Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator (START)
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| ClinicalTrials.gov Identifier: NCT03876600 |
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Recruitment Status : Unknown
Verified February 2019 by Nantes University Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pacemaker Ddd | Procedure: Replacement of permanent pacemakers for elective wear. | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 750 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator |
| Estimated Study Start Date : | April 2019 |
| Estimated Primary Completion Date : | April 2022 |
| Estimated Study Completion Date : | April 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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 |
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. |
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Active Comparator: 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 |
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. |
- 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.
- 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 [ Time Frame: on a time horizon of 5 years ]Annual and global net profit cost in € of different diffusion scenarios for ambulatory to replace conventional hospitalization.
- Evaluate and compare the rate of complications of different management within 6 months after the intervention in both arms. [ Time Frame: on time horizon of 6 months ]Complication statement requiring a rehospitalization with reoperation. This objective is assessed by the complication statement requiring rehospitalization without reoperation and complication with not requiring rehospitalization.
- Evaluate the ambulatory failure rate [ Time Frame: during all the study, during 30 months. ]Ambulatory failure rate. It is a ratio of the number of ambulatory visits converted to conventional hospitalization and the total number of ambulatory visits.
- Evaluate and compare patients satisfaction between intervention and hospital management in both arms [ Time Frame: during hospitalization, during 2 days ]Satisfaction with the intervention and management at the hospital with questionnaire
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876600
| Contact: Vincent Probst | 0240165093 | vincent.probst@chu-nantes.fr | |
| Contact: Imen Fellah | 0240165102 | imen.fellah@chu-nantes.fr |
| France | |
| Lyon University Hospital | |
| Lyon, Bron, France, 69677 | |
| Contact: Philippe Chevalier philippe.chevalier@chu-lyon.fr | |
| Principal Investigator: Philippe Chevalier, PUPH | |
| Angers University Hospital | |
| Angers, France, 49933 | |
| Contact: Jean-Marc Dupuis jeanmarc.dupuis@chu-angers.fr | |
| Principal Investigator: Jean-Marc Dupuis, PH | |
| Brest University Hospital | |
| Brest, France, 29200 | |
| Contact: Jacques Mansourati jacques.mansourati@chu-brest.fr | |
| Principal Investigator: Jacques Mansourati, PUPH | |
| Dijon University Hospital | |
| Dijon, France, 21079 | |
| Contact: Laurent Gabriel gabriel.laurent@chu-dijon.fr | |
| Principal Investigator: Laurent Gabriel, PUPH | |
| Grenoble University Hospital | |
| Grenoble, France, 38000 | |
| Contact: Pascal Defaye pdefaye@chu-grenoble.fr | |
| Principal Investigator: Pascal Defaye, PUPH | |
| AP-HM | |
| Marseille, France, 13005 | |
| Contact: Jean-Claude Deharo eanclaude.deharo@ap-hm.fr | |
| Principal Investigator: Jean-Claude Deharo, PUPH | |
| Montpellier University Hospital | |
| Montpellier, France, 34295 | |
| Contact: Jean-Luc Pasquié jl-pasquie@chu-montpellier.fr | |
| Principal Investigator: Jean-Luc Pasquié, PUPH | |
| Nancy University Hospital | |
| Nancy, France, 54511 | |
| Contact: Nicolas Sadoul n.sadoul@chru-nancy.fr | |
| Principal Investigator: Nicolas Sadoul, PUPH | |
| AP-HP, La Pitié Salpétrière | |
| Paris, France, 75013 | |
| Contact: Estelle Grandjbach estelle.gbk@gmail.com | |
| Principal Investigator: Estelle Grandjbach, PH | |
| Rennes University Hospital | |
| Rennes, France, 35033 | |
| Contact: Philippe Mabo philippe.mabo@chu-rennes.fr | |
| Principal Investigator: Philippe Mabo, PUPH | |
| Saint-Etienne University Hospital | |
| Saint-Étienne, France, 42100 | |
| Contact: Antoine Da Costa antoine.dacosta@univ-st-etienne.fr | |
| Principal Investigator: Antoine Da Costa, PUPH | |
| Strasbourg University Hospital | |
| Strasbourg, France | |
| Contact: Laurence Jesel laurence.jesel@chru-strasbourg.fr | |
| Principal Investigator: Laurence Jesel, PH | |
| Toulouse University Hospital | |
| Toulouse, France, 31059 | |
| Contact: Pierre Mondoly mondoly.p@chu-toulouse.fr | |
| Principal Investigator: Pierre Mondoly, PH | |
| Tours University Hopsital | |
| Tours, France, 37044 | |
| Contact: Dominique Babuty d.babuty@chu-tours.fr | |
| Principal Investigator: Dominique Babuty, PUPH | |
| Principal Investigator: | Vincent Probst | Nantes University Hospital |
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT03876600 |
| Other Study ID Numbers: |
RC18_0034 |
| First Posted: | March 15, 2019 Key Record Dates |
| Last Update Posted: | March 15, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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pacemaker replace for elective wear french context cost-utility analysis |
prospective multicentric randomized study |