Condition category
Not Applicable
Date applied
24/03/2020
Date assigned
25/03/2020
Last edited
25/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

25/03/2020: Trial's existence confirmed by the ethics committee at the South-Eastern Norway Regional Health Authority.