Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator
START
1 other identifier
interventional
750
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 15, 2019
February 1, 2019
3 years
February 14, 2019
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
6 month
Secondary Outcomes (4)
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
Study Arms (2)
conventional hospitalization management.
EXPERIMENTALThe 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
ambulatory management
ACTIVE COMPARATORThe 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
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- Ministry of Health, Francecollaborator
Study Sites (14)
Lyon University Hospital
Lyon, Bron, 69677, France
Angers University Hospital
Angers, 49933, France
Brest University Hospital
Brest, 29200, France
Dijon University Hospital
Dijon, 21079, France
Grenoble University Hospital
Grenoble, 38000, France
AP-HM
Marseille, 13005, France
Montpellier University Hospital
Montpellier, 34295, France
Nancy University Hospital
Nancy, 54511, France
AP-HP, La Pitié Salpétrière
Paris, 75013, France
Rennes University Hospital
Rennes, 35033, France
Saint-Etienne University Hospital
Saint-Etienne, 42100, France
Strasbourg University Hospital
Strasbourg, France
Toulouse University Hospital
Toulouse, 31059, France
Tours University Hopsital
Tours, 37044, France
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Probst
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 15, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
March 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share