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Shared decision making in the treatment of severe stroke

Development and implementation of realistic medicine for severe stroke through shared decision making at the Royal Infirmary of Edinburgh (RIE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN92552885
Enrollment
116
Registered
2022-01-06
Start date
2022-01-17
Completion date
Unknown
Last updated
2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Nervous System Diseases

Interventions

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

Sponsors

University of Edinburgh
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
The TIDIER checklist will be used to report on the shared decision making process and implementation over 18 months

Secondary

MeasureTime frame
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.

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026