Improved involvement of multiple sclerosis patients in discussions about treatment
| ISRCTN | ISRCTN42739508 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42739508 |
| Protocol serial number | 2015/FO7408 |
| Sponsor | Akershus University Hospital |
| Funder | Norwegian Foundation for Health and Rehabilitation, ExtraStiftelsen (EkstraStiftelsen Helse og Rehabilitering) |
- Submission date
- 23/06/2016
- Registration date
- 24/06/2016
- Last edited
- 18/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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 2019
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
Contact information
Scientific
HØKH Research Centre
Akershus University Hospital
Lørenskog
1475
Norway
| Phone | 95827288 |
|---|---|
| pal.gulbrandsen@medisin.uio.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Preclinical randomised parallel study |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Enabling shared decision-making about treatment with multiple sclerosis patients: A preclinical intervention study |
| Study objectives | A three hour course in how to provide information will improve MS patients' ability to recall information given by doctors. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The amount of information provided by the doctors that is recalled by the patients is measured using patient interviews immediately after the consultation. |
| Key secondary outcome measure(s) |
1. Patient involvement is measured using: |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Total final enrolment | 51 |
| Key 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 |
| Key exclusion criteria | No exclusion criteria. |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Norway
Study participating centre
Lørenskog
1478
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | As soon as the results article is published, an anonymized version of reported data will be made available as an SPSS file by request from the principal investigator Prof Pål Gulbrandsen (pal.gulbrandsen@medisin.uio.no). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/03/2022 | 18/03/2022 | Yes | No | |
| Other publications | Assessment of physician adherence to intervention | 13/10/2021 | 29/12/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | in Norwegian | 21/05/2014 | 18/10/2022 | No | No |
Additional files
- 32248 Protocol 21May2014.pdf
- in Norwegian
Editorial Notes
18/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
18/03/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
29/12/2021: The following changes have been made:
1. Publication reference added.
2. The publication and dissemination plan has been changed.
3. The IPD sharing statement has been added.
4. The intention to publish date has been changed from 31/12/2021 to 30/06/2022.
15/01/2021: The following changes were made to the trial record:
1. The publication and dissemination plan was changed.
2. The intention to publish date was changed from 31/12/2020 to 31/12/2021.
13/12/2017: Internal review.
11/12/2017: The overall trial end date was changed from 31/12/2016 to 31/12/2019. Intention to publish date was changed from 01/02/2018 to 31/12/2020.
