Condition category
Nervous System Diseases
Date applied
23/06/2016
Date assigned
24/06/2016
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of problems including loss of vision, problems with balance and coordination as well as fatigue (extreme tiredness), stress and mental health difficulties such as depression. Patients with MS often face difficult decisions about their choice of treatment. The reasons for this are several: the natural course of the disease is unpredictable but potentially serious, there are several new drugs available with different effects, side effects, and risks, and because of the drugs' novelty long-term effects are not well-known, while the disease itself is life-long usually spanning decades. It is hard, even for a doctor, to keep track of all the information available, and even experts will admit uncertainty about choice of treatment. Patient involvement in these situations is a difficult task. Patient involvement in decision-making requires information too be provided during medical encounters. Several studies indicate that doctors do not provide sufficiently structured, precise information and it is often characterized by use of jargon, and not adjusted to the patient's needs. This study aims to try out whether a rather simple training session for doctors leads to an improvement in these respects, in a way that helps patients to better recall the information they received.

Who can participate?
Adults with MS who are currently on their first drug treatment and doctors working in the Neurological department of Akershus University Hospital who regularly meet MS patients.

What does the study involve?
All participating doctors receive a three hour training session in groups of 5-8. The training session involves a brief introduction followed by learning about how best to provide patients with information. The rest of the session involves role playing, reflecting on the content of the session and providing feedback, before a brief summary at the end. Patients are randomly allocated to one of two groups. Those in the first group meet with the doctor for a consultation before they have attended the training session and those in the second group meet with the doctor after they have attended the training session. For both groups, the consultations are videotaped so that they can be reviewed by the research team to assess the information provided in the session. Patients are also interviewed before and immediately after the consultation in order to find out how much information the doctor gave them they are able to remember.

What are the possible benefits and risks of participating?
Not provided at time of registration

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

When is the study starting and how long is it expected to run for?
April 2014 to December 2016

Who is funding the study?
Norwegian Foundation for Health and Rehabilitation, ExtraStiftelsen (Norway)

Who is the main contact?
Professor Pål Gulbrandsen
pal.gulbrandsen@medisin.uio.no

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pål Gulbrandsen

ORCID ID

Contact details

HØKH Research Centre
Akershus University Hospital
Lørenskog
1475
Norway
95827288
pal.gulbrandsen@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2015/FO7408

Study information

Scientific title

Enabling shared decision-making about treatment with multiple sclerosis patients: A preclinical intervention study

Acronym

Study hypothesis

A three hour course in how to provide information will improve MS patients' ability to recall information given by doctors.

Ethics approval

The Regional Committee for Medical and Health Research Ethics (Southeast Norway) decided that as this experiment is not medical or health research and therefore exempted from review. 24/03/2015, ref: 2015/161

Study design

Preclinical randomised parallel study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Available in Norwegian by contacting the principal investigator: pal.gulbrandsen@medisin.uio.no

Condition

Multiple sclerosis

Intervention

Participating patients are randomly allocated to meet a doctor before or after the doctor has been trained. One researcher observes the doctor-patient interaction and notes all information that is provided. The researcher interviews the patient directly after, first using open questions to elicit understanding and recall, followed by prompted, but not leading questions about information the doctor provided to elicit as accurate recall as possible. Both doctor-patient interaction and post-visit interview are videotaped, and independent coders that will not know if the interaction is pre or post intervention identify and decide whether patient recall of each information the doctor has given is sufficiently precise to represent the information given. Following these procedures the percentage of given information that is recalled, and whether there is a significant difference between patients in the pre-course and post-course arms of the study is calculated. In addition, a battery of questionnaires (MAPPIN'SDM, Collaborate, Four Habits Patient Questionnaire) will be used to map the patients' evaluation of communication, information provision, and involvement in decision-making.

The training session for doctors is led by an experienced teacher in clinical communication and lasts 3 hours and is run for groups of 5-8 doctors at a time. The training session involves being given a brief introduction about the 6 main steps of information provision:
1. Inducing a trusting atmosphere
2. Finding out what the patient knows
3. Prioritising which information to convey
4. Portioning information using micropauses
5. Rationing information when sensing that the patient feels unsafe
6. Checking what the patient has understood.
The rest of the session consists of role-plays, reflections, and feedback, and there is a brief summary round at the end.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The amount of information provided by the doctors that is recalled by the patients is measured using patient interviews immediately after the consultation.

Secondary outcome measures

1. Patient involvement is measured using:
1.1. Control preference scale (Degner et al), before and after consultation (patients and doctors)
1.2. MAPPIN’ SDM (Kasper et al.) after the consultation (patients and doctors)
1.3. Collaborate (Elwyn et al.) after the consultation (patients only)
2. Communication and information quality is measured using the Four Habits Patient Questionnaire (patients)
3. Doctor communication self-efficacy is measured using Parle et al.’s self-efficacy questionnaire before and after the consultation and three months later
4. Adherence to information principles is measured through reviewing the video recordings of the sessions using the Four Habits Coding Scheme

Overall trial start date

01/04/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Patients with relapsing remitting MS
2. Currently use a first line drug
3. Not previously been exposed to the decision to begin with a second line drug
4. Aged 18 years and over

Doctors:
1. All doctors working in the Neurological department of Akershus University Hospital
2. Regularly meet multiple sclerosis patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Patients: 32 Doctors: 16

Participant exclusion criteria

No exclusion criteria.

Recruitment start date

01/05/2016

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Norway

Trial participating centre

Akershus University Hospital
Post office box 1000
Lørenskog
1478
Norway

Sponsor information

Organisation

Akershus University Hospital

Sponsor details

Sykehusveien 25
Lørenskog
1478
Norway

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Norwegian Foundation for Health and Rehabilitation, ExtraStiftelsen (EkstraStiftelsen Helse og Rehabilitering)

Alternative name(s)

Norwegian Foundation for Health and Rehabilitation, ExtraStiftelsen

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Norway

Results and Publications

Publication and dissemination plan

Planned publication of several papers in scientific journals:
The effect of the training on patient recall
2. The effect of the training on patient evaluation of communication, information, and involvement
3. The effect of the training on doctor adherence to principles of information provision
4. Several other papers using qualitative methods, not about effects of the trial, but rather about how training affects the interaction in other ways

Intention to publish date

01/02/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes