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ClinicalTrials.gov ID

NCT03876600

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

750Estimated

Last Update Posted

Mar 15, 2019Actual

Start Date

Apr 2019Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2022Estimated

Official Title

Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator

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.

• Pacemaker Ddd

• Replacement of permanent pacemakers for elective wear.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

Ministry of Health, FranceOTHER_GOV

jeanmarc.dupuis@chu-angers.fr

jacques.mansourati@chu-brest.fr

gabriel.laurent@chu-dijon.fr

pdefaye@chu-grenoble.fr

eanclaude.deharo@ap-hm.fr

jl-pasquie@chu-montpellier.fr

n.sadoul@chru-nancy.fr

estelle.gbk@gmail.com

philippe.mabo@chu-rennes.fr

antoine.dacosta@univ-st-etienne.fr

laurence.jesel@chru-strasbourg.fr

mondoly.p@chu-toulouse.fr

d.babuty@chu-tours.fr