Shared decision making in the treatment of severe stroke

Not Applicable

• Conditions: Stroke; Nervous System Diseases

• Registration Number: ISRCTN92552885
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-06
• Last Update Posted: 17 January 2022
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 116

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

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The TIDIER checklist will be used to report on the shared decision making process and implementation over 18 months

Secondary Outcome Measures

Name	Time	Method
<br> 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.<br> 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.<br> 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.<br> 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.<br>