Clinical trial NCT03876600: Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
Official title: Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker Ddd
Keywords: pacemaker
replace for elective wear
french context
cost-utility analysis
prospective
multicentric
randomized study
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2019-03-15
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.

The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.

Detailed description: In France, nearly 49,000 permanent pacemakers are implanted each year. The pacemaker longevity is about 10 years which leads to their replacement.

In France, in 2016, 15,764 pacemaker replacement hospital stays took place. 10.6% of them were made during an outpatient stay, 12.4% during a one-night hospitalization and 70.7% during hospitalization for two or more than two nights for the severity level 1.

If the outpatient care management is deployed at 90%, the economy of the cost care will be estimated to be 3,5 million euros and a reduction of 15 582 hospitalization night's stay.

The aim of START study is to compare cost-utility between ambulatory and conventional hospitalization care of permanent pacemakers replacement for elective replacement indicator and to demonstrate equivalence between outpatient management and conventional hospitalization management.

This study is in adequation with the national ambition to deploy the outpatient management in France. Surgery is the same with both hospitalization managements.

An ambulatory surgery need to present different advantages and benefits like high quality care and substantial cost savings.

The benefits of ambulatory care management are :

* An economy of hospitalization nights cost.
* A decrease in health costs related to the surgery realization.
* Patient satisfaction expected due to hospital discharged within 24 hours. Patient is expected to go home the same day as the surgery with good perception of ambulatory surgery.
* A decrease in the disorientation risk in the elderly patient is also expected.

Surgery is the same with both hospitalization managements.

Patients will be randomized in 2 arms. An arm conventional hospitalization management (control arm) and an arm outpatient care management.

Study period is 30 months. Patients will be following during 6 months. The recruitment time will be 24 months.

Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years old.
* Replacement of permanent pacemakers for battery elective wear without programmed act in the sensors regardless of pacemaker type, simple, dual or triple chambers and regardless pacemaker label.
* Patient living less than an hour from a hospital center
* Patient is able to answer the phone.
* Patient has an accompaniment the go out night
* Pacemaker-dependent patient or not regardless of indication of placement of the pacemaker
* Patient with or without anticoagulant treatment: the anticoagulant treatment is managed by center under these habits.
* Patient has given this free and informed consent.
* Patient having insurance in France.

Exclusion Criteria:

* Ambulatory Hospitalization is impossible.
* Patient refuses to participate
* Patient has hemostasis disorder yielding ambulatory hospitalization impossible.
* Woman is pregnant, nursing mothers or the patient don't receive an effective contraception.
* Patient under guardianship, safeguard of justice

Primary outcomes:
measure: Cost-utility analysis,from the perspective of the society and a time horizon of 6 months,of ambulatory management compared to the intervention in conventional hospitalization of a replacement,for elective wear,permanent pacemakers
timeFrame: 6 month
Secondary outcomes:
measure: Assess, the point of view of health insurance and health care institutions with a time horizon of 5 years, the annual and global budgetary impact in € of different diffusion scenarios for ambulatory to replace conventional hospitalization
timeFrame: on a time horizon of 5 years
measure: Evaluate and compare the rate of complications of different management within 6 months after the intervention in both arms.
timeFrame: on time horizon of 6 months
measure: Evaluate the ambulatory failure rate
timeFrame: during all the study, during 30 months.
measure: Evaluate and compare patients satisfaction between intervention and hospital management in both arms
timeFrame: during hospitalization, during 2 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Lyon University Hospital
state: Bron
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nancy
country: France
facility: Nancy University Hospital
city: Paris
country: France
facility: AP-HP, La Pitié Salpétrière
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Étienne
country: France
facility: Saint-Etienne University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hopsital
Study officials:
affiliation: Nantes University Hospital
name: Vincent Probst
role: PRINCIPAL_INVESTIGATOR
References: