Ready for shared decision making: decision coaching

ISRCTN	ISRCTN44143097
DOI	https://doi.org/10.1186/ISRCTN44143097
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University Hospital of North Norway
Funders	Helse Nord RHF, Helse Sør-Øst RHF

Submission date: 13/02/2023
Registration date: 14/02/2023
Last edited: 12/02/2025

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 of protocol

Background and study aims
Nurses play a crucial role in supporting patients to participate in healthcare decisions. However, in Norway training programs to strengthen nurses’ decision-support skills are missing and shared decision-making (SDM) have not yet been routinely adopted in clinical practice. The aim of this study is to develop, deliver and evaluate a nurse-led decision coach training module.

Who can participate?
Nurses working at departments with SDM-relevant decisions and preferably where there was developed/in development a decision aid to be published on the national platform.

What does the study involve?
Nurses are invited to participate in decision coaching training. The two-fold training comprises part A (6 hours): SDM basics and behavior skills, and part B: individualized feedback on an own audio tape of an SDM coaching submitted by the nurse (1 hour). Participating nurses have to fill in a questionnaire at the end of parts A and B of the training.

What are the possible benefits and risks of participating?
Participants may benefit by getting increased knowledge and skills in SDM and decision coaching, and it may have future benefits, as the results of the study are likely to influence the implementation of SDM in Norway. If the nurses implement their new knowledge and skills the researchers think that patients will benefit from the opportunity to reflect on the different options and from the personal and individually adapted contact with the decision coach. The researchers do not foresee any serious risks concerning their intervention.

Where is the study run from?
University Hospital of North Norway (Norway)

When is the study starting and how long is it expected to run for?
August 2019 to August 2020

Who is funding the study?
1. Northern Norway Regional Health Authority (Norway)
2. South–Eastern Norway Regional Health Authority (Norway)

Who is the main contact?
Simone Kienlin, simone.kienlin@helse-sorost.no

Contact information

Mrs Simone Kienlin
Scientific

Parkgata 36
Hamar
2317
Norway

ORCID ID	0000-0001-7367-2009
Phone	+47 (0)93642406
Email	simone.kienlin@gmail.com

Study information

Primary study design	Observational
Study design	Descriptive study, informed by Kirkpatrick’s four-stage model of evaluation
Secondary study design	Pretest
Scientific title	Preliminary testing of a training module for nurses preparing to provide decision coaching
Study objectives	The aim of this study is to develop, deliver and evaluate a nurse-led decision coach training module.
Ethics approval(s)	1. Approved 10/12/2019, the ethics committee at the South-Eastern Norway Regional Health Authority (Helse Sør-Øst RHF, Postboks 404, 2303 Hamar, Norway; +47 (0)62 58 55 00; postmottak@helse-sorost.no), ref: 2017/82 C 2. Approved 08/10/2019, the ethics committee at the University Hospital in North Norway (UNN; Universitetssykehuset Nord-Norge HF, Postboks 100, 9038 Tromsø, Norway; +47 (0)776 26000; personvernombudet@unn.no), ref: 2017/1461
Health condition(s) or problem(s) studied	Communication training, decision coaching
Intervention	The training program was composed of two parts (A and B) with corresponding learning objectives. The total amount of time required to complete the training was about seven hours, comprising 6 hours of classroom training and 1 hour for the “home task” and receiving feedback. Learning objectives: Part A: 1. Explain the background and rationale for shared decision-making (SDM) and decision coaching (DC) and the situations in which it is relevant 2. Know about the nurse’s role in SDM 3. Explain and justify the structure of an SDM process and its quality criteria 4. Navigate easily within a decision-making process 5. Hold basic skills in guiding patients through the six steps for SDM applied to medical problems from their local domain 6. Know various measures to support the patient in making decisions 7. Holds basic skills in guiding patients through decision aids addressing medical problems from their local medical domain 8. Know the answers to frequently asked questions Part B: 1. Adopt the nurse’s role in SDM 2. Navigate easily within a decision-making process 3. Hold basic skills in guiding patients through the six steps for SDM applied to medical problems from their local domain 4. Holds basic skills in guiding patients through decision aids addressing medical problems from their local medical domain
Intervention type	Behavioural
Primary outcome measure(s)	1. Demographic data such as gender, age, clinical departments, and years of clinical practice collected for sample description purposes at the end of part A of the training 2. After part A of the training the participants will be given a self-administered paper questionnaire assessing the three levels of Kirkpatrick's training evaluation model: 2.1. Level one (reaction); relevance and satisfaction will be assessed using a questionnaire and field observations (four items, Likert scale, open-ended questions regarding applicability and the need for revision of the training). 2.2. Level two (learning); knowledge, attitude, skills, confidence, and commitment will be assessed with a questionnaire (six items, Likert scale). 2.3. Level three (behavior): 2.3.1. Nurses anticipated needs regarding the implementation of decision coaching and providing decision aids (two open-ended questions end of part A of the training), in the face of volition state. 2.3.2. If the participants complete part B of the training, the task of providing decision support to a patient with decisional needs (providing an audio recording for individual feedback). To provide individual feedback to the participants the extent of patient involvement in the audio recordings will be assessed using the observer scale from the MAPPIN’SDM inventory.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	01/08/2020

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	20
Total final enrolment	19
Key inclusion criteria	Nurses working at departments with SDM relevant decisions and preferably where there was developed/in development a decision aid to be published on the national platform.
Key exclusion criteria	Physicians and health professionals working in administrative functions.
Date of first enrolment	01/09/2019
Date of final enrolment	20/01/2020

Locations

Countries of recruitment

Norway

Study participating centres

University Hospital of North Norway

Sykehusvegen 38
Tromsø
9019
Norway

Akershus University Hospital

Sykehusveien 25
Nordbyhagen
1478
Norway

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request: Simone Kienlin (simone.kienlin@helse-sorost.no). The type of data that will be shared: information about the intervention such as the Powerpoint presentation and materials and anonymized data material used in the analysis. All participating nurses signed a consent form before leaving the training.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		10/02/2025	12/02/2025	Yes	No

Editorial Notes

12/02/2025: Publication reference added.
15/02/2023: Contact details updated.
14/02/2023: Trial's existence confirmed by the ethics committee at the University Hospital in North Norway.