Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05102812 |
| Other study ID # |
STH20859 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2022 |
| Est. completion date |
February 8, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Current evidence shows that many people living with stroke experience major problems with
eating and drinking. We know that this can lead to malnutrition, dehydration, reduced muscle
strength and depression. It can also lead to longer stays in hospital, reduced ability to
participate in rehabilitation and in the long term poorer quality of life. People living with
stroke say the pleasure gained from eating and drinking changes after a stroke. They describe
feeling embarrassed and ashamed and report a loss of self-confidence.
Therefore, being able to eat and drink independently is essential for health and well-being.
People with stroke welcome opportunities to address eating and drinking problems early in
their rehabilitation and would like more opportunities to practice the necessary skills
needed, to regain independence. Early rehabilitation interventions have the potential to
improve long-term outcomes by providing strategies, assistive devices and rehabilitation as
early as possible in stroke recovery.
Health care professionals are using breakfast groups to provide opportunities to practice
preparation and consumption of food and drink with enabling support. Consultations with
patients and health care professionals have found that the processes involved in breakfast
group interventions lack rigour and multi-disciplinary team coordination, thus leading to
uncertainty about what outcomes are achieved for each patient.
This co-designed study aims to find out if it is possible to improve patient outcomes by
providing more intensive interventions in a breakfast group format delivered by a range of
health care professionals over five days of the week. The intervention will be co-designed
with a stakeholder group comprising of patients, carers and stroke unit health care
professionals supported by an advisory group, comprising of experts in the field. The
intervention will be delivered in three sites and it will include a tool kit to support the
integrated assessment, care plan and outcome measures.
Description:
This study will develop a breakfast group intervention for acute stroke services, followed by
an exploration of the feasibility and acceptability of this intervention in clinical
practice. Feasibility studies are required to build the foundations for future research by
exploring the practicalities of intervention delivery and the acceptability from a recipient
perspective. The Medical Research Council (MRC) Framework definition for complex
interventions has been used to guide study design as breakfast groups are considered to be
complex, as they contain several complex interacting components and has a range of possible
outcomes which are variable due to the nature of stroke impairments. Purposive or commonly
known as selective sampling is an appropriate method for the study as there are only a
limited number of primary data sources who can contribute to the study.
Number of sites involved:
- Non-participant Observations Site - 1,2,3
- Interview Sites - 3
- Co-design Site - 1
- Intervention delivery sites - 3
- Focus groups sites - 2
Size of sample Non-participant Observations (Pre-intervention) Site 1 = 10 patients and 7
staff members Interviews Site 1 (pre-intervention) = 2 patients and 2 staff members = 4
Interviews Site 2 and 3 (post intervention) = 6-8 patient across both sites Co-design site 1
= 10 participants in the stakeholder group Intervention delivery and non-participant
observations sites 1,2,3 = 15 across 3 sites Focus groups sites 2 and 3 = 6-8 staff members
across 2 sites
Total patients= 35 Total Stakeholders = 10 Total Health care professionals = 17 Total
participants = 62
Sampling technique Purposeful sampling is widely used in qualitative research for the
identification and selection of information-rich cases with limited resources, relevant to
the phenomenon of interest. This involves identifying and selecting individuals or groups of
individuals that are especially knowledgeable about or experienced with a phenomenon of
interest. Three acute stroke wards in South Yorkshire and Bassetlaw Integrated Care System
(SYB ICS) will be included in the study therefore availability and willingness to
participate, and the ability to communicate experiences are important factors.
Research methods used in the study include in-depth interviews, non-participant observations,
co-design stakeholder workshops and focus groups. A strength of Co-design is that tools such
as prototypes can be used to engage stakeholders. A prototype intervention and tool-kit will
be developed and tested in three stroke wards in SYB ICS (Sheffield Teaching Hospitals FT,
Rotherham Hospitals FT and Doncaster and Bassetlaw Teaching Hospitals FT).
Co-design of Intervention A Stakeholder Group will be established with key stakeholders
including a stroke service manager, National Health Service (NHS) staff (Nurses,
Physiotherapists, Speech and Language Therapists, Dieticians, Psychologists, Occupational
Therapists, support workers) and two patient representatives. This group will design a
breakfast group intervention and co-create an actionable toolkit encompassing an assessment,
a personalised care plan and a range of outcomes measures. Frequency and intensity of
meetings will vary according to the stage of the project although it is anticipated there
will be up to 10, 1 hour meetings (virtual or in person). The stakeholder Group will be
recruited using an expression of interest advertisement via Sheffield Stroke Pathway and the
local Sheffield Teaching Hospitals Patient and Public Involvement (PPI) Stroke Group. A Study
Steering Group will be established with key national and international experts and stroke
charities representatives to support study development by proving iterative feedback. The
Steering Group will support the study providing guidance and have oversight on the progress
of the study to ensure it is conducted rigorously in line with both, governance frameworks
and good clinical research practice. The group will meet at key stages during the study and
will inform strategic decisions. They will meet online.
Steering Group Participants Two patient representatives and NHS staff (including Occupational
Therapists, Physiotherapists, Speech and Language Therapists, Psychologists, Nurses and
support staff) will be invited to join ten 1 hour workshops where they will co-design a
breakfast group intervention and supporting tool-kit. The tool kit will comprise of an
interdisciplinary assessment for eating and drinking difficulties, a care plan with
goalsetting and clinical outcome measures. Participants will be recruited with informed
consent.
Stakeholder Group Activities Patient journey mapping will be used at the start of the project
to delve into the depths of the patient and staff experience. A short film (10 minutes) will
be co-created with NHS staff, patients and carers to convey how they experience the current
delivery of eating and drinking interventions and their priorities for change. Both patient
mapping and the 10-minute film are methods used in experienced-based co-design, a six staged
process that uses design thinking and co-design methods, bringing stakeholders together to
reflect on their experiences.
Video A short video of six patients and/or carer talking about their eating experiences will
be co-created by the researcher. A consent process will take place in accordance with NHS
policy. Each participant will be filmed for 30 minutes, and the videos will be edited
together in soundbites so that the patient's story is told, and Health Care Professional
(HCP) can understand the experience of the service user. Members of the stakeholder group and
advisory group will be invited to help in the editing processes. Using Video stories to help
others understand the patient experience is a methodology used to co-design.
Non-participant Observations Breakfast interventions and how breakfast is delivered on a
stroke ward at Sheffield Teaching Hospitals will be observed on two occasions by the
researcher and one other observer from the stakeholder group. They will observe the routines
and rituals, how breakfasts are operationally managed, and the type of support provided for
patients to eat and drinking during the breakfast period. Patients and staff being observed
will have agreed to take part in an informed consent process and the observation will be
explicit. They will have been provided with a participant information sheet about the study
before informed consent was taken. Observations will be recorded on paper and combined
afterwards. Non-participant observations will provide insights into the culture of breakfast
on an acute stroke ward, the patterns of behaviours and the social interactions that occur
between patients and staff. The participants will be a purposive sample of patients on an
acute stroke ward and health care professionals delivering breakfast meals.
There will be three methods of data collection:
- Observe practice- Non-participant observations
- Ask patients about their thoughts, experiences and feelings while observing through
informal conversations
- Review the documentation of the breakfast processes and interventions.
The researcher and accompanying stakeholder will keep field notes of observations, jotting
down thoughts and experiences making theoretical commentary. These will be used in the future
as a reminder of practical issues, solutions, and important issues for intervention design.
Interviews A semi-structured interview with pre-determined topics and open-ended questions be
developed by the stakeholder group. Two patients and two members of the stroke team will be
interviewed about their experiences of mealtimes on the unit, meal-time interventions and
experiences of eating and drinking difficulties. Interviews provide an opportunity to explore
the phenomenon of eating and drinking difficulties in-depth, exploring complexity from the
perspective of stroke survivors and health care professionals. These can be conducted in
person on online participants will be given a choice. Interviews will be recorded and
transcribed verbatim. The interviews will be flexible and interactive however a consistent
approach with an experienced researcher and a well-designed schedule will provide rigour. Two
patient and Two staff will be interview pre=intervention design (site 1) and six to eight
patients that have participated in the intervention pilot in sites 2 & 3 will be interviewed
in-depth after the pilots are complete.
Intervention delivery/ Non-participant observations The breakfast group intervention will be
piloted in site 1 (Sheffield Teaching Hospitals) for 1-2 weeks. It will then be refined and
piloted in two further stroke wards (site 2 & 3) for 2 weeks (Rotherham Hospitals NHS FT and
Doncaster and Bassetlaw Teaching Hospitals FT). Non-participant structured observation will
occur when the first prototype intervention and tool kit is tested in site 1. To inform the
development of future data collection and the main study of the intervention structured
observations will provide data about interactions in the breakfast group between patients and
staff. Two complete observers (the researcher and a stakeholder) will observe the
intervention in action recording activities and interactions in a systematic approach using a
framework for data collection. This will be developed prior to the observations with the
stakeholder group. A framework will facilitate the collection of data in a systematic
approach and as far a possible limiting observer bias and subjectivity. A detailed
understanding of the intervention in action can contribute to the understanding of the
phenomena being investigated. Observations will be used to support data collected through the
semi-structured interviews. Observations can help provide a means of recording what actually
happens as opposed to what people recall has happened or prevent bias by participants giving
socially acceptable responses. They can support self-report data and contribute to the
trustworthiness and rigour of a study.
Focus Groups Following intervention pilots in site 2 (Rotherham Hospitals FT) & 3 (Doncaster
and Bassetlaw FT)a focus group consisting of Health Care Professionals involved in the
delivery of the intervention will be conducted. Participants will be purposively sampled from
the NHS staff taking part in the intervention delivery. They will be recruited as part of the
intervention delivery team recruitment from sites 2 & 3. Informed consent to take part will
be obtained. The group will be recorded and transcribed verbatim. If necessary due to
COVID-19 restrictions this group will be conducted online. A focus group will be used to
obtain views of the health care professionals delivering the intervention. A topic guide for
the focus group will be developed with the stakeholder group informed by the aims and
objectives of the study. Open-ended questions will be used to elicit views on the
intervention delivery, acceptability, and feasibility. Focus groups are a popular method of
enquiry in stroke research and will provide in-depth insights into how the health care
professionals think and feel about the intervention and toolkit.
Nominal Data Collection NHS Staff- Gender, years of experience in stroke rehabilitation,
profession/role Patients- Gender, age, demographic, type of stroke, weeks from stroke, number
of interventions received Stakeholders- Gender, role/profession, experience in stroke or
lived experience of stroke Patient record- the content of meal-time interventions, number and
frequency
