Update on randomised controlled trial

by Mehdi Juma

HN would like to inform participants of a change in the randomised controlled trial “Implementation of a Telephone-Based Case Management Intervention for Patients at risk of High Emergency Department Utilisation in the English NHS”.

If you think you may have taken part in the study, conducted by HN (Health Navigator) between August 2015 and October 2019 at 6 NHS trusts, this is a change to what you have originally consented to.

Find out more and read the full participant information sheet below.

Evaluation of a Health Coaching Service

We are informing you about a change in the randomised controlled trial “Implementation of a Telephone-Based Case Management Intervention for Patients at risk of High Emergency Department Utilisation in the English NHS” (INJU 4610, CPMS ID 19857). It was managed by HN (Health Navigator) with a principal investigator the Nuffield Trust. The trial opened for recruitment in August 2015 in York Teaching Hospitals and closed in October 2021.

The purpose of the research study is to evaluate a health coaching service for people with long term health problems or people who’ve needed frequent emergency care. Urgent and emergency care is one of the largest policy and implementation challenges in the NHS and HN have brought the trusted and independent research partner the Nuffield Trust to lead on the review and evaluation of patient outcomes and impact on hospital services recorded during the study.

If you have taken part in the study, this is a change to what you have originally consented to. If you do not want your information to be used in the evaluation led by the Nuffield Trust, please inform us by 24th January 2022. You can write to HN electronically or by post using the details below. This will not affect in any way the care you currently receive. Before you decide if you would like to opt-out, we would like to inform you why the research is being done and what it would mean for you.

What is the purpose of the study?

The purpose of the study is to measure whether a new service for supporting people who have long term health conditions helps to reduce their need for emergency hospital visits and admissions. The service involves giving people advice and support from a dedicated health coach (usually a nurse by background with additional training). A health coach is someone who works with the patient by telephone to help them manage their health risks and hopefully improve your how they feel and their quality of life. The coach also helps people to identify additional services available in the community that they may require. That could mean GPs, social services or other specialists in the voluntary sector. Health coaching has already been tried in other European countries such as Sweden and we want to evaluate if it would help patients in England too. The health coaches are trained NHS nurses.

HN (Health Navigator) contact details:

Contact details:

Email: An Nguyen, Head of Analytics

[email protected]

Address: HN (Health Navigator),

2 Smith Square,

77 Fulham Palace Road,

London, W6 8AF

How do I know if I have taken part in the research study?

The below table shows the patient recruitment at each of the participating sites in the research study. You must have had a hospital admission in the respective time period and contacted by directly by HN (Health Navigator). If you are unsure whether you have taken part, get in touch electronically or via the post sharing your first, second name, the hospital site and the NHS number at the time you participated in the study.

Hospital Site/Trust

Start date 

End date

York Teaching Hospital Trust

August 2015

October 2018

Royal Wolverhampton Trust

April 2017

November 2018

University Hospital of North Midlands Trust

May 2018

March 2019

University Hospitals of Derby and Burton

October 2018

April 2019

Mid-Essex Hospital Trust

January 2018

October 2019

East-Kent Hospitals University Foundation Trust

October 2018

September 2019

Who is organising and funding the research?

The study is being run by a company called HN (Health Navigator), that provides health care services to patients with long term health problems in England. The research also has the support of Clinical Commissioning Groups (groups of GPs) in several areas in England where the study took place.

Do I have to opt-out?

No. It is up to you to decide whether or not to opt-out from the evaluation undertaken by the Nuffield Trust. If you decide to opt-out, this would not affect the standard of care you receive in the future.

Will my taking part in the study or opting out be kept confidential?

Yes. All the data that will be analysed is pseudonymised, which means that personal identifiable details are removed. If you have joined the study, your data collected for this study will be looked at by authorised people at HN (Health Navigator), your CCG, the hospital trust where you will have been recruited to this study, NHS Digital, the Nuffield Trust and any NHS organisations that collect your patient identifiable data. All these people will have a duty of confidentiality to you as a research participant.

How will my information be used?

If you have participated in the study we will collect information about the health care you receive for a period of one year before and two years after you join the study so that we can evaluate if receiving support from a health coach has any impact on the health of patients, their consumption of hospital care and survival rates. We can gather this information from your records at your CCG, the hospital trust where you will have been recruited to this study, NHS Digital, and any NHS organisations that collects your patient data. Only authorised people have access to the dataset. The results of the study will only be described as a summary of the whole group experience; individuals will not be named or identified.

What will happen to the results of the research study?

We intend to publish the results of the study in reports and specialised medical journals. The results of the study will only be described as a summary of the whole group experience; individuals will not be named or identified.

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people called the Research Ethics Committee which assess formally if the proposed research is ethical. This is to protect your safety, rights, well-being and dignity. This study has been reviewed and given a favourable opinion by NRES Committee London- Bromley Research Ethics Committee (Ref 15/LO/0992). The study is registered with the National Institute for Health Research (INJU 4610, CPMS ID 19857).

Further information and contact details

If you would like further information about the study, please contact HN directly.

Contact details:

Email: An Nguyen, Head of Analytics

[email protected]

Address: HN (Health Navigator),

2 Smith Square,

77 Fulham Palace Road,

London, W6 8AF

Data privacy notice

HN (Health Navigator) is the sponsor for this study based in the United Kingdom. HN and the Nuffield Trust will be using pseudonymised data collected from you, your CCG, the hospital trust where you will have been recruited to this study, NHS Digital, and any NHS organisations that collect your patient data in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. HN (Health Navigator) will keep identifiable information about you for at least 12 months or a maximum of 6 months after the results of the study have been published.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information at https://www.hn-company.co.uk/data-privacy/ or by contacting HN’s IG lead, An Nguyen at [email protected].