Feasibility study of the use of point-of-care NP measurement

ISRCTN	ISRCTN12866009
DOI	https://doi.org/10.1186/ISRCTN12866009
Protocol serial number	36644
Sponsor	University of Oxford
Funder	National Institute for Health Research

Submission date: 04/12/2017
Registration date: 07/12/2017
Last edited: 31/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Heart failure is a condition where the heart does not pump blood around the body as well as it should. Although it is called heart “failure”, the heart is still working, but it might need extra help to make sure it works as well as it can. When someone has been diagnosed with heart failure, they are regularly monitored by their health care team. A blood test for natriuretic peptide (NP) is sometimes used to help diagnose heart failure, and there is some research that shows that monitoring NP may also be useful for monitoring patients with heart failure. It is possible for a doctor or nurse to measure NP from a blood sample themselves with a special machine (a “point of care” test), instead of sending it to a laboratory. This means that they get the result quickly, which would be important if they want to use it to make a decision about whether to change someone’s treatment, or to send them to hospital. The aim of this study is to see if it is practical for a GP or nurse to use the quick blood test to monitor patients with heart failure during their normal care.

Who can participate?
Adults aged 18 and older who have a confirmed diagnoses of heart failure and are currently manged in a primary care setting.

What does the study involve?
Participants are asked to make three extra visits to their GP practice over a year to have the quick blood test, along with some laboratory blood tests and a general check of their heart health. It will be seen if it is practical for the quick blood test to be used when participants come to see a GP or nurse during that year about their heart failure. At the end of the study participants are asked and the GPs and nurses to take part in separate focus groups so that we can find out how they feel about the new test.

What are the possible benefits and risks of participating?
People who take part in the study will get extra monitoring during the study, including the new point of care test, but there is no guarantee that this will directly benefit them. However, all the results of the tests done during the study will be available to their GP, so that they can be used to help care for them. The main risk of the study is the blood sample needed for the new test. This is a standard procedure, which may cause some pain and bruising, but should not result in any other problems.

Where is the study run from?
This study is being run by the Nuffield Department of Primary Care Health Sciences, University of Oxford (UK) and will take place in GP surgeries within the Thames Valley Primary Care Research Network (UK).

When is the study starting and how long is it expected to run for?
October 2016 to May 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Rafael Perera (Scientific)
rafael.perera@phc.ox.ac.uk

Contact information

Prof Rafael Perera
Scientific

Nuffield Department of Primary Care Health Sciences
Radcliffe Primary Care 554
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 9SH
United Kingdom

ORCID ID	0000-0003-2418-2091
Phone	+44 (0)1865 2 89220
Email	rafael.perera@phc.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Non-randomised; Both; Design type: Process of Care, Device, Qualitative
Secondary study design	Non randomised study
Participant information sheet	ISRCTN12866009 _PIS_V1.2_19Oct17.pdf
Scientific title	Feasibility study of the use of point-of-care NP measurement in primary care in patients with heart failure
Study objectives	The primary aim of the study is to determine the variability in natriuretic peptide measurements made using point-of-care technology in heart failure patients in primary care settings, including both between- and within- person variability.
Ethics approval(s)	HSC REC B, 07/11/2017, ref: 234119
Health condition(s) or problem(s) studied	Specialty: Primary care, Primary sub-specialty: Cardiovascular disease; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease
Intervention	This is a feasibility study. The intervention is point-of-care NT-proBNP measurement, using a Roche cobas h 232 device, added to current clinical measures at all visits. There is study visits at baseline, 6 and 12 months, as well as point-of-care measurement of NT-proBNP at routine visits for heart failure during the 12 month study period. Following the final study visit at 12 months, focus groups are held separately with patients and participating clinicians to discuss the acceptability of the intervention.practice or patient's home.
Intervention type	Other
Primary outcome measure(s)	Between- and within- person variability of point-of-care NP is measured using point-of-care NT-proBNP test results at baseline, 6 months, 12 months, and routine visits for heart failure.
Key secondary outcome measure(s)	1. Proportion of planned tests for which results are available is measured using the presence of expected point-of-care NT-proBNP tests results at baseline, 6 months, 12 months, and routine visits for heart failure 2. Proportion of NP tests that GPs report would have changed or did change decision-making process is measured using GP feedback on decision making at baseline, 6 months, 12 months, and routine visits for heart failure 3. Proportion of proposed tests actually carried out is measured using reports of point-of-care test use at baseline, 6 months, 12 months, and routine visits for heart failure 4. Patient acceptability is measured using 5 point Likert score at the 12 month visit 5. Clinician acceptability is measured using 5 point Likert score after the last patient visit at their site 6. Patient views about point-of-care NP testing in primary care is measured using a focus group after their 12 month visit 7. Clinician views about point-of-care NP testing in primary care is measured using a focus group after the last patient visit at their site 8. Recruitment rate is measured using a recruitment log at and before the baseline visit 9. Retention rate is measured using withdrawals before the 6 month and 12 month visits 10. Comparison to lab NT-proBNP measures is measured using point-of-care and lab NT-proBNP results taken at baseline, 6 months and 12 months 11. EQA comparison is measured using test samples at a convenient time for clinical staff 12. EQA precision assessment is measured using test samples at a convenient time for clinical staff
Completion date	01/05/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	27
Total final enrolment	27
Key inclusion criteria	1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Confirmed diagnosis of heart failure made by cardiologist and/or echocardiography 4. Currently managed in a primary care setting where the clinician is willing to take part in routine POC NP monitoring
Key exclusion criteria	Participant is considered to be terminally ill or receiving palliative care for another condition only at the time of recruitment.
Date of first enrolment	21/02/2018
Date of final enrolment	20/03/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nuffield Department of Primary Care Health Sciences

The University of Oxford
Oxford
OX2 6GG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during the current study will be available upon request from Rafael Perera (rafael.perera@phc.ox.ac.uk). Following publication of the research, fully-anonymised data may be shared with other academic researchers, including those outside the UK, for research purposes only (e.g. for individual patient data meta-analysis). Data will be available for up to 10 years after conclusion of the research, and will be limited to quantitative data (i.e. excluding data from focus groups, for which consent to further sharing will not be available). Consent and ethical approval for this form of sharing will be available, provided that data is not shared further by the recipient, and is used only for the agreed purpose.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results	version v1	28/07/2020	31/07/2020	No	No
Participant information sheet	version V1.2	19/10/2017	07/12/2017	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version V1.3	19/10/2017	07/12/2017	No	No

Additional files

ISRCTN12866009 _PIS_V1.2_19Oct17.pdf: Uploaded 07/12/2017
ISRCTN12866009_PROTOCOL_V1.3_19Oct17.pdf: Uploaded 07/12/2017
ISRCTN12866009_BasicResults_v1_28Jul2020.pdf: Uploaded 31/07/2020

Editorial Notes

31/07/2020: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The final enrolment number has been added from the basic results summary.
23/07/2018: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2018 to 21/02/2018.
2. The recruitment end date was changed from 31/03/2018 to 20/03/2018.
3. The overall trial end date was changed from 31/03/2019 to 01/05/2019.
4. The intention to publish date was changed from 30/06/2019 to 31/12/2019.
5. The target number of participants was changed from 40 to 27.
07/12/2017: Uploaded protocol Version 1.8 19 October 2017 (not peer-reviewed).