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
Secondary identifying numbers 19/00754
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Mrs Simone Kienlin
Scientific

Enggata 66
Hamar
2317
Norway

ORCiD logoORCID ID 0000-0001-7367-2009
Phone +47 (0)93642406
Email simone.kienlin@helse-sorost.no

Study information

Study designObservational study using the Kirkpatrick Modell (2016) as orientation in choosing outcome parameters
Primary study designObservational
Secondary study design
Study setting(s)Hospital
Study typeOther
Scientific titleEvaluating a train-the-trainer program to facilitate implementation of shared decision making in Norway
Study acronymReady for SDM – TTT
Study hypothesisThe 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
ConditionShared decison making
InterventionIntervention: 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 typeBehavioural
Primary outcome measureNumber 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 measuresAssessed 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 study start date01/01/2018
Overall study end date09/09/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participantsTwo 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.
Total final enrolment29
Participant inclusion criteriaParticipants from all health trusts (HF) of the region will be recruited consecutively, based on an invitation by the South-Eastern Regional Health Authority
Participant exclusion criteriaThose without occasion to give SDM courses
Recruitment start date01/01/2018
Recruitment end date09/01/2020

Locations

Countries of recruitment

  • Norway

Study participating centre

Helse Sør-Øst
Parkgata 36
Hamar
2317
Norway

Sponsor information

University Hospital of North Norway
Hospital/treatment centre

Sykehusvegen 38
Tromsø
9019
Norway

Phone +47 (0)77 62 60 00
Email post@unn.no

Funders

Funder type

Government

Helse Sør-Øst RHF
Government organisation / National government
Alternative name(s)
South-Eastern Norway Regional Health Authority, Southern and Eastern Norway Regional Health Authority, helsesorost, Helse Sør-Øst RHF, sorost
Location
Norway
Helse Nord RHF
Government organisation / Local government
Alternative name(s)
Northern Norway Regional Health Authority
Location
Norway

Results and Publications

Intention to publish date01/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned 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 planThe 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.