This study is aimed at optimizing the bridge between medical curative care and care that comes from the social domain, for children and adolescents. The primary goal is to offer the best fitting care to children with psychosocial- and social…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
sociale en psychosociale problematiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study there are two primary outcome measures: parental/children*s*
satisfaction and throughput.
Parental/children*s* satisfaction
One primary outcome measure is parental/children*s satisfaction with the new
working method. A questionnaire that is regularly used in youth healthcare as
an indicator for client satisfaction is the *Exit questionnaire youth and
parenting help*.
The *Exit* questionnaire is a short validated questionnaire with a separate
version for parents and children aged 12 years and over. It is the only
questionnaire with an item concerning *whether a client can go on without
help*, which is an important indicator of the effect of the intervention in our
study. In the current research proposal, the *Exit* questionnaire will be used
to measure parental/children*s satisfaction with the assistance they received
during the study. Extra questions will be added to the questionnaire to
evaluate the process of care.
The *Exit* questionnaire will be completed at two different moments:
immediately after completing the intervention (intervention group)/three months
after the first consultation with the pediatrician (control group) and three
months after completing the intervention (intervention group)/six months after
the first consultation with the pediatrician (control group). De measurements
in the control group, three and six months after the first consult with the
pediatrician are based on the mean expected time that is necessary to accompany
the child to the best fitting care.
For both groups, the goal of the first measurement is to evaluate whether the
parents and children are satisfied with the care they received, directly after
finishing the care process. With the second measurement it is evaluated whether
this satisfaction continuous over time.
Throughput
The other primary outcome measure is the throughput (the time between the
reference by the pediatrician to the point of fitting *follow-up* care) of the
new working method compared to *care as usual*. With this outcome measure a
better insight is derived ofwhether care is fast and timely delivered. With
additional questions to the above mentioned *Exit* questionnaire we collect the
following information:
Intervention group:
- The period from the first consultation with the pediatrician to the first
consultation with the pediatric nurse. For this measurement a correction will
be made for the time that will be taken by the informed consent and
randomization procedure.
- The period from the first to the final consultation with the pediatric nurse.
Control group:
- The period from the first consultation with the pediatrician to the first
consultation with youth healthcare or the general practitioner. For this
measurement a correction will be made for the time that will be taken by the
informed consent and randomization procedure.
- The period from the first consultation with youth care/general practitioner
to follow-up care.
Secondary outcome
The pilot study showed that many problems the children face are related to the
way they are parented. Therefore we also to study (changes in) parental
feelings concerning parenting their children. In order to study this we use the
parenting stress questionnaire. This questionnaire is developed for parents
with children aged of 0 to 19 years, which makes it suitable for the purpose of
this study. The questionnaire will be completed at two moments: immediately
after inclusion and at the end of the intervention (intervention group)/3
months after the first consultation with the pediatrician.
Visual Analogue Scale and Strengths and Difficulties Questionnaire: parental
perspective
There is no single standard instrument that measures changes in problem
severity for children aged 0-19 years. Therefore we to use multiple instruments.
For children aged 0-2 years parents complete a *Visual Analogue Scale*(VAS) for
the subjects: crying, sleeping, eating and development. A VAS is a psychometric
instrument with which the problem severity can be measured. 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).
For children aged 2-19 years the parents complete a *Strengths and Difficulties
Questionnaire* (SDQ). The SDQ is a questionnaire with which the
social-emotional health of children can be measured. The SDQ total score shows
the severity of social-emotional problems the children suffer from. By use of
five subscales (behavioral problems, hyperactivity/attention deficit, problems
with peers, pro social behavior) it can be studied in which field problems
occur. 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.
Visual Analogue Scale: professional perspective
To get an impression of the perspective of the professional on (changes) in
problem severity, pediatricians complete a VAS at the first and control
consultation with the child. At the end of these consultations they give an
overall score for problem severity.
Other study parameters
Professionals
In this study we value the professionals (pediatric nurses, pediatricians)
experiences with the intervention. At months 8, 11 and 14 a focus group
interview will be held with these professionals in which the program integrity,
the efficiency and effectivity of the new working method, the collaboration
process and the total approach will be evaluated. In this way there will be
also an active knowledge exchange between different professionals and work
fields.
Intervention costs and structural funding
With this study we are able to give an indication of the costs involved with
the new working method. By use of qualitative analysis of a few cases the
activities of pediatricians, pediatric nurses and supporting staff will be
documented. In this way an overview of the variety in the cases can be given.
Where possible, the costs of the different activities will be documented. For
this purpose we use a cost manual (Hakkaart-van Roijen L, et al. Bijlage 1:
Kostenhandleiding: methodologie van kostenonderzoek en referentieprijzen voor
economische evaluaties in de gezondheidszorg. 2015.
https://www.zorginstituutnederland.nl). Costs of activities that are not
documented in this manual will be collected during interviews that will be held
with financial experts from the hospital, youth healthcare and the medical
advisor of het health insurance company. In assessing the healthcare costs a
differentiation will be made between costs for the municipality and the health
insurance company.
During the 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. The results from
the expert interviews will be used into the recommendations concerning the
costing of the new working method.
Background summary
In their diagnosis and care for children Dutch pediatricians face a wide
variety of problems. Beside biological problems they face social- and
psychosocial problems. The type of complaints within these problems varies. The
Dutch Society of Pediatrics distinguishes six main groups:
1) Somatic diseases which give rise to psychosocial problems
2) Psychosocial problems that play a role in the development and cure of
diseases
3) Somatic complaints that hide psychical problems
4) Development problems
5) Threatening of safety and health due to parental functioning
6) Specific referral because of psychical and social problems
According to the literature the incidence of the entire group of complaints
varies between 6.3% (Central Bureau of Statistics) and 10% (Dutch Society of
Pediatrics).
Because of the above mentioned complaints pediatricians feel the need to a more
intensive collaboration with youth healthcare. This need has become even
stronger since the decentralization of youth healthcare. Moreover, the
pediatricians that are involved in the working method of this study, expect
that the incidence of the above mentioned complaints is higher than described
by the Central Bureau of Statistics and Dutch Society of pediatrics. This
expectation is based on their experience with this study group.
From studies into collaborations between youth healthcare and hospitals, we
distinguish a few cooperation forms. From 2014 on doctors working in youth
healthcare have the possibility to directly refer children to specialized care.
Also there are initiatives in which pediatricians and doctors working in youth
healthcare have agreements concerning the transfer of information of children
with health risks. In addition there are examples of joint thematic meetings,
which encourage informal acquaintance, knowledge exchange and alignment of
referral patterns. It is expected that such collaborations, if implemented
correctly, contribute to the quality of care for children. However, at current
these collaborations are still limited in nature and scale and scarcely aimed
at making psychological support available in pediatrics. Finally, from
literature studies it appears that the collaboration between youth healthcare
and pediatrics is slow and difficult. Sauer et al. Showed that youth healthcare
and pediatrics have drifted apart in the last decades. He therefore pleads for
a different, integral model for the organization of care for children in which
both youth healthcare and pediatrics collaborate in patientcare, education and
research.
The Amphia hospital (a hospital with establishments in Breda, Etten-Leur and
Oosterhout, the Netherlands) has started with an integrated model of care for
children with complaints in which social and psychosocial factors are involved.
In this model there is an intensive collaboration between pediatricians and
pediatric nurses. Since August 2015, pediatric nurses are seconded at the
pediatric outpatient clinic during one shift per week. They are in close
collaboration with children and their parents, pediatricians and other
professionals in the youth- and social domain. In this way they are the linking
pin between pediatrics and social domain.
The purpose of this working method is to accompany children with (psycho)social
problems to the best fitting support in a faster way than can be done according
the regular route. From the evaluation of a pilot study that was performed in
2016 there are indications that by the timely addition of the pediatric nurse
and the quick reference to the best fitting support, worsening of problems can
be prevented. The next step in the scientific foundation of this working method
is to study the effectivity in terms of children*s and parental satisfaction
with the intervention as well as the efficiency in terms of shortening the
throughput time to the best fitting support.
Study objective
This study is aimed at optimizing the bridge between medical curative care and
care that comes from the social domain, for children and adolescents. The
primary goal is to offer the best fitting care to children with psychosocial-
and social problems by a direct collaboration between pediatric nurses and
pediatricians at the outpatient clinic. It is expected that by this
collaboration, the throughput time to the best fitting care can be shortened
and children and parents become more satisfied with the entire process. In
addition it is expected that this working method contributes to the reduction
in psychosocial- and social problems in children in the long-term. The
secondary goal of this study is to gather insight into the costs of the new
working method and the way this working method can be funded on a regular base.
In this study the goals will be evaluated comparing the added value of the new
working method at process- and effect level to *care as usual*. The evaluation
will be performed following the next research questions:
Primary questionnaires:
* Are parents/children from the intervention group more satisfied than
parents/children that received *care as usual*?
* What are the effects of the intervention (the new working method), in terms
of throughput time in comparison with *care as usual*?
Secondary questionnaires
* How do involved professionals experience the process (effectivity and
efficiency) of the new working method in comparison to *care as usual*?
* How and where can the intervention be improved?
* Is there (from the perspective of the professional and the parents/children a
difference in the development of problem severity in children that received the
intervention compared to children that received *care as usual*?
* Is there (from the perspective of the parents) a difference in the
development of parenting stress in families that received the intervention
compared to families that received *care as usual*?
* What are the considered costs from the intervention and how can this be
funded on a regular base?
Study design
As mentioned before this study is aimed at optimizing the bridge between
medical curative care and care that comes from the social domain, for children
aged 0-19 years. The primary goal is to offer fitting care to children with
social- and psychosocial problems by a direct collaboration between pediatric
nurses and pediatricians at the outpatient clinic. It is expected that by this
collaboration, the throughput time to the best fitting care can be shortened
and children and parents become more satisfied with the entire process. In
addition it is expected that this working method contributes to the reduction
in social- and psychosocial problems in children in the long-term.
Because of the relatively short duration of the study (2 years) it is yet not
possible to study the effectiveness of the ultimate goal, lowering problem
severity. However parental/children*s satisfaction with the new working method
is indicative for the eventual effectivity of the care received. Therefore one
the primary outcome measures of this study is parental/children*s satisfaction
with the new working method. The other primary outcome measure is the
throughput (the time between the reference by the pediatrician to the moment
the best fitting *follow-up* care) of the new working method compared to *care
as usual*.
This study is directed to demonstrate effects as well as to understand these
effects. The best fitting design to answer the research questions is a
randomized controlled trial (RCT).The argumentation for this is as follows:
We study an experimental intervention, the new working method in the Amphia
hospital. The intervention is performed with an experimental group
(intervention group) which is compared to a group that receives *care as
usual* (control group). To assure that by the start of the study there are no
(prognostic) differences between the groups which may influence the results,
the children will be randomly allocated to the intervention- or control group.
The pediatricians as well as the researchers cannot influence the randomization
process.
The content and execution of the study will be monitored by the researchers. In
this way it is possible to perform a process evaluation in parallel to the
effect evaluation. The process evaluation reveals insight in the question
whether the new working method works, whether this method shows unexpected
outcomes and how and where this method can be improved.
Intervention
Intervention
The intervention consists of 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.
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. 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. If 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 the child visits the
pediatrician for a control consultation. This consultation is not part of the
intervention, but necessary for the scientific study.
Whenever the child suffers from somatic problems which need attention of a
pediatrician, the pediatrician takes care of these problems.
*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.
Study burden and risks
The study is non-invasive with respect to diagnostics and treatment. Medical
treatment will not be denied or postponed and it does not involve medical
risks. The study is an evaluation of a possibility to offer psychosocial care.
Nevertheless, whenever a child suffers from a serious adverse event (SAE), this
will be reported immediately to the employer A. van der Zijden, principal of
GGD West-Brabant, and to the pediatrician A.A.P.H. Vaessen-Verberne, Amphia
Hospital, Breda. The employer reports the SAE by the web portal
*Toetsingonline* to the METC Brabant within seven days after she has taken
knowledge of an SAE that resulted in the death or a life-threatening situation
of a child that is included in the study. This report will be followed by an
initial report within eight days. All other SAEs will be reported within a
period of a maximum of 15 days after the employer has taken knowledge of the
SAE. In case of a SAE that doesn*t need to be reported directly to the
employer, this SAE will be reported to the pediatrician A.A.P.H.
Vaessen-Verberne, Amphia hospital, Breda.*
Doornboslaan 225-227
Breda 4816CZ
NL
Doornboslaan 225-227
Breda 4816CZ
NL
Listed location countries
Age
Inclusion criteria
All children, aged 0-19 years, who visit the outpatient clinic of the Amphia hospital from June 2017 to February 2018, and suffer from the following problems are eligible for the study:
1. Somatic diseases which give rise to psychosocial problems
2. Psychosocial problems that are involved in the development and cure of disease
3. Somatic complaints that hide psychic problems
4. Problems in development
5. Threat of safety and health as a result of parental functioning
6. Reference because of psychic and social problems.
Prior to the consultation with the pediatrician, the children will be randomized to the intervention or control group. 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 criteria
Whenever a child suffers from serious psychiatric problems or (complex) medical problems which needs immediate intensive care, the child will not be included. There can be two forms of urgency:
1. Acute care because of an other form of specialized medical care.
2. Acute care which needs extra assistance from the social domain.
whenever above mentioned problems present themselves during the studie, the child will be excluded from the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 26702 |
CCMO | NL61202.028.17 |