RecruitingNAINTERVENTIONAL

Evaluation of the Effectiveness of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism.

This study looks at how best to care for people who have had a mild blood clot in their lungs, called a non-severe pulmonary embolism. These clots are common and can sometimes lead to serious problems like more clots or bleeding from the medicines used to treat them. Currently, patients see a doctor after leaving the hospital for follow-up appointments. This study wants to see if adding extra support from a highly trained nurse, called an Advanced Practice Nurse (APN), can make a difference. These nurses can check on your progress, help with your medicine, and offer advice. The study will compare patients who receive the usual doctor follow-up with those who also get this extra nurse support, to find out if the enhanced care leads to better results and fewer complications.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

360

Start

11 Dec 2024

Estimated completion

01 Jul 2027

Non-severe Pulmonary Embolism

What is this study about?

Blood clots in the lungs, known as pulmonary embolisms, are a serious health issue. Even mild ones, called non-severe pulmonary embolisms, need careful attention. After being diagnosed and treated, people often have follow-up appointments with a specialist doctor. These appointments are important for checking how you're doing, making sure your medicines are working safely, and deciding if you need to continue treatment long-term.

However, even with current care, some people still face problems like another blood clot developing or bleeding because of the medicines they take. This study is exploring a new way of providing care to see if these risks can be reduced. It focuses on the role of specially trained nurses, known as Advanced Practice Nurses (APNs). These nurses have advanced skills and can do things like monitor your health closely, help manage your prescriptions, and offer support and education.

The main aim of this study is to compare the standard follow-up care with an approach that includes this extra support from an Advanced Practice Nurse. Researchers want to see if having an APN involved in your care, alongside your doctor, makes it safer and more effective. They believe this extra attention could help reduce the chances of complications like bleeding from blood-thinning medications, ultimately leading to better health for people with non-severe pulmonary embolisms.

Key takeaways

The study compares standard follow-up care with an enhanced approach for mild lung blood clots.
The enhanced care involves a highly trained Advanced Practice Nurse (APN).
It aims to reduce risks like new clots or bleeding from medication.
Eligibility depends on your age, location, and recent diagnosis at specific hospitals.
Participation involves different types of follow-up appointments.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and registered with the social security system in France, specifically living in the 21-52 region. You must have been diagnosed with a non-severe pulmonary embolism (a mild lung blood clot) within the last 24 hours at specific hospitals – Dijon University Hospital or Langres University Hospital.

Your doctor will have confirmed your diagnosis of a lung blood clot using tests like a special lung scan, an ultrasound for other clots, or a CT scan. It's also important that there are no medical reasons why you shouldn't take blood-thinning medication.

Some people can't join the study. This includes anyone under 18, pregnant or breastfeeding women, or those who can't legally give their consent to take part. Also, if you have a medical reason that prevents you from taking blood-thinning medication, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you live in the 21-52 region of France?
Have you been diagnosed with a non-severe pulmonary embolism in the last 24 hours at Dijon or Langres University Hospital?
Are you not pregnant or breastfeeding?
Are you able to take blood-thinning medication?
Are you able to provide your consent to participate?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll either receive the usual follow-up care from a doctor, or the intensive follow-up which includes additional support from an Advanced Practice Nurse (APN). The APN can help with monitoring your health, managing your prescriptions for blood thinners, and offering important advice. The total duration of the enhanced follow-up through the study is not specified but usually lasts several months to a year as your doctors manage your treatment. Both groups will likely have regular check-ups at 1, 3, and 6 months after your diagnosis to monitor your condition, adjust medication if needed, and discuss the causes of your blood clot. The study interventions are focused on the type of follow-up care you receive.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the intensive follow-up, which includes care from a specially trained nurse, might lead to better management of your condition and potentially reduce complications from your blood clot or the medication you take. However, there's no guarantee this will happen. The risks associated with this study are generally low, as it primarily involves different approaches to follow-up care rather than experimental treatments. The main risks are linked to the condition itself and the standard medications for blood clots (like bleeding). You are always free to leave the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (1)

Chu Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is a 'pulmonary embolism'?

It's a medical term for a blood clot that travels to your lungs, which can be serious. This study focuses on a 'non-severe' type, meaning a milder clot.

What is an 'Advanced Practice Nurse'?

An Advanced Practice Nurse (APN) is a highly trained nurse with extra qualifications. They can do more advanced tasks like monitoring your health, managing prescriptions, and offering expert advice.

Why is this study important for people with lung clots?

It's important because it aims to find the best way to help people recover after a lung clot and to reduce potential problems like more clots or bleeding from their medicines.

Will I have to pay to be in this study?

No, you will not have to pay to participate in the study. Your standard medical care is covered by your social security system.

What happens if I decide I don’t want to be in the study anymore?

You can leave the study at any point without it affecting your regular medical care, and you don't need to give a reason.

How to find out more

Anne-Lise ANTEMI-RIBREUX

anne-lise.antemi@chu-dijon.fr 0380669363 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.