Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nantes University Hospital
- Enrollment
- 750
- Locations
- 27
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Replacement of permanent pacemakers for elective wear. (Procedure)
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
Intervention: Replacement of permanent pacemakers for elective wear. (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: 6 month
Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of outpatient management compared to compared to the intervention in conventional hospitalization (≥1 night) of a replacement, for elective wear, permanent pacemakers. This analysis is from the perspective of the society and a time horizon of 6 months.
Secondary Outcomes
- 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(on a time horizon of 5 years)
- Evaluate and compare the rate of complications of different management within 6 months after the intervention in both arms.(on time horizon of 6 months)
- Evaluate the ambulatory failure rate(during all the study, during 30 months.)
- Evaluate and compare patients satisfaction between intervention and hospital management in both arms(during hospitalization, during 2 days)