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

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Pacemaker Ddd

Treatments: Procedure: Replacement of permanent pacemakers for elective wear.

Study type: Interventional

Funder types: Other

Identifiers

NCT03876600

RC18_0034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

conventional hospitalization management.

Experimental group

Description:

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

Treatment:

Procedure: Replacement of permanent pacemakers for elective wear.

ambulatory management

Active Comparator group

Description:

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

Treatment:

Procedure: Replacement of permanent pacemakers for elective wear.