2021.
3. The intention to publish date has been changed from 01/10/2019 to 31/03/2022.
4. The plain English summary has been updated to reflect the changes above.
29/01/2019: Publication reference added.
26/01/2018: Ethics approval information added.
