Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06258655 |
| Other study ID # |
SA332962 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2021 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Turku |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overall aim of the study is to implement an evidence-based intervention called 'Close
Collaboration with Parents' in Estonian neonatal units. The goal of the intervention is to
educate the whole multi-professional NICU staff and promote a positive change in the
family-centered care culture of the units. Thus, the first aim of the study is to implement
the intervention in an Estonian NICU context, in three hospitals, and study the fidelity of
the intervention. More precisely, the study questions are whether adaptations are needed for
the successful implementation of the intervention in the Estonian context and how feasible
are the used implementation strategies. Secondly, the aim is to study the effectiveness of
the Close Collaboration with Parents intervention in this context by using a
quasi-experimental, pre-test - post-test, study design. The questions are whether the
implementation of the intervention in the Estonian setting will result in positive effects
such as 1) an improved development environment for the infants during hospital stay (less
noise, more parental speech, and more parent-infant physical closeness), 2) intensified
parental bonding to the infant, and 3) increased parental confidence and emotional well-being
at the time of discharge from hospital.
Description:
Materials and Methods: Design A quasi-experimental, before and after intervention, design is
used to test the effect of the intervention, where the impact mechanisms are treated as
mediators of the change.
Sample: The subjects are employees of five neonatal units of three Estonian hospitals
participating in the Close Collaboration with Parents intervention (hereinafter: staff) and
newborns cared for in the units and their parents (hereinafter: families). Three of the units
are at Tallinn: West-Tallinn Maternity Hospital (NICU and neonatal unit), the Department of
Anesthesiology and Intensive Care (PICU/level IIIB), and the Department of Neonatal and
Infant Medicine (NICU/level II) at the Children's Hospital. Another two units are located in
Tartu University Hospital: the Department of Neonatal and Pediatric Intensive Care (PNICU,
level IIIC) and a step-down unit (level II).
Families are recruited during a four-month period before and after the intervention, with the
aim to recruit at least 50 families per participating hospital in both periods. Some newborns
may be treated in a different hospital or in different units of the same hospital. In the
case of a transfer, the family is asked to fill in only the Family Center questionnaire if
the newborn has been in that unit for more than 72 hours.
A log will be kept of all infants discharged home from the unit i.e. to evaluate drop-out
rate and biases. The log includes the patient's gestational age, birth weight, diagnosis,
type of feeding at discharge, and length of hospital stay. If there is missing information in
the log, it is completed with the information from the medical records. A log is also kept to
follow the units' restrictions related to Covid-19 and concerning family visitation and
participation policies.
Outcomes:
The fidelity is analyzed by tracking the participants' behavior in the e-learning module with
analytic software, such as Google Analytics, Hotjar, and Vimeo. The participants are informed
about this and they are asked for their written consent and agreement when entering the
module for the first time. Furthermore, a log is kept about the practices the mentors are
carrying out with their colleagues in the units.
Staff outcomes Background questionnaire A questionnaire is used to collect background
information on staff members Collaboration competence questionnaire A questionnaire is used
to assess the collaboration competence of the staff at the beginning of the intervention, in
the middle of the implementation, and at the end. The questionnaire is specifically created
to assess competencies that are relevant to the Close Collaboration with Parents training
program. The questionnaire includes 21 questions that are evaluated with a scale from 1 to 10
(1=not competent at all, 10=extremely competent). If the question does notably the daily work
role of the professional option, "Doesn't belong to my role" can be used.
The reflective thinking The level of reflective thinking of the staff is measured using the
Reflective Thinking Measure. The 16-question measure determines whether an individual engages
in reflective thinking and to what extent s/he does that. The questions are answered with
options varying from strongly agree, which is scored as 5, to strongly disagree, which is
scored as 1. The 16 questions form four factors: 1) Habitual Actions, 2) Understanding, 3)
Reflection, and 4) Critical reflection. The structural validity of the scale has been tested
on healthcare professionals and it has been shown to be good.
The level of reflective thinking is also assessed with questions related to a fictitious
case. The case represents a so-called 'critical incident' that the staff is asked to describe
from three perspectives: (a) how they would normally act in a similar situation in their
unit; (b) a general meaning and reflect how the general meaning resonates with their own
experience; and (c) potential new ways of acting in the situation that would provide better
support for the family The FCC care provision The perception of multi-professional staff
members on parent support they have given that day is measured with DigiFCC web questions.
The question will reflect the staff's point of view on the support provided for parents in
the following dimensions: 1) active listening, 2) parent participation in infant care, 3)
individualized parent education, 4) parent participation in decision-making, 5) the parent
trust staff in infant care, 6) the staff feel the parents trust them in infant care, 7)
participation in medical round/medical care decision making, 8) information sharing, and 9)
emotional support. Staff members answer the questions through a website that is always open
on the research computer in the unit. Every staff member (regardless of qualifications)
working in the participating units is asked to answer a daily question through a website
after each work shifts for a 3-month period. There are 9 questions that are randomized in
3-question blocks. Answers are numbers from 1 to 5 or 0 if the staff member hasn't been
working with the parents on that shift or didn't participate in the medical round.
Regarding the same 4-month period, the researcher/administrator collects the number of
nursing staff working shifts in the unit to calculate the response rate. The research will
create a questionnaire for each unit through the Master account website. The responsible
researcher will have access to the research account to collect the answers.
Family outcomes Infant-parent background questionnaire A questionnaire is used to collect
background information on infants/parents Parents' depressive symptoms The depressive
symptoms of parents are measured with Edinburgh Postnatal Depression Scale (EPDS). The
10-question EPDS is a valid method to measure depressive symptoms both in mothers and
fathers. The 10-question scale includes symptoms such as insomnia, mood, tearfulness, and
thoughts of self-harm. The scale asks how the parent has felt during the previous week. The
parents rate each question on a scale from 0 to 3. The EPDS is easy to administer and has
high sensitivity as a screening tool.
Parent's anxiety symptoms The anxiety symptoms of the parents are assessed with State and
Trait Anxiety Inventory (STAI). State anxiety is an emotional reaction that varies from one
situation to another, whereas trait anxiety is a personality characteristic. The STAI
measurement provides separate scores for both types of anxiety. There are 20 questions about
state anxiety that are rated with a 4-point scale (1=not at all, 4=very much) and 20
questions about trait anxiety that are also rated with a 4-point scale (1=almost never,
4=almost always). The recommended cut-off for postnatal anxiety measured with STAI-S is
34/80.
The research assistant will calculate the parent's scores of EPDS and STAI-S when the
questionnaires are returned. She informs the responsible researcher of the unit if the total
score of the EPDS is >12 or if the parent has suicidal thoughts and if the total score of
STAI-S is >33.
Parenting self-efficacy scale Parenting self-efficacy is measured Perceived Maternal
Parenting Self-Efficacy (PMP S-E) instrument. The PMP S-E instrument consists of 20 items
(scoring ranges 20-80) with four subscales: 1) care-taking procedures, 2) evoking behaviors,
3) reading behaviors or signaling, and 4) situational beliefs. The items are rated with a
four-point Likert scale ranging from 'strongly disagree' (score 1) to 'strongly agree' (score
4). The PMP S-E tool is a psychometrically robust, reliable, and valid measure of parenting
self-efficacy in mothers of relatively healthy hospitalized preterm neonates.
Parent's readiness for discharge The readiness for discharge is measured with the Readiness
for Hospital Discharge Scale (RHDS). The questionnaire includes 23 items. Four attributes of
readiness for discharge are measured within the subscales: Personal Status (7 items),
Knowledge (7 items), Coping Ability (4 items), and Expected Support (5 items). Answers are on
a 10-point scale from 0 to 10 (not at all - totally). The RHDS has been shown to be a
reliable and valid measure of patients' perception of readiness for discharge.
Parent's perceived FCC The parent participation and the support parents feel they receive
from the staff is measured using a questionnaire modified from DigFCC SMS questions. The
questionnaire includes 9 questions covering the following aspects of staff support 1) active
listening, 2) parent participation in infant care, 3) individualized parent education, 4)
parent participation in decision-making, 5) the parent trust staff in infant care, 6) the
parent feel the staff trust them in infant care, 7) participation in medical round/medical
care decision making, 8) received information, and 9) emotional support. They are asked to
answer the question with the Likert scale from 1 to 7 (1=not at all-7=very much; 0= if they
did not visit the unit).
Data management The investigators will utilize REDcap (Research Electronic Data Capture) for
data transfers from Estonia to Finland and for data storage. REDcap is an electronic tool for
data collection that is provided from the server facilities owned and operated by the
University of Turku IT Services, which also means all data collected to the system is stored
and kept at the University of Turku. When the data is stored in the online file storage of
Turku University it is automatically copied to three independent servers that also function
as data backup systems.
Data security description:
- Centralized administration by separate administration accounts and compartmentalized
user privileges
- Use of current and reliable hardware, and software which is updated continuously
- Centralized identity management (IDM)
- Locally administered industry-standard network infrastructure and services
- Common server platforms with minimal tailoring
- Continuous monitoring of network traffic patterns and service statistics
- Widely deployed security software and other monitoring tools The principal investigator
(PI) controls access to the data. The co-researchers can approach the PI to request
access to the data. The PI will apply to the University of Turku IT Services to provide
the access to the online storage. If a co-researcher is not working at the University of
Turku, the PI can ask the IT services to give that person a visitor status and, thereby,
access to the online file storage. All new users are identified using government-issued
identification documents or by citizens' identification and payment service. The IP will
keep a record of those who have active access to the data.
All the data will be handled anonymously. The participants will get an ID code that is used
when data is stored and analyzed. The recruitment log of the parents and staff members are
used to undo the ID codes and, therefore, they are kept separately from the data files. The
analytic software (Google Analytics, Hotjar, and Vimeo) also track anonymously participants'
behavior on the e-learning module's website. The personal details (password, email, etc) are
not recorded and the IP addresses are anonymized by cutting out the last few digits, so only
the rough geographical area of access to the e-learning module is identified. The logs and
all the data will be destroyed five years after the last publication of the data.
Ethical considerations Ethical approval for the study protocol was given by the Research
Ethics Committee of the University of Tartu on the 10th of February 2021 (no: 3331T-21).
Written informed consent will be obtained from each staff member and parent before study
participation. The analytic software (Google Analytics, Hotjar, and Vimeo) will be activated
only after consent has been obtained from a participant. The application for ethics includes
an opportunity to complete the information received from the parents (infant and family
characteristics questionnaire) using patient medical records.
