Condition category
Circulatory System
Date applied
01/02/2017
Date assigned
07/02/2017
Last edited
18/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1517002

Contact information

Type

Scientific

Primary contact

Dr Christopher Gidlow

ORCID ID

http://orcid.org/0000-0003-4990-4572

Contact details

Staffordshire University
Brindley Building
Leek Road
Stoke-on-Trent
ST4 2DF
United Kingdom
+44 1782 294330
c.gidlow@staffs.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/170/02; 2016_11

Study information

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

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

Not provided at time of registration

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2015

Overall trial end date

30/09/2019

Reason abandoned

Eligibility

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 type

Mixed

Age group

Adult

Gender

Both

Target number of participants

240

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

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Staffordshire University
College Road
Stoke-on-Trent
ST4 2DF
United Kingdom

Sponsor information

Organisation

Staffordshire University

Sponsor details

Brindley Building
Leek Road
Stoke-on-Trent
ST4 2DF
United Kingdom

Sponsor type

University/education

Website

www.staffs.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

01/06/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/07/2017: Acronym added.