Ready for SDM - evaluation of a multidisciplinary training module in Shared Decision Making
| ISRCTN | ISRCTN14184328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14184328 |
| Secondary identifying numbers | 15154 |
- Submission date
- 17/04/2018
- Registration date
- 09/05/2018
- Last edited
- 10/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
In response to an obvious lack of professional training about shared decision making (SDM) in Norway, a draft of the “Ready for SDM” program was developed based on a proven effective German module (doktormitSDM). Two applications (Norw. “Klar for samvalg”) (M1 / M2) have recently been tested in a pilot study, indicating a need for better adaptation to various health professions and inter-professional learning. This study aims at testing the effectiveness of the revised M2 regarding improvement of SDM-related evaluation competences.
Who can participate?
6-10 District Psychiatric Centers recruited from the South – Eastern Norway Regional Health Authority and the Western Norway Regional Health Authority
What does the study involve?
Participating District Psychiatric Centers are randomly allocated to either an intervention or a waiting control group. After a demographic questionnaire, the intervention group starts with the introduction module A, followed by B: SDM in-depth, and C: interactive training. After completion of modules A-C the intervention group participants are assessed, and the control group participants are assessed as long as the group is untrained (has not yet received the training module). After the study, the training module is also conducted for participants in the control group.
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 receive the same training.
Where is the study run from?
University Hospital of North Norway
When is the study starting and how long is it expected to run for?
March 2016 to June 2019
Who is funding the study?
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@gmail.com |
Study information
| Study design | Cluster randomized waiting control group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of a multidisciplinary training module in Shared Decision Making (Ready for SDM): a cluster randomized controlled trial |
| Study acronym | Ready for SDM |
| Study hypothesis | The specialist health service in Norway includes the district Psychiatric Outpatient Services (DPS), where both patients with acute problems and those who need long-term follow-up can receive help. The intervention provided in this study addresses patient involvement in making medical decisions. The overarching aim of this approach is to enhance patient involvement by provision of evidence-based patient information, alongside with the patients’ encouragement to participate in the decision process and thereby to increase the frequency of patient led informed choices. Patient involvement in this study is approached to via training of health professionals’ communication skills. The psychiatric domain has been chosen as the medical context for the study, to demonstrate efficacy of the intervention. Hypothesis: A 2-hour group training module can improve health professionals' communication competencies in Shared Decision Making (SDM), operationalized as accuracy of observer judgements regarding realized SDM made by use of the MAPPIN´SDM observer instrument. |
| Ethics approval(s) | 1. The local ethics committee at the University Hospital in Northern Norway (UNN), ref: 2017/1461 2. South-eastern regional ethics committee, ref: 2017/82 C |
| Condition | Shared decision making |
| Intervention | Participants are randomized to either an intervention or a waiting control group: Intervention: an SDM training module addressing health professionals, which includes the following: 1. 30-min didactics, introduction to SDM 2. 30-min deepening in SDM 3. Interactive SDM observer training using a video-recording of a psychiatric consultation and a set of evaluation criteria After administering a demographic questionnaire, the intervention group starts with the introduction module A, followed by B: SDM in-depth, and C: interactive training. After completion of modules A-C, primary and secondary endpoints are assessed. Control: waiting/no intervention Primary and secondary endpoints will be assessed as long as the group is untrained (has not yet received the training module). After the study, the training module will also be conducted for participants in the control group. |
| Intervention type | Behavioural |
| Primary outcome measure | Accuracy of observation-based judgements made on SDM performance in a given medical consultation, which is provided as a video-recorded consultation. Judgements will be made in terms of the dyadic MAPPIN´SDM immediately after provision of the SDM training module or the waiting condition, respectively. Accuracy is calculated using weighted T coefficients calculated pairwise between participants’ judgements and an expert standard rating. |
| Secondary outcome measures | SDM related knowledge assessed by using a five-item multiple choice knowledge test, previously used in a similar study. The level of achieved knowledge will be assessed immediately after provision of the SDM training module or the waiting condition, respectively. |
| Overall study start date | 15/03/2016 |
| Overall study end date | 16/06/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6-8 District Psychiatric Centers representing clusters in the study design, recruited from the South–Eastern Norway Regional Health Authority and the Western Norway Regional Health Authority. Power calculation was made using G-Power program software. Based on data (mean values and SDs) from a previous comparable study, a given alpha of 0.05 and a power of 0.95 and allowing for use of two-tailed analysis, N=54 is needed per study group. Considering a cluster factor of 0.25 and an estimated drop-out rate of 25%, total sample size is N = 158 participants (control group: N=79; Intervention group: N=79), to not oversee a difference of 0.15 weighted T coefficient. |
| Total final enrolment | 357 |
| Participant inclusion criteria | 1. Health professional teams from District Psychiatric Centers 2. Actively involved in psychiatric patient care |
| Participant exclusion criteria | 1. Non-health professionals and professionals from other settings than the pre-defined institutions 2. Health professionals working in administrative functions |
| Recruitment start date | 16/04/2018 |
| Recruitment end date | 16/06/2018 |
Locations
Countries of recruitment
- Norway
Study participating centres
5145
Norway
5113
Norway
5353
Norway
5054
Norway
5228
Norway
5705
Norway
2819
Norway
Sponsor information
Hospital/treatment centre
Sykehusvegen 38
Tromsø
9019
Norway
| Phone | +47 (0)77 62 60 00 |
|---|---|
| post@unn.no | |
| Website | https://unn.no/om-oss/university-hospital-of-north-norway |
"ROR" |
https://ror.org/030v5kp38 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Northern Norway Regional Health Authority
- Location
- Norway
Results and Publications
| Intention to publish date | 16/06/2020 |
|---|---|
| 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 | Planned publication in a high-impact peer reviewed, open access journal within one year after the overall trial end date. The results will also be presented at relevant national and international conferences. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2020 | 04/06/2020 | Yes | No |
| Results article | 30/04/2021 | 04/10/2022 | Yes | No | |
| Results article | 17/03/2022 | 10/06/2024 | Yes | No |
Editorial Notes
10/06/2024: Publication reference added.
04/10/2022: Publication reference added.
04/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/10/2018: Internal review.
