Clinical trial NCT04188457: Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.
Official title: Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Accidents
Myocardial Infarction
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 1720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stroke or myocardial infarction

Brief summary: Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries.

International data, including French data and data from our own registries, illustrate that:

* risk factors that are common, mainly hypertension, smoking, high cholesterol or diabetes, remain insufficiently controlled, although they are easily detectable and treatable;
* the incidence rate of stroke has doubled in 20 years in people under 55 years of age, increasing the number of people with chronic disabilities;
* 1-month and 1-year mortality rates for stroke and MIs have decreased by 17% in 5 years, increasing the number of survivors but with chronic disabilities;
* the aging of the population and the arrival of the baby boomers of the 1950s in the at-risk age groups has increased the at-risk population;
* Stroke and MI recurrence rates reached a threshold of 6% / year, in contrast to the very high rates of re-hospitalization at 1 year: 30% post-stroke and 20% post-MI, due to poorly anticipated and controlled complications. These reasons explain the lack of significant progress in preventing recurrences, preventable complications (heart failure and arrhythmias after MI; falls, sphincter and swallowing disorders, dementia and arrhythmias after stroke) and re-admission. This observation is aggravated by problems of medical demography and therefore the availability of neurologists, cardiologists and general practitioners.

Local and foreign experiments have demonstrated the value of intensive, coordinated and multi-professional stroke and MI monitoring, including nurses, in terms of: better control of risk factors and reduction of the rate of re-hospitalization by recurrence in stroke follow-up; improvement of the patient's general condition, control of risk factors, reduction in the number of events, decrease in the number of re-hospitalizations and their duration in MI follow-up. The value of pharmacists' additional intervention in intensive post-MI follow-up compared to routine follow-up has also been demonstrated, particularly in terms of significant improvement in patient compliance.

The hypothesis is that 2 years of intensive follow-up for both post-stroke or post-MI patients, by trained hospital and liberal nurses, in conjunction with doctors and pharmacists, is of medico-economic interest compared to usual follow-up. Therefore a medico-economic evaluation was designed to evaluate the efficiency of this model, which combines community-based and recourse care, prevention and coordination of care compared to usual follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient or legal representative who has given oral consent
* Patient over 18 years of age
* Patient with:

  * either a primary MI or a recurrent MI, not previously included, defined according to the criteria of the European Society of Cardiology and ICD-10
  * either a primary stroke, a recurrent stroke not previously included, hemorrhagic, ischemic or Transient Ischemic Attack (TIA), defined according to WHO criteria, the TOAST score and the ICD-10, with a Rankin score \< 5.
* Patient followed up in one of the 6 public health establishments of the GHT 21-52 (regional group of hospitals) or at the Valmy clinic in Dijon also participating in the project
* Patient with estimated survival beyond 12 months

Exclusion Criteria:

* A patient who is not affiliated to the national health insurance system;
* A patient subject to legal protection (curatorship, guardianship)
* To be a patient subject to a measure of judicial safeguard;
* Pregnant, parturient or breastfeeding woman;
* Admitted for a condition other than stroke, TIA and MI;
* Experiencing heart failure before the MI;
* Be managed in EHPAD before and/or after stroke or IDM.

Primary outcomes:
measure: Cost-utility ratio of the intensive monitoring strategy for each condition (stroke / myocardial infarction)
timeFrame: 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: