Breakfast Group Interventions in Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Breakfast Group Intervention
Intervention type(s): Behavioral
Intervention description(s): An actionable toolkit encompassing an assessment, a personalised care plan and a range of outcome measures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Breakfast Intervention; Co-design