Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
NCT ID: NCT03876600
Last Updated: 2019-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
750 participants
INTERVENTIONAL
2019-04-30
2022-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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conventional hospitalization management.
The patients who are randomized to have a conventional hospitalization for the pacemaker replacement have conventional management.
In this management patient come to hospital one day before this surgical operation and he is operated next day
Replacement of permanent pacemakers for elective wear.
START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms.
The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day.
ambulatory management
The patients who are randomized to have a ambulatory surgery for the pacemaker replacement have ambulatory management.
In the ambulatory hospitalization patients come to hospital and have a surgical operation the same day
Replacement of permanent pacemakers for elective wear.
START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms.
The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day.
Interventions
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Replacement of permanent pacemakers for elective wear.
START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms.
The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Vincent Probst
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Lyon University Hospital
Lyon, Bron, France
Angers University Hospital
Angers, , France
Brest University Hospital
Brest, , France
Dijon University Hospital
Dijon, , France
Grenoble University Hospital
Grenoble, , France
AP-HM
Marseille, , France
Montpellier University Hospital
Montpellier, , France
Nancy University Hospital
Nancy, , France
AP-HP, La Pitié Salpétrière
Paris, , France
Rennes University Hospital
Rennes, , France
Saint-Etienne University Hospital
Saint-Etienne, , France
Strasbourg University Hospital
Strasbourg, , France
Toulouse University Hospital
Toulouse, , France
Tours University Hopsital
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC18_0034
Identifier Type: -
Identifier Source: org_study_id
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