Exploring the use of a stroke patient concerns inventory during stroke follow-up appointments

ISRCTN	ISRCTN10559956
DOI	https://doi.org/10.1186/ISRCTN10559956
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	344756
Protocol serial number	CPMS64325, NIHR206217
Sponsor	University of Central Lancashire
Funder	NIHR Central Commissioning Facility (CCF)

Submission date: 07/11/2024
Registration date: 22/11/2024
Last edited: 14/10/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Stroke survivors experience ongoing physical, psychological and social concerns affecting quality-of-life. There is a lack of systems and tools that allow healthcare staff to identify stroke survivors’ concerns and so they are often not adequately addressed. Stroke outpatient follow-up appointments are time-limited, reducing opportunity for patients to discuss, and staff to identify, concerns.

The Patient Concerns Inventory (PCI), is used in cancer-care appointments. The PCI lists potential concerns for patients to select from before their appointment which they would like to discuss. Research shows that using the PCI increased satisfaction with appointments and improved patient quality-of-life, without lengthening appointment time. The PCI has been adapted for stroke (Stroke Patient Concerns Inventory (sPCI)) and a large study is needed to see if it is also effective. Firstly, the study design and the sPCI need to be tested in a smaller study. This study, funded by the NIHR, aims to determine if the sPCI can be used in stroke outpatient services by both staff and patients.

Who can participate?
Four stroke services performing follow-up appointments will recruit a total of 96 participants, who are: stroke survivors within 7-months of stroke, aged 18 years and over, and attending their first follow-up appointment.

What does the study involve?
Two sites will receive training in the sPCI (using it during appointments to discuss concerns and manage them appropriately), and provide their participants the sPCI to complete before their appointment (in addition to their usual practice). The remaining two sites will continue their usual practice. Data collection will include: participants’ demographic and stroke information, and quality-of-life at baseline; completed sPCI and participants’ feedback on its use immediately after the appointment; participants’ satisfaction and empowerment within one-week of the appointment; and participants’ quality-of-life and use of health services three-months later. A selection of participants and staff will be interviewed about their experiences of the study.

What are the possible benefits and risks of participating?
Benefits: Not provided at time of registration
Risks: The main disadvantages are that this will take some of your time and you may find thinking or talking about some of the issues is upsetting. If this happens, the research practitioner or university researcher can provide suggestions of who you can talk to, such as helplines or your GP.

Where is the study run from?
University of Central Lancashire (UK)

When is the study starting and how long is it expected to run for?
May 2024 to March 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
esaviciute@uclan.ac.uk

Contact information

Miss Kulsum Patel
Principal investigator

Brook Building 247, University of Central Lancashire
Preston
PR1 2HE
United Kingdom

ORCID ID	0000-0002-0865-3941
Phone	+44 1772 893635
Email	Kpatel@UCLan.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional non-randomized
Secondary study design	Non randomised study
Participant information sheet	46356 SPaCIS PIS Control Group v1.1 27-09-2024.pdf
Scientific title	Use of the Stroke Patient Concerns Inventory in Stroke Outpatients Clinics: a feasibility cluster randomised controlled trial
Study acronym	SPaCIS
Study objectives	To determine whether a future, larger study can be conducted to explore how effective the Stroke Patient Concerns Inventory (sPCI) is when used in stroke outpatient clinics.
Ethics approval(s)	Approved 04/10/2024, Wales REC 3 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 940963; Wales.REC3@wales.nhs.uk), ref: 24/WA/0259
Health condition(s) or problem(s) studied	Stroke
Intervention	Four stroke services performing follow-up appointments will recruit a total of 96 participants, who are: stroke survivors within 7-months of stroke, aged 18 years and over, and attending their first follow-up appointment. Two sites will receive training in the sPCI (using it during appointments to discuss concerns and manage them appropriately), and provide their participants the sPCI to complete before their appointment (in addition to their usual practice). The remaining two sites will continue their usual practice. Data collection will include: participants’ demographic and stroke information, and quality-of-life at baseline; completed sPCI and participants’ feedback on its use immediately after the appointment; participants’ satisfaction and empowerment within one-week of the appointment; and participants’ quality-of-life and use of health services three-months later. A selection of participants and staff will be interviewed about their experiences of the study.
Intervention type	Behavioural
Primary outcome measure(s)	1. The rate of completed sPCIs is measured using the number of sPCIs completed at the clinical follow-up appointment 2. sPCI use in consultation is measured using a participant's immediate feedback question on whether they recall the use of the sPCI in their consultation and audio recordings of consultations at clinical follow-up appointments and immediate feedback 3. Participant feedback on the use of sPCI is measured using an immediate feedback question on whether they recall the use of the sPCI in their consultation at immediate feedback 4. Patients completing sPCI is measured using the number of sPCIs completed at clinical follow-up appointments and process evaluation interviews 5. sPCI use during the consultation is measured using a participant's immediate feedback question on whether they recall the use of the sPCI in their consultation and audio recordings of consultations at clinical follow-up appointments and process evaluation interviews 6. Staff trained in sPCI use is measured using the number of staff trained during the training period and process evaluation interviews 7. sPCIs provided before the appointment are measured using the number of sPCIs sent to patients at the clinical follow-up appointment 8. Completed sPCIs available to staff conducting consultations are measured using data on consultation CRF about whether sPCI was available at the clinical follow-up appointment 9. Sites recruited are measured using the number of sites in the study at the end of the recruitment period 10. Participants recruited are measured using the number of participants recruited to the study at the end of the recruitment period 11. Eligibility rate is measured using screening logs at the end of the recruitment period 12. The recruitment rate is measured using screening logs and the number of participants recruited to the study at the end of the recruitment period 13. Retention/completion rates are measured using the number of completed 3-month questionnaires at the end of the data collection period 14. Questionnaire completion rates are measured using the number of completed 1-week and 3-month questionnaires at the end of the data collection period and process evaluation interviews 15. Patient satisfaction, empowerment, and quality of life are measured using the Patient Satisfaction Survey and Southampton Stroke Self-Management Scale at 1-week, and EQ-5D-5L at 3-months of data collection and process evaluation interviews 16. Case report form completion rates are measured using the number of completed 1-week and 3-month questionnaires at the end of the data collection period and process evaluation interviews 17. Stop/Go criteria is measured using pre-defined criteria and process evaluation at the end of the study
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	31/03/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	96
Key inclusion criteria	1. >= 18 years. 2. Experienced acute stroke within previous 7 months. 3. Attending first routine post-discharge stroke clinic appointment. 4. Able to complete sPCI, either themselves, with assistance for those physically unable to complete for themselves (e.g. have visual or motor problems), or by proxy for those without capacity to consent (i.e. relative/carer completes with their opinion of what the participant’s concerns are). 5. Able to communicate in English, or have a relative/carer willing to translate trial communications and materials for the participant, or able to use site-specific translation services, if available.
Key exclusion criteria	1. Lack of capacity to consent themselves and no consultee assent available.
Date of first enrolment	25/11/2024
Date of final enrolment	01/03/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Lancashire Teaching Hospitals NHS Foundation Trust

Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Royal Cornwall Hospitals NHS Trust

Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom

The Royal Wolverhampton NHS Trust

New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

East Lancashire Hospitals NHS Trust

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

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	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Control group version 1.1	27/09/2024	18/11/2024	No	Yes
Participant information sheet	Intervention group version 1.1	27/09/2024	18/11/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

46356 SPaCIS PIS Control Group v1.1 27-09-2024.pdf: Control group
46356 SPaCIS PIS Intervention Group V1.1 27-09-2024.pdf: Intervention group

Editorial Notes

14/10/2025: The completion date was changed from 31/10/2025 to 31/03/2026.
07/11/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).