Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Simone Kienlin
ORCID ID
https://orcid.org/0000-0001-7367-2009
Contact details
Enggata 66
Hamar
2317
Norway
+47 (0)93642406
simone.kienlin@helse-sorost.no
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
19/00754
Study information
Scientific title
Evaluating a train-the-trainer program to facilitate implementation of shared decision making in Norway
Acronym
Ready for SDM – TTT
Study hypothesis
The train-the trainer workshop facilitates implementation of “Ready for SDM” in clinical practice.
Ethics approval
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
Study design
Observational study using the Kirkpatrick Modell (2016) as orientation in choosing outcome parameters
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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)
Secondary outcome measures
Assessed immediately after the course:
1. Observation competence assessed using the observer-based instrument MAPPIN-O of the “multifocal approach to the ‘sharing’ in shared decision-making” (MAPPIN) inventory, applied to a test video. The observer instrument assesses the extent and quality of patient involvement in HCP -patient consultations. Accuracy is calculated using weighted T coefficients calculated pairwise between participants’ judgements and an expert standard rating.
2. Reaction and learning assessed using a self-administered questionnaire containing three free text questions and 13 questions in a Likert scale format
Overall trial start date
01/01/2018
Overall trial end date
09/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
Two to three participants from each Hospital Trust within the region. A maximum number of 50 participants. Participants must be interested in teaching SDM and/or have been given a dedicated task related to implement SDM trainings at the hospital trust.
Participant exclusion criteria
Those without occasion to give SDM courses
Recruitment start date
01/01/2018
Recruitment end date
09/01/2020
Locations
Countries of recruitment
Norway
Trial participating centre
Helse Sør-Øst
Parkgata 36
Hamar
2317
Norway
Sponsor information
Organisation
University Hospital of North Norway
Sponsor details
Sykehusvegen 38
Tromsø
9019
Norway
+47 (0)77 62 60 00
post@unn.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Helse Sør-Øst RHF
Alternative name(s)
South-Eastern Norway Regional Health Authority, Southern and Eastern Norway Regional Health Authority, sorost
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Norway
Funder name
Helse Nord RHF
Alternative name(s)
Northern Norway Regional Health Authority
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Norway
Results and Publications
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 statement
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.
Intention to publish date
01/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list