Condition category
Not Applicable
Date applied
17/04/2018
Date assigned
09/05/2018
Last edited
01/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Simone Kienlin

ORCID ID

Contact details

Enggata 66
Hamar
2317
Norway
+47 (0)93642406
simone.kienlin@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15154

Study information

Scientific title

Evaluation of a multidisciplinary training module in Shared Decision Making (Ready for SDM): a cluster randomized controlled trial

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

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

Study design

Cluster randomized waiting control group trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

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 trial start date

15/03/2016

Overall trial end date

16/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Health professional teams from District Psychiatric Centers
2. Actively involved in psychiatric patient care

Participant type

Health professional

Age group

Adult

Gender

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.

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

Trial participating centre

Betanien District Psychiatric Center
Bergen
5145
Norway

Trial participating centre

Bjørgvin District Psychiatric Center
Bergen
5113

Trial participating centre

Øyane District Psychiatric Center
Straume
5353

Trial participating centre

Kronstad District Psychiatric Center
Bergen
5054

Trial participating centre

Solli District Psychiatric Center
Bergen
5228

Trial participating centre

Voss District Psychiatric Center
Voss
5705

Trial participating centre

Gjøvik District Psychiatric Center
Gjøvik
2819

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

https://unn.no/om-oss/university-hospital-of-north-norway

Funders

Funder type

Government

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 data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

16/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes