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The pediatric nurse: link between pediatrics and youth health care


- candidate number26702
- NTR NumberNTR6287
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2017
- Secondary IDs736200015 ZonMw
- Public TitleThe pediatric nurse: link between pediatrics and youth health care
- Scientific TitleThe pediatric nurse as linking pin between pediatrics and the social domain: is it effective and efficient?
- ACRONYMJIVES
- hypothesisThe deployment of the pediatric nurse as linking pin between pediatrics and the social domain, shortens the duration of referral to appropriate support for children with (psycho)social problems and it increases the satisfaction of parents and children with the care provided.
- Healt Condition(s) or Problem(s) studiedSocial problems, Psychosiocial problems, Interdisciplinary collaboration, Mental problems, Psycho-somatic problems
- Inclusion criteriaAll children, aged 0-19 years, who visit the outpatient clinic of the Amphia hospital from June 2017 to February 2018, and suffer from psycho(social) problems are eligible for the study:

During the consultation, the pediatrician checks whether the child is eligible for inclusion in the study. If a child is eligible, the pediatrician explains the study and hands over an informed consent form. At the moment a parent of the child or the child itself (age 16 and over) has signed the informed consent, the child is included in the study.
- Exclusion criteriaWhenever, at the moment of inclusion, the child is suffering from serious psychiatric problems or (complex) medical problems for which acute care is required, the child will not be included. There are two forms of urgency:
- Acute care concerning another form of specialized medical care
- Acute care which needs extra assistance from the social domain

Whenever these problems reveal themselves during the study, the child will be excluded from the study. It will be documented how many and for what reason children will be excluded from the study.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate30-apr-2018
- Target number of participants150
- InterventionsThe intervention comprises the procedure that started in 2015 at the Amphia hospital, Breda, The Netherlands. In this procedure, pediatric nurses act as the linking pin between pediatrics, Dutch Youth healthcare and youth counselors within the social domain.
Two pediatric nurses are present at the outpatient clinic of the Amphia hospital during one shift/week for the execution of the intervention. In addition as part of the intervention, they have the availability to pay visits to other locations (i.e. the clients home) during 1.5 day/week. The procedure starts at the moment a child (and its parents) consults a pediatrician. If it appears from the anamnesis by the pediatrician that the child suffers from problems in which (psycho)social factors are involved, the child can be considered for inclusion in the study. If so, the pediatrician explains the study to the child and its parents, hands them over the research information as well as an informed consent form. Once the informed consent form is signed, the child is included in the study and allocated by randomization to the intervention group, the child is referred to the pediatric nurse for (psycho)social problems. The pediatric nurse contacts the family by telephone within two weeks after the consultation with the pediatrician. In consultation with the child and the parents an appointment is made at the parents’ house or at the outpatient clinic. During this consultation the pediatric nurse clarifies the problem and together with the parents and the child she considers which care fits best to the child. This procedure can take several consultations. When necessary, the pediatric nurse connects the child to other professional authorities in the field as for example the infant welfare center (i.e. teaching in upbringing) or specialized youth assistance. When it becomes clear that the family is able to go on by itself or when they are transferred to another professional authority the pediatric nurse closes the contact after a written feedback to the family, the pediatrician and (with parental consent) the general practitioner and other professional parties involved. Three months after closing down the contact with the pediatric nurse there is a control consultation with the pediatrician. Whenever the child suffers from somatic problems which need attention of a pediatrician, the pediatrician takes care of this.

‘Care as usual’
For the control group the procedure starts with a consultation to the pediatrician as well. If it appears from the anamnesis by the pediatrician that the child suffers from problems in which (psycho)social factors are involved, the child can be considered for inclusion in the study. If so, the pediatrician explains the study to the child and its parents, hands them over the research information as well as an informed consent form. Once the informed consent form is signed, the child is included in the study and allocated by randomization to the control group, the child is offered ‘care as usual’. In this study ‘care as usual’ implies that the parents/child get the advice to contact youth healthcare or their general practitioner. Whenever the child suffers from somatic problems which need attention of the pediatrician, the pediatrician takes care of this. Six months after the consultation with the pediatrician there is a control consultation with the pediatrician.
- Primary outcomeParental and children’s satisfaction with the care provided (Exit questionnaire)
Parental and children’s satisfaction with the care provided is measured by use of the validated Youthand parental help questionnaire, Exit. The Exit questionnaire contains a parental and children’s (12 years and over version.

Throughput
The timespan between the first consultation with the pediatrician and the first contact with follow-up care, after the child is referred by the pediatric nurse
- Secondary outcomeParenting stress
Parenting stress and changes in parenting stress are measured by use of the parenting stress questionnaire.

Severity
Problem severity is measured from the parental and professional perspective.

Parental perspective
Parents complete a ‘Visual Analogue Scale’(VAS) for the subjects: crying, sleeping, eating and development for children aged 0-2 years. For children aged 2-19 years they complete a ‘Strengths and Difficulties Questionnaire’ (SDQ).

Professional perspective
To get an impression of the perspective of the professional on (changes) in problem severity, pediatricians complete a VAS. With this instrument they give an overall score for problem severity.

Other study parameters

Evaluation new working method
The professionals experiences with the intervention are valued to measure the program integrity, the efficiency and effectivity of the new working method, the collaboration process and the total approach.

Intervention costs and structural funding
To give an indication of the costs involved with the new working method qualitative analysis of a few cases are performed. Where possible, the costs of the different activities will be documented.

During interviews with experts from the health insurance company and youth healthcare it will be discussed how the new working method can be funded structurally and which factors have to be taken into account
- TimepointsThroughput
Intervention group: first consultation with the pediatrician, first consultation with the pediatric nurse, last consultation with the pediatric nurse.
Control group: first consultation with the pediatrician, first consultation with youth healthcare or general practitioner, last consultation with youth healthcare or general practitioner.

Parental and children’s satisfaction (Exit-questionnaire)
First measurement
Intervention group: immediately upon ending the intervention
Control group: Three months after the first consultation with the pediatrician
Second measurement
Intervention group: Three months upon ending the intervention
Control group: Six months after the first consultation with the pediatrician

Parenting stress
First measurement: immediately after inclusion
Second measurement: at the end of the intervention (intervention group)/ three months after the first consultation with the pediatrician (control group)

Problemseverity
Parental perspective VAS:
0-2 years: the VAS will be completed immediately after inclusion and end of the intervention (intervention group)/three months after the first consultation with the pediatrician (control group). 2-19 years: The SDQ will be completed immediately after inclusion and at the end of the intervention (intervention group)/three months after the first consultation with the pediatrician (control group).
Both parents and children aged 11 and over will complete this questionnaire.

Professional perspective
at the end of the first and control consultation with the child.

Evaluation new working method
At months 8, 11 and 14 a focus group interview will be held with professionals to evaluate the program integrity, the efficiency and effectivity of the new working method, the collaboration process and the total approach.

Intervention costs and structural funding
At the end of 2017/beginning of 2018 information concerning the costs will be collected and interviews with experts concerning structural funding of the new working method will be planned.
- Trial web sitewww.Trialregister.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProject manager and principal investigator S Kuiper
- CONTACT for SCIENTIFIC QUERIESCo-applicant and scientific advisor L.A.M. Van de Goor
- Sponsor/Initiator GGD West-Brabant
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN.A.
- Brief summaryDutch pediatricians are confronted with several problems in which (psycho)social factors are involved. Because of these problems pediatricians feel the need to a close cooperation with the Dutch Youth healthcare.

The Amphia hospital in Breda in the Netherlands has started with an integral model of cooperation concerning the care for children with these types of problems. Two pediatric nurses are present at the outpatient clinic of the Amphia hospital. They form the linking pin between pediatrics and the social domain. Purpose: Is this model of cooperation effective and is it of added value compared to usual care? Study design: Randomized Controlled Trial.

Study population: The study population concerns of children aged 0-18 years, in which (psycho)social factors are involved.
Intervention: The intervention is the new cooperation model at the outpatient clinic of the Amphia hospital. Whenever the anamneses of the paediatrician shows that the child suffers from (psycho)social problems, the study will be explained to the child and its parents and the research information as well as an informed consent form will be hand over by the paediatrician. Once the informed consent form is signed, the child is included in the study and allocated by randomization to the intervention group, the child is referred to the pediatric nurse for (psycho)social problems.If the child is suffering from somatic problems for which specialist help is necessary, these problems will be treated by the paediatrician. The children (and parents) in the intervention group will be contacted by the pediatric nurse. Together with the children and parents she considers what is necessary for the child. If necessary she transfers the children to other professional authorities. Children in the control group receive ‘care as usual’, which implies in this study that the parents/child get the advice to contact youth healthcare or their general practitioner

Primary study parameters: The primary study parameters are parental and children’s satisfaction with the care provided (Exit questionnaire) and the throughput from the first consultation to fitting care. Other study parameters are parenting stress and taxation of problem severity from the professional’s point of view.

Secondary study parameters:
The secondary study parameters are problem severity from a parental- (VAS: for children 0-2 years, SDQ: for children 2-19 years) and professional (VAS) perspective as well as costs involved in the new working method.

Record: May 8th 2017
- Main changes (audit trail)
- RECORD14-feb-2017 - 14-mei-2017


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