Ready for shared decision making - evaluating a train-the-trainer module to facilitate the implementation of shared decision making in Norway
| ISRCTN | ISRCTN99432465 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99432465 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 19/00754 |
| Sponsor | University Hospital of North Norway |
| Funders | Helse Sør-Øst RHF, Helse Nord RHF |
- Submission date
- 24/03/2020
- Registration date
- 25/03/2020
- Last edited
- 05/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Despite strong international advocacy for shared decision making (SDM) and increasing implementation efforts, it has not yet been routinely adopted in most of the decisions, where alternatives exist. To implement SDM, there is a need for both training modules with proven efficacy and strategies to distribute them and make them part of the routines in the health system. In Norway, researchers have developed “Ready for SDM”, a comprehensive curriculum tailored to various HCP, settings, and levels. The interprofessional SDM training module has proven feasible and efficient in previous studies. The aim of this study is to evaluate a corresponding train-the-trainer module aiming at facilitating use of the latter in clinical practice in Norway.
Who can participate?
Healthcare professionals working within the South-Eastern Norway Regional Health Authority
What does the study involve?
The intervention includes a 3-day SDM train-the-trainer program for healthcare professionals located at different hospital Trusts within the South-Eastern Norway Regional Health Authority. Using a self-administered questionnaire, demographic data and the secondary endpoints are assessed immediately after the training. Three months after the course the number of SDM trainings carried out by the participants and the number of trainees trained will be evaluated.
What are the possible benefits and risks of participating?
Participants taking part in this study may benefit from increased knowledge and skills in SDM and teaching SDM. Furthermore, it may have future benefits, as the results of the study are likely to influence the implementation of SDM in Norway. If the initiative fails or is perceived as either irrelevant or too challenging, attitudes towards SDM and its implementation might impede future attempts.
Where is the study run from?
South-Eastern Norway Regional Health Authority
When is the study starting and how long is it expected to run for?
January 2018 to September 2020
Who is funding the study?
1. South-Eastern Norway Regional Health Authority
2. Northern Norway Regional Health Authority
Who is the main contact?
Simone Kienlin
simone.kienlin@helse-sorost.no
Contact information
Scientific
Enggata 66
Hamar
2317
Norway
 ORCID ID |
0000-0001-7367-2009 |
|---|---|
| Phone | +47 (0)93642406 |
| simone.kienlin@helse-sorost.no |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study using the Kirkpatrick Modell (2016) as orientation in choosing outcome parameters |
| Secondary study design | |
| Scientific title | Evaluating a train-the-trainer program to facilitate implementation of shared decision making in Norway |
| Study acronym | Ready for SDM – TTT |
| Study objectives | The train-the trainer workshop facilitates implementation of “Ready for SDM” in clinical practice. |
| Ethics approval(s) | Approved 06/09/2019, ethics committee at the South-Eastern Norway Regional Health Authority (Heidi Thorstensen, Postbox 403, 2303 Hamar, Norway; Switchboard: 02411; postmottak@helse-sorost.no), ref: 19/00754 |
| Health condition(s) or problem(s) studied | Shared decison making |
| Intervention | Intervention: A 3-day train-the-trainer workshop addressing healthcare professionals, comprising: Day 1: Introduction, dissemination of learning objectives, a two-hour SDM training, several exercises and group reflections, such as a behaviour change technique to overcome barriers towards SDM. Day 2 and 3: Participants practice applying quality criteria for SDM. The MAPPIN´SDM observer instrument is used for judging clinical consultations regarding patient involvement. At the end of day 3, an online platform hosting a toolkit and information is presented and the participants are given access. Learning objectives: 1. Be able to conduct the 2-hour “Ready for SDM” module (comprising basic SDM lecture and an interactive part using videos of clinical consultations) 2. Be able to define the quality criteria for SDM 3. Be able to judge decision consultations, (using SDM quality criteria) 4. Be able to provide feedback on quality of patient involvement |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Number of SDM trainings carried out by the participants and the number of trainees trained, measured using a questionnaire based on an email request at 3 months post intervention (TTT workshop) |
| Key secondary outcome measure(s) |
Assessed immediately after the course: |
| Completion date | 09/09/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 29 |
| Key inclusion criteria | Participants from all health trusts (HF) of the region will be recruited consecutively, based on an invitation by the South-Eastern Regional Health Authority |
| Key exclusion criteria | Those without occasion to give SDM courses |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 09/01/2020 |
Locations
Countries of recruitment
- Norway
Study participating centre
Hamar
2317
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Simone Kienlin (simone.kienlin@helse-sorost.no). Type of data: qualitative and quantitative data. Available after publishing around 01/12/2020 until 2025. Access criteria: according to the ethical approval data can be shared only with researchers and purposes associated with the “Ready for SDM” project. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2021 | 05/05/2021 | Yes | No |
Editorial Notes
05/05/2021: Publication reference added.
03/09/2020: Total final enrolment number added.
25/03/2020: Trial's existence confirmed by the ethics committee at the South-Eastern Norway Regional Health Authority.
