Assessing a healthcare bundle designed to improve the management of patients with artery disease. The CHABLIS Study
| ISRCTN | ISRCTN13202085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13202085 |
| IRAS number | 289220 |
| Secondary identifying numbers | 0749, IRAS 289220 |
- Submission date
- 21/01/2021
- Registration date
- 27/01/2021
- Last edited
- 09/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and Study Aims
Peripheral Arterial Disease (commonly referred to as PAD) is the commonest cause of amputation and a leading cause of heart problems. More than half of people found to have PAD are expected to die, have an amputation, a stroke or heart attack within five years. Many of the PAD risk-factors, such as smoking, high blood pressure, high cholesterol, high blood-sugars, can be changed when someone has the right medical care. Current doctors' guidelines for the NHS sets clear targets regarding how these risk-factors should be addressed if someone has PAD. Unfortunately, these guidelines are usually not followed in the NHS. To change this, we developed a bundle of checklists and letters called "LEGS" with the help of patients and experts. LEGS is meant to support patients with PAD, GPs, and hospital doctors manage the common PAD risk factors. This might help prevent amputations and other health problems in these patients.
The aim of this study is to test how well the LEGS intervention can be used in real life at three NHS hospitals across England. With the help of patient and healthcare professional interviews (held remotely if necessary due to COVID-19), and a conference when the study finishes (remotely if necessary), there will be the opportunity to make any changes to the intervention before it is adopted across the NHS.
Who can participate?
Adult patients with symptomatic PAD (i.e. intermittent claudication, ischaemic rest pain, or chronic limb threatening ischaemia) referred to secondary care either in a clinic, or for inpatient treatment.
What does the study involve?
Patient Involvement:
Once a patient provides informed consent, we will then use the LEGS bundle of letters and checklists from the first day they receive care for their PAD in hospital. This includes clinic(s) appointments and/or an inpatient stay. Doctors providing their care will use our checklist of the common things that patients with PAD should be offered in terms of medications and/or tests. All of these suggestions are already part of what is standard NHS care for PAD. Using the patients’ medical notes, we will record blood pressure, current medications, medical history, previous surgeries, imaging results, routine blood test results (cholesterol, lipid profile, full blood count), smoking status, and demographic information (age, height, weight, gender). This is all standard information that the NHS already collects. Patients will be given a leaflet which will provide information about PAD and other things they can do to help reduce associated risks.
After patients are discharged from either clinic, or their first patient admission, we will contact them by phone to fill in a questionnaire commonly used to assess people’s quality of life. Also, we will make an appointment to see them again in six months after we have used the LEGS bundle checklist and letters to check their legs and overall health. This is standard for someone with PAD. We will again record patients’ blood pressure, current medications, medical history, previous surgeries, imaging results, routine blood test results (cholesterol, lipid profile, full blood count), smoking status, and demographic information (age, height, weight, gender). During that appointment we will ask them to fill in a questionnaire which assesses how well people are taking their prescribed medication, called the MARS questionnaire. In addition, patient’s GPs will be contacted in order to review prescriptions and medical history to ensure that they received the LEGS bundle documents as intended. We will then record how many times the LEGS bundle was used correctly.
As part of this study patients will also have the option of participating in an interview with a researcher. This will take up to two hours and will be perfomed either remotely, or face-to-face depending upon the patients’ preference. In this interview patients will be asked how they found the management of their PAD at hospital and in their GP practice, what their thoughts are of the information leaflet, and if they think it has been of any benefit or not.
Healthcare professionals:
We will invite healthcare professionals who provide care to patients with have symptomatic peripheral arterial disease to attend an interview. During this, we will explore their experiences of delivering the intervention. This will help us evaluate the ability/feasibility of staff in delivering the intervention, overall impression, validity, usability, acceptability and engagement with the intervention. It will include barriers to engagement or delivery and ideas for improving the intervention.
Consensus conference:
We will invite all patients and healthcare professionals who took part in the interviews to attend a consensus conference. The conference will help us decide how to adapt the elements of the LEGS bundle (if necessary) and how to proceed with future large-scale studies.
What are the possible risks and benefits of participating?
If the study is successful, this may benefit thousands of patients across the UK and may prevent hundreds of admissions and deaths every year. It could bring significant cost savings to the NHS as the treatment of these health problems is very expensive. There are no risks.
Where is the study run from?
University of Leicester (UK)
When is the starting and how long will it run for?
February 2020 to June 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Mr Prakash Sara, prakash.saha@gstt.nhs.uk
2. Professor Christopher Imray, christopher.imray@uhcw.nhs.uk
3. Mr Andrew Garnham, andrew.garnham@nhs.net
4. Professor Matt Bown, mjb42@le.ac.uk
5. Ms Ann Elsworth, ame29@le.ac.uk
Contact information
Scientific
500 Groby Road
BHF Cardiovascular Research Facility
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-3399-094X |
|---|---|
| Phone | +44 (0)116 252 4875 |
| as875@le.ac.uk |
Scientific
Department of Cardiovascular Sciences
University of Leicester
BHF Cardiovascular Research Centre
Glenfield General Hospital
Leicester
LE2 7LX
United Kingdom
| ORCID ID |
0000-0002-6180-3611 |
|---|---|
| Phone | +44 (0)116 252 3190 |
| mjb42@le.ac.uk |
Public
Office 65
Clinical Sciences Building
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 2502381 |
|---|---|
| ame29@le.ac.uk |
Study information
| Study design | Prospective feasibility multicentre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.dropbox.com/s/v3cag3qmravde5w/289220%20Localised%20UHL%20PIS%20%28HCP%29%20CHABLIS%20v1.0%2001.12.2020.docx?dl=0 |
| Scientific title | A Community and Hospital cAre Bundle to improve the medical treatment of cLaudIcation and critical limb iSchaemia. The CHABLIS study |
| Study acronym | CHABLIS |
| Study hypothesis | Peripheral arterial disease (PAD) happens when the arteries supplying blood to the legs become narrowed or blocked. Patients with PAD may lose their leg, develop heart-attacks or strokes, or die early. Smoking, diabetes, high blood-pressure and cholesterol increase the chances of having PAD. Current NHS guidelines state that patients with PAD should be offered blood-thinners, blood-pressure, and cholesterol tablets. They should also be supported to manage their diabetes better, stop smoking, and exercise more. Our research has shown that very few patients receive this care. This leads to unnecessary deaths and amputations. When we asked patients with PAD how their NHS care could be improved, they said not enough information about PAD treatments was given. They also did not understand the high risk of heart attacks, strokes, and amputations that comes with PAD. Finally, their prescriptions were often wrong. Hospital doctors, GPs and nurses felt communication between doctors should be improved. Based on this information, we developed a bundle of doctors checklists and patients leaflets to help patients with PAD get the right treatment. We called this “LEGS” (LEaflet Gp letter Structured bundle). We are now going to assess whether LEGS can be used in NHS hospitals. |
| Ethics approval(s) | Approved 02/12/2020, Wales National Health Service (NHS) Review Ethics Committee (REC) 7 (Public Health Wales, Building 1, Jobswell Road, St David’s Park, SA31 3HB, UK; +44 (0)1267234567; sasha.barrate@wales.nhs.uk), ref: 20/WA/0319 |
| Condition | Peripheral arterial disease |
| Intervention | The intervention used in this research is called "LEGS". It was developed by patients and experts in peripheral arterial disease. It addresses the five key treatment areas (i.e. best medical therapy) identified in our review of best available evidence and clinical guidelines, including National Institute for Health and Care Excellence (NICE) guidance: i) Lipid control ii) Antiplatelet therapy iii) BP control iv) Smoking cessation v) Blood-glucose control. The aim is to improve the medical care of patients with peripheral arterial disease by using the LEGS intervention. The final LEGS intervention consists of: i) Inpatient doctors’ checklist One-page checklist developed with the help of Foundation Doctors, Core Surgery and Vascular Trainees, Vascular Surgery and Interventional Radiology Consultants, for patients admitted in a hospital setting. The list is filled initially with the first patient clerking (on admission) by the relevant doctor and then immediately before discharge (last day of inpatient stay). ii) Outpatient doctors’ checklist One-page checklist for those seen in a clinic. It has been developed with the help of two NHS Vascular Clinic Co-ordinators, a GP, Specialist Vascular Nurses, and Vascular Surgery Consultants. The list is filled in during the outpatient consultation, prompting the doctor or nurse to address all BMT key areas. iii) LEGS leaflet for patients and relatives (both inpatients and outpatients) A concise leaflet with information aiming to support patients to achieve their medical care targets. We used the British Heart Foundation and Circulation Foundation PAD documents as a basis, on which the patients’ helping us with the development pathway expanded as per their perceptions/preferences. The leaflet covers (in lay language) the implications of a diagnosis of PAD and the key treatment targets of NICE guidance. This is given to the patient upon the diagnosis of symptomatic PAD in the form of severe intermittent claudication or chronic limb threatening ischaemia either during their inpatient stay or at the outpatient consultation. The leaflet is also mailed to the GP and Practice Nurse. It is available in five languages. iv) LEGS GP letter A standardised letter with specific action points that cover the main aspects of Best Medical Therapy for PAD. This document was developed by GPs in eleven different regions in England. The letter will be sent to the patient’s GP immediately after discharge from hospital (inpatients) or after each clinic visit (outpatient). Specific action points are suggested to the GP and Practice Nurse. The letter addresses the poor and occasionally confusing structure of secondary care communications. It will help support primary care in providing more streamlined Best Medical Therapy for those with PAD. v) LEGS GP follow-up letter A follow-up letter will be sent automatically to the GP four weeks after each contact with secondary care (discharge from inpatient stay or visit to the clinic), again prompting action for NICE treatment targets. Follow-up is 6 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Number of elements of the LEGS intervention delivered successfully by the clinical team measured using patient records at day of discharge/day of clinic appointment and 15 days later |
| Secondary outcome measures | 1. Has the participant been made aware of the diagnosis of peripheral arterial disease and whether relevant medications have been prescribed? (yes/no) by contacting the primary care surgery at day 15 2. Patient medication history from day 0 to 6 months, measured using patient records 3. Health events from day 0 to 6 months, measured using patient records 4. Quality of life measured using the EuroQol-5D (EQ-5D) questionnaire at 6 months |
| Overall study start date | 01/02/2020 |
| Overall study end date | 04/06/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 186 |
| Total final enrolment | 120 |
| Participant inclusion criteria | Patients: 1. Adult (>18 years of age) patient with incapacitating intermittent claudication or chronic limb threatening ischaemia (Rutherford stages 3–6) 2. Referred to secondary care, either in a clinic or for inpatient treatment 3. Willing and able to give written informed consent for participation in the study 4. Access to a telephone or computer with internet access (for those taking part in remote interviews/consensus meeting) Healthcare professionals: 5. Healthcare professionals who provide care to patients with have symptomatic peripheral arterial disease |
| Participant exclusion criteria | 1. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study 2. Patients who do not have the capacity to consent for themselves 3. Patients with a life-limiting condition whereby conservative management is most appropriate 4. Patients with asymptomatic peripheral arterial disease |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 30/10/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Groby Road
Leicester
LE3 9QP
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Sponsor information
University/education
Research Governance Office
Research & Enterprise Division
Leicester General Hospital
Sponsor's Office
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)116 258 4867 |
|---|---|
| RGOsponsor@le.ac.uk | |
| Website | https://le.ac.uk/research/regi |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The findings of the study, once completed, will be submitted for publication in a medical journal with broad international readership across disciplines. Wherever possible, data will be published in open-access format as per NIHR policies. Anonymised open data will be shared on appropriate platforms (ClinicalStudyDataRequest and “Supporting Open-Access for Researchers” initiative). The scientific community will receive regular updates (at least yearly) at the VSGBI, European Society of Vascular Surgery (ESVS) and Society of Vascular Nurses (SVN) meetings. Given the importance of engaging and informing primary care nursing networks, we will also target the Royal College of Nursing and more specifically the General Practice Nursing Forum with lay and specialist updates. Similarly, the National Association of Primary Care, providing access to both clinicians and primary care managers nationwide, will receive the same updates. In addition, to ensure wider dissemination, a study website will be maintained, including three-monthly updates in the form of an online blog (lay and expert language) – this will link to the Vascular and Endovascular Network (VERN) website, which has an international monthly readership of >2,000 individuals, and the VSGBI website. All updates will also be linked to social media feeds managed by the NIHR Leicester BRC and VERN (>3,000 specialist and lay subscribers). |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v1.0 | 01/12/2020 | 04/02/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 28/11/2022 | 29/11/2023 | Yes | No | |
| Results article | embedded qualitative feasibility results | 23/01/2023 | 29/11/2023 | Yes | No |
| Preprint results | 09/04/2024 | No | No | ||
| Results article | 29/01/2024 | 09/04/2024 | Yes | No |
Additional files
- ISRCTN13202085_PROTOCOL_v1.0_01Dec2020.docx
- uploaded 04/02/2021
- ISRCTN13202085 preprint results.pdf
Editorial Notes
09/04/2024: Publication reference and preprint results file added.
29/11/2023: Two publication references added.
06/07/2022: The following changes have been made:
1. The overall trial end date has been changed from 03/10/2022 to 04/06/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/06/2022 to 01/10/2022.
3. The total final enrolment number has been added.
10/03/2022: A scientific contact and a public contact have been added and the plain English summary updated accordingly.
04/02/2021: Uploaded protocol (not peer reviewed) Version 1.0, 01 December 2020.
27/01/2021: Trial’s existence confirmed by Health Research Authority.
