Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic
Conditions: Type1 Diabetes
Sponsor: Imperial College London

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 1 of 12 
© Imperial College of Science, Technology and Medicine   
 
 
 
 
5.1 
Appendix 2: Template Protocol for non-CTIMPs 
 
 
ONSET 
 
 
 
 
Optimising Consultation Summaries to Promote Good Health; Views of 
Adolescents Attending Diabetes Clinic 
 
 
 
 
Version 7, 25November2018 
 
 
 
 
MAIN SPONSOR: Imperial College London  
 
STUDY COORDINATION CENTRE: University College London Hospital  
 
IRAS Project ID: 240163 
REC reference:  
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 2 of 12 
© Imperial College of Science, Technology and Medicine   
Study Management Group 
 
Chief Investigator: Dr David Inwald, Consultant in Paediatric Intensive Care,  
Honorary Clinical Senior Lecturer, Imperial College London  
 
Co-investigators:  
 
Dr Billy White, Consultant in Adolescent Diabetes and Obesity, University London College 
Hospital, Hon Senior Lecturer, UCL Institute of Child Health, Specialist in adolescent diabetes and 
obesity 
 
Ann-Eneli Allas, MSc student, Imperial College London, Paediatrics and Child Health 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr David Inwald who will direct the query to the appropriate 
person 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 9459/ 0207 594 1862 
http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice  
 
 
 
 
 
 
 
 
 
 
This protocol describes the “Optimising Consultation Summaries to Promote Good Health; Views of 
Adolescents Attending Diabetes Clinic” study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be necessary. These 
will be circulated to investigators in the study.  Problems relating to this study should be referred, in the first 
instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance Framework for Health and 
Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data Protection Act and 
other regulatory requirements as appropriate.  

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 3 of 12 
© Imperial College of Science, Technology and Medicine   
Table of Contents 
1. 
INTRODUCTION ............................................................................................................ 6 
1.1 
BACKGROUND ..................................................................................................................... 6 
2.  STUDY OBJECTIVES ........................................................................................................ 6 
3.  STUDY DESIGN .................................................................................................................. 6 
4. 
PARTICIPANT ENTRY .................................................................................................. 7 
4.1 
PRE-REGISTRATION EVALUATIONS ................................................................................ 7 
4.2 
INCLUSION CRITERIA .......................................................................................................... 7 
4.3 
EXCLUSION CRITERIA ........................................................................................................ 7 
4.4 
WITHDRAWAL CRITERIA .................................................................................................... 7 
5. 
ADVERSE EVENTS ....................................................................................................... 7 
5.1 
DEFINITIONS ......................................................................................................................... 7 
5.3 
REPORTING PROCEDURES ............................................................................................... 7 
6. 
ASSESSMENT AND FOLLOW-UP .............................................................................. 8 
7. 
DATA ANALYSIS .......................................................................................................... 9 
8. 
REGULATORY ISSUES ................................................................................................ 9 
8.1 
ETHICS APPROVAL ............................................................................................................. 9 
8.2 
CONSENT .............................................................................................................................. 10 
8.3 
CONFIDENTIALITY .............................................................................................................. 10 
8.4 
INDEMNITY ........................................................................................................................... 10 
8.5 
SPONSOR ............................................................................................................................. 10 
8.6 
FUNDING ............................................................................................................................... 10 
8.7 
AUDITS .................................................................................................................................. 10 
9. 
STUDY MANAGEMENT .............................................................................................. 10 
10. 
PUBLICATION POLICY .............................................................................................. 11 
11. 
REFERENCES ............................................................................................................. 11 
Kessels, R. (2003). Patients' memory for medical information. JRSM, 96(5), pp.219-222. .......... 11 
 
 
 
 
 
 
 
 
 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 4 of 12 
© Imperial College of Science, Technology and Medicine   
GLOSSARY OF ABBREVIATIONS 
UCLH 
University College London Hospital 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 5 of 12 
© Imperial College of Science, Technology and Medicine   
STUDY SUMMARY 
 
TITLE Optimising Consultation Summaries to Promote Good Health; Views of 
Adolescents Attending Diabetes Clinic 
DESIGN Qualitative study involving interviews with young adults face to face and over 
the phone  
AIMS What are young people's beliefs about the role of consultation summaries 
and how they can be improved to promote good health 
OBJECTIVES To understand whether consultation letters are being read by the young 
people  
To explore their opinions about consultation letter contents and their impact  
To explore young people’s ideas for optimising these letters  
POPULATION 12-18 young people aged 12-18 who have been visiting UCLH adolescent 
diabetes outpatient clinic chosen using purposive sampling 
ELIGIBILITY Adolescents aged 12-18 years attending a diabetes outpatient clinic  
DURATION 16 Months. April 2018 – August 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 6 of 12 
© Imperial College of Science, Technology and Medicine   
1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
Patient participation in decision making process about their care promotes patient satisfaction and 
confidence (Harris and Boaden, 2006). As part of this, allowing patients to see letters written about 
them enables trust, encourages patients to be involved in decision making process and allow 
patient understanding (Baxter et al., 2008). Given all above, the 2000 NHS plan made it a 
requirement that all medical correspondence between health professionals is shared with patients 
(Department of Health, 2004).  
 
It is estimated that 40-80% of information discussed during a consultation is forgotten immediately 
(Kessels, 2003). Given this, written summaries have shown to be an effective method of improving 
patient recall of information by 20.8% (Chan et al., 2002).   
 
The literature on the benefits/disadvantages of consultation summaries is largely focused on adult 
patients with little research done to explore the views of adolescent population. Where the patient 
is a child, the literature is only focussed on parents of children and not the children themselves. 
Limited research has shown that parents/care givers report clinic letters being useful in assisting 
with better understanding and management of their child’s condition (Lawton et al., 2015; 
Waterston and Lazaro, 1994).  
 
It is not known if young people value consultation summaries in the same way. Only one study 
focused on adolescent views reports young people wishing to receive summaries about 
themselves and finding them useful (Bartle et al., 2004). 
 
Adolescence is an important time of an individual’s life. This is the time when many independent 
health behaviours are established. During adolescence, young people start showing more interest 
in their own health and often wish to participate in decision making processes regarding their care. 
The role of health workers at this stage is to appreciate young people as individuals (Viner and 
Macfarlane, 2005). Clinic summaries addressed directly to young people might play an important 
role in assisting with establishment of health behaviours and promoting good health in young 
people. 
 
1.2 
RATIONALE FOR CURRENT STUDY 
The aim of this research is to understand the views of adolescent patients on consultation 
summaries and identify factors can improve these summaries and subsequently their health and 
well-being.  
 
2.  STUDY OBJECTIVES 
 
1. To understand whether consultation letters are being read by the young people  
2. To explore their opinions about consultation letter contents and their impact  
3. To explore young people’s ideas for optimising these letters  
 
 
3.  STUDY DESIGN 
 
We are using patients attending a specialist diabetes clinic as our cohort and conducting a 
qualitative study involving individual interviews in clinic or over the phone.  
Duration of the study is 16 months, April 2018 – August 2019. 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 7 of 12 
© Imperial College of Science, Technology and Medicine   
Study population is 12-18 young people aged 12-18 who have been visiting UCLH adolescent 
diabetes outpatient clinic chosen using purposive sampling.  
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
We will recruit patients from a single diabetes clinic serving patients from a very wide geographic 
area with wide socio-economic backgrounds. We will recruit and interview between August 2018 
– April 2019.  
 
4.2 
INCLUSION CRITERIA 
Adolescents aged 12-18 years attending a diabetes outpatient clinic  
 
4.3 
EXCLUSION CRITERIA 
Young people who cannot speak English (effective communication with colleagues during the 
study is the major aspect for valid data collection) 
 
Young people who refuse to participate in individual interviews 
 
4.4 
WITHDRAWAL CRITERIA 
Participant’s wish to voluntarily withdraw from the study  
 
5. 
ADVERSE EVENTS 
 
5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe 
 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other situations.  
Important AEs that are not immediately life-threatening or do not result in death or hospitalisation 
but may jeopardise the subject or may require intervention to prevent one of the other outcomes 
listed in the definition above, should also be considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported. Depending on the nature of the event the reporting 
procedures below should be followed. Any questions concerning adverse event reporting should 
be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 8 of 12 
© Imperial College of Science, Technology and Medicine   
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  However, 
relapse and death due to <condition>, and hospitalisations for elective treatment of a pre-existing 
condition do not need reporting as SAEs. 
 
All SAEs should be reported to the <name of REC> where in the opinion of the Chief Investigator, 
the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  The 
Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics Committee, 
Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
jrco@imperial.ac.uk 
CI email d.inwald@imperial.ac.uk 
Attention Dr David Inwald 
Please send SAE forms to: REC 
Tel: xxx (Mon to Fri 09.00 – 17.00) 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
We will identify potential participants by accessing UCLH adolescent diabetes clinic clinic 
schedule. All patients attending an adolescent diabetes outpatient clinic on a particular day will be 
invited to participate in the study. Every potential participant will receive an invitation pack with the 
age appropriate information sheet enclosed by post 1 month before the appointment. Individuals 
will be invited to express interest via email or by phone, details of both will be provided on the 
participant information sheet.  
 
The research team will telephone each potential participant 2 weeks before scheduled 
appointment with their doctor to remind them of their pending appointment, ensure that they have 
received the invitation pack and answer any questions about the study.  
 
The patient’s standard clinician will be able to answer any patient concerns about the study during 
their standard clinic appointment. We will run interviews on the day of the participant’s scheduled 
appointment at the clinic (approximately 30-60 minutes after standard clinic appointment). 
 
If a potential participant is unable to participate in the interview on the day of the appointment but 
would like to express his/her views and opinions on the matter, we will offer this participant an 
interview over the phone at a convenient time. Informed consent to participate in the interview over 
the phone will be taken in clinic by our researcher.  
 
Prior to the beginning of the phone interview, we will inform the participant that the interview will be 
audio-recorded and they will be put on loud speaker. We will also let the participant know who is 
present in the room whilst he/she is being interviewed. We will ask the participant to remain in a 
quiet room with no relatives/friends present while being interviewed. 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 9 of 12 
© Imperial College of Science, Technology and Medicine   
 
Participants will only be interviewed once. We will interview 12-18 participants in total or until 
theme saturation occurs (Peterson-Sweeney, 2005). Interviews will be held on the day of a 
participant's clinic appointment within the same hospital to optimise study participation rate and 
reduce associated travel expenses and time burden.  
 
Interviews will be conducted by a researcher experienced in qualitative studies. The discussion will 
be held in a quiet room with refreshments provided. Phone interviews will also be conducted in a 
quiet room with one researcher in the room communicating with a participant.  The discussion will 
take no longer than 30 minutes. Parents will be asked to remain in the waiting area during the 
study as per NCB Guidelines (NCB Guidelines for Research with Children and Young Adults, 
2011). 
 
The researcher will voice a series of prepared statements/questions to promote interview 
(appendix 1). Written assent/consent will be obtained from study participants and their parents (if 
present) at the beginning of the discussion or in clinic if phone interview is preferred. The 
discussion will be audio-recorded. 
 
Audio-recordings from each discussion will be transcribed by Ms Ann-Eneli Allas. The transcripts 
will be immediately anonymised. Data analysis will involve a general thematic coding method and 
will be analysed by two independent researchers (Flick 2009). 
 
 
7. 
DATA ANALYSIS 
 
We will use constant comparative method for the coding process (Krueger and Casey, 2015). The 
coding process will consist of reading the transcript and analysing responses to statements given 
by the study participants one by one. We will examine responses to each statement and code 
each response according to what it describes. If there are several responses to the same 
statement given, these will be analysed for similarity. If similar, the same code will be given to 
each, if different, different codes will be given. This coding approach will be maintained for all 
responses.   
 
In order to avoid analysis errors, transcripts will be coded by two researchers (Ann-Eneli Allas and 
Dr Billy White) independently and differences agreed. Once the coding process is complete, we 
will categorize codes and analyse them for frequency, extensiveness, intensity, specificity, internal 
consistency and participant perception of importance (Krueger and Casey, 2015).  
 
We will share the study outcomes with all participants and their families. We will submit the 
findings in a peer-reviewed medical journal. 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Study Coordination Centre has obtained approval from the North West Haydock Research 
Ethics Committee (REC) and Health Regulator Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 
participants into the study or any research activity is carried out. The study will be conducted in 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 10 of 12 
© Imperial College of Science, Technology and Medicine   
accordance with the recommendations for physicians involved in research on human subjects 
adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation has 
been given, an information leaflet offered and time allowed for consideration.  Signed participant 
consent should be obtained.  The right of the participant to refuse to participate without giving 
reasons must be respected.  After the participant has entered the study the clinician remains free 
to give alternative treatment to that specified in the protocol at any stage if he/she feels it is in the 
participant’s best interest, but the reasons for doing so should be recorded.  In these cases, the 
participants remain within the study for the purposes of follow-up and data analysis.  All 
participants are free to withdraw at any time from the protocol treatment without giving reasons 
and without prejudicing further treatment.  
 
We will follow NRES guidance on informed consent: 
 
• 
Young people 16-18: informed consent will be obtained directly from the study participant.  
• 
Young people aged 12-15 
o If parent/carer present, then consent will be obtained from the parent/carer. Assent 
will be obtained from the study participant. 
o If no parent/carer present, then individual will be assessed for Gillick competence, 
and if competent, consent will be obtained from the young person. 
 
We will notify participants’ General Practitioners of patient recruitment.  
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study and is 
registered under the Data Protection Act. 
 
8.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies which 
apply to this study.  
 
8.5 
SPONSOR 
Imperial College London will act as the main Sponsor for this study. Delegated responsibilities will 
be assigned to the NHS trusts taking part in this study.   
 
8.6 
FUNDING 
Funding is not available for this study 
 
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their remit as 
sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy Framework 
for Health and Social Care Research.  
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through UCLH.   
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 11 of 12 
© Imperial College of Science, Technology and Medicine   
10. 
PUBLICATION POLICY 
 
The study registration and publication will be supported by The Imperial Open Access Fund and 
will be available in fully open access journals only.  
 
 
11. 
REFERENCES 
 
Bartle, D. (2004). Copies of clinic letters to the family. Archives of Disease in Childhood, 89(11), 
pp.1032-1033. 
 
Baxter, S., Farrell, K., Brown, C., Clarke, J. and Davies, H. (2008). Where have all the copy letters 
gone? A review of current practice in professional–patient correspondence. Patient Education and 
Counseling, 71(2), pp.259-264. 
 
Chan, Y., Irish, J., Wood, S., Rotstein, L., Brown, D., Gullane, P. and Lockwood, G. (2002). Patient 
Education and Informed Consent in Head and Neck Surgery. Archives of Otolaryngology–Head & 
Neck Surgery, 128(11), p.1269. 
Copying Letters to Patients Good Practice Guidelines (2004) Department of Health  
Flick, U. (2009). INTRODUCTION TO QUALITATIVE RESEARCH. 7th ed. [S.l.]: Sage 
Publications. 
 
Harris, C. and Boaden, R. (2006). Copying letters to patients: the view of patients and health 
professionals. Journal of Health Services Research & Policy, 11(3), pp.133-140. 
 
Kessels, R. (2003). Patients' memory for medical information. JRSM, 96(5), pp.219-222. 
 
Krueger, R. and Casey, M. (2015). Focus groups. Los Angeles [u.a.]: Sage Publ., pp.137-161. 
 
Lawton, J., Waugh, N., Noyes, K., Barnard, K., Harden, J., Bath, L., Stephen, J. and Rankin, D. 
(2015). Improving communication and recall of information in paediatric diabetes consultations: a 
qualitative study of parents’ experiences and views. BMC Pediatrics, 15(1). 
 
Medical Research Council (2017). Consent and Participant Information Sheet Preparation 
Guidance. 
 
NCB (2011). Guidelines for Research with Children and Young Adults. London. 
 
Peterson-Sweeney, K. (2005). The use of focus groups in pediatric and adolescent 
research. Journal of Pediatric Health Care, 19(2), pp.104-110. 
 
The NHS Plan, paragraph 10.3 (2000) Department of Health  
 
Viner, R. and Macfarlane, A. (2005). ABC of adolescence: Health promotion. BMJ, 330, pp.527-9. 
 
Waterston, T. and San Lazaro, C. (1994). Sending parents outpatient letters about their children: 
parents' and general practitioners' views. Quality and Safety in Health Care, 3(3), pp.142-146. 
 
 

Joint Research  
Compliance Office 
 
SOP Ref: JRCO/SOP/012  
V9.0 01/03/2018 
 
Page 12 of 12 
© Imperial College of Science, Technology and Medicine   
EXAMPLE APPENDICES 
 
Appendix 1 – Focus group discussion schedule 
 
Tell us a bit about the letters you get 
 
1. Is the letter directed to you, your parent/carer, GP or another doctor?  
2. Who reads the letter, you or your parent/carer? 
3. Do you show consultation letters to? 
 
Letter content  
 
4. Is the language easy to understand (eg medical terms) What could be better? 
5. Does the letter sound friendly or professional to you? How could it be better? 
6. Is it too long/short? How could it be better? 
7. Does it talk about the right things? How could it be better? 
 
Do these letters help you to improve your health? 
 
8. Are they helpful in any way? (motivate, remind, congratulate, give ideas) 
9. Are they unhelpful in any way? (remind of negatives, demoralise, feel 
sad/worried/angry) 
10. What else about your letters could help? Other ideas? 
  
Potential areas of improvement  
 
1. Is there anything that can be improved? 
2. Is getting them by post ok? (email/text/postcards better?)