Understanding the Experience of the Dietetic Consultation and the Perceptions of Its Value From the Perspective of Nutritionally Vulnerable Older Patients, Dietitians and Other Key Stakeholders: an Illuminative Evaluation
Conditions: Malnutrition
Sponsor: King's College London

 
 Amendment No. 3, Research Protocol Version 1.9 
 
*For confidentiality and anonymity purposes, a redacted version of protocol version 1.9 dated 21/1/2020 is 
provided here. 
 
 
 
 
 
Study Protocol 
(Redacted Version) 
 
 
 
 
 
 
 
 
 
 
 
 
NCT03509116 
Unique Protocol ID: 184290 
 

 
Amendment No.3, Research Protocol Version 1.9 
 
 
Experiences and value perceptions of the dietetic consultation or the nutritionally vulnerable: an illuminative evaluation 
 
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Qualitative Protocol Guidance and Template 
 
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Experiences and value perceptions of the dietetic consultation or the nutritionally vulnerable: an illuminative evaluation 
 
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FULL/LONG TITLE OF THE STUDY 
 
Understanding the experience of the dietetic consultation and the 
perceptions of its value for nutritionally vulnerable older patients, 
dietitians and other key stakeholders: an illuminative evaluation  
 
SHORT STUDY TITLE / ACRONYM 
Experiences and value perceptions of the dietetic consultation for the 
nutritionally vulnerable: an illuminative evaluation 
 
DELETE AS APPROPRIATE: 
• 
This protocol has regard for the HRA guidance and order of content; OR 
• 
This protocol has regard for the HRA guidance; OR 
• 
This protocol does not have regard to the HRA guidance and order of content 
 
 
 

 
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Experiences and value perceptions of the dietetic consultation or the nutritionally vulnerable: an illuminative evaluation 
 
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RESEARCH REFERENCE NUMBERS 
 
PROTOCOL VERSION NUMBER AND DATE  
 
 
Version 1.9, Date: 21/1/2020 
 
OTHER RESEARCH REFERENCE NUMBERS  
 
SPONSOR / CO-SPONSORS / JOINT-SPONSORS 
 
 
184290

 
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Experiences and value perceptions of the dietetic consultation or the nutritionally vulnerable: an illuminative evaluation 
 
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FULL/LONG TITLE OF THE STUDY 
Understanding the experience of the dietetic consultation and the perceptions of its value from the 
perspective of nutritionally vulnerable older patients, dietitians and other key stakeholders: an 
illuminative evaluation  
 
SHORT STUDY TITLE / ACRONYM 
Experiences and value perceptions of the dietetic consultation for the nutritionally vulnerable: an 
illuminative evaluation 
 
PROTOCOL VERSION NUMBER AND DATE 
Protocol Version 1.9 (Date 21/1/2020) 
 
 
 

 
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Experiences and value perceptions of the dietetic consultation or the nutritionally vulnerable: an illuminative evaluation 
 
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RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 
184290 
 
 
 
SPONSORS Number: 
Generated by the Sponsor. Enter if applicable 
 
FUNDERS Number: 
Not applicable. 
 
 
 

 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigators agree to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor. 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
 
Name (please print): 
...................................................................................................... 
 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigators: 
 
Signature:  
..................................................................................................... 
 
 
Date: 
31/05/2018  
Name: (please print):  Dr Christine Baldwin 
 
 
Signature:  
 
..................................................................................................... 
 
Date:  
31/05/2018 
Name: (please print):  Professor Peter Emery 

 
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KEY STUDY CONTACTS 
Chief Investigators 
Dr Christine Baldwin (Primary Research Supervisor) 
Lecturer in Nutrition & Dietetics 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: christine.balwdin@kcl.ac.uk 
Telephone: 0207 848 4318 
 
Prof Peter Emery (Secondary Research Supervisor) 
Professor of Nutrition & Metabolism 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: peter.emery@kcl.ac.uk 
Telephone: 0207 848 4415 
 
Study Co-ordinator (PhD Student) 
Mrs Michelle Gibbs (Research Dietitian) 
Research Training Fellow & PhD Student 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: michelle.gibbs@kcl.ac.uk 
Telephone: 02078484162 (KCL office) / 07376555247 (study 
mobile) 
Sponsor 
Professor Reza Razavi 
Vice President & Vice Principal (Research) 
King’s College London 
Room 5.31, James Clerk Maxwell Building 
57 Waterloo Road 
London SE1 8WA 

 
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Tel: +44 (0)207 8483224 
Email: reza.razavi@kcl.ac.uk 
 
Joint-sponsor(s)/co-sponsor(s)  
Rachel Fay 
Guy's & St Thomas' Foundation NHS Trust 
R&D Department 
16th Floor, Tower Wing, Great Maze pond 
London SE1 9RT 
Ext Tel: 020 7188 7188 
Int tel:  54462 
Fax: 0207 188 8330 
R&D@gstt.nhs.uk 
 
Funder(s) 
The Dunhill Medical Trust 
6 New Bridge Street 
London 
EC4V 6AB 
Telephone: 0207 403 3299 
Email: admin@dunhillmedical.org.uk 
 
Key Protocol Contributors 
Mrs Michelle Gibbs  
Research Training Fellow & PhD Student 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: michelle.gibbs@kcl.ac.uk 
Telephone: 02078484162 (KCL office) / 07376555247 (study 
mobile) 
 
Dr. Christine Baldwin 
Lecturer of Nutrition & Dietetics 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 

 
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Email: christine.balwdin@kcl.ac.uk 
Telephone: 0207 848 4318 
 
Professor Peter Emery 
Professor of Nutrition & Metabolism 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: peter.emery@kcl.ac.uk 
Telephone: 0207 848 4415 
 
Mrs. Sharon Markless 
Senior Lecturer in Higher Education 
King’s College London 
King’s Learning Institute 
Room G6 Waterloo Bridge Wing 
Franklin Wilkins Building 
Waterloo Road 
London, SE1 9NN 
Email: sharon.markless@kcl.ac.uk 
Telephone: 0207 848 3718 
 
Dr. C. Elizabeth Weekes 
Senior Consultant Dietitian & NIHR Clinical Lecturer 
Guy’s & St. Thomas’ Foundation NHS Trust 
Department of Nutrition & Dietetics 
St. Thomas’ Hospital 
3rd Floor, South Wing, B Block 
Westminster Bridge Road 
London, SE1 7EH 
Email: elizabeth.weekes@gstt.nhs.uk  
Telephone: 0207 188 2010  
 
Committees 
Dr. Christine Baldwin 
Lecturer in Nutrition & Dietetics 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 

 
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Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: christine.balwdin@kcl.ac.uk 
Telephone: 0207 848 4318 
 
Professor Peter Emery 
Professor of Nutrition & Metabolism 
King’s College London 
Diabetes & Nutritional Sciences Division 
Faculty of Life Sciences & Medicine 
Franklin Wilkins Building 
150 Stamford Street 
London, SE1 9NH 
Email: peter.emery@kcl.ac.uk 
Telephone: 0207 848 4415 
 
Mrs. Sharon Markless 
Senior Lecturer in Higher Education 
King’s College London 
Room G6 Waterloo Bridge Wing 
Franklin Wilkins Building 
Waterloo Road 
London, SE1 9NN 
Email: sharon.markless@kcl.ac.uk 
Telephone: 0207 848 3718 
 
Dr. C. Elizabeth Weekes 
Senior Consultant Dietitian & NIHR Clinical Lecturer 
Guy’s & St. Thomas’ Foundation NHS Trust 
Department of Nutrition & Dietetics 
St. Thomas’ Hospital 
3rd Floor, South Wing, B Block 
Westminster Bridge Road 
London, SE1 7EH 
Email: elizabeth.weekes@gstt.nhs.uk  
Telephone: 0207 188 2010  
 
Dr. Louise Goff 
Senior Lecturer in Nutritional Sciences 
Diabetes and Nutritional Sciences Division 

 
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Faculty of Life Sciences & Medicine 
King's College London  
Room 2.29 Henriette Raphael Building  
Guy’s Campus  
London, SE1 1UL 
Email: louise.goff@kcl.ac.uk 
Telephone: 0207 848 6111 
Fax: 0207 848 4171  
 
 

 
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STUDY SUMMARY 
Study Title 
Understanding the experience of the dietetic consultation and 
the perceptions of its value from the perspective of 
nutritionally vulnerable older patients, dietitians and other key 
stakeholders: an illuminative evaluation. 
Internal ref. no. (or short title) 
Experiences and value perceptions of the dietetic 
consultation for the nutritionally vulnerable: an illuminative 
evaluation 
Study Design 
Qualitative design 
Study Participants 
Study participants to include: 
Patients: 
1. Adults (aged > 60 years) 
2. National Health Service (NHS) number 
3. Capable of giving informed consent 
4. Able to communicate well in English  
5. Nutritionally vulnerable according to the Nutrition 
Screening Tool in use at Guy’s & St. Thomas’ Trust 
prompting referral to a dietitian 
6. Receiving or likely to receive a form of oral nutrition 
support in the management of malnutrition  
7. A variety of the characteristics below: 
Age 
• 
60-65 years 
• 
Over 65 years 
Gender 
• 
Male 
• 
Female 
Ethnicity 
• 
Mixture of ethnicities to be 
included in the sample as 
represented in the local area 
according to the Lambeth State of 
the Borough (Lambeth Council, 
2016) & Southwark Demographic 
Fact Sheet (Southwark Council, 
2015) 
Type of nutritional 
support received 
• 
Food-based advice (food first) 
• 
ONS  
• 
Combination of the two strategies 
Number of consultations 
• 
Attended one appointment with 
dietitian 
• 
Attended 2 or more appointments  
Consultation type 
• 
Face-to-face 

 
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• 
Telephone   
Clinical setting 
• 
Hospital outpatient (HOP) 
• 
Hospital inpatient (HIP) 
• 
Home visit (HV) 
• 
Intermediate care (IC) 
Family support 
• 
Yes 
• 
No 
 
Dietitians: 
1. Consulting registered dietitian providing the nutritional 
advice to patient above 
2. Employee of Guy’s & St. Thomas’ NHS Trust and 
member of the Nutrition & Dietetic Team 
 
Key Stakeholders: 
Up to 2 optional patient-nominated key stakeholders who are 
involved in the dietetic consultation and success of the 
dietetic intervention e.g. other HCP, carer or family member.  
Their criteria for inclusion will include: 
1. Nominated by a patient (Group 2) participating in the 
study 
2. Involved in some aspect of the subsequent 
implementation of goals agreed between the patient 
and dietitian during the consultation i.e. the nutritional 
intervention  
3. Available for a separate interview 
4. Capable of giving informed consent 
5. Able to communicate well in English  
Participants with visual or hearing impairment or other 
physical disabilities will NOT be excluded from the study. 
Planned Size of Sample (if applicable) The minimum, theoretical sample will be constructed to reflect 
the variability expected to arise from the characteristics listed 
above, which are factors that may potentially affect the oral 
nutrition support consultation with the dietitian. Preliminary 
analysis of data will be undertaken after the first few 
interviews and the findings used to focus the sample and 
refine the topic guide for subsequent interviews. Data 

 
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saturation will be sought and interviews will be continued until 
no further new themes emerge.  Applying the principle 
proposed by Francis et al (2010) for defining an a priori point 
for data saturation, a minimum sample and ceasing criterion 
will be defined.  For this study, a minimum of 3 data collection 
rounds providing approximately 10 data sources (i.e. 3 
observations, 3 patient interviews, and interviews with 
associated dietitians and nominated key stakeholders, and 
associated documents) will form the initial analysis sample.  
After this point, when 3 more data collection rounds have 
been completed and no new themes emerge, this will define 
the point of data saturation.  After that point, no further 
recruitment will occur.      
Follow up duration (if applicable) 
It may be necessary for the researcher to contact participants 
during the 24-month post-interview period.  There will be no 
further contact with participants regarding the study 
thereafter. 
Planned Study Period 
31/01/2018 – 28/12/2020 (35 months)  
Research Question/Aim(s) 
 
Aim:  
To understand the experience of the dietetic consultation 
from the perspective of nutritionally vulnerable older patients 
receiving oral nutrition support and dietitians, as well as other 
key stakeholders involved in the process of such a 
consultation. 
Research Questions:  
1. What is the experience of the dietetic consultation for 
nutritionally vulnerable older patients receiving oral 
nutrition support? 
2. What is the experience of the nutrition support 
consultation for dietitians involved in the management 
of nutritionally vulnerable patients? 
3. What is the experience of the dietetic consultation for 
the management of malnutrition for other patient-
nominated key stakeholders involved? 
4. How is the usefulness and value of the dietetic 
consultation perceived by these groups? 
 
 

 
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FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
FINANCIAL AND NON FINANCIALSUPPORT GIVEN 
The Dunhill Medical Trust 
6 New Bridge Street 
London 
EC4V 6AB 
Telephone: 0207 403 3299 
Email: admin@dunhillmedical.org.uk 
Research Training Fellowship 
 
 
ROLE OF STUDY SPONSOR AND FUNDER 
The joint study sponsors will be King’s College London and Guy’s & St. Thomas’ NHS Trust. The 
study sponsors are responsible for ensuring that specific duties are performed, properly distributed, 
allocated and accepted by investigators and the research institutions. The study sponsors confirm that 
formal arrangements are in place to ensure that specific duties are performed, properly distributed, 
allocated and accepted and for governance of the research from conception to completion, including 
design, management, financial probity, legal reputation, initiation, first recruit target and subsequent 
recruitment to both time and target.  The sponsors are responsible for checking that the study meets 
all the relevant standards are put and kept in place for authorisation, management, monitoring and 
reporting. The study sponsors will have minimal influence on the design of the study. 
 
The study funder, The Dunhill Medical Trust, has provided full funding for the study but will have no 
influence on its design and execution as described in this protocol.   
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
Study Steering Groups 
As a PhD student within the Diabetes and Nutritional Sciences Division at King’s College London, 
Michelle Gibbs (Research Dietitian/PhD Student) receives support in the conduct and coordination of 
her research project(s) from members of her appointed PhD Thesis Progress Committee which 
comprises Dr Christine Baldwin (primary PhD supervisor), Prof Peter Emery (secondary PhD 
supervisor), Mrs Sharon Markless (qualitative research expert), Dr C. Elizabeth Weekes (clinical 
dietetics expert).  In addition, each PhD student also has an assigned Postgraduate Research 
Coordinator (Dr Louise Goff). The PhD Thesis Progress Committee will continue to provide expert 
advice on the study design, conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results and operates independently from the Sponsor and Funder. According to 

 
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King’s College London academic regulations, for the purposes of this protocol, the research 
supervisors are named as chief investigators and the PhD student as the study coordinator.   
 
 
Protocol contributors 
 
This protocol was written by the Michelle Gibbs (Research Dietitian) under the close supervision of Dr. 
Christine Baldwin (Primary Research Supervisor) and Prof Peter Emery (Secondary Research 
Supervisor).  This included the design and plans for the conduct of the study, data analysis and 
interpretation, manuscript writing, and dissemination of results as described in this protocol. Members 
of the PhD Thesis Progress Committee aforementioned have provided expert advice on the study 
design and content of the protocol.  Neither the sponsor nor funder have been involved in decisions 
about the study design or the content of this protocol.         
  
KEY WORDS: 
patient experience; disease-related malnutrition; 
nutritional care; dietetic consultation; older adults; oral 
nutritional support 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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LIST OF CONTENTS 
 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
2 
RESEARCH REFERENCE NUMBERS 
 
5 
SIGNATURE PAGE 
6 
STUDY SUMMARY  
12 
FUNDING 
 
15 
KEY STUDY CONTACTS 
 
7 
ROLE OF SPONSOR AND FUNDER 
15 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
15 
LIST of CONTENTS  
17 
STUDY FLOW CHART 
 
18 
SECTION  
1. BACKGROUND 
 
19 
2. RATIONALE 
 
25 
3. THEORETICAL FRAMEWORK 
26 
4. RESEARCH QUESTION/AIM(S)  
28 
5. STUDY DESIGN/METHODS 
29 
6. STUDY SETTING 
36 
7. SAMPLE AND RECRUITMENT 
37 
8. ETHICAL AND REGULATORY COMPLIANCE 
48 
9. DISSEMINATION POLICY 
54 
10. REFERENCES 
54 
11. APPENDICIES 
60 
 
 

 
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STUDY FLOW CHART  
 
 
 

 
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STUDY PROTOCOL 
Understanding the experience of the dietetic consultation and the perceptions of its value from the 
perspective of nutritionally vulnerable older patients, dietitians and other key stakeholders: an 
illuminative evaluation. 
 
1 
BACKGROUND 
Malnutrition 
Malnutrition is common and associated with negative consequences to nutritional, clinical and patient-
centred outcomes as well as being associated with a greater chance of developing complications of 
illness, prolonged length of hospital stay and more hospital admissions resulting in greater costs of 
healthcare.  Malnutrition has been estimated to affect around 3 million people in the UK, the greatest 
number of whom are thought to be living in their own homes (Elia & Russell, 2009a).  The prevalence 
of malnutrition is particularly high in older people, affecting more than 10% of people over 65 years of 
age and its management in this group accounts for more than half of the total cost of managing 
malnutrition (European Nutrition for Health Alliance, 2006).  Older people not able to live in their own 
homes have a higher prevalence of malnutrition.  In a recent survey 14 % of those living in sheltered 
housing and 41 % of people being cared for in nursing homes were at high or medium risk of 
malnutrition (Russell & Elia, 2012; Elia & Russell, 2009b).  
Malnutrition is both a cause and consequence of ill health (Lean & Wiseman, 2008; NCCAC, 2006). Its 
causes are multi-factorial, with illness making a significant contribution, although patient 
circumstances can also be a contributing factor. One study of 794 hospital patients in Berlin, 22% of 
whom were malnourished, demonstrated that risk of malnutrition was significantly increased by patient 
circumstantial factors such as old age, living alone, and poor educational background (Pirlich et al., 
2005).  However, malnutrition arising from social and environmental factors gradually diminishes once 
nutritional intake improves (Skipper, 2012) highlighting  the importance of identifying and managing 
the causes of what is a complex condition.  
 
The management of malnutrition 
The management of malnutrition frequently focuses on nutritional issues with provision of food-based 
interventions and oral nutritional supplement drinks provided by a range of healthcare professionals 
representing first line strategies (Multi-professional consensus panel, 2012).  Some benefits to 
nutritional and clinical outcomes have been reported from the use of such strategies but the effects 
were heterogeneous and it is not possible to characterize the groups most likely to benefit. There is 
low to moderate quality evidence that food-based advice given with or without oral nutritional 
supplements (ONS) to nutritionally vulnerable patients results in short-term improvements to nutritional 
intake, weight, as well as measures of body composition and muscle strength however, evidence for 
clinical benefits, healthcare outcomes and indeed patient-centred outcomes is frequently lacking 
(Baldwin & Weekes, 2011).   

 
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Several systematic reviews have sought to determine the relative efficacy of ONS but the findings 
were heterogeneous (Baldwin & Weekes 2012; Stratton & Elia 2007; Smith 2013; Baldwin & Weekes 
2016). An early overview of systematic reviews of ONS suggested that they were associated with 
some clinical and nutritional benefits, supporting their use in clinical practice, but the authors didn’t 
consider the methodological quality of the systematic reviews included and may have been overly 
optimistic in their interpretation of findings (Stratton and Elia, 2007). Since this time numerous other 
systematic reviews of ONS and the findings summarised in an overview, compared the findings of 
reviews and examined their methodological quality.  The key findings were that there was 
considerable discordance for a number of nutritional, clinical and healthcare outcomes.  Only 29% of 
reviews were of high methodological quality and therefore the findings of a substantial proportion may 
be at risk of bias (Baldwin & Weekes, 2016).  
There are a number of factors which might contribute to the variation observed in studies of oral 
nutrition support including differences in clinical background of the included patients, variation in 
disease severity and progression and differences in healthcare setting. The frequency of 
consultations, intensity of dietetic input and the skills and experience of the practitioner may also 
contribute to the observed heterogeneity in amongst findings (Baldwin and Weekes, 2012).  
Investigation of how the skills and experience of the practitioner impact on the dietetic consultation has 
received relatively little attention. There is a small amount of evidence that patients’ perceptions and 
experience of the content, purpose and outcomes of a dietetic consultation differ from those of the 
dietitian resulting in failure of patients to adhere to dietary prescriptions, reducing the effectiveness of 
the consultation and leading to dissatisfaction of both patients and dietitian.  A questionnaire-based 
study of 141 consultations between patients with diabetes and dietitians or nurses demonstrated that 
patients and healthcare professionals frequently disagreed on what had been discussed and indeed 
the decisions made (Parkin, 2003). Greater motivation in patients to achieve the desired outcomes 
was associated with greater autonomy within the consultation. Two further small studies of dietetic 
consultations for patients with diabetes demonstrated that amount of empathy demonstrated by the 
dietitian was associated with greater levels of patient satisfaction and greater agreement between the 
patient and dietitian on what was discussed in the consultation (Goodchild et al, 2005; Parkin, 2014). 
An ability to demonstrate empathy within a consultation is only one of several aspects of patient-
centred care.  Patient-centred care has been associated with improved outcomes of treatment and 
improved quality of life as well as significant benefits to healthcare practitioners and to healthcare 
organizations (Mead & Bower, 2000; Little et al, 2001; Stewart, 2001).  A recent integrative review 
identified that patient-centred care is an important feature of dietetic practice, with benefits to both 
patients and dietitians, although it is an area which still presents opportunities for further research 
(Sladdin et al, 2017).  
A qualitative study of patient’s experience of the dietetic consultation for long-term conditions such as 
cardiovascular disease and diabetes highlighted some factors in common between patients such as 
the need for information, the approach used by the dietitian, the need for good communication skills 
and the patients’ own expectations and feelings about the appointment, although there were 
differences in how different patients reacted to similar aspects of the consultation (Hancock et al, 
2012).  Two key findings were that patients that had a negative experience of the consultation were 

 
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less likely to achieve the desired outcomes and that patients frequently perceived a difference 
between the dietitian’s agenda and what the patient expected of the consultation.  A small 
questionnaire–based study of nutritionally vulnerable patients who had received two consultations 
from a dietitian reported that more than half of the patients were unaware of the role of a dietitian, the 
reason for the referral and greater than two thirds of patients failed to understand the link between 
their underlying clinical problem and nutrition (Bird et al, [n.d.]).  A recent systematic review of the lived 
experience of patients with reduced intakes of food and drink in mainly hospital settings, highlighted 
the lack of support and help with eating experienced by patients in different care environments and a 
lack of caring dialogue about food and nutrition, although in situations where a caring attitude was 
exhibited by healthcare staff, patients acknowledged a greater willingness to make improvements to 
their nutritional intake (Larsen & Uhrenfeldt, 2013).  Taken together these data suggest that ‘the 
consultation’ is a key element in determining effectiveness of dietetic care and it might be speculated 
that how the dietetic consultation is delivered might be a factor accounting for some of the 
heterogeneity in the evidence base on nutritional support interventions. 
 
The role of the dietitian in patient management 
Dietitians have a key role in providing nutritional support to patients who are nutritionally vulnerable.  
For the purpose of this study, the term “consultation” refers to a consensual 1:1 interaction between a 
dietitian and a patient for the purpose of the provision of nutritional counselling.  The majority of 
interactions between dietitians and patients take place in individual consultations when a detailed 
assessment of the patient’s nutritional background is taken to guide the provision of tailored dietary 
advice aiming to improve the patient’s nutritional status.  Dietitians must also take into consideration, 
practical issues and social factors that might be contributing to the patient’s poor nutrition.  For this to 
be effective, the dietitian needs to use an appropriate range of communication skills, or patient-centred 
communication. 
In the context of the provision of nutritional support to nutritionally vulnerable patients, effectiveness 
can be considered as the ability of both parties to achieve a shared understanding of the purpose, 
aims and reason for the consultation, resulting in agreed management of goals. Therefore, for a 
consultation between a patient and a dietitian to be considered effective, a shared understanding is 
needed of the reasons for the consultation, the recommended goals and the proposed nutritional 
intervention.  There are a number of elements of the consultation likely to influence effectiveness.  The 
background, skills and experience of the dietitian is just one element.  The organisational system 
within which consultations operate is likely to be another factor.   
 
Organisation of dietetic services 
Traditionally the dietetic management of nutritionally vulnerable patients has relied on one-to-one 
consultations, which are time consuming and involve patients being able to travel to appointments.   
Increased demands on health services and the need to meet quality targets have resulted in some 
dietetic services being offered in different ways, e.g. the use of telephone consultations, greater 

 
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reliance on training of carers and other health professionals to offer nutritional support and increased 
use of visits to patients own homes.  All of these models have arisen from the need for greater 
efficiency of services rather than being informed by patient needs.  It is not known how patients or 
indeed dietitians perceive this way of working or the impact on effectiveness of consultations.  Taken 
together, features of the patient, how a consultation is delivered, communication skills used by the 
healthcare practitioner, and organisational elements might be considered to be part of the patient 
experience. 
The importance of effective management of nutritionally vulnerable patients is a key priority for 
organisations with a stake in the care and management of nutritionally vulnerable adults.  The National 
Institute for Health and Clinical Excellence (NICE) recently highlighted the potential for effective 
management of malnourished individuals as fifth of fifty-two guidelines that could generate the most 
cost savings to the NHS (NICE, 2017).  However, the focus of guidelines and policies in this area has 
tended to be on the provision of services and roles of healthcare staff rather than on understanding 
the patient perspective.  A recent report from Age UK poignantly drew attention to the patient 
perspective, suggesting that the first action in effective provision of nutritional care should be to ‘listen 
to us (patients)’ (Age UK, 2010).  
 
What is patient experience? 
In both clinical practice and health care research, there has been a growing interest and use of the 
term "patient experience" as it has become a focus for many healthcare leaders and policy makers, 
recognised as a top priority (Wolf et al, 2014). Over the past 10 years, there has been a drive towards 
both understanding how patients experience healthcare services and the best approaches to 
measuring expectations, satisfaction and experiences of healthcare (de Silva, 2013). Despite this, the 
meaning of “patient experience” remains controversial.  Amidst the lack of a universally accepted 
definition, most would agree that "patient experience" cannot be explained without the consideration of 
the patient (and family) perspective (Wolf et al, 2014).  Measurement approaches should ideally also 
consider the experience of the family and carers as extended participants in healthcare experience of 
the patient, but often don’t, and recommendations for the best ways of understanding their views 
remains a notable gap in the evidence (de Silva, 2013).   
 
The Beryl Institute, a global organisation made up of over 45,000 members who seek to improve the 
patient experience through collaboration and sharing of knowledge, defines patient experience as "the 
sum of all interactions, shaped by an organisation's culture, that influence patient perspectives, across 
the continuum of care" (The Beryl Institute, [n.d.]).  Wolf et al (2014) recently conducted a narrative 
synthesis of existing literature on “patient experience”, which identified a number of key themes on the 
meaning of the term (Wolf et al, 2014).   The authors felt that despite the many efforts to define patient 
experience in the literature, many are limited in scope (Wolf et al, 2014). Indeed, many studies have 
captured the quantitative measures and outcomes relating to patient experience but there is a need for 
studies to capture the holistic nature of this phenomena, for which qualitative investigation is ideal.  In 
considering whether patient experience and patient satisfaction were synonymous, authors of the 
narrative synthesis recommended a move beyond purely metric measures as captured in patient 

 
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satisfaction surveys, cautioning readers that patient experience is more than just satisfaction (Wolf et 
al 2014), a view also supported by others (de Silva, 2013, LaVela & Gallan, 2014). A study by The 
World Health Organisation found that although patient experience does significantly impact on patient 
satisfaction, other variables such as self-reported health status, expectations and personality also 
affect patient satisfaction levels as well as external variables such as the media (Bleich et al, 2009).  In 
the narrative synthesis by Wolf et al (2014), the three themes which were consistently identified and 
may help in the creation of a framework to optimise patient experience included “active patient and 
family partnership and engagement, the integral need for person-centeredness, and an 
acknowledgement of the broad and integrated of experience overall” (Wolf et al 2014, pg. 12).   
 
In the UK, the National Institute for Health and Clinical Excellence has published a Clinical Guideline 
(CG138) on the patient experience in adult NHS services, last updated in 2016 (NCGC, 2012).  It 
offers comprehensive, up-to-date, evidence-based guidance, derived from extensive literature 
searches, reviews of relevant policy documents, consultation with experts and qualitative narrative 
synthesis culminating in a series of clinical recommendations and quality statements on patient 
experience of healthcare services in the NHS (NCGC, 2012).  The recommendations include knowing 
the patient as an individual, the essential requirements of care, the importance of tailoring healthcare 
services for each patient, the benefits of continuity of care and relationships and enabling patients to 
actively participate in their care including shared decision making (NCGC, 2012). The patient remains 
the centrepiece of the relationship between the consultation, the experience and the outcomes.  
Indeed, the patient is an essential participant in the interaction we label as the consultation for which 
there might be quantitative, measurable outcomes or observations, often reported in studies. 
However, significant gaps in the literature are apparent in relation to the experience of nutritionally 
vulnerable patients receiving nutrition support, perhaps the more qualitative, and less quantifiable 
element of the dietetic consultation.  Despite the comprehensiveness of the NICE thematic qualitative 
review, there are some limitations in its relevance to this work. It specifically identified themes and 
sub-themes of the experiences of patients with cancer, diabetes and cardiovascular disease and then 
used these to develop a generic framework extendable to all adult patients (NCGC, 2012).  Therefore, 
included studies did not specifically address patient experiences of dietetic services for older people 
with malnutrition, although the themes might be extrapolated to such a patient group more generically 
regarding their experience of healthcare in the NHS. Furthermore, carer experiences were not 
addressed in this review and papers which described interventions designed to improve patient 
experience were excluded.  Other notable limitations included the absence of grey literature searches, 
study selection was completed by one reviewer, the absence of a list of excluded studies, the absence 
of a PRISMA diagram (Liberati et al, 2009) to enable the reader to track study decisions, no 
descriptions of the characteristics of included studies, and no reported assessment of the quality of the 
included studies.  
 
The role of the patient experience in the effectiveness of the dietetic consultation for the provision of 
nutritional support remains unknown and requires investigation.  As seen in the Wolf et al (2014) 
evidence synthesis, an in-depth understanding of patient experience is often limited by the quantitative 
study designs adopted in many studies (Wolf et al, 2014).  Furthermore, both Wolf et al (2014) and 

 
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NICE (NCGC, 2012) have reviewed the overall concept of the patient experience of healthcare 
services, but neither have explored this phenomenon in the literature specifically in relation to dietetic 
consultations. The illuminative evaluation approach proposed will allow exploration of the dietetic 
consultation and its function, how it is influenced by its context including the various settings in which it 
occurs, its advantages and disadvantages as perceived by everyone involved, the perceived value 
from the perspective of key stakeholders and its impact on outcomes (Partlett & Hamilton, 1972). 
 
The patient experience of the dietetic consultation 
Preliminary synthesis of studies which explore the experience of the dietetic consultation has identified 
22 studies for inclusion. Of these, a small number focus on the patient experience of the consultation 
with the dietitian alone and centre around the following themes with regard to the patient experience:  
1. Dietitian’s conduct, style or approach (Hancock et al, 2012) 
2. Verbal or non-verbal communication (Cant, 2009; Cant & Aroni, 2008; Hancock et al, 2012; 
Goodchild et al, 2005) 
3. Knowledge, information and education (Roberts et al, 2014; Hancock et al, 2012; Kim et al, 
2014) 
4. Patient satisfaction (Isenring et al, 2008; Hung et al, 2014; Isenring et al, 2004; Izquierdo et al, 
2003; Kim et al, 2014; Sutton et al, 2008) 
5. Nature of appointment including structure, setting, frequency, consistency, waiting times 
(Hancock et al, 2012; Spikmans et al, 2013; Izquierdo et al, 2003; Sutton et al, 2008) 
Of these eight studies, two were of qualitative design (Roberts et al 2014; Hancock et al, 2012), three 
were quantitative (Isenring et al, 2008, Hung et al 2014, Spikmans et al 2013) and three were mixed 
method studies (Cant, 2009; Cant & Aroni, 2008; Goodchild et al, 2005).  Some of these studies also 
reported effects on emotional, clinical, nutritional, functional outcomes (Izqiuerdo et al, 2003; Kim et al, 
2014). Additionally, an equally small number of studies examined the patient experience of a joint 
consultation with a dietitian and other healthcare professional including four qualitative studies, five 
quantitative studies and no mixed method studies, so far.  While these studies have explored some of 
the factors which contribute to the patient’s experience of the dietetic consultation and some have 
even attempted to measure it, they have all done so in the absence of a standard definition and none 
have explored the experience of the dietetic consultation exclusively for nutritionally vulnerable older 
adults receiving nutritional support.   Many have attempted to measure “patient experience” using 
quantitative methods.  Whilst the evidence base supports a variety of approaches to measuring patient 
experience, from those that employ a detailed, descriptive, qualitative exploration to those that collate 
quantitative data, the depth of description obtainable and the generalisability of the findings remains 
an important consideration when choosing amongst various approaches to investigating patient 
experience (de Silva, 2013).  Therefore, there is a gap emerging of in depth, qualitative exploration in 
the area and population proposed by this study.  The Health Foundation further suggest that another 
notable gap in the evidence is that despite successful efforts to validate surveys and other methods for 
measuring patient experience, subsequent improvements in patient experience has not been well 

 
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established and simply measuring patient experience should be a means to a better outcome, rather 
than an end in itself (de Silva, 2013).  
Sladdin and colleagues (2017) recently published an integrative review which aimed to synthesise 
both qualitative and quantitative literature relating to patient-centred care in dietetic practice. Critical 
appraisal of this review using the SIGN methodology checklist (SIGN, 2015) suggest it is of high 
methodological quality with only minor limitations.  Unlike the previously described narrative syntheses 
which considered patient experience more generically, this integrative review specifically focuses on 
dietetic consultations.  However, it is heavily concentrated on patient-centred dietetic care which, 
according to Wolf et al (2014) forms one of the domains of but does not entirely equate to patient 
experience.  Wolf et al (2014) considered such alignment with patient-centred care principles to be 
one aspect of the definition of patient experience, rather than the definition in itself.  Furthermore, the 
review considers dietetic consultations non-discriminately, and is therefore not specific to nutrition 
support consultations in nutritionally vulnerable older adults. 
Therefore, this study seeks an understanding of the experience of the dietetic consultation from the 
perspective of the malnourished older patient receiving nutrition support and other key stakeholders by 
means of illuminative evaluation and will use the information gained to inform the design of a model for 
the provision of nutritional care that maximises the patient experience. 
 
2 
RATIONALE 
Malnutrition is highly prevalent, particularly amongst older people, and leads to an increased risk of 
health complications and socioeconomic burden. It remains a significant public health problem 
associated with poor social circumstances, economic constraints and patient–related factors such as 
reduced mobility, depression and social isolation playing an important part, all of which are more 
common in older people.  Patients with malnutrition are often older patients with complex needs and 
therefore may require specialist knowledge and skills to provide nutritional support.  Dietitians are 
uniquely skilled to assess and understand the multiple factors that underpin diet and to individualise 
nutritional support, which has the potential to improve outcomes.  Although the causes of malnutrition 
are multifactorial, it’s clinical management places emphasis on a variety of nutritional support 
interventions by dietitians and other healthcare professionals including oral nutritional supplements, 
dietary advice and food-based interventions or a combination of approaches.   
 
The relative efficacy of oral nutritional support interventions has received variable attention, with the 
findings on food-based interventions suggesting lack of evidence and the extensive literature on ONS 
being discordant across outcomes and of variable methodological quality. Despite the heterogeneous 
nature of the evidence regarding the clinical management of nutritionally vulnerable patients, the 
factors responsible for the variability have not been identified.  One possible factor is failure of the 
patient to adhere to the dietary recommendations, which could result from failings in the relationship 
achieved during the consultation between the dietitian and the patient. There are no studies that we 
are aware of that have examined the patient experience of the consultation with the dietitian in the 
context of nutritional support and indeed whether the nature of the consultation had any impact on 

 
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patient satisfaction and achievement of goals.  A small group of studies have investigated elements of 
how dietetic and healthcare interventions are delivered, suggesting areas with potential to contribute 
to the success or failure of oral nutritional support interventions in the treatment of malnutrition.  The 
patient experience of consultations is increasingly being recognised as an important part of 
investigating their effectiveness in healthcare. To date there are a number of limitations in this 
literature, including use of methodologies which have limited understanding to just one or two 
domains, lack of holistic patient-centred approaches to understanding patient experience and lack of a 
standardised, universally-accepted definition for patient experience, resulting in use of a variety of 
measures to describe and quantify it (Wolf et al, 2014, LaVela & Gallan, 2014).  Failure to recognise 
the patient perspective in healthcare delivery has also been recognised at the organisational and 
national level as the Mid Staffordshire NHS Foundation Trust Public Inquiry repeatedly highlighted the 
failure to recognise the patient perspective in healthcare delivery (Francis, 2013). As patient 
experience of the nutritional support consultation has not been adequately explored in this population, 
it could be hypothesised that this is one contributing factor to the heterogeneity observed in studies of 
oral nutrition support interventions for the management of malnutrition.  Deeper understanding of the 
patient-related factors impinging on the effectiveness of consultations has important implications for 
the design of dietetic consultations for the management of nutritional support interventions.   
The research questions and aims are described in section 4 of this protocol.  A review of the literature 
indicates a need for exploration of the patient experience and its possible impact on the success or 
failure of the dietetic encounter in relation to its outcomes, particularly in the population of interest.  
This study aims to address some of the deficiencies in the literature and these gaps are precisely why 
the research questions outlined urgently need investigation.  The use of qualitative interviews will 
facilitate an in-depth understanding of the patient and practitioner experience in the management of 
clinically significant malnutrition and an overall illuminative evaluation approach will broaden that 
understanding of the dietetic consultation by triangulating multiple data sources.  
 
3 
THEORETICAL FRAMEWORK 
The study will adopt the qualitative model of illuminative evaluation as proposed by Partlett & Hamilton 
(1972).  Illuminative evaluation, a form of naturalistic enquiry, is based more on description and 
interpretation and less on measurement and prediction and was developed as an alternative to 
quantitative methods of evaluation (Partlett & Hamilton, 1972).  As a qualitative model, illuminative 
evaluation is proposed as it best-suits the aims of the study, utilizing in-depth semi-structured 
interviews, observations and documentary analysis as techniques for exploring the experiences, 
understanding, attitudes, processes, context and the perceived impact of the dietetic consultation. 
Therefore, it will build on the limitations of previous studies in the area, which are mainly quantitative 
or capture only some of the possible domains of patient experience.  Its purpose will be to evaluate 
the process of the dietetic consultation from all perspectives in order to gain full insight into its context 
and impact.  It will present different angles to the experience and function of the dietetic consultation 
and will allow identification of features that may affect its success or failure.  As an overarching 
approach, it will also provide in-depth illumination of how the dietetic consultation is experienced and 
perceived by those involved in various aspects of it, highlighting the factors which contribute to its 

 
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value and effective implementation. 
Gordon (1991) explains that illuminative evaluation seeks to: 
“understand the most significant aspects of an entire milieu, including important structures and 
inter-relationships, negotiations between parties, reciprocal influences, alternative 
conceptualizations and value orientations, critical processes, resource utilization, and any 
other aspects of the environment deemed significant” (Gordon, 1991, p. 370). 
Originally developed for evaluating innovative educational programmes, illuminative evaluation has 
been successfully adapted and used in studies relevant to health and social care.  Sloan & Watson 
(2001) used illuminative evaluation to investigate the interactions within the clinical supervision 
process by means of in-depth interviews, critical incident journals, session documents and audio 
recordings of supervision.  Russell et al (2004) conducted an illuminative evaluation study to explore 
the process of knowledge and information exchange by email to support evidence based healthcare.  
Gallini (2001) successfully applied the illuminative evaluation in an investigation of the response to the 
National Dignity in Care campaign, within an acute healthcare Trust in England. 
At the core of illuminative evaluation as a model are two concepts, namely the “instructional system” 
and the “learning milieu” (Partlett & Hamilton, 1972).  The instructional system, carries a catalogue 
description or idealised specification of the programme under study, where the ideal formulations, 
objectives, performance criteria or desired outcomes are formally recognised (Partlett & Hamilton, 
1972).  For this study, the instructional system will constitute professional standards of practice, 
evidence-based clinical guidelines, or policy documents which serve as benchmarks for the conduct of 
consultations and the clinical decisions made within the dietetic consultation for the provision of 
nutritional support.  However, as the execution of the programme rarely adopts the prescriptive ideals 
originally formulated in the “instructional system”, the second concept serves to describe the reality of 
its implementation, where the complicated interplay of circumstantial pressures, constraints, individual 
work styles or practices and environmental factors results in a unique configuration (Partlett & 
Hamilton, 1972).  This second concept is that of the “learning milieu”. Arguably, it is the diverse and 
complex learning milieu that arguably has the greatest impact on the experience of the dietetic 
encounter for all stakeholders who interact in an inevitably complex way, influenced by factors 
affecting the total consultation process.     
For this study, the chosen qualitative design which adopts an illuminative evaluation approach is 
justified primarily on the basis of providing an opportunity to open-mindedly explore the unknown in 
relation to the patient, dietitian and other key stakeholder experiences of the nutrition support dietetic 
consultation.  There remains a need to explore the experience of the dietetic consultation for the 
provision of nutrition support as a possible factor in the observed heterogeneity of response to 
nutritional interventions in the management of malnutrition. This need is further supported by the 
discordance evident in the systematic review literature as to the efficacy of various oral nutrition 
support strategies used by dietitians, the unknown factors which contribute to their success or failure, 
and the variation in dietitians’ choices of nutritional support strategies for individual patients.  As the 

 
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available evidence fails to answer these questions and so far, there have been no attempts in the 
literature to qualitatively explore the experience of the dietetic consultation in nutrition support practice 
from various perspectives, an interpretivist rather than a positivist paradigm was chosen.  The 
proposed approach will paint a “portrait” of how patients, dietitians and key stakeholders experience 
and interpret the process and value of the dietetic consultation.  It will also support the development of 
recommendations and inform practical suggestions for improvements to the processes involved in 
dietetic consultations for the management of malnutrition using oral nutrition support.  
 
4 
RESEARCH QUESTION/AIM(S) 
The aim of this study is to understand the experience of the dietetic consultation from the perspective 
of nutritionally vulnerable older patients receiving oral nutrition support and dietitians, as well as other 
key stakeholders involved in the process of such a consultation. 
 
Research Questions:  
1. What is the experience of the dietetic consultation for nutritionally vulnerable older patients 
receiving oral nutrition support? 
2. What is the experience of the nutrition support consultation for dietitians involved in the 
management of nutritionally vulnerable patients? 
3. What is the experience of the dietetic consultation for the management of malnutrition for other 
patient-nominated key stakeholders involved? 
4. How is the usefulness and value of the dietetic consultation perceived by these groups? 
 
4.1 
Objectives 
 
1. To understand the experience and perceptions of usefulness and value of the dietetic 
consultation and its function through in-depth, semi-structured interviews, observations and 
supporting documentary evidence (e.g. medical/dietetic records, relevant policy documents, 
clinical guidelines) of nutritionally vulnerable older patients receiving oral nutrition support.  
2. To understand the experience and perceptions of usefulness and value of the nutrition support 
dietetic consultation and its function by means of in-depth, semi-structured interviews, 
observations and supporting documentary evidence (e.g. medical/dietetic records, relevant 
policy documents, clinical guidelines) of dietitians involved in managing nutritionally vulnerable 
patients.  
3. To understand the experience and perceptions of usefulness and value of the nutrition support 
dietetic consultation from the perspective other key stakeholders involved in the process of 
such a consultation using in-depth, semi-structured interviews, observations and supporting 
documentary evidence (e.g. medical/dietetic records, relevant policy documents, clinical 
guidelines). 

 
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4. To use in-depth, semi-structured interviews, observations and supporting documentary 
evidence (e.g. medical/dietetic records, relevant policy documents, clinical guidelines) to further 
understand the function, implementation, context and outcome of the oral nutrition support 
dietetic consultation.  
 
4.2 Outcomes 
Outcomes of this study will include themes and sub-themes related to the patient experience, dietitian 
experience and key stakeholder experience of the consultation with quotes to provide context to the 
themes and to represent the voice of the participant regarding important factors affecting the patient 
experience.    
 
5 STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
Study Design 
As aforementioned, the study will adopt the qualitative, illuminative evaluation model (Partlett & 
Hamilton, 1972) to gather data on the nutrition support consultation experiences for patients, 
associated dietitians and key stakeholders.  
As the overall aim of illuminative evaluation is to describe and interpret the programme and process 
under study to facilitate understanding and improvement, the paradigm stipulates a variety of data 
collection sources so that the milieu under study can be understood from diverse perspectives 
(Gordon, 1991). Partlett and Hamilton (1972) suggest that there are typically four elements involved in 
illuminative evaluation: observations, interviews, questionnaire/test data & documentary information. 
However, Partlett & Hamilton propose that illuminative evaluation is not a prescriptive methodological 
package but a general and adaptable research strategy (Partlett & Hamilton, 1972).   The choice of 
data collection methods is dictated by the process under investigation, although there is a definite 
emphasis on observation and participant interviews particularly because of the concentration on the 
process under study as central to the “learning milieu” (Partlett & Hamilton, 1972).   
The Health Foundation recommend when attempting to measure patient experience and deciding on 
an appropriate data collection method, that available time, expertise and resources be taken into 
consideration (de Silva, 2013). Taking this into account for this study as well as the nature of the 
consultation process under investigation, data will be collected using: 
• 
Observations 
• 
Interviews 
• 
Documentary information.  
This will provide the widest range of data sources feasible.     
 
The variety of general characteristics to be considered in the patient sample are summarised below:  

 
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Age 
• 
60-65 years 
• 
Over 65 years 
Gender 
• 
Male 
• 
Female 
Ethnicity 
• 
Mixture of ethnicities to be 
included in the sample as 
represented in the local area 
according to the Lambeth State 
of the Borough (Lambeth 
Council, 2016) & Southwark 
Demographic Fact Sheet 
(Southwark Council, 2015) 
Type of nutritional support 
received 
• 
Food-based advice (food first) 
• 
ONS  
• 
Combination of the two 
strategies 
Number of consultations 
• 
Attended one appointment with 
dietitian 
• 
Attended 2 or more 
appointments  
Consultation type 
• 
Face-to-face 
• 
Telephone   
Clinical setting 
• 
Hospital outpatient (HOP) 
• 
Hospital inpatient (HIP) 
• 
Home visit (HV) 
• 
Intermediate care (IC) 
Family support 
• 
Yes 
• 
No 
 
Observations 
Observations will be used to record the sequence of events of the consultation, verbal and non-verbal 
communication and the patient and dietitian interaction throughout.   Dietetic consultations will be 
observed in each setting to include the hospital ward, the outpatient clinic, the intermediate care 
setting and within the patient’s own home as relevant. Observations will not be audio-recorded due to 
the risk of recording potentially sensitive conservations from nearby, non-participants.  Instead, 
observations will be made and detailed field notes recorded as described here. In order to avoid 
patients associating the Research Dietitian with their clinical and nutritional care, the patients who are 
observed (Group 1) will not be interviewed.  Rather, the focus of the observations will be on elements 
of the patient and dietitian communication and interaction during the consultation.  However, where 

 
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possible some Group 2 patients may be observed by another member of the research team.  The 
series of steps outlined by Creswell (2013) and recommended for the conduct of observations in 
qualitative enquiry will be followed:  
1. Required permissions will be sought from various observation sites in the form of verbal 
agreement from ward managers, clinical dietetic leads, intermediate care managers and the 
patients themselves.  Written agreement for observation will also be sought from participants 
as part of the informed consent procedures.    
2. Within each setting, the details of what and who will be observed will be specified.  For 
consultations that take place in any of the four settings proposed, the entire dietetic encounter 
between the patient (and carer/relative, if present) and the dietitian will be observed.  Joint 
consultations involving other healthcare professionals will be included only if the additional 
healthcare professional consents to being observed.  The exact nature of what is observed will 
be predefined and informed by literature review. Some aspects of the interaction to be 
observed within the various settings might include but not limited to: 
a. The patient – age, nutritional status, clinical condition, general state of well-being, 
willingness to see dietitian, knowledge & understanding, apparent satisfaction, mobility. 
b. The dietitian – general conduct, style or approach, communication (verbal/non-verbal 
and use of patient-centred communication), knowledge & information delivery, 
education style 
c. The setting/environment – the time of day, atmosphere on the ward/home/clinic, 
privacy, waiting time (if applicable),  
d. The consultation – whether initial appointment or review, duration, structure, frequency 
(if applicable), focus, agreed goals.  
3. The role as an observer will be defined.  This will be as a non-participant observer, so that the 
researcher will remain an outsider to the process under study, watching and taking notes 
without an active role in the consultation.  This will involve data collection without direct 
involvement in the activity of the dietetic consultation.   
4. An observational protocol will be used as a method for collection observation data in the field.  
The final content of the proforma will be informed by the literature review but will allow both 
descriptive and reflective notes (own thoughts, experiences, hunches).  The date, setting and 
time of observation will be recorded alongside the field notes.   
5. Details of the participants, physical setting, notable events or activities will be recorded along 
with a description of what happened and own reflections (insights, ideas, initial interpretations) 
will also be noted.   
6. The dietitian involved in the consultation will introduce the Research Dietitian (outsider) and 
explain her role before the observation begins to ensure the patient is still happy for the 
consultation to be observed.  
7. Once the consultation is completed, the researcher will thank the participants and remind them 
of the use of the data and its role in the study. 
8. Complete field notes will be prepared as soon as possible following the observation to give a 
rich, dense description of the participants and the consultation observed.   

 
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Interviews 
Interviews will be used to uncover the participant’s experience of the consultation and 
perceptions of its value.  The use of qualitative interviews has the greatest potential to uncover the 
range and complexity of experiences of dietetic consultations as well as to facilitate identification of 
factors influencing the practices of dietitians providing nutritional support.  Interviews will be 
undertaken with patients booked to see a dietitian for advice on nutritional support and their consulting 
dietitian.  In addition, included patients will be asked to nominate up to two additional individuals 
considered to be key stakeholders in their care, i.e. have some notable involvement in the dietetic 
consultation or its outcome. They might include carers, spouses or partners, or other healthcare 
professionals but must be nominated by the patient.   
As several different types of participants will be interviewed, separate interview topic guides 
will be developed for each participant type.  The key themes identified by Wolf and colleagues (2014), 
the quality standards outlined in the recent NICE guidelines on patient experience (NCGC, 2012) as 
well as topics explored quantitatively in a questionnaire study examining current oral nutrition support 
practice amongst UK dietitians (Gibbs, 2014) will contribute to the construct of the interview topic 
guides. Review of the literature will also inform the topic guide for interview.   
The first few in-depth interviews undertaken will also help to guide the focus of the remaining 
interviews including participant recruitment, in line with the recommendation to start with a wide focus 
without pre-judgement, and then to narrow the field of focus as the study progresses (Cohen, 2011).  
This is also referred to in illuminative evaluation as “progressive focusing” (Partlett & Hamilton, 1972). 
All interviews will be conducted by one researcher (MG).  They will be audio-recorded and 
transcribed using the professional transcription services of Clayton Research Support. 
 
a. Patient interviews:  
Qualitative semi-structured interviews will be used to collect data on the experiences of 
patients who have been identified as malnourished or at risk of malnutrition and referred to a 
dietitian for management. In order to avoid patients associating the Research Dietitian with their 
clinical and nutritional care, a separate group of patients (Group 2) will be selected for qualitative 
interviews, so that those patients who participate in the consultation observations (Group 1) will not 
be interviewed.  A suitable time for the interview will be agreed and arranged with the patient.  For 
hospital inpatients, an interview in a private room on the ward will be arranged.  This will also apply 
to those in intermediate care.  For all other patients, an interview in their own home or at King’s 
College London will be arranged.  If interview at the patient’s home isn’t possible, patients will be 
invited to King’s College London, Waterloo Campus for interview in a private room.  For the 
community dwelling-patients face-to face interviews will be conducted at the patient’s home unless 
the patient explicitly objects to this. As with the hospital/intermediate care patients, should 
interview at the patient’s home not be possible, patients will be invited to King’s College London, 

 
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Waterloo Campus for interview in a private room. In such cases, travel expenses for a return 
journey to and from King’s College London will be subsequently reimbursed.     
The critical incident technique was developed by Flanagan for the collection and analysis of 
objective, reliable information about specific human activities (Flanagan, 1954). Although this 
methodology will not be adopted in its entirety, it will be used to help formulate the semi-structured 
interview guide for the older patients by use of specific questions throughout. The majority of 
nutritionally vulnerable patients are elderly and less structured forms of interviewing which aim to 
explore the abstract and general may be more difficult for older patients.  Critical incident 
technique typically uses specific questions that seek to identify contextualised examples of the 
real-life human activity of interest and its significance for the participant. The greater structure and 
specificity of questions make this technique particularly valuable for interviewing this group of 
patients. The steps of the critical incident technique will not be followed explicitly but the style of 
interview questioning will be adopted as appropriate in constructing the interview guide.  
Participants will be asked to focus on the recently observed consultation with the dietitian.  
Questions and prompts will be used (as appropriate) to encourage patients to describe positive or 
negative experiences of the consultation.  It has been demonstrated to be important that the 
definition of “successful” or “unsuccessful” in the context of describing the consultation is 
determined by the participants themselves, to avoid imposing definitions that reflect the 
researchers’ perspective.  
 
b. Dietitian interviews: 
Semi-structured interviews will be used to understand the experience and perceptions of value 
of the consultation for the dietitians involved in providing nutritional support to participating 
patients. A suitable time will be agreed with the dietitian for the qualitative interview.  Interviews will 
take place in a private room either within the healthcare environment or at King’s College London.   
It has been demonstrated in consultations between some patients and dietitians that the 
recollection of goals agreed in the consultation frequently differ. To facilitate exploration of views 
from both parties involved in the oral nutritional support consultation, patient and dietitian “pairs” 
will be included in the study, where possible.  Dietitians taking part in the study may be observed 
only, interviewed only or both observed and interviewed in order to capture as many elements as 
possible of their experience of the dietetic consultation.  The semi-structured interviews will be 
based on a pre-developed topic guide specific for the dietitians guided by the literature review. 
Open-ended questions will be used to draw out experiences of providing nutritional support in 
different healthcare settings, and of factors guiding the provision of different types of nutritional 
support. 
 
 
c. Key stakeholder interviews: 

 
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Semi-structured interviews will be used to explore the experience of the consultation for 
carers/relatives/other healthcare professionals who have been nominated by the patient. The 
experience of carers and others indirectly involved in the healthcare process for any given patient 
is an area which has received little attention in the literature and it is not clear whether the 
experience of such individuals should be measured using the same tools for exploring the patient 
experience (de Silva, 2013).   However, for the purpose of this study, and because the key 
stakeholders will be nominated by the patient and therefore could include a range of possible 
individuals with a wide range of knowledge, expertise, input and involvement, separate interview 
guides will be produced for this participant group.  The extent to which they are involved in the 
consultation, their communication with the dietitian, or the degree to which they might be involved 
in the implementation of the nutritional intervention for the patient will also be explored.   
Patient–nominated key stakeholders will be nominated by the patients (Group 2) who will be 
interviewed and they will be invited to King’s College London, Waterloo campus for a separate 
interview.  It is preferred that they are interviewed privately to avoid their responses being 
influenced by the presence of the patient in the interview.   
 
Documentary Information  
Documentary information will be used to further understand the full range of factors affecting the 
consultation experience through data triangulation.  As required for good clinical practice, dietitians are 
required to document the details of each consultation in the patient’s medical records and sometimes 
additionally in dietetic departmental records although the two often merge to avoid having duplicate 
records. The data required from medical/dietetic records will include the patient’s date of birth, gender, 
nutritional status, ethnicity, number of dietitian appointments, clinical setting, details of the agreed 
nutritional intervention, social circumstances/family support, and the clinical dietitian’s documentation of 
the details of the consultation.  Any copies of patient records will be anonymised but labelled with a 
unique participant identifier to enable interpretation alongside the interview and observational data.  
Data for documentary analysis will be obtained as soon as possible after the consultation observation 
(Group 1), which may depend on how quickly consultation notes are documented by the clinical dietitian 
but it is anticipated that this will be within a couple of days of the consultation.  Documentary data may 
be obtained prior to the qualitative interview (Group 2) and might also be used to modify the interview 
topic guides as appropriate. All cases will include the dietitian’s medical/dietetic notes of the consultation 
as a triangulated data source.   
As part of the illuminative evaluation approach to be used, these records as well as relevant 
clinical guidelines or trust policies will be included for document analysis as relevant.  These may include 
local departmental protocols or pathways for management of malnutrition or national clinical guidelines, 
or other relevant published documents.   
Supporting documentary information will be required for all patients in the study (Groups 1 & 2) 
to help in the triangulation of data.  As the limitations of this data source have been considered, every 
effort to improve the credibility of this information e.g. through triangulation with other data sources will 

 
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be undertaken. The document analysis procedures for application to qualitative research as outlined by 
Bowen (2009) will be used. 
 
Data Analysis  
Data analysis will commence as soon as possible after the first few observation notes have been 
written up and interviews transcribed and will take the form of thematic analysis.  Documents will be 
first categorised into: 
1. ‘Umbrella Documents’ comprising mainly local and national clinical guidelines, standards and 
policy documents  
2. ‘Patient-level documents’ comprising the medical/ dietetic notes and any other individualised 
documents pertaining to that particular consultation as relevant to the study.   
The Umbrella Documents will be used to create a guiding framework for analysing the Patient-level 
documents but will be eventually used in the triangulation of all data sources.  A core principle of 
illuminative evaluation as recommended by Partlett & Hamilton (1972) is that there are three stages in 
that researchers “observe [or interview], inquire further and then seek to explain” (p18).  So, it is 
important that further inquiry is informed by preliminary analysis of the observations and interviews 
that have gone before to allow progressive focussing and refinement of the data collection that follows.  
Transcripts of each interview will be read and re-read alongside listening to recordings of interviews 
several times. Once this is achieved for the first few observations and interview transcripts, possible 
codes will be noted to begin to develop a coding structure.  It is acknowledged that meaning and 
explanations begin to emerge from the start of data collection and that these may be used to guide 
subsequent data collection as well as analysis, although final conclusions will not be drawn until all 
data are collected. Memos will be used to record thorough processes for code classification.  Codes 
will then be grouped into categories and categories into themes.  As themes emerge from the data, 
this will allow us to begin to draw conclusions and analysis will continue until no new themes emerge.  
As analysis progresses, interpretation will continue with the development of patterns and explanations 
with reference to the literature.   Data management software will be used to collate and manage the 
large volume of data, following appropriate training.    
 
Data Storage, Transfer, Access & Archiving 
During the course of the research study, all data will be the responsibility of the Research Dietitian under 
the supervision of the Chief Investigators, who will ensure that any personal study data are kept in 
secure conditions i.e. on password-protected Trust/ University computers or in a locked filing cabinet in 
the Department of Nutrition & Dietetics, King’s College London.  These will only be accessible only by 
the Research Dietitian or Chief Investigators.  All data collected will be stored using password-protected 
software and will be accessed only by the Research Dietitian or Chief Investigators for the purposes of 
analysis. 

 
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Interviews will be recorded using a digital recording device. A second digital recording device will be 
used to protect against potential equipment failure.   
The professional transcription services of Clayton Research Support will be used to transcribe the 
qualitative interviews.  Data transfer between the Research Dietitian and Clayton Research Support will 
employ the following secure method: a secure disk or memory stick will be sent by post using Royal 
Mail Special Delivery to send the audio recordings to Clayton Research Support.  Clayton Research 
Support will then email the transcript back and password protect it.  Details of the password would be 
sent by Clayton Research Support in a separate email. The memory stick will be returned to the 
Research Dietitian by Clayton Research Support by Royal Mail Special Delivery for safe discard. 
Copies of the confidentiality agreement, data protection agreement and general security policies and 
procedures from Clayton Research Support are available on request.  
When the study is complete, the research records will be kept for a further five years in accordance 
with the requirements of the Research Governance Framework and Health Board Policy.  
 
6 
STUDY SETTING 
Data will be collected from the following four clinical settings including: 
1. Hospital ward 
2. Outpatient clinic 
3. Intermediate care 
4. Community (home visits) 
A variety of clinical settings was chosen for the purpose of maximum variation sampling in order to 
cover a broad range of clinical experiences.  The four clinical settings represent both institutionalised 
and non-institutionalised patients which might highlight differences in the nutritional management of 
malnutrition by dietitians working in these settings.  Amongst these clinical settings, there are 
conceivable variations in the amount of time available for individual dietetic consultations, frequency of 
dietetic consultations, impact of the artificial (e.g. hospital ward) versus real life (e.g. home) setting, 
degree of illness or wellness of the patient, and differences in organisational constraints, amongst 
other factors which may influence the process of the dietetic consultation. Thus, the impact of these on 
the patient’s perception of the dietetic consultation merits further exploration and will be achieved by 
recruitment of patients from a variety of settings.    
Patient recruitment procedures will vary according to clinical setting and are detailed under 
‘Recruitment’ below.  Dietitians will be accessed from the Nutrition & Dietetic Service within the Guy’s 
and St. Thomas’ NHS Trust.  Patients will be accessed from the current caseload (including new 
referrals) of the clinical dietitians included in the sample.  Key stakeholders will be accessed by means 
of patient nomination by patients in Group 2 (those being interviewed).   
 
Hospital ward: 

 
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It is anticipated that recruitment of hospital inpatients (HIP) will come from the three wards on the older 
person’s unit at St. Thomas’ Hospital including Anne ward, Henry ward and Alex ward.  However, any 
patients potentially eligible for the study will be approached for recruitment irrespective of their acute 
ward admission across the Trust.   
 
Outpatient clinic: 
It is anticipated that recruitment of hospital outpatients (HOP) will come from the Older Person’s 
Assessment Unit (OPAU) at Guy’s Hospital where the dietitians are likely to see older patients and 
provide nutritional support.  Any additional clinics covered by dietitians employed by the Trust and 
participating in the study will also be considered, irrespective of their speciality area, as long as the 
patient meets the study inclusion criteria.     
 
Intermediate care: 
It is anticipated that recruitment of Intermediate Care (IC) patients will come from the Pulross Centre in 
Brixton where patients are seen by dietitians from the LAMP team.  
 
Community (home visits): 
It is anticipated that recruitment of home visit (HV) patients living in the community will come from the 
caseload of the LAMP team of dietitians who regularly see patients in their own homes who may 
require nutritional support.    
 
7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
Details of the study inclusion and exclusion criteria are given below.   
 
7.1.1 Inclusion criteria  
Study participants to include: 
Patients: 
• 
Adults (aged > 60 years) 
• 
National Health Service (NHS) number 
• 
Capable of giving informed consent 
• 
Able to communicate well in English 
• 
Nutritionally vulnerable according to the Nutrition Screening Tool in use at Guy’s & St. 
Thomas’ Trust prompting referral to a dietitian 
• 
Likely to receive a form of oral nutrition support in the management of malnutrition  

 
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• 
Not receiving end-of-life care i.e. with a life expectancy of more than three months (as 
determined by a Consultant or GP in accordance with local policies).  However, a decision 
will be made in consultation with the multidisciplinary team and the patient in such cases 
regarding inclusion/exclusion as this is a one-off patient interview with the patient with no 
subsequent, active follow-up.  Therefore, restrictions on participation will not be placed upon 
the patient if considered appropriate for inclusion by the parties aforementioned. 
• 
Consents to having their qualitative interview audio-recorded (Group 2) 
• 
A variety of the characteristics below: 
Age 
• 
60-65 years 
• 
Over 65 years 
Gender 
• 
Male 
• 
Female 
Ethnicity 
• 
Mixture of ethnicities to be 
included in the sample as 
represented in the local area 
according to the Lambeth 
State of the Borough 
(Lambeth Council, 2016) & 
Southwark Demographic Fact 
Sheet (Southwark Council, 
2015) 
Type of nutritional 
support received 
• 
Food-based advice (food first) 
• 
ONS  
• 
Combination of the two 
strategies 
Number of consultations 
• 
Attended one appointment 
with dietitian 
• 
Attended 2 or more 
appointments  
Consultation type 
• 
Face-to-face 
• 
Telephone   
Clinical setting 
• 
Hospital outpatient (HOP) 
• 
Hospital inpatient (HIP) 
• 
Home visit (HV) 
• 
Intermediate care (IC) 
Family support 
• 
Yes 
• 
No 
 
Dietitians: 

 
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• 
Consulting dietitian providing the nutritional advice to participating patient 
• 
Employee of Guy’s & St. Thomas’ NHS Trust and member of the Nutrition & Dietetic team 
• 
Minimum of three different dietitians across the healthcare settings to be included 
 
Key Stakeholders: 
Up to 2 optional patient-nominated key stakeholders who are involved in the dietetic consultation and 
success of the dietetic intervention e.g. other HCP, family member, carer or friend. Their criteria for 
inclusion will include: 
• 
Nominated by the patient (from Group 2) participating in the study 
• 
Involved in some aspect of the implementation of goals agreed between the patient and 
dietitian during the consultation i.e. the nutritional intervention  
• 
Available for separate interview at a mutually agreed location 
• 
Capable of giving informed consent 
• 
Able to communicate well in English 
Participants with visual or hearing impairment or other physical disabilities will NOT be excluded from 
the study. 
 
7.1.2 Exclusion criteria  
Exclusion criteria (patients): 
• 
Participated or due to participate in another aspect of the study i.e. a patient will not be recruited 
to participate in consultation observations (Group 1) if they have already been or due to be 
recruited to take part in the qualitative interviews and vice versa (Group 2). 
• 
Outside of stated age range for inclusion 
• 
Incapable of giving informed consent  
• 
Cognitive impairment 
• 
No National Health Service (NHS) number 
• 
Unable to communicate well in English 
• 
Not considered nutritionally vulnerable according to Nutrition Screening Tool 
• 
Not referred to a dietitian for nutrition support 
• 
Patients receiving artificial nutrition support 
• 
Judged to be receiving end-of life care (i.e. unlikely to live for more than three months as 
assessed by a consultant or GP in accordance with local policies).  However, a decision will 
be made in consultation with the multidisciplinary team and the patient in such cases regarding 
inclusion/exclusion as this is a one-off patient interview with the patient with no subsequent, 
active follow-up.  Therefore, restrictions on participation will not be placed upon the patient if 
considered appropriate for inclusion by the parties aforementioned.  
• 
Does not wish to have their qualitative interview audio-recorded (Group 2) 

 
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7.2  
Sampling 
 
As described by Brinkmann (2013), information-oriented selection will be used to ensure that 
participants are chosen on the basis of expectations of the information they will provide in relation to 
the study.  More specifically, maximum variation sampling will be employed to ensure data from the 
widest variety of patient circumstances can be captured (Brinkmann, 2013).  Therefore, patients of 
differing age brackets, both males and females, those receiving different types of oral nutritional 
support, those who have had just one or more than one consultation, different consultation modes, 
different clinical settings and the presence or absence of family support will all be recruited.  Maximum 
variation sampling technique has been theoretically justified on the basis of prior knowledge of some 
of the factors which could potentially influence the outcome of a nutrition support consultation. It has 
already been stated that each patient from Group 2 will be invited to nominate a maximum of two key 
stakeholders for separate interview and the consulting dietitian will be invited for interview in all cases.  
Therefore, for each patient interviewed, there could be up to three additional persons interviewed.        
  
7.2.1  Size of sample 
It is not possible at this stage to specify a sample size as it is planned to continue sampling and 
recruitment until data saturation is reached and until no new themes emerge.  However, Brinkmann 
(2013) has expressed caution against recruiting large samples (over 50 interviews) for qualitative 
interview studies and argues that in such cases a survey might be more appropriate. Data saturation will 
be sought and interviews will be continued until no further new themes emerge.  Applying the principle 
proposed by Francis et al (2010) for defining an a priori point for data saturation, a minimum sample and 
ceasing criterion will be defined.  For this study, a minimum of 3 data collection rounds providing 
approximately 10 data sources (i.e. 3 observations, 3 patient interviews, and interviews with associated 
dietitians and nominated key stakeholders, and associated documents) will form the initial analysis 
sample.  After this point, when 3 more data collection rounds have been completed and no new themes 
emerge, this will define the point of data saturation.  After that point, no further recruitment will occur.  
 
7.2.2  Sampling technique 
The population to be sampled are nutritionally vulnerable older adults seeing a dietitian for oral nutritional 
support.  Purposive sampling will be used to derive a small, defined sample for illuminative evaluation of 
the dietetic consultation.   The rationale for this sampling strategy is to intentionally recruit a small, defined 
sample of participants with specific characteristics to illuminate their experiences of the oral nutrition 
support consultation by means of in-depth interviews, triangulated with observational and documentary 
data.  Purposive sampling will allow selection of participants to represent the widest possible range of 
experiences to shed light on the phenomenon of interest.  There will be a snowball effect with regard to 
sampling of the key stakeholders as these will be recruited on the basis of patient (Group 2) nomination, 
however, the core patient sample (Groups 1 & 2) will be recruited purposively.   
 

 
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7.3 
 Recruitment 
Recruitment procedures will vary according to clinical setting and are detailed here in turn: 
Hospital ward: 
1. Clinical dietitians working in the department of Nutrition & Dietetics at St. Thomas’ Hospital, 
who regularly see patients on the elderly care wards for nutrition support will be briefed on the 
study eligibility criteria. 
2. Clinical dietitians will be invited to participate in the study and will be provided with a Participant 
Information Sheet (specific to the clinical dietitians). 
3. Clinical dietitians will be asked to provide written, informed consent.  This will be by means of a 
consent form which will be signed and dated by both the participating clinical dietitian and the 
Research Dietitian. The clinical dietitians may be asked to participate in the consultation 
observations only, qualitative interviews only or both the observations and interviews.  They 
may also be asked to assist the Research Dietitian in acquiring relevant supporting 
documentation.  
4. Clinical dietitians will be asked to pre-screen potential patients on their current caseload, in 
collaboration with the Research Dietitian, to identify all those who meet the study inclusion 
criteria. This is in order to reduce selection bias by the clinical dietitians who may apply their 
own biases in selection of potential participants due to their familiarity with the patients in a care 
capacity.  As the Research Dietitian will not know the patients, selection of patients for invitation 
will be purely based upon the inclusion criteria and the requirement for maximum variation in 
the sampling strategy. The Research Dietitian will not be reviewing the patient’s entire 
medical/dietetic record at this stage, and will only access patient information directly related to 
the inclusion and exclusion criteria, required to determine their study eligibility. This pre-
screening procedure will be completed in close collaboration the clinical dietitians as the 
Research Dietitian will not access patient records independently at this stage.  The clinical 
dietitians will be reminded to remain objective at all times during the pre-screening process to 
ensure any unfounded selectivity is avoided.  
5. The clinical dietitians will be asked to approach potential participant patients, currently under 
their care who are pending a dietetic consultation or review, for potential inclusion based on the 
pre-screening procedures.  
6. A brief introduction to the study will be provided by the clinical dietitian and if the patient is 
interested, the clinical dietitian will inform the Research Dietitian who will provide the patient 
with the participant information sheet on the ward and an opportunity to ask any questions. 
7. The Research Dietitian will leave the patient to consider the invitation for a minimum of 24 
hours (this may be less under some circumstances).  The patient will then be asked to complete 
written, informed consent procedures with the Research Dietitian before any data collection 
commences. 
8. For patients whose consultations will be observed (Group 1), the next scheduled dietetic 
consultation will be arranged for observation on the ward.    
9. For patients who will be interviewed (Group 2), the Research Dietitian will agree a date and 
time for the private, qualitative interview with the patient. Written, informed consent procedures 

 
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will be followed at this stage.  Any relevant supporting documentary information may be 
reviewed before or after the qualitative interview, as required and as available.  Patients will 
also be asked to nominate a maximum of two key stakeholders to be contacted for invitation to 
a separate interview.  Contact details of the nominated key stakeholders will be obtained from 
the patient.  If the nominated key stakeholder is present at the time of nomination, the Research 
Dietitian will provide an overview of the study and explain why they are being invited to 
participate.  Otherwise, the Research Dietitian will contact the nominated key stakeholders by 
telephone or letter to invite them to participate in the study.  They will be sent a Participant 
Information Sheet specific for the key stakeholders by post (or hand delivered if present on the 
ward) and allowed enough time to consider their participation.  The Research Dietitian will then 
contact the key stakeholders by telephone to find out whether they would like to participate in 
the study and if yes, will arrange a mutually agreed date/ time/ venue for a separate qualitative 
interview. Written, informed consent procedures will be followed for the key stakeholders.   
Outpatient clinic: 
1. Clinical dietitians working in the department of Nutrition & Dietetics at Guy’s and St. Thomas’ 
NHS Trust, who regularly see patients for nutrition support in the outpatient clinics will be 
briefed on the study eligibility criteria. 
2. Clinical dietitians will be invited to participate in the study and will be provided with a 
Participant Information Sheet (specific to the clinical dietitians). 
3. Clinical dietitians will be asked to provide written, informed consent.  This will be by means of a 
consent form which will be signed and dated by both the participating clinical dietitian and the 
Research Dietitian. The clinical dietitians may be asked to participate in the consultation 
observations only, qualitative interviews only or both the observations and interviews.  They 
may also be asked to assist the Research Dietitian in acquiring relevant supporting 
documentation. 
4. Clinical dietitians will be asked to pre-screen clinic lists for potential patients, in collaboration 
with the Research Dietitian, to identify all those who meet the study inclusion criteria. This is in 
order to reduce selection bias by the clinical dietitians who may apply their own biases in 
selection of potential participants due to their familiarity with the patients in a care capacity.  As 
the Research Dietitian will not know the patients, selection of patients for invitation will be 
purely based upon the inclusion criteria and the requirement for maximum variation in the 
sampling strategy. The Research Dietitian will not be reviewing the patient’s entire 
medical/dietetic record at this stage, and will only access patient information directly related to 
the inclusion and exclusion criteria, required to determine their study eligibility. This pre-
screening procedure will be completed in close collaboration the clinical dietitians as the 
Research Dietitian will not access patient records independently at this stage.  The clinical 
dietitians will be reminded to remain objective at all times during the pre-screening process to 
ensure any unfounded selectivity is avoided.  
5. The clinical dietitians who see patients in these outpatient settings will be asked to review their 
clinic lists for eligible patients who are pending a dietetic consultation or review in clinic, for 
potential inclusion based on the pre-screening procedures.  A brief introduction and invitation 

 
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to the study will be provided by means of a departmental headed letter sent to the patient by 
post along with a PIS in advance of the clinic date.   
6. This will allow the patient sufficient time to consider the invitation to participate in the study.   
7. The patient will be informed in that letter that they may be approached by a member of the 
research team in the clinic waiting area  when they arrive for their clinic appointment to find out 
whether they would be interested in taking part in the study and be given the opportunity to 
have any questions answered regarding the study.   
8. For patients whose consultations will be observed (Group 1), on arrival to their outpatient 
appointment with the clinical dietitian, they will be asked to complete the written, informed 
consent procedures before observation of the dietetic consultation commences.   Any relevant 
supporting documentary information may be reviewed after the consultation observation, as 
required and as available.   
9. For patients who will be interviewed (Group 2), a date and time for the private, qualitative 
interview with the patient will be arranged.  Again, written, informed consent procedures will be 
followed at this stage.  Any relevant supporting documentary information may be reviewed 
before or after the qualitative interview, as required and as available.  The patient will also be 
given the option to nominate a maximum of two key stakeholders to be contacted for invitation 
to a separate interview. Contact details of any nominated key stakeholders will be obtained 
from the patient.  If the nominated key stakeholder is present at the time of nomination, an 
overview of the study will be provided and why they are being invited to participate will be 
explained.  Otherwise, the research team will contact any nominated key stakeholders by 
telephone or letter to invite them to participate in the study and will provide them with a 
Participant Information Sheet specific for the key stakeholders by post (or by hand if present).  
They will be given time to consider their participation. The research team will again contact the 
key stakeholders to find out whether they would like to participate in the study and if yes, will 
arrange a mutually agreed date/time/venue for a separate qualitative interview.  Written 
informed consent will also be followed for the key stakeholders. 
 
Intermediate care: 
1. The LAMP dietitians working in the department of Nutrition & Dietetics at Guy’s and St. 
Thomas’ NHS Trust, who regularly see patients for Nutrition Support in the intermediate care 
setting will be briefed on the study eligibility criteria. 
2. LAMP dietitians will be invited to participate in the study and will be provided with a Participant 
Information Sheet (specific to the clinical dietitians). 
3. LAMP dietitians will be asked to provide written, informed consent.  This will be by means of a 
consent form which will be signed and dated by both the participating clinical dietitian and the 
Research Dietitian. The LAMP dietitians may be asked to participate in the consultation 
observations only, qualitative interviews only or both the observations and interviews.  They 
may also be asked to assist the Research Dietitian in acquiring relevant supporting 
documentation. 

 
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4. The LAMP dietitians will be asked to pre-screen potential patients on their current caseload, in 
collaboration with the Research Dietitian, to identify all those who meet the study inclusion 
criteria. This is in order to reduce selection bias by the LAMP dietitians who may apply their 
own biases in selection of potential participants due to their familiarity with the patients in a 
care capacity.  As the Research Dietitian will not know the patients, selection of patients for 
invitation will be purely based upon the inclusion criteria and the requirement for maximum 
variation in the sampling strategy. The Research Dietitian will not be reviewing the patient’s 
entire medical/dietetic record at this stage, and will only access patient information directly 
related to the inclusion and exclusion criteria, required to determine their study eligibility. This 
pre-screening procedure will be completed in close collaboration the LAMP dietitians as the 
Research Dietitian will not access patient records independently at this stage.  The LAMP 
dietitians will be reminded to remain objective at all times during the pre-screening process to 
ensure any unfounded selectivity is avoided.  
5. The LAMP dietitians will be asked to approach potential participant patients, currently under 
their care who are pending a dietetic consultation or review, for potential inclusion based on 
the pre-screening procedures. 
6. A brief introduction to the study will be provided by the LAMP dietitians and if the patient is 
interested, the LAMP dietitian will inform the Research Dietitian, who will provide the patient 
with the PIS and an opportunity to ask any questions.  
7. The Research Dietitian will leave the patient to consider the invitation for a minimum of 24 
hours (may be less under some circumstances) for the patient to consider the invitation to 
participate in the study.   
8. For patients whose consultations will be observed (Group 1), the next scheduled dietetic 
consultation will be arranged for observation at the intermediate care unit.   Any relevant 
supporting documentary information may be reviewed before or after the consultation 
observation, as required and as available.   
9. For patients who will be interviewed (Group 2), the Research Dietitian will agree a date and 
time for the private, qualitative interview with the patient. Written, informed consent procedures 
will be followed at this stage.  Any relevant supporting documentary information may be 
reviewed before or after the qualitative interview, as required and as available.  Patients will 
also be asked, to nominate a maximum of two key stakeholders to be contacted for invitation to 
a separate interview.  Contact details of the nominated key stakeholders will be obtained from 
the patient.  If the nominated key stakeholder is present at the time of nomination, the 
Research Dietitian will provide an overview of the study and explain why they are being invited 
to participate.  Otherwise, the Research Dietitian will contact the nominated key stakeholders 
by telephone or letter to invite them to participate in the study.  They will be sent a Participant 
Information Sheet specific for the key stakeholders by post (or hand delivered if present) and 
allow them enough time to consider their participation.  The Research Dietitian will then contact 
the key stakeholders by telephone to find out whether they would like to participate in the study 
and if yes, will arrange a mutually agreed date/ time/ venue for a separate qualitative interview. 
Written, informed consent procedures will be followed for the key stakeholders.  

 
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Community (home visits): 
1. The LAMP dietitians working in the department of Nutrition & Dietetics at Guy’s and St. 
Thomas’ NHS Trust, who regularly see patients for Nutrition Support in the community setting 
will be briefed on the study eligibility criteria. 
2. LAMP dietitians will be invited to participate in the study and will be provided with a Participant 
Information Sheet (specific to the clinical dietitians). 
3. LAMP dietitians will be asked to provide written, informed consent.  This will be by means of a 
consent form which will be signed and dated by both the participating clinical dietitian and the 
Research Dietitian. The LAMP dietitians may be asked to participate in the consultation 
observations only, qualitative interviews only or both the observations and interviews.  They 
may also be asked to assist the Research Dietitian in acquiring relevant supporting 
documentation. 
4. The LAMP dietitians who see patients in the community setting will be asked to identify 
patients, currently under their care (or newly referred), for potential inclusion based on the 
inclusion criteria. 
5. The LAMP dietitians will be asked to pre-screen potential patients on their current caseload, in 
collaboration with the Research Dietitian, to identify all those who meet the study inclusion 
criteria. This is in order to reduce selection bias by the LAMP dietitians who may apply their 
own biases in selection of potential participants due to their familiarity with the patients in a 
care capacity.  As the Research Dietitian will not know the patients, selection of patients for 
invitation will be purely based upon the inclusion criteria and the requirement for maximum 
variation in the sampling strategy. The Research Dietitian will not be reviewing the patient’s 
entire medical/dietetic record at this stage, and will only access patient information directly 
related to the inclusion and exclusion criteria, required to determine their study eligibility. This 
pre-screening procedure will be completed in close collaboration the LAMP dietitians as the 
Research Dietitian will not access patient records independently at this stage.  The LAMP 
dietitians will be reminded to remain objective at all times during the pre-screening process to 
ensure any unfounded selectivity is avoided.  
6. A brief introduction and invitation to the study will be provided by means of a departmental 
headed letter and PIS sent either along with the home visit appointment booking letter or 
separately.   
7. The patient will be informed in that letter that they will be contacted by telephone following their 
receipt of the letter but before the home visit appointment to find out whether they would be 
interested in taking part in the study.   
10. The Research Dietitian will leave at least 24 hours after anticipated receipt (3-5 days after 
posting) for the patient to consider the invitation to participate (maybe less under some 
circumstances).  
8. If the patient expresses a willingness to participate when contacted by telephone (either by the 
LAMP dietetic assistants or by the Research Dietitian), they will be given the opportunity to ask 
the Research Dietitian questions about the study.  

 
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9. The Research Dietitian will answer any questions they may have about the study.  If the patient 
is contacted by the LAMP dietetic assistants and there are any queries about the study or their 
participation, the Research Dietitian will contact the patient to answer these questions.   
10. The patient will be asked to provide written, informed consent.  
11. For patients whose consultations will be observed (Group 1), the Research Dietitian will 
arrange to attend an upcoming home visit booked for that patient.   Prior to that home visit, the 
LAMP dietitian will check with the patient that they would still like to participate and whether it’s 
still okay for the Research Dietitian to attend the home visit.  On arrival for the home visit 
appointment, the patient will be asked by the Research Dietitian to complete the written, 
informed consent procedures before observation of the dietetic consultation commences.    
11. For patients who will be interviewed (Group 2), the Research Dietitian will agree a date and 
time for the private, qualitative interview with the patient. Written, informed consent procedures 
will be followed at this stage.  Any relevant supporting documentary information may be 
reviewed before or after the qualitative interview, as required and as available. Patients will 
also be asked, to nominate a maximum of two key stakeholders to be contacted for invitation to 
a separate interview.  Contact details of the nominated key stakeholders will be obtained from 
the patient.  If the nominated key stakeholder is present at the time of nomination, the 
Research Dietitian will provide an overview of the study and explain why they are being invited 
to participate.  Otherwise, the Research Dietitian will contact the nominated key stakeholders 
by telephone or letter to invite them to participate in the study.  They will be sent a Participant 
Information Sheet specific for the key stakeholders by post (or hand delivered if present) and 
allow them enough time to consider their participation.  The Research Dietitian will then contact 
the key stakeholders by telephone to find out whether they would like to participate in the study 
and if yes, will arrange a mutually agreed date/ time/ venue for a separate qualitative interview. 
Written, informed consent procedures will be followed for the key stakeholders.  
 
7.3.1 
Sample identification 
Dietitians to be approached for inclusion will be identified by the Research Dietitian in discussion with the 
clinical dietetic leads at both St. Thomas’ and Guy’s Hospitals and will be invited to the study either face-
to-face or by email, as appropriate.  The dietitians who have agreed to participate in the study will then be 
asked to review their clinical caseloads (including both new referrals and follow-ups) alongside the 
Research Dietitian in a pre-screening exercise to identify patients who might be eligible for inclusion in the 
study.  This will constitute review of electronic patient records and departmental/dietetic records by the 
clinical dietitian caring for that patient, who would be a member of their care team, in collaboration with 
the Research Dietitian.  Potentially eligible patients as identified during the pre-screening process and in 
discussion with the Research Dietitian to ensure they meet all eligibility criteria and characteristics 
required for maximum variation sampling will be approached for invitation to participate in the study.  Key 
stakeholders will be nominated by the patients included and their name and contact details will be 
obtained from the patient.  
Payments to participants to reimburse reasonable travel expenses for any visits additional to normal care 
are intended. This will apply to the patients and key stakeholders who opt to have their qualitative 

 
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interviews at King’s College London.  Therefore, the cost of a return journey between their home address 
and King’s College London will be reimbursed once the interview has been completed.  
 
7.3.2 Consent 
The Research Dietitian will obtain written informed consent from each dietitian, patient and key 
stakeholder prior to participation. This will follow full explanation of the aims, methods, anticipated 
benefits and potential hazards of the study.  A Participant Information Sheet (PIS) will be offered, the 
potential participant will be encouraged to ask any questions, and time will be allowed (minimum 24 
hours but maybe less under some circumstances) for them to consider the potential impact of consenting 
to study inclusion.  If for any reason, a potential participant makes a decision in less than 24 hours this 
will be documented together with a justification for this decision. The date that the PIS is given to the 
patient will be documented within the patient’s notes.  Signed participant consent will be obtained.  The 
original signed form will be placed in the study records, a copy will be given to the participant and for 
patients included, a copy will be placed in the patient’s notes. The right of the participant to refuse to 
participate without giving reasons will be respected. 
The Mental Capacity Act 2005 states that no person can give consent on behalf of another adult.   
Accordingly, where a prospective participant is unable to provide informed consent they will be excluded 
from the study.  Where uncertainty exists as to an individual’s capacity, an assessment consistent with 
the Mental Capacity Act 2005 will be made by the clinical dietitian caring for the patient. Due to its nature, 
the proposed study will be minimally invasive providing no additional risk to the participant. 
In order to fully explore the processes and function of the dietetic consultation, and determine its impact 
on the overall experience for dietitians, patients and key stakeholders, it will be necessary for the 
Research Dietitian to access relevant medical/dietetic records. These data will be accessed, analysed 
and stored securely at all times.  Any patient-identifiable data will be anonymised but will be linked to 
the interview and observational data for data analysis purposes.  Each potential participant will be 
informed of this, should they agree to inclusion in the study, will be required to provide written consent 
to their medical/dietetic records being accessed and included in the study in this way.  
All potential participants will be informed by the Research Dietitian that they are free to withdraw at any 
time from the study without giving reasons and without prejudicing further treatment.  
Since this is a non-invasive, qualitative study we do not anticipate that any safety issues will arise during 
the conduct of the study.  However, in the unanticipated event that they do, the PIS will be reviewed and 
updated accordingly. All participants who are actively enrolled on the study will be informed of the 
updated information and given a revised copy of the PIS in order to confirm their wish to continue on 
the study.  
Since it is known that the management of malnutrition in the community is sub-optimal it is possible that 
the researcher will observe and document examples of neglect in the care of vulnerable adults during 
the data collection period.  Should this occur, the Research Dietitian will inform her supervisors and will 
be responsible for reporting this to the appropriate authorities in accordance with local safeguarding 
policies.  

 
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8.1 
Assessment and management of risk 
Potential risks of the study will include: 
1. As food/nutrition is an emotive subject, patients and key stakeholders may become upset when 
discussing aspects of the patient’s nutritional care.  Participants will be made aware that they 
can withdraw feely from the study at any time without consequence. The Research Dietitian 
will aim to ensure that the participant is comfortable and at ease at all times during the 
qualitative interviews.  This will include prior to commencement of the interview and before 
more probing questions.  The Research Dietitian will employ communication skills to establish 
a rapport with the patient and observe any cues from the participant during the interview 
indicative of distress including if they might be perceiving the questions to be intrusive.  The 
Research Dietitian will respond by checking with the participant at several points within the 
interview whether or not they are happy to proceed with answering the questions and share 
their experience.  The Research Dietitian will also remind the participant that it is perfectly 
acceptable to pause or stop at any time, at their discretion and without consequence.          
2. There is the potential that whilst undertaking an interview the Research Dietitian might obtain 
information that the participant is at risk of potential harm or reveals an intention to harm 
others.  The Safeguarding policies in place within the Guy’s and St. Thomas’ Trust will be 
followed, including notification of all necessary parties.  The Research Dietitian will make every 
effort to arrange to attend the Trust Safeguarding Training prior to commencement of the study 
to ensure knowledge of these policies is up-to-date.  
3. The Research Dietitian lone working to conduct the various patient, dietitian and key 
stakeholder interviews.  The location of these interviews will vary with each set of participants.  
The department’s policy on Lone Working will be strictly followed and a Chief Investigator will 
be made aware at all times of the whereabouts of the Research Dietitian during the interview 
period of the study.  Interviews will only be conducted in mutually agreed locations and where 
the Research Dietitian feels safe.  In instances where the Research Dietitian is uncertain of the 
safety of the location, a Chief Investigator will accompany the Research Dietitian to the 
interview location.  In the event that the Research Dietitian perceives a situation that puts her 
in imminent danger, she will not intervene but will instead remove herself from danger 
immediately and when clear, contact the police with the details. If she is in a situation where 
she is unable to leave, she will phone the Chief Investigator and alert her by using a pre-
agreed coded statement question to indicate that she is in danger and needs the police 
urgently. 
 
8.2  
Research Ethics Committee (REC) review & reports 
Before the start of the study, approval will be sought from an NHS REC for the study protocol, 
informed consent forms and other relevant documents. Substantial amendments that require review 
by REC will not be implemented until the REC grants a favourable opinion for the study.  In addition, 

 
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approval of proposed amendments will also be sought from the Guy’s and St. Thomas’ R&D 
department before their implementation. 
All correspondence with the REC will be retained. 
The Chief Investigators will be responsible for producing annual reports as required.  The Chief 
Investigators will also notify the REC of the end of the study. 
An annual progress report (APR) will be submitted to the REC within 30 days of the anniversary date 
on which the favourable opinion was given, and annually until the study is declared ended.  If the 
study is ended prematurely, the Chief Investigators will notify the REC, including the reasons for the 
premature termination. Within one year after the end of the study, the Chief Investigators will submit a 
final report with the results, including any publications/abstracts, to the REC. 
 
8.3  
Peer review 
The study was intitially prepared as a research proposal for a funding application to The Dunhill 
Medical Trust.  Through a competetive process the Research Dietitian was awarded a Research 
Training Fellowship from The Dunhill Medical Trust, which is funding the study.  With some 
refinement, the research proposal has evolved into this study protocol which has been reviewed by 
two academic research supervisors, experts in Nutrition & Dietetics. The proposed study procedures 
have been reviewed in detail by the Research Dietitian’s PhD Thesis Progress Committee which 
includes experts in Nutrition, Dietetics & Qualiative Research Methodology.  
 
8.4  
Patient & Public Involvement 
Anecdotal evidence from direct patient communication during my previous clinical role helped to suggest 
the idea for the project.  Unfortunately, due to the timing of the research design process and application 
for relevant approvals, it was not possible to formally involve patients, service users, and/or their carers, 
or members of the public in the research process so far.   
As the project will be conducted on a small scale for the requirements of a PhD, patient and public 
involvement will be incorporated at the earliest possible stage and any feedback generated will be used to 
refine any relevant study tools (e.g. interview topic guide, observational pro forma, patient letters), any 
subsequent plans for the project, if necessary, or inform future research projects, as appropriate.  This 
involvement may take the form of a series of presentations to members of the public or patient groups 
given by the Research Dietitian including conference presentations, speaking to patient/support groups or 
presenting study findings to service providers (including healthcare professionals).  Results of the study 
will be fed back to study participants in an appropriate format as well as those who were consulted or 
collaborated in the project.   Patient groups or charities will be consulted for information about relevant 
groups and forums with potential interest, to which the study can be presented.   
 
8.5 
Regulatory Compliance  

 
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Before patients are recruited to the study, the Research Dietitian/ Chief Investigators will apply for 
NHS permission from the site management organisation, HEI or NHS Research & Development 
(R&D).  
For any amendment that will potentially affect a site’s NHS permission, the Research Dietitian/ Chief 
Investigators will confirm with that site’s R&D department that NHS permission is ongoing.   
 
8.6  
Protocol compliance  
Accidental protocol deviations can happen at any time. They must be adequately documented on the 
relevant forms and reported to the Chief Investigators and Sponsor immediately.  
Deviations from the protocol which are found to frequently recur are not acceptable, will require 
immediate action and could potentially be classified as a serious breach. 
 
8.7 
Data protection and patient confidentiality  
As ‘custodian’ of all data collected during this study, the Chief Investigator(s) will ensure that patient 
anonymity is protected and maintained at all times by the Research Dietitian, and will also ensure that 
participant identities are protected from any unauthorised parties. All investigators will comply with the 
requirements of the Data Protection Act 1998 with regards to the collection, storage, processing and 
disclosure of personal information and will uphold the Act’s core principles.  In addition, all information 
relating to study participants will be kept confidential and managed in accordance with the NHS 
Caldicott Guardian, The Research Governance Framework for Health and Social Care and Research 
Ethics Committee Approval. 
Upon recruitment, all participants will be issued with a unique non-identifiable participant code/number 
which will be recorded on all proformas relating to the study.  A master list of the unique identifiers, 
together with the name, date of birth, NHS number and home address of each study participant, will be 
kept in a password-protected database securely on a Trust/ University computer, separate from the rest 
of the data. Only the research team will have access to the database.  
The following identifiable data will be collected for each study participant as relevant: 
• 
Name – required in order to contact study participants to arrange qualitative interviews.  This 
will apply to all participants.  
• 
Date of Birth, Gender and Ethnicity – required in order to confirm study eligibility as part of the 
inclusion criteria and/or maximum variation sampling requirement. 
• 
Address and postcode – required in order to contact study participants to arrange qualitative 
interviews and/or to send study information by post.  This will apply to patients and key 
stakeholder participants only and not to dietitian participants.   
• 
Contact phone numbers – required in order to contact study participants to arrange qualitative 
interviews.  This will apply to all participants. 
• 
NHS number – to permit access to dietetic records in relation to the consultation observed.  This 
will apply only to the patients included in the study, and not to the dietitians or key stakeholder 
participants.   

 
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• 
GP/Consultant details – This will apply to patients only to ensure that the participant’s GP or 
Consultant is aware of their participation in the study.   
• 
Relationship with patient – This will apply to the key stakeholders only.  Relations might include 
parent, child, spouse, civil partner, other relation, friend, carer, or healthcare professional. This 
information is required to record the link to the patient for the purpose of data interpretation.  
This will apply to all participants.   
 
For the key stakeholders, identifiable data required for the arrangement of qualitative interviews i.e. 
name, address, contact details and relationship with patient, will be entered on a password-protected 
database securely onto a Trust/ University computer and will be accessed only by the Research 
Dietitian. 
Patient-identifiable data required to permit access to electronic health records i.e. NHS number, will be 
entered on a password-protected database on a computer and will be accessed by the Research 
Dietitian for the purposes of data analysis and interpretation alone.   
As part of the consenting procedure all participants will be requested to give their consent to the use of 
their data and will be directed to confirm this in writing on the informed consent form.   
All participants will be informed during the recruitment process of their right to revoke their 
authorisation for the use of their data.  All participants will be anonymised with regards to any future 
publications relating to this study. Pseudonyms may be used for the purpose of publication, if more 
appropriate but participants will remain unidentifiable at all times.   In addition to previously stated 
measures to ensure the anonymity of participants, the Trust will not be identified in any reports, 
presentations or publications generated from the study.  Furthermore, any staff, wards, treatment units 
involved in the study will also remain unnamed.  Any contextual information which is not relevant to 
the research question being answered will not be included in any direct participant quotes used in any 
reports, presentations or publications generated from the study. No recognisable labels will be used to 
describe any aspect of the study in publication which would make participants identifiable.  
 
Observation data at each site will be collected by the Research Dietitian using a standard pro forma 
designed for use in this study.  The pro forma for the observation protocol will not contain any patient-
identifiable data and will carry the unique non-identifiable participant code/number assigned to that 
patient. 
All interview transcripts and notes will be labelled with the unique non-identifiable participant 
code/number assigned to that patient.  The transcripts will be checked for identifiable information and 
edited accordingly to remove such data without adversely affecting the data collected.   
Participants may be informed of the study findings in a specially designed newsletter or invited to a 
presentation. Study results will be available at the participant’s request only after they have been 
published. This will require the retention of the participant’s name and contact information beyond the 
end of the research project, until study findings have been published.  These details will be securely 
stored in a password-protected file only accessible by the research team. Participants will be offered 

 
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the opportunity to opt-in to notification of the study findings by any of the means specified.  If they 
chose to be notified, their name and contact details will need to be retained for that purpose only, 
under the conditions of valid consent. Equally, participants will be given the option to not be contacted 
after the study ends in which case no identifiable information will be kept for up to 3 years beyond the 
study’s end.  
 
The Research Dietitian will abide by the information governance policies in place within the various 
clinical settings.   
 
8.8 Indemnity 
Arrangements for insurance and/or indemnity to meet the potential legal liability of the sponsor(s) for 
harm to participants arising from the management of the research will be the responsibility of the study 
sponsor(s). Arrangements for insurance and/ or indemnity to meet the potential legal liability of the 
sponsor(s) or employer(s) for harm to participants arising from the design of the research will also be the 
responsibility of the study sponsor(s). 
Arrangements for insurance and/ or indemnity to meet the potential legal liability of investigators/ 
collaborators arising from harm to participants in the conduct of the research in the NHS settings 
proposed will be covered by the NHS indemnity scheme, where appropriate.  Activity within the other 
clinical settings proposed, will be covered under the professional indemnity of the Research Dietitian 
(Michelle Gibbs), provided by the British Dietetic Association. 
 
8.9 
Amendments  
Once study approvals have been obtained, all subsequent amendments (substantial or non-substantial) 
will be notified to the Guy’s and St. Thomas’ NHS R&D department as a first port of call, to assess 
whether the amendment affects the NHS permission.  R&D will be responsible for the decision to amend 
the protocol and for deciding whether an amendment is substantial or non-substantial.  Any substantive 
changes will be communicated to relevant stakeholders. 
If the sponsor(s) wishes to make a substantial amendment to the REC application or the supporting 
documents, the sponsor(s) will submit a valid notice of amendment to the REC for consideration. It will be 
the sponsors’ responsibility to decide whether an amendment is substantial or non-substantial for the 
purposes of submission to the REC.  
Amendment history will be tracked by identifying the most recent protocol versions as “Protocol 
Amendment Version 1,2,3” and so on. 
 
8.10 
Access to the final study dataset 
The Research Dietitian (Michelle Gibbs), the Chief Investigators (Christine Baldwin & Peter Emery) 
and any additional members of the research team will have access to the full dataset.   

 
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Any secondary analysis will only be undertaken with the consent of the participants.  All patient 
documentation will reflect any proposed future use of these data in research. 
9 
DISSEMINIATION POLICY 
9.1  
Dissemination policy 
Data arising from the study will be owned by King’s College London.  On completion of the study, the data 
will be analysed and a Final Study Report prepared. While the study progresses, oral poster 
presentations may be given and abstracts produced on preliminary results within the Diabetes & 
Nutritional Sciences department at King’s College London in fulfilment of the Research Dietitian’s PhD 
registration.  A full study report will be produced at the end of the study in the form of a PhD thesis and 
accessible in line with King’s College London academic regulations.  The Research Dietitian intends to 
publish the study data in (an) appropriate academic peer-reviewed journal(s) for which all participating 
investigators will be named authors.  The funding body (The Dunhill Medical Trust) will be acknowledged 
within any publications.  The Guy’s & St. Thomas’ NHS Trust or LAMP teams involved will specifically 
remain unnamed to preserve the anonymity of all participants.  Participants will be notified of the outcome 
of the study by provision of the publication or by other means as appropriate (e.g. via a specifically 
designed newsletter or presentation).  If participants specifically request results of the study, these will be 
provided to the participant after the results have been published.   The study results may also be 
presented to the Ageing & Frailty Research Forum at Guy’s at St. Thomas’ NHS Trust and oral poster 
presentations maybe given and abstracts produced for professional conferences, as relevant. The study 
protocol, full study report, anonymised participant level dataset, and statistical code for generating the 
results will not be made publicly available. Patient and public involvement will also be incorporated during 
dissemination of findings.   
 
9.2  
Authorship eligibility guidelines and any intended use of professional writers 
Authorship will be granted to individuals who have made a significant academic contribution to the 
study. 
 
10 
REFERENCES 
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malnourished in later life [online].  Available from 
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Baldwin C., and Weekes C.E. (2016) OR07: What is the quality of the evidence supporting the role 
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ESPEN (2016): Oral Communications II: Nutritional Chronic Disease: Abstracts of the 38th ESPEN 
Congress, ESPEN 2016, 17-20 September 2016, Copenhagen, Denmark. Clinical Nutrition, 35, p. 
S3.  

 
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Baldwin, C. and Weekes, C.E. (2011). Dietary advice with or without oral nutritional supplements 
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2017] 
 

 
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Elia M., and Russell C.A. (2009a). Combating malnutrition; Recommendations for Action. A report 
from the Advisory Group on Malnutrition, led by BAPEN. BAPEN. Available from 
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Elia M., and Russell C.A. (2009b). Screening for malnutrition in sheltered housing.  A report from 
BAPEN with the Group on Nutrition in Sheltered Housing [online].  BAPEN. Available from 
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European Nutrition for Health Alliance. (2006). Malnutrition among Older People in the Community: 
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nutrition.org/index.php/events/malnutrition_among_older_people_in_the_community_policy_recom
mendations_for  [last accessed 4th April 2017] 
 
Flanagan J.C. (1954) The critical incident technique. Psychological Bulletin, 51(4), 327-58. 
 
Francis R (2013) Report of the Mid-Staffordshire NHS Foundation Trust Public Inquiry [online] The 
Mid-Staffordshire NHS Foundation Trust Public Inquiry. Available:  
http://webarchive.nationalarchives.gov.uk/20150407084003/http://www.midstaffspublicinquiry.com/
report [accessed 1st March 2017] 
 
Francis, J., Johnston, M., Robertson, C., Glidewell, L., Entwistle, V., Eccles, M.P,. and Grimshaw, 
J.M. (2010) What is an adequate sample size? Operationalising data saturation for theory-based 
interview studies? Psychology & Health, 25(10), 1229-1245.  
 
Gallini, A. (2011). An illuminative evaluation of the response of an acute healthcare NHS Trust to 
the National Dignity in Care Campaign in England (PhD Thesis), (Portsmouth: University of 
Portsmouth). 
 
Gibbs, M. (2014). Oral nutrition support interventions for patients who are malnourished or at risk 
of malnutrition: a survey of current practice amongst UK dietitians (MRes Dissertation), (London: 
City, University of London). 
 
Goodchild, C.E., Skinner, T.C., and Parkin, T., (2005). The value of empathy in dietetic 
consultations. A pilot study to investigate its effect on satisfaction, autonomy and agreement. 
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65(3), 365–378. 
 

 
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11.  
APPENDICIES 
 
11.1 
Appendix 1- Required documentation  
 
The following documents are attached separately: 
 
• 
CV of study co-ordinator / PhD Student – Mrs Michelle Gibbs 
• 
CV of primary research supervisor / Chief Investigator 1 -  Dr Christine Baldwin 
• 
CV of secondary research supervisor / Chief Investigator 2 – Professor Peter Emery 
• 
Consent form for Patients on headed paper 
• 
Consent form for Dietitians on headed paper 
• 
Consent form for Key Stakeholders on headed paper 
• 
Participant Information Sheet for Patients on headed paper 
• 
Participant Information Sheet for Dietitians on headed paper 
• 
Participant Information Sheet for Key Stakeholders on headed paper 
• 
GP letter template with notification of patient participation in study 
 
 
11.2  Appendix 2 – Schedule of Procedures  
 
Procedures 
Visits  
Screening 
Data collection 
days 
 
Informed consent 
x 
 
Observation of treatment (Group 1) 
 
x 

 
Amendment No.3, Research Protocol Version 1.9 
 
 
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61 
Interview (Group 2) 
 
x 
Document review (Groups 1 & 2) 
 
x 
 
13.3 
Appendix 3 – Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
1 
1.8 
1.6.18 
Michelle 
Gibbs 
Changes to the research design, 
question, study procedures and study 
documents. 
2 (Minor) 
1.8 
1.6.18 
Michelle 
Gibbs 
Study end date extension by 12 
months (executed December 2019). 
No changes made to protocol. 
3 (Minor) 
1.9 
21.2.19 
Michelle 
Gibbs 
Updated study dates in light of 
extension above.  Changes to 
Transcription Service provider from 
NJC Secretarial to Clayton Research 
Support. 
 
List details of all protocol amendments here whenever a new version of the protocol is produced. 
Protocol amendments must be submitted to the Sponsor(s) for approval prior to submission to the 
REC committee.