NCT03876600

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker Ddd

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2019-03-15
• Last updated: 2019-03-15

Locations

14 sites across 1 country: France