Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information



Primary contact

Dr Friedemann Geiger


Contact details

Klinik für Allgemeine Pädiatrie
Campus Kiel
Arnold-Heller-Straße 3
Haus 9

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Investigating a Training Supporting Shared Decision Making (ITS SDM)



Study hypothesis

1. To evaluate a new intervention's ability to improve the communication in terms of SDM.
2. To further validate a newly deduced coefficient expressing the degree to which a communication involved physician and patient in an evidence based decision making process as the gold standard for measuring SDM
3. To evaluate SDM regarding its effects on decisional conflict and internal processes of elaboration
4. To further validate the 24 items short version of the Qualities of Uncertainty in Chronic Conditions (QUiCC24)
5. To yield data on the interrelatedness of different perspectives on communication

Ethics approval

Medical Faculty Ethics Board of Christian Albrecht University of Kiel, Germany approved on 12th April 2011, ref: D424/11

Study design

Multicentre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

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


Cancer, multiple sclerosis


1. A training curriculum addressing the participating physicians and goals at enhancing their efforts to involve their patients in the decision making process
2. It has been developed based on the newest available scientific knowledge on evidence based patient information (EBPI) and SDM
3. Its didactic is inspired by training techniques from psychotherapy education
4. Participants of doktormit SDM trainings are stimulated in three different ways:
4.1 They get insight into the framework of reference of SDM including a list of skills and corresponding theory and background information
4.2 They get an observer training incorporating the framework into the individual cognitive structure and motivating to increased awareness regarding own communication skills
4.3. They get opportunity to practice SDM and to incorporate newly learned skills and receive face to face feedback referring to their own communication style
5. The training includes three educational components
5.1. The manual was developed to comprehensively explain background and idea of SDM as well each of a set of 15 SDM skills which represent an extension of the range of skills published by Elwyn [2005]. Within the manual examples are used to illustrate varying degrees of performance.
5.2. The training video: Based on videos recording decision making consultations in a broad variety of medical indications a training video was developed showing every skill in a good to excellent performance. Within the video the skills are verbally edited according to the same framework of 15 skills.
5.3. The face to face feedback: Trainees get structured feedback based on a assessment of the video document of an own consultation in terms of the same framework of reference.
6.The feedback session lasts a maximum of 15 minutes follows a guideline passing six separate steps:
6.1. Introduction via surveying subjective benefit of the previous training steps
6.2. Statement that feedback does not refer to communication performance in general, but just to our specific viewpoint. The trainer indicates, that there are a lot of other important aspects of communication, one could focus on. The present focus is the way, the physician involves the patient into the decision to be made.
6.2. Actualisation of the specific consultation. Reporting context or particular events. e.g. by presenting a sequence of the video. Noting subject of the decision and duration of the decision sequence
6.4. Feedback referring to observable skills: concrete and with video examples
6.5. Asking for own ideas regarding potential for improvement
6.6. Specifying areas of potential improvement, using concrete examples and as far as possible building up on existing competencies. Checking understanding, reassuring tolerable volume of input.
7. The training deliberately abandons to provide the trainees with a general judgment of their performance, or to reach completeness in the feedback of the communication skills
8. The feedback should not create overall associations within the context of the other consultations. The feedback aims at concreteness and traceability.
9. Intervention is applied to intervention group, accompanied by a waiting period in the control group
10. Afterwards, the control group gets the full intervention while the intervention group is heading for a follow up assessment (6 months after randomisation) without any further interventions

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Coefficient SDM-MASS of the MAPPIN'SDM inventory
2. Components of the coefficient SDM-MASS of the MAPPIN'SDM inventory in comparison to:
2.1. OPTION (observing patient involvement) scale
2.2. SDM-Q
2.3. Dyadic coding scales (DCS)
3. Coefficient ELAB composed from the QUiCC24 questionnaire
4. As it is considered important that the trial does not negatively affect the practice process by burdening doctors and patients too much, measurement is limited to the necessary amount of instruments. Most of the measures were tested in previous studies to explore item properties and validity. In particular measures were selected to assess:
4.1. Both parties’ involvement in the decision making process using the SDM-MASS coefficient from the MAPPIN’SDM inventory, including video taping, questionnaires (15 items) from physician and patient
4.2. The patients’ perception of SDM using the SDM-Q (9 items)
4.3. To which extent involvement (in terms of SDM) impacts on the dyadic perception of decisional conflict using the Decisional Conflict scale (16 items to be administered by physicians and patients)
4.4. The pattern of uncertainty as it is represented in the patients’ cognitive system using the ELAB coefficient from the QUiCC24 (24 items to be administered by the patient before and after the consultation)

Secondary outcome measures

1. Item characteristics of QUiCC24 for validation purposes (Cronbach's alpha)
2. Item difficulty
3. Item total correlations coefficients between different foci of MAPPIN'SDM (doctor, patient, observer scales)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Doctor patient dyads facing a decision (between treatment or diagnostic options) within a encounter
2. Aged 18-75, male or female

Participant type


Age group




Target number of participants

40 physicians with 4 consultations each - 160 consultations

Participant exclusion criteria

Less than two possible options to decide upon

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Klinik für Allgemeine Pädiatrie

Sponsor information


Kiel Cancer Centre (Tumorzentrum Kiel) (Germany)

Sponsor details

Niemannsweg 4

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Kiel Cancer Centre (Tumorzentrum Kiel) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 study protocol in

Publication citations

  1. Study protocol

    Geiger F, Liethmann K, Hoffmann F, Paschedag J, Kasper J, Investigating a training supporting Shared Decision Making (IT'S SDM 2011): study protocol for a randomized controlled trial., Trials, 2011, 12, 232, doi: 10.1186/1745-6215-12-232.

Additional files

Editorial Notes