Understanding the influence of NHS Health Check Cardiovascular Disease (CVD) Risk Assessment Tools
| ISRCTN | ISRCTN10443908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10443908 |
| Secondary identifying numbers | HTA 15/170/02; 2016_11 |
- Submission date
- 01/02/2017
- Registration date
- 07/02/2017
- Last edited
- 24/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Cardiovascular disease (CVD) is a general term for conditions that affect the heart and blood vessels, such as heart disease and stroke. CVD accounts for over a quarter of all UK deaths. The risk of
developing CVD can be reduced through, for example, being more active, stopping smoking or some medications. In 2009 the NHS Health Check programme was launched to reduce CVD in England. This national programme invites people to have their CVD risk measured in general practice, usually by a practice nurse or health care worker. The clinician should then discuss the patients’ CVD risk with them and, if required, advise them how to reduce it. Much of the value of Health Checks is likely to depend on how well clinicians understand CVD risk and if they are able explain it to patients in a way that encourages them to follow advice to reduce risk. The programme uses two main ways to measure risk. Firstly, QRISK2, which is a percentage risk of developing CVD in the next 10 years, which is currently used in most general practices. There is evidence that clinicians and patients often do not understand this kind of percentage score and have unanswered questions about their own CVD risk after a Health Check. Secondly, the JBS3 Risk Calculator, which is a new tool that measures ‘lifetime’ risk. It has different displays and functions to make it easier for clinicians to understand and explain why and how patients should reduce CVD risk. The aim of this study is to assess these risk assessment tools.
Who can participate?
Patients who are eligible for NHS Health Checks (aged 40-74 with no long-term diseases or taking cholesterol-lowering medication) and the staff who deliver these checks.
What does the study involve?
Participants are invited for a Health Check using the usual practice methods. At the appointment, they receive their Health Check as usual with the only differences being: in half of the Health Checks, the clinicians will use the usual CVD risk calculator which focuses on a 10-year % risk score and the other half use a risk calculator that includes lifetime risk; all consultations are video-recorded to allow the study team to see how CVD risk is communication and how patients respond. A sub-sample of participants then take part in interviews within two weeks following their Health Check. During these interviews, they are shown clips of the Health Check and asked a series of open questions to ask them to which help them to recall and reflection on CVD risk communication during the Health Check, their personal perceptions and understanding of CVD risk as a result of the Health Check, and subsequent advice/treatment, and related patient intentions and behaviour
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
The study is run from Staffordshire University and takes place in 12 General Practices in the West Midlands, England (UK)
When is the study starting and how long is it expected to run for?
November 2016 to September 2019
Who is funding the study?
National Institute for Health and Care Excellence (UK)
Who is the main contact?
Dr Christopher Gidlow
c.gidlow@staffs.ac.uk
Contact information
Scientific
Staffordshire University
Brindley Building
Leek Road
Stoke-on-Trent
ST4 2DF
United Kingdom
 ORCID ID |
0000-0003-4990-4572 |
|---|---|
| Phone | +44 (0)1782 294330 |
| c.gidlow@staffs.ac.uk |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Qualitative video-stimulated recall study to explore cardiovascular disease risk communication in NHS Health checks using QRISK2 10-year risk and JBS3 lifetime risk calculators |
| Study acronym | RICO (RIsk COmmunication in NHS Health Checks) |
| Study hypothesis | The aim of this study is to explore clinician and patient perception of CVD risk when using the JBS3 lifetime risk calculator or the QRISK2 10-year risk calculator, the associated advice or treatment offered by the clinician and the response of the patient. |
| Ethics approval(s) | Approved 11/09/2017, London - Dulwich Research Ethics Committee, ref: 17/LO/1463 |
| Condition | Cardiovascular disease |
| Intervention | Patients will attend their general practice for their NHS Health Check according to usual practice procedures. Patients will be sent study information sheets and have verbal explanations from practice staff when booking the Health Check. On arrival, written informed consent would be sought to video-record the Health Check consultation (all participants), participation in a post-consultation interview (subsample within 2 weeks), and to allow searching of their medical records to gather information about possible actions following the Health Check (all participants). Patients would then have their Health Check (lasting 20-30 minutes), which would be will be video-recorded. For a subsample of patients, a post-consultation semi-structured, video-stimulated recall (VSR) interview will be arranged within 2 weeks of their Health Check. VSR interviews will be held at a location of patient preferences (GP practice, participant’s home. During interviews, participants will be shown the excerpts of the Health Check and then be asked a series of open questions. This Video-Simulated Recall (VSR) approach is designed to facilitate recall and reflection on CVD risk communication, individual perceptions and understanding, and subsequent advice/treatment, and related patient intentions and behaviour. VSR interviews are expected to last 30-60 minutes. The maximum time from participant consent to completion of the VS interview should be up to 2 weeks. |
| Intervention type | Other |
| Primary outcome measure | Patient understanding of CVD risk based on analysis of qualitative data from recorded NHS Health Check consultations and VSR interviews. |
| Secondary outcome measures | 1. Clinician understanding of CVD risk based on analysis of qualitative data from VSR interviews 2. Patient response to the risk information based on analysis of qualitative data from recorded NHS Health Check consultations and VSR interviews 3. Patient intentions with respect to health-protective behaviours based on analysis of qualitative data from VSR interviews 4. Action following Health Checks as assessed by a review of patient records within four weeks of the Health Check (e.g., GP appointment, lifestyle referrals, physiotherapy referral, lifestyle referral, smoking cessation referral, alcohol advice, or statin prescription) |
| Overall study start date | 01/11/2015 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 74 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 173 |
| Participant inclusion criteria | Patient population: 1. Eligible for NHS Health Checks based on national criteria 2. Adults aged 40-74 years 2. Without chronic disease diagnosis or statin prescription Clinician population: Staff delivering NHS Health Checks (e.g., practice nurse, health care worker). |
| Participant exclusion criteria | Patient population: 1. Those not eligible for NHS Health Checks based on national criteria 2. Adults aged <40 or >74 years 3. With existing chronic disease diagnosis or statin prescription Clinician population: No exclusion criteria |
| Recruitment start date | 01/08/2017 |
| Recruitment end date | 31/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stoke-on-Trent
ST4 2DF
United Kingdom
Sponsor information
University/education
Brindley Building
Leek Road
Stoke-on-Trent
ST4 2DF
England
United Kingdom
| Website | www.staffs.ac.uk |
|---|---|
"ROR" |
https://ror.org/00d6k8y35 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The main dataset will be audio and video files and related transcripts, which will not be made available to protect participant identities. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/01/2019 | 16/01/2019 | Yes | No | |
| Results article | Quantitative results | 25/09/2020 | 28/09/2020 | Yes | No |
| Results article | Qualitative results | 03/12/2020 | 07/12/2020 | Yes | No |
| Funder report results | 25/08/2021 | 25/08/2021 | No | No | |
| Results article | Qualitative results | 26/10/2021 | 15/03/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | Qualitative results | 23/04/2024 | 24/04/2024 | Yes | No |
Editorial Notes
24/04/2024: Publication reference added.
15/03/2023: Publication reference added.
25/08/2021: Publication reference added.
07/12/2020: Publication reference added.
28/09/2020: Publication reference and total final enrolment number added.
30/07/2019: The following changes have been made:
1. The overall trial end date has been changed from 30/09/2019 to 31/12/2019.
2. The ethics information has been added.
11/03/2019: The recruitment end date has been changed from 28/02/2019 to 31/03/2019.
16/01/2019: Publication reference added.
16/10/2018: The recruitment end date was changed from 30/09/2018 to 28/02/2019.
17/07/2017: Acronym added.
