Family-centered Round in Neonatology (VINCI)

April 15, 2021 updated by: University Hospital, Brest

Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession

Description

Parents Group:

Inclusion Criteria:

  • French speaking
  • voluntary to participate
  • parents of an hospitalized newborn

Exclusion Criteria:

  • not fluent in French speaking
  • mental health problems

Professional group:

  • any staff member
  • voluntary to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parents
parents of hospitalized children, speaking and understanding enough French, not presenting psychiatric disorders, voluntary to participate in focus groups
Other: Qualitative focus group
A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.
Professionals
Nurses, assistant nurses, psychologist, physiotherapist, physicians, residents and fellows
Other: Qualitative focus group
A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience of participating to a Family-Centered Care (FCR)
Time Frame: 1 day during the last week of their newborn 'hospitalisation
Qualitative focus group interview performed at one occasion where the parent describes the experience of the FCR
1 day during the last week of their newborn 'hospitalisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience of staff members in participating to a (FCR)
Time Frame: 1 day after 3 months of FCR experience
Qualitative focus group interview performed at one occasion where the staff members describes the experience of the FCR
1 day after 3 months of FCR experience

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Jacques Sizun, University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VINCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity

Clinical Trials on Qualitative focus group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe