Shared decision making in the treatment of severe stroke
| ISRCTN | ISRCTN92552885 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92552885 |
| IRAS number | 294697 |
| Secondary identifying numbers | IRAS 294697 |
- Submission date
- 21/12/2021
- Registration date
- 06/01/2022
- Last edited
- 23/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Worldwide, stroke is the second leading cause of death, the third leading cause of disability and results in 6.5 million years being lived with disability. For most people, a stroke is a shock. With no prior experience of dealing with stroke they are not only unprepared; also they just don’t know what options they have nor do they have a benchmark for supporting them to make the best decisions for themselves or their loved one. The objective of this study is to develop and embed a Shared Decision Making (SDM) process that will enable staff to be empowered confident to have difficult conversations with patients and families, including the communication of poor prognosis and uncertainty, and enabling patients and carers to be more effectively able to participate in these conversations. This should ensure that treatment decisions are more aligned with patient’s values and beliefs.
Who can participate?
Stroke survivors, their family members, and healthcare professionals.
What does the study involve?
The SDM process will be developed through co-production workshops involving clinical staff who work with stroke patient as well as survivors of stroke and their relatives. Once the SDM process is adopted into practice we will explore how well it is implemented and whether it is associated with change in clinical processes and outcomes through an audit of stroke patients in the Royal Infirmary of Edinburgh and talking to participants at 6 months after their stroke. In order to understand the views of staff, patients and relatives of the SDM process, we will use questionnaires, interviews and focus groups. It will take 19 months to collect and analyse the data.
What are the possible benefits and risks of participating?
There are potential benefits to taking part as some people find it helpful to be able to provide feedback about the quality of care they have received. The information you provide will help us improve the way that the clinical team communicate with patients who have had a severe stroke, and their families.
There are no risks to your health by taking part but some people might find it difficult or upsetting to talk about the care they received after stroke. If you find that the questions are too difficult or upsetting, you will be referred to service and professionals to help and you can change your mind about participating.
Where is the study run from?
The Royal Infirmary of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
November 2021 to July 2023
Who is funding the study?
Edinburgh and Lothians Health Foundation (UK)
Who is the main contact?
Prof Gillian Mead, gillian.e.mead@ed.ac.uk
Contact information
Principal Investigator
Room S1642
Royal Infirmary
Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
 ORCID ID |
0000-0001-7494-2023 |
|---|---|
| Phone | +44 131 242 6481 |
| gillian.e.mead@ed.ac.uk |
Study information
| Study design | Observational mixed methods study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40843 SSD_Coproduction_PIS_V2.0_13April2021.pdf |
| Scientific title | Development and implementation of realistic medicine for severe stroke through shared decision making at the Royal Infirmary of Edinburgh (RIE) |
| Study objectives | The primary objective of this project is to develop and embed a process for Shared Decision Making (SDM) for severe stroke into the stroke service at Royal Infirmary, Edinburgh, starting at the point of admission to RIE, in either Medical Assessment Unit or the Emergency Department (ED). This process will incorporate Tailored Talks. The goal of the SDM process is to enable staff to be empowered and confident to have difficult conversations with patients and families, including the communication of poor prognosis and uncertainty, and enabling patients and carers to be more effectively able to participate in these conversations. This should ensure that treatment decisions are more aligned with patient’s values and beliefs. The SDM process will be developed through co-production. |
| Ethics approval(s) | Approved 17/11/2021, Scotland A Research Ethics Service (2nd Floor Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 7814609032; manx.neill@nhslothian.scot.nhs.uk), ref: 21/SS/0044 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | The outcome of the shared decision making process will be assessed by measuring how well it was implemented and whether it was associated with a change in clinical processes and outcomes. This will be measured through an audit of stroke patients in the Royal Infirmary of Edinburgh and talking to participants at 6 months after their stroke. In order to understand the views of staff, patients and relatives of the SDM process, we will use questionnaires, interviews and focus groups. |
| Intervention type | Other |
| Primary outcome measure | The TIDIER checklist will be used to report on the shared decision making process and implementation over 18 months |
| Secondary outcome measures | 1. To evaluate implementation, the number of time 'tailored talks' is recorded in the medical notes will be counted using the audit at monthly timepoints throughout the study; months 1 to 18. 2. To explore how the outcome of the shared decision-making process relates to clinical outcomes, the number of death, admissions to institutional care, discharge to another hospital, and use of feeding tubes will be counted using the audit at monthly timepoints throughout the study; month 1 to 18. 3. Patients', relatives' and staff's views of the shared decision-making process will be explored by collecting qualitative data (questionnaires) and qualitative data (interviews and focus groups) between months 3 to 18. 4. Comparison of actual outcome to the preferred outcome as stated at the time of stroke will be made using quantitative questionnaires at baseline (time of stroke) and 6 months later. |
| Overall study start date | 17/11/2021 |
| Completion date | 01/07/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Key inclusion criteria | For the Coproduction workshop 1. Stroke survivors will be eligible for co-production workshops provided they: 1.1. Are aged 16 years or over 1.2. Have experienced a severe stroke within the last 18 months and are either currently receiving stroke related care or treatment in community based services, or have previously received care or treatment from a participating stroke service 1.3. Are able to attend RIE co-production workshops on line 1.4. Are able and willing to provide written informed consent 1.5. Are English-speaking and have access to email 1.6. Are able to attend the dates of at least three of the five workshop sessions (i.e. four co-production workshops and one pre-meeting) 1.7. Are able to use online packages e.g. Microsoft Teams 2. Caregivers will be eligible for co-production provided they: 2.1. Are aged 16 years or over 2.2. Are a family member/close friend of a stroke survivor who is either currently receiving stroke related care or treatment, or has previously received care or treatment from a participating stroke service; or bereaved in the past five years from stroke 2.3. Are able and willing to provide written informed consent 2.4. Are English-speaking and have access to email 2.5. Are able to attend the dates of at least three of the five workshop sessions 3. At least one older lay person who has no experience of stroke, who has capacity, access to the internet and able to attend at least three of the five workshops. 3.1. Are able and willing to provide written informed consent 3.2. Are English-speaking and have access to email 3.3. Are able to attend the dates of at least three of the five workshop sessions 4. Healthcare professionals will be eligible for co-production provided they: 4.1. Are health care professional working in a stroke service in Scotland or in an A&E department, or in acute medicine and have regular contact with stroke patients-and are regularly involved in conversations to make shared decisions about severe stroke (’regularly’ means at least once a month) 4.2. Are able and willing to provide written informed consent 4.3. Are English-speaking and have access to email 4.4. Are able to attend the dates of at least three of the five workshop sessions For the questionnaire, interview or focus group 1. Patient and Relative: 1.1. Patient (or next of kin/welfare guardian if patient does not have capacity) with severe stroke NIHSS of 15 or more 1.2. Aged 16 or more 1.3. Proficient in English 2. Staff: Staff will be eligible if they provide care in A&E, medical assessment or the integrated stroke unit at RIE, and are willing to provide informed consent. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 17/01/2022 |
| Date of final enrolment | 28/02/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Sponsor information
University/education
The University of Edinburgh and Lothian Health Board ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 1312423330 |
|---|---|
| accord@nhslothian.scot.nhs.uk | |
| Website | http://accord.ed.ac.uk |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- ELHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Coproduction version 2.0 |
13/04/2021 | 23/12/2021 | No | Yes |
| Participant information sheet | Guardian version 5.0 |
16/11/2021 | 23/12/2021 | No | Yes |
| Participant information sheet | Patient version 2.0 |
13/04/2021 | 23/12/2021 | No | Yes |
| Participant information sheet | Patient easy access version 2.0 |
13/04/2021 | 23/12/2021 | No | Yes |
| Participant information sheet | Patient representative version 2.0 |
16/11/2021 | 23/12/2021 | No | Yes |
| Protocol file | version 2.0 | 13/04/2021 | 23/12/2021 | No | No |
Additional files
- 40843 SSD_Coproduction_PIS_V2.0_13April2021.pdf
- Coproduction
- 40843 SSD_PIS_Patient Representative_v2.0_16Nov21.pdf
- Patient representative
- 40843 SSD_PIS_WA WG or NR_V5.0_16Nov21.pdf
- Guardian
- 40843 SSD_PIS_Patient_EA_V2.0_13Apr2021.pdf
- Patient easy access
- 40843 SSD_PIS_Patient_V2.0_13Apr2021.pdf
- Patient
- 40843 SSD_Protocol_V2.0_13Apr2021.pdf
Editorial Notes
23/12/2021: Trial's existence confirmed by Scotland A Research Ethics Service
