Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care
Conditions: Chronic Kidney Diseases
Sponsor: Imperial College London

 
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Qualitative study to determine how Chronic Kidney Disease is managed by healthcare 
professionals in primary care.  
 
 
 
Version 1 
June 2023  
 
 
 
 
MAIN SPONSOR: Imperial College London 
FUNDERS: N/A 
STUDY COORDINATION CENTRE: 001 
 
IRAS project ID 310547 
 
REC reference: xxx 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator: Professor Frederick W K Tam 
 
Co-investigators:, Dr Rakesh Dattani, Professor Hutan Ashrafian 
 
Statistician: N/A 
 
Study Management:       
 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: Dr Rakesh Dattani 
Address: Imperial College London, Institute of global health and innovation. 10th Floor, 
Queen Elizabeth the Queen Mother Wing (QEQM), St Mary's Campus London w21ny 
Registration: GMC 7461672 
Tel: 07855455492  
 
 
 
 
 
 
                                                 
E-mail: rakesh.dattani@nhs.net 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Rakesh Dattani 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: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 1862 
Imperial College - Research Governance and Integrity Team (RGIT) Website 

 
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Funder 
 
Imperial college London 
 
This protocol describes the “Qualitative study to determine how Chronic Kidney Disease is 
managed by healthcare professions in primary care” 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 UK Policy Frame Work for Health and 
Social Care Research. It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
 
Table of Contents                                                             Page No 
1. 
INTRODUCTION 
6 
1.1. 
BACKGROUND 
7 
1.2. 
RATIONALE FOR CURRENT STUDY 
7 
2. 
STUDY OBJECTIVES 
8 
3. 
STUDY DESIGN 
8 
3.1. 
STUDY OUTCOME MEASURES 
Error! Bookmark not defined. 
4. 
PARTICIPANT ENTRY 
9 
4.1. 
PRE-REGISTRATION EVALUATIONS 
9 
4.2. 
INCLUSION CRITERIA 
9 
4.3. 
EXCLUSION CRITERIA 
9 
4.4. 
WITHDRAWAL CRITERIA 
9 
5. 
ADVERSE EVENTS 
9 
5.1. 
DEFINITIONS 
Error! Bookmark not defined. 
5.2. 
REPORTING PROCEDURES 
Error! Bookmark not defined. 
6. 
ASSESSMENT AND FOLLOW-UP 
9 
7. 
STATISTICS AND DATA ANALYSIS 
9 
8. 
REGULATORY ISSUES 
10 
8.1. 
ETHICS APPROVAL 
10 
8.2. 
CONSENT 
10 
8.3. 
CONFIDENTIALITY 
10 
8.4. 
INDEMNITY 
10 
8.5. 
SPONSOR 
11 
8.6. 
FUNDING 
11 
8.7. 
AUDITS 
11 
9. 
STUDY MANAGEMENT 
11 
10. 
PUBLICATION POLICY 
11 
 

 
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GLOSSARY OF ABBREVIATIONS 
CKD 
Chronic Kidney Disease 
ESRD 
End Stage Renal Disease 
ICB 
Integrated Care Board 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KEYWORDS 
Type 2 Diabetes Meliitus, Diabetic Kidney Disease, Chronic Kidney Disease 
 
 
 
 
 
 
STUDY SUMMARY 
 

 
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TITLE Qualitative study to determine how Chronic Kidney Disease is managed by 
healthcare professions in primary care.  
 
DESIGN Qualitative 
AIMS To better understand how healthcare providers in primary care within the 
National Health System in the United Kingdom, manage Chronic Kidney Disease 
(CKD). Through this we hope to be able to identify ways in which we can improve 
the overall care of patients with CKD.      
OUTCOME MEASURES The primary outcome measure is to determine current understanding on the 
management of CKD and to identify ways in which the screening, diagnosis, and 
management of patients at risk of CKD can be improved upon. 
POPULATION Doctors, clinical pharmacists, and advanced nurse practitioners, working in 
primary care. 
ELIGIBILITY Primary care doctors (General practitioners) and health care providers (clinical 
pharmacists, and advanced nurse practitioners working in primary care across the 
United Kingdom. 
DURATION 6 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. INTRODUCTION  
 

 
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1.1. 
BACKGROUND 
15% of the population in England aged >35 years of age have Chronic Kidney Disease (CKD). 
This results in 45,000 premature deaths, 100,000 excessive hospitalisations and £1.45 billion 
in costs to the NHS per year. Type 2 Diabetes is the commonest cause, with other common 
causes for CKD including but not limited to hypertension, ischaemic heart disease, heart 
failure and multisystemic disorders. 
With the rising prevalence of diabetes, hypertension, and ischaemic heart disease amongst 
other clinical risk factors for CKD, the prevalence of CKD is expected to increase, with a 
substantial proportion of patients developing cardiovascular complications or progressing to 
ESRD. Primary care is instrumental in the screening of patients for CKD in the presence of 
known clinical risk factors as well as the early and effective management of confirmed CKD 
with prognostically beneficial medication. With prior working by myself highlighting the lack 
of screening of patients for CKD in the presence of clinical risk factors for CKD in North West 
London, alongside poor prescribing practices of prognostically beneficial medications. We 
therefore aim to better understand how healthcare professionals working in primary care 
could be better supported to screen patients for CKD and ensure appropriate subsequent 
management.  
 
1.2. 
RATIONALE FOR CURRENT STUDY 
Chronic Kidney Disease is a progressive condition that affects more than 10% of the general 
population worldwide, resulting in in excess of 800 million people currently affected. With 
the rising prevalence of Type 2 Diabetes, hypertension and ischaemic heart disease amongst 
other clinical risk factors for CKD, the prevalence of CKD over the coming ten years is expected 
to increase 2-3 fold. CKD is associated with significant degree of morbidity with patients not 
only going on to develop end stage renal disease, but also an array of cardiovascular diseases, 
resulting in premature morbidity and mortality resulting in an overall poor quality of life. 
 
Primary care is vital in the 1. screening of patients with clinical risk factors for CKD 2. Diagnosis 
and coding of CKD and 3. Management of CKD. However, through prior work done by our 
group, we have identified poor screening of patients with clinical risk factors for CKD, poor 
coding of patients post diagnostic tests confirming CKD, poor communication with patients 
with regards to CKD diagnosis, cause and long term outcome in addition to inadequate 
prescribing of prognostically beneficial medication. This study therefore aims to determine 
how healthcare professionals in primary care screen for, diagnose and manage CKD in the 
community. Furthermore, it aims to determine areas done well as well as areas where 
improvement is needed to improve a patient’s clinical journey and management. This will be 
done in the form of an online questionnaire and focus groups, advertised via Integrated Care 
Boards (ICB’s) across the United Kingdom. Through this, we hope to gain further insight into 
areas of clinical management done well and areas of improvement as well as how primary 
care feel current management could be improved upon, obstacles faced, additional resources 
required and how they could be better supported by hospital specialists. Study results will be 
analysed and published in a peer reviewed journal with recommendations made with regards 

 
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to how care should be altered to help delay and prevent CKD onset and progression alongside 
the associated health care complications. 
 
2. STUDY OBJECTIVES 
 
The main research objective is to determine the current understanding amongst primary 
care health care professionals with regards to the screening and management of CKD, in 
addition to developing an understanding of the barriers faced by primary care in ensuring 
optimal clinical care.  By gaining a better understanding of how GPs looking after patients 
with risk factors for CKD/confirmed CKD manage their patients, we hope to be able to 
identify areas of improvement, in order to create change and prevent the onset and 
progression of CKD. 
 
3. STUDY DESIGN 
The study is designed in the form of an online questionnaire, with participants recruited 
through advertisement of the study through ICB’s across the United Kingdom. 
Qualiatrics.com will be utilised to create and share the questionnaire, with participants 
expected to take to 15 minutes to complete the questionnaire in total. The main research 
objective is to identify ways in which the management of patients with clinical risk factors 
for CKD can be improved upon in primary care. By gaining a better understanding of the 
barriers faced by healthcare professionals in primary care will allow us to identify new ways 
in which to improve patient care and management. Furthermore, we will seek to better 
understand ways in which healthcare professionals in primary care feel they could be better 
supported to prevent or delay progression of   CKD and associated complications. Their 
views on the use of a risk prediction score and biomarkers for the diagnosis and assessment 
of progression will be sought as well as their opinions on the use of digital health within 
primary care for patients with CKD.  
The study will be validated by primary and secondary care clinicians. Following validation 
and HRA approval, Integrated care boards (ICBs) across the UK will be sent an online link to 
the questionnaire and requested to share amongst health care providers within their ICB. 
The participant information sheet will be presented electronically, and participants 
consented electronically utilising Qualiatrics.com. Participants will be asked if they are 
willing to partake in an online focus group (lasting up to 1 hour in total) to further discuss 
the study and gain a further understanding of how care could be improved. For those willing 
to take part, an email address contact will be requested as a mode of communication 
between study organisers and participants. Participation is completely voluntary, and 
participants may change their decision at any time. Participants can withdraw consent at 
any time prior to the end of the focus group and can leave the session without any 
explanation. There is no financial incentive for clinicians partaking in the focus groups. Focus 
groups will be recorded utilising Microsoft Teams, with focus groups transcribed 
anonymously within 1 week of the focus group and the recording subsequently deleted. The 

 
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transcribed focus group will be deleted form records within 1 week, with the transcription 
stored electronically on the Imperial College Server. 
Data from both components of the study will subsequently be analysed, with 
recommendations made of changes required to improve the screening and management of 
patients at risk of CKD.  
 
4. PARTICIPANT ENTRY 
 
4.1. 
PRE-REGISTRATION EVALUATIONS  
No tests are required to be done prior to the patient entering the study. 
 
4.2. 
INCLUSION CRITERIA 
 
Doctors, clinical pharmacists, and advanced nurse practitioners, working in primary care. 
 
4.3. 
EXCLUSION CRITERIA 
Secondary care health care professionals. 
 
4.4. 
WITHDRAWAL CRITERIA  
 
Participants can withdraw at any point prior to submission of the online questionnaire. 
Questionnaires left prior to completion, will not be submitted and no data will therefore be 
retained. Once submitted, responses cannot be withdrawn as all data is collated collectively 
and anonymously. With regards to the focus group, participants can exist the online focus 
group at any time without explanation. Where participants withdraw, responses given by 
the individual will no longer be transcribed and considered. Once the focus group is 
transcribed and focus group recording deleted, it will not be possible to withdraw responses 
due to the anonymous nature in which the focus group will be transcribed prior to its 
deletion. 
 
5. ADVERSE EVENTS  
 
Not applicable. 
 
6. ASSESSMENT AND FOLLOW-UP  
 
Given the nature of the study, an online anonymous questionnaire/focus group there will be 
no follow up or assessment of study participants. 
 
7. STATISTICS AND DATA ANALYSIS 
 

 
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This is a qualitative study, with qualitative methods applied to analyse the data generated. 
The qualitative data analysis approach will systematise descriptive data collected through 
the online questionnaire and subsequent focus groups, with the aim being to identify 
patterns and themes behind the interviews, surveys, and observations and interpreting it. 
The method aims to identify patterns and themes behind textual data. Specific analysis 
undertaken will utilise: 1. Discourse analysis whereby we will review the received answers 
from the questionnaire and the transcript form the focus groups to determine relationships 
between the received information and its context. 2. Conversion of qualitative data within 
the online questionnaire to quantitative data to allow for conclusions to be made 3. 
Thematic analysis for the transcript of the focus group to identify themes on how patients 
feel their care would have been improved upon. 
 
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 sought approval from the Health Research Authority 
(HRA), who deemed HRA approval not necessary. The study will be conducted in 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.  Participant 
consent will be obtained electronically utilising Qualiatrics.com.  The right of the participant 
to refuse to participate without giving reasons must be respected.  All participants are free to 
withdraw at any time from the protocol without giving reasons and without prejudicing 
further treatment. 
 
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. 
 
Data will be pseudo anonymised. 
 
 
8.4. 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study. 

 
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8.5. 
SPONSOR  
Imperial College London will act as the main Sponsor for this study.   
 
8.6. 
FUNDING  
There is no specific funding for this study. There are no investigator payments.  Health care 
professionals undertaking the questionnaire and focus groups will not receive any payment 
for their participation. 
 
8.7. 
AUDITS   
The study may be subject to audit by Imperial College London under their remit as sponsor 
and other regulatory bodies to ensure adherence to GCP and the UK Policy Frame Work for 
Health and Social Care Research.  
 
 
9. STUDY MANAGEMENT  
 
The day-to-day management of the study will be co-ordinated through Imperial College 
London.   
 
 
10. PUBLICATION POLICY  
 
Study results will be analysed and published in a peer reviewed journal with 
recommendations made with regards to how care should be altered to improve the 
screening, coding and management of individuals with clinical risk factors for 
CKD/confirmed CKD.