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Early Postnatal Discharge in a French Perinatal Network (SORPRISE)

Primary Purpose

Pregnancy Complications Nos, Labor/Delivery Problems Nos, Vitality; Newborn

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multi-pronged program to improve early postpartum discharge
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Complications Nos focused on measuring patient discharge, hospital readmission, postnatal care, Home Care Services, Cost-Benefit Analysis, Personal satisfaction, Community Care Networks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

"1" low risk mothers ith uncomplicated pregnancy and birth defined as

  • lack of mental disability
  • lack of referred problems about mother to infant bonding
  • lack of precarious state
  • vaginal delivery without bleeding more than 500cc
  • lack of postpartum complications during hospitalization

"2" low risk baby defined as

  • singleton
  • gestational age >= 38 weeks
  • apgar score > 7 at 5 minutes life
  • normal weight expected for gestational age
  • lack of infection, or jaundice

Exclusion Criteria:

  • person deprived of liberty
  • person who does not speak French
  • person not covered by health insurance

Sites / Locations

  • Clinique des Cèdres
  • Clinique Mutualiste
  • Hopital Couple Enfant
  • Clinique Belledonne
  • CH Voiron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Phase 1 (before multi-pronged program)

Phase 2 (after multi-pronged program)

Arm Description

400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of a French perinatal network consecutively, whatever the duration of their hospital stay

400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of the same French perinatal network 3 months after the intervention (introduction of the multi-pronged program) consecutively, whatever the duration of their hospital stay

Outcomes

Primary Outcome Measures

rate of early discharge
number of early postnatal discharges (2-72 hours after delivery) among eligible population: i.e. low risk mothers and low risk newborns, before and after a major change in the organization of integrated managed care, in a perinatal network. The rate of emergency medical consultations and or re-hospitalization for mothers and babies will be recorded among women who had an early postnatal discharge compared to women with standard hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess the duration of hospitalization in the maternity ward and to report any emergency medical consultation or rehospitalization after discharge of mother and baby.

Secondary Outcome Measures

rehospitalization or emergency visits for mothers and babies
number of rehospitalization or emergency medical visits for mothers and/or babies observed during the first 15 days after delivery, among the eligible population i.e. low risk mothers and low risk newborns, whatever the duration of their hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess type of hospital discharge (early or standard), and if necessary, report any emergency medical consultation or rehospitalization after hospital discharge for baby and/or mother
continuation of breastfeeding
number of women continuing breastfeeding beyond 60 days postpartum, before and after intervention. Every women who had early postnatal discharge will have a phone interview 60 days after delivery to assess the duration of breastfeeding
maternal satisfaction
maternal satisfaction based on adapted WOMen's views of Birth Postnatal Satisfaction Questionnaire mean scores (WOMBSQ questionnaire). The WOMen's views of Birth Postnatal Satisfaction Questionnaire (WOMBSQ questionnaire) asks about quality of postnatal care provided both in the maternity ward during the hospital stay, and at home by the midwife during 2-4 days follow-up. The scores will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the WOMen's views of Birth Postnatal Satisfaction Questionnaire form (on line or by post) 45 days after delivery
maternal depression
postnatal depression defined as a score higher than 12 on Edinburgh Postpartum Scale (EDPS) among women with early discharge from hospital will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the EDPS form (on line or by post) 45 days after delivery to assess maternal depressive symptoms
maternal quality of life
mean scores of Short-Form Health Survey (SF-12) among women with early discharge from hospital to be compared before and after intervention. Every women who proceeded to early postnatal discharge, will be asked to complete SF-12 form (on line or by post) 45 days after delivery to asses maternal quality of life
satisfaction about the medical feed back after discharge
mean scores of satisfaction adapted from the questionnaire Satisfaction of the Patients at the Hospital in Region Aquitaine-Committee of evaluation 2009(SAPHORA-Committee of evaluation 2009) French form, about the quality of medical feedback after early discharge from hospital to be compared before and after intervention. Every community practitioner (general practitioner, paediatrician, midwife) who saw the mothers and baby during follow-up will be asked to complete a form , 45 or 60days after delivery to assess the quality of medical information given by the hospital to community practitioners, and the quality of the discharge summary
cost effectiveness
cost of early discharge, that is cost of hospitalization and cost of follow-up and cost of readmission to be compared with cost of routine hospitalization and eventual readmission for healthy mothers and babies, assessed during phone interviews with mothers
associated factors to early discharge
information about early discharge during pregnancy, socioeconomic factors, medical antecedents, type of prenatal follow-up, assessed by phone call interview with every eligible mother
compliance to french guidelines
compliance to French guidelines edited in 2014 about the organization of early discharge and home follow-up to be assessed by phone interview with midwife who performed home follow-up of mothers after early discharge
mother-infant bonding
mean Mother to Infant bonding scale (MIB score ) at 15 days after delivery, among eligible population that is low risk mothers and low risk newborns, whatever the duration of hospital stay. Every eligible women will get a form (on line or by post) 15 days after delivery to assess the feelings of mother towards their new baby. Mothers will be asked during the phone interview how they would like to complete this form : paper sent by post, or on line.

Full Information

First Posted
August 29, 2014
Last Updated
March 23, 2016
Sponsor
University Hospital, Grenoble
Collaborators
Réseau Périnatal Alpes-Isere
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1. Study Identification

Unique Protocol Identification Number
NCT02298569
Brief Title
Early Postnatal Discharge in a French Perinatal Network
Acronym
SORPRISE
Official Title
Early Postnatal Discharge in a French Perinatal Network
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Réseau Périnatal Alpes-Isere

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.
Detailed Description
In March 2014, the French Health Authorities edited new guidelines about early discharge after delivery. Early discharge is defined as a discharge during the 72 hours following vaginal delivery of low-risk mothers and their healthy newborn. These guidelines defined the conditions of eligibility for early discharge for mothers and babies, and the different criteria of their follow-up at home by midwives . The average length of stay following normal delivery is higher in France than in other European countries: eg : 4.3 days in France vs 2.2 days in Sweden (OECD indicators 2011) On the other hand, according to an investigation conducted by a patients association, 38% women declared that they felt that their hospitalization was too long after their baby's birth, but their request for a shorter stay had not been taken into account by hospital caregivers. The investigators hypothesis is that the rate of early discharge could be increased by a multi-pronged program coordinated in a perinatal network, and could improve quality of postpartum care, and women's satisfaction. The "Réseau Périnatal Alpes Isère" is a perinatal network located in French Alps region. Its purpose is to coordinate 5 maternity services an organization of midwives providing pre and postnatal home care, for about 10000 births annually. In 2010, according to the hospital database provided by the Medical Information Systems Program, early discharge concerned only 4.1% of mothers between 0 and 48 hours after delivery . At the same time, 65% of women could be considered as at low risk, considering they gave birth to a healthy singleton, born after 38 weeks of gestation by vaginal delivery. This rate is not precise, in view of the lack of availability of documented rate of non-eligibility for early discharge such as non- eutrophic babies, or adverse events during postpartum and the neonatal period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications Nos, Labor/Delivery Problems Nos, Vitality; Newborn
Keywords
patient discharge, hospital readmission, postnatal care, Home Care Services, Cost-Benefit Analysis, Personal satisfaction, Community Care Networks

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 (before multi-pronged program)
Arm Type
No Intervention
Arm Description
400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of a French perinatal network consecutively, whatever the duration of their hospital stay
Arm Title
Phase 2 (after multi-pronged program)
Arm Type
Experimental
Arm Description
400 low-risk mothers having given birth without any complication to a healthy newborn are to be recruited in the 5 maternity wards of the same French perinatal network 3 months after the intervention (introduction of the multi-pronged program) consecutively, whatever the duration of their hospital stay
Intervention Type
Behavioral
Intervention Name(s)
multi-pronged program to improve early postpartum discharge
Other Intervention Name(s)
team integration and culture change, transition optimisations, implementation of best practices
Intervention Description
Better team integration and changes to promote interprofessional collaboration and communication between healthcare providers involved in pre- and post-natal care in a perinatal network. Transition optimization: all involved healthcare professionals will complete a specific form during pregnancy and hospitalization to coordinate support safe process, and to improve quality transitions to outpatient midwives and pediatrician. A check-list will be completed by the mother to assess whether she agrees to early discharge and that she is aware of its conditions Implementation of best practices about early discharge after delivery to improve safety of early discharge particularly for neonates at risk (jaundice and dehydration).
Primary Outcome Measure Information:
Title
rate of early discharge
Description
number of early postnatal discharges (2-72 hours after delivery) among eligible population: i.e. low risk mothers and low risk newborns, before and after a major change in the organization of integrated managed care, in a perinatal network. The rate of emergency medical consultations and or re-hospitalization for mothers and babies will be recorded among women who had an early postnatal discharge compared to women with standard hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess the duration of hospitalization in the maternity ward and to report any emergency medical consultation or rehospitalization after discharge of mother and baby.
Time Frame
15 days after delivery
Secondary Outcome Measure Information:
Title
rehospitalization or emergency visits for mothers and babies
Description
number of rehospitalization or emergency medical visits for mothers and/or babies observed during the first 15 days after delivery, among the eligible population i.e. low risk mothers and low risk newborns, whatever the duration of their hospital stay. Every eligible women will have a phone interview 15 days after delivery to assess type of hospital discharge (early or standard), and if necessary, report any emergency medical consultation or rehospitalization after hospital discharge for baby and/or mother
Time Frame
from postnatal discharge up to 15 days after delivery
Title
continuation of breastfeeding
Description
number of women continuing breastfeeding beyond 60 days postpartum, before and after intervention. Every women who had early postnatal discharge will have a phone interview 60 days after delivery to assess the duration of breastfeeding
Time Frame
60 days after delivery
Title
maternal satisfaction
Description
maternal satisfaction based on adapted WOMen's views of Birth Postnatal Satisfaction Questionnaire mean scores (WOMBSQ questionnaire). The WOMen's views of Birth Postnatal Satisfaction Questionnaire (WOMBSQ questionnaire) asks about quality of postnatal care provided both in the maternity ward during the hospital stay, and at home by the midwife during 2-4 days follow-up. The scores will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the WOMen's views of Birth Postnatal Satisfaction Questionnaire form (on line or by post) 45 days after delivery
Time Frame
45 days after delivery
Title
maternal depression
Description
postnatal depression defined as a score higher than 12 on Edinburgh Postpartum Scale (EDPS) among women with early discharge from hospital will be compared before and after the intervention. Every women who had early postnatal discharge, will be asked to complete the EDPS form (on line or by post) 45 days after delivery to assess maternal depressive symptoms
Time Frame
45 days after delivery
Title
maternal quality of life
Description
mean scores of Short-Form Health Survey (SF-12) among women with early discharge from hospital to be compared before and after intervention. Every women who proceeded to early postnatal discharge, will be asked to complete SF-12 form (on line or by post) 45 days after delivery to asses maternal quality of life
Time Frame
45 days after delivery
Title
satisfaction about the medical feed back after discharge
Description
mean scores of satisfaction adapted from the questionnaire Satisfaction of the Patients at the Hospital in Region Aquitaine-Committee of evaluation 2009(SAPHORA-Committee of evaluation 2009) French form, about the quality of medical feedback after early discharge from hospital to be compared before and after intervention. Every community practitioner (general practitioner, paediatrician, midwife) who saw the mothers and baby during follow-up will be asked to complete a form , 45 or 60days after delivery to assess the quality of medical information given by the hospital to community practitioners, and the quality of the discharge summary
Time Frame
45 - 60 days after delivery
Title
cost effectiveness
Description
cost of early discharge, that is cost of hospitalization and cost of follow-up and cost of readmission to be compared with cost of routine hospitalization and eventual readmission for healthy mothers and babies, assessed during phone interviews with mothers
Time Frame
15 days
Title
associated factors to early discharge
Description
information about early discharge during pregnancy, socioeconomic factors, medical antecedents, type of prenatal follow-up, assessed by phone call interview with every eligible mother
Time Frame
15 days
Title
compliance to french guidelines
Description
compliance to French guidelines edited in 2014 about the organization of early discharge and home follow-up to be assessed by phone interview with midwife who performed home follow-up of mothers after early discharge
Time Frame
15 days
Title
mother-infant bonding
Description
mean Mother to Infant bonding scale (MIB score ) at 15 days after delivery, among eligible population that is low risk mothers and low risk newborns, whatever the duration of hospital stay. Every eligible women will get a form (on line or by post) 15 days after delivery to assess the feelings of mother towards their new baby. Mothers will be asked during the phone interview how they would like to complete this form : paper sent by post, or on line.
Time Frame
15 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: "1" low risk mothers ith uncomplicated pregnancy and birth defined as lack of mental disability lack of referred problems about mother to infant bonding lack of precarious state vaginal delivery without bleeding more than 500cc lack of postpartum complications during hospitalization "2" low risk baby defined as singleton gestational age >= 38 weeks apgar score > 7 at 5 minutes life normal weight expected for gestational age lack of infection, or jaundice Exclusion Criteria: person deprived of liberty person who does not speak French person not covered by health insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudine MARTIN
Organizational Affiliation
RPAI (Réseau Périnatal Alpes Isere), CHU Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique des Cèdres
City
Echirolles
ZIP/Postal Code
38432
Country
France
Facility Name
Clinique Mutualiste
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hopital Couple Enfant
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
Clinique Belledonne
City
Saint Martin d'Hères
ZIP/Postal Code
38400
Country
France
Facility Name
CH Voiron
City
Voiron
ZIP/Postal Code
38506
Country
France

12. IPD Sharing Statement

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Early Postnatal Discharge in a French Perinatal Network

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