Ready for SDM - The effect of a digital training module for clinicians supporting the implementation of shared decision-making
| ISRCTN | ISRCTN74230763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74230763 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Helse Sør-Øst RHF - South-Eastern Norway Regional Health Authority |
| Funder | Helse Sør-Øst RHF - South-Eastern Norway Regional Health Authority |
- Submission date
- 15/02/2023
- Registration date
- 17/02/2023
- Last edited
- 17/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Shared decision-making (SDM) is a strongly recommended approach for health care providers (HCPs) to use when supporting people in making decisions about their health.
Ready for SDM was developed as a comprehensive modularized curriculum for health care providers (HCP) in response to a lack of SDM professional training in Norway. The curriculum consists of several SDM training modules using various formats, providing guidance for tailoring SDM training to the different contexts and needs of HCPs. The “Ready for SDM e-learning training program was developed based on a proven effective German module, and builds on behaviour and learning theory. As didactic methods, video examples of suboptimal/optimal SDM consultations and additional exercises are applied.
There is limited formal evaluation of such training program despite the increased availability of e-learning training for HCPs internationally. This study will investigate the efficacy of a 1-hour online SDM training designed to enhance SDM competencies.
Who can participate?
Physicians working in hospital trust within the South-eastern Norway Regional Health Authority.
What does the study involve?
Clusters of physicians attending planned SDM trainings within the South – Eastern Norway Regional Health Authority are going to be included and randomized to either an intervention - or a waiting list control group. The intervention includes a 1-hour online SDM training module.
What are the possible benefits and risks of participating?
Participants taking part in this study may benefit by getting increased knowledge and skills in SDM, furthermore it may have future benefits, as the results of the study are likely to influence the implementation of SDM in Norway. There are no notable risks to participants in this study, and both groups will receive the same training.
Where is the study run from?
Helse Sør-Øst RHF - South-Eastern Norway Regional Health Authority
When is the study starting and how long is it expected to run for?
February 2023 to March 2025
Who is funding the study?
Helse Sør-Øst RHF - South-Eastern Norway Regional Health Authority
Who is the main contact?
Simone Kielin, simone.kienlin@helse-sorost.no
Contact information
Scientific
Parkgata 36
Hamar
2317
Norway
 ORCID ID |
0000-0001-7367-2009 |
|---|---|
| Phone | +47 93642406 |
| simone.kienlin@helse-sorost.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of a digital training module for clinicians supporting implementation of shared decision-making - a randomized controlled trial. |
| Study acronym | Ready for SDM |
| Study objectives | A 1-hour online training module can improve clinicians’ communication competencies in shared decision-making (SDM), operationalized as accuracy of observer judgements made by use of the MAPPIN´SDM observer instrument of patient involvement in a test video of a doctor-patient consultation. |
| Ethics approval(s) | 1. Approved 16/02/2023, The ethics committee at the South-Eastern Norway Regional Health Authority (Helse Sør-Øst RHF, Postboks 404, 2303 Hamar, Norway; +47 (0)62 58 55 00; postmottak@helse-sorost.no), ref: 2017/82 C 2. Approval pending, The ethics committee at the University Hospital in North Norway (UNN; Universitetssykehuset Nord-Norge HF, Postboks 100, 9038 Tromsø, Norway; +47 (0)776 26000; personvernombudet@unn.no), ref: 2017/1461 |
| Health condition(s) or problem(s) studied | Training in Shared Decision-making |
| Intervention | Intervention: The “Ready for SDM digital training module was developed based on a proven effective German module. Learning objectives; After the course the participants should be able to: 1. Explain background and rationale for SDM and the situations in which it is relevant 2. Explain and justify the structure of an SDM process and its quality criteria 3. Apply the structure of an SDM process in clinical practice The course consists of films and assignments and give the clinicians the opportunity to reflect on SDM in clinical practice. The digital training module is underpinned by behavior and learning theories and contains video examples of suboptimal/optimized SDM consultations and additional exercises. The Ready for SDM e-learning includes the following: • Basic introduction to SDM • SDM-relevant decisions • Risk communication • SDM-case in oncology • 6 - step model of SDM including video examples • Refection exercises on SDM in clinical practice • Exercises about risk communication and the suboptimal/optimized video examples • Course test Study procedures Clusters of physicians attending planned SDM trainings within the South – Eastern Norway Regional Health Authority are going to be included and randomized to either an intervention - or a waiting list control group. Block randomization will be used to randomize clusters. The allocation will be concealed. An independent external person will prepare sealed opaque envelopes. After baseline assessment (demographic questionnaire) of the respective cluster the sealed opaque envelope will be opened, the intervention group starts with the training module. After completion of the training module primary and secondary endpoints are assessed. Primary and secondary endpoints will be assessed in the control group untrained (before starting the training). After assessment of the study endpoints, the training will also be conducted for participants in the control group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Agreement between the participants’ and an expert assessment of patient involvement in a video recorded consultation. |
| Key secondary outcome measure(s) |
1. The ability to identify SDM relevant decisions will be assessed using a open-ended question within a questionnaire before (control group) or after (intervention group) the intervention. |
| Completion date | 01/03/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Physicians working in hospital trust within the South-eastern Norway Regional Health Authority. |
| Key exclusion criteria | Those already having undertaken any SDM-training in the past two years. |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 01/04/2023 |
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 used and/or analysed during the current study are available from the corresponding author on reasonable request: Simone Kienlin (simone.kienlin@helse-sorost.no). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/02/2023: Trial's existence confirmed by The ethics committee at the South-Eastern Norway Regional Health Authority.
