[2905-HP-QA.174]
Development of a methodology to assess the care burden for the children who require advanced medical care,
despite being highly functional
Results
Hirotoshi Maeda, M.D. 1), Izumi Iikura 2), Masahiro Ikari 3), Ikuko Tomomatsu, Ph.D. 4)1), 2), 3) Medical Incorporated Foundation Harutaka Kai
COI: This study was funded by the Ministry of Health and Labor Sciences Research Grants. [2018-2019]4) TOMO Lab LLC

Methods *chronological flow of data collection

Background

Pilot study: Video data collection (Max: 24 hours)

１）Neonatal mortality is sharply declining in Japan・Neonatal mortality rate (neonatal mortality / 1,000 birth) is sharply declining in Japan.
・Neonatal mortality rate in 2017 was 0.9 in Japan.
【Reference：Health and Labor Sciences Research Grants：201918009A】

２）Increasing number of the children who need advanced
medical care (C-NAMC) in Japan・The number of C-NAMC is rapidly increasing in Japan.
・The number of C-NAMC in 2019 was 20,155人 in Japan. The number was doubled over the past 14 years.
・As of C-NAMC, especially, the number of children who require ventilator management is increasing.
The number was 4,600. It is 17-fold over the past 14 years.

••••３）2 types of C-NAMC•••

Bedridden
children

They are conventionallyconsidered as severelydisabled.

Existing concept of severely
disabled children

There are public welfare supports for them.
There are also respite facilities, although thenumber is limited.
When the medical condition is stable, thesechildren do not need complex medical care.

Notbedridden
children
They are not bedridden, or not
intellectually disabled, and arein the category of new types ofdisabled children.
Existing public social and welfare system do notcover their supports and expenses.
Even though their medical condition is stable,
the requirements for their care are heavy (e.g.,
These children often remove the ventilator tubeby themselves.)
In addition, the number of respite facilities forthem is low.

Data collection period: May, 2019 – February, 2020
Survey forms were sent to 1,162 pediatric home-based patients, and 567 caregivers responded.
The time spent for home medical care was measured by self-reported Time Study.
Evaluation of the level of burden felt by main caregivers by questionnaire survey.
The risk relating to medical care at home were assessed by physicians

Data collection period: November, 2019 – June, 2020
Participants: (informed consents were obtained beforehand): Interview: 27 participants from 26 families / Video: 8 participantsfrom 8 families / Web questionnaire: 79 participants
Telephone interview / Face-to-face interview
Time study by using video recording
Questionnaire (participants: caregivers who have experienced cares both of bedridden C-NAMC and non-bedridden C-NAMC)

・[EP-110.624], this study NOT prove an increase in care burden with improvement of child’s physical ability, which
physicians and nurses are empirically feeling.
Motor function was classified into the following three levels: 1) bedridden, 2) not bedridden but unable to stay in sitting
position, and 3) not bedridden and able to stay in sitting position).
◆ There were no correlation between the time required for medical care and the level of motor function of patients (* r = 0.08, p=0.1).
◆ There was a weak negative correlation between the level of care-burden and the level of physical function of patients (* r =-0.2, p=0.19). The care burden tended to reduce as the level of motor function increased.

(1) Developing an assessment model for “Mimamori” by combining quantitative and qualitative
studies⚫ By combining multiple assessment methods, the weaknesses of individual evaluation methods were mutuallycomplemented.
⚫ Qualitatively, we focused on interviews with primary caregivers. The interview data was coded with two axes (medicalcare x child's behavior). The two-axes coding made it possible to analyze individual medical care separately.
⚫ We found that the burden and risk of each medical device differed.
⚫ The Video data demonstrated the overall picture of the burden of medical care with objective evidences.

Figure#2

2) unable to stayin sitting position

3) able to stayin sitting position

1) bedridden2) unable to stayin sitting position

3) able to stayin sitting position

The time-based study using the video data and self-reported questionnaire were not sufficient enough todemonstrate the increasing care burden with the improved child’s motor function which are perceived empirically byphysicians and nurses.⇒The development of New methods is needed.

Aim/ObjectiveThe purpose of is study is to demonstrate the increased burden on caregivers along with the improvement ofchild’s physical ability, which is known empirically to physicians and nurses.
For this purpose, we developed assessment methods for evaluating the level of “Mimamori: Watching-Over” ofwhich need becomes higher when the motor functions of C-NAMC (Children who Need Advanced Medical Care)
improve.
“Mimamori” : Watching Over”
Both at home and in-facilities, for non-bedridden C-NAMC, the risk of accidents, such as removing tracheal cannula or gastrostomy tube bythemselves, becomes higher than bedridden C-NAMC. Therefore, caregivers of such children always need to watch and check the medicaldevices to prevent accidents from occurring. This task increases the burden for caregivers. Physicians, nurses, and caregivers haveempirically known this fact. However, the increase of burden was not demonstrated with objective indices. Thus, services to support theburden of Mimamori were not included in the conventional disability welfare system.
Initially, we considered that the burden regarding Mimamori would be quantified by investigating the time and burden needed by primary
caregivers at home [No. 1]. However, this method alone was insufficient, except tube feeding (time for medical care and burden increased)
and tracheostomy (risk level increased). Therefore, in order to demonstrate the overall correlation between “the improvement of the bodyfunction of C-NAMC” and “the level of burden of caregivers,” a different approach was necessary.

Score

Ventilator management
Tracheostomy

88

Gastric tube feeding

5

Intestinal tube feeding

8⚫

The 'Mimamori' score is assessed based on therisklevel
whichmaycauseany
accidents/complications due to not-bedridden
condition (move hands and arms, turning,crawling and walking), intellectual disabilities(corresponding to below 6 years of age), andbehavioral disabilities of C-NAMC.

✓Not-bedridden condition: move hands and arms,turning, crawling, walking, and walking✓

Intellectual disabilities: cannot understand whathe/she should not do, intellectually less than 6years old✓

Behavioral disabilities: cannot behave well⚫

The basic score for medical care and Mimamori
score are assessed based on written opinion of
the attending physician.

Table#2"Mimamori“*Extract(Watching-Over)〇 Narrative of tube feeding
A child with a ventilator often uses nasal tube to be fed with milk. It is difficult to change the tube
when the child begins to be active. Recently, it‘s been difficult even at home. When the child isbedridden, he didn’t move much. It was fine, but now, I have to hold him down and hold his face[caregiver’s responses]. When the child refuses and resists [child’s behaviors], everything
becomes a little difficult. 【code: nutrition injection x refusing/resisting】〇 Narrative of tracheostomy cannula(When the tracheostomy cannula came out) I was already in a panic [Caregiver's response]: It
would be fine if I could put it in immediately after it came out, but it did not go in. I could not get itin, and it gets stuck. The child also started crying. My wife tried to put it in, but it wouldn't go inproperly. He could not speak, and could not cry out like a normal child when he is disturbed andwants the attention of parents. He knows that parents come to see him immediately if he tries topull it (cannula) out [child’s behavior]. 【code: tracheostomy cannula x pulling out by himself】■Medical Care ｘ2-axis code for each hypothesis
Hypo 1
Medical device/

Care burden

NewBase Score

Risk Assessment by physical ability
highmiddle

low2

10

Ventilator management

10Tracheostomy

820

Gastric tube feeding

820

Intestinal tube feeding

820*ExtractTable#3Discussion
In order to demonstrate the increase in the burden on caregivers along with the improvement of child’s physical ability (observed
empirically physicians and nurses), it was not enough to conduct a time study asking the primary caregivers about the duration of
medical care and subjective sense of care burden of medical care.
The reason for this is that the care burden for a child in medical care is not solely due to medical care. Relieving children to give
medical care, and to pay attention and watch (Mimamori) over the child's behaviors and activities, are important in order toeliminate risks arising with medical care.

Medical care（additional moves, time,labor)

Higher risk increases care

2 axes codes for Hypo 1

The first coding was done using only keywords expressing the child's moves. No significant results were obtained for the burden
and risk of different medical care and medical devices. Then, we reached to 2 axes coding which consists of 'medical care x child'sbehaviors'. The 2-axes coding demonstrated child’s behaviors as cause of the burden of caregivers (by even increasing theburden).

burdentracheostomy cannula

06ーtracheostomy cannula x act violently
tracheostomy cannula x pulling out by himself“C-NAMC care burden” Triangle Assessment Model which was developed in this study, has made it possible to reveal the actual
situation of 'Mimamori', which had been considered difficult to prove, and its assessment has become possible.

Ventilator x act violently
Ventilator x turning over014―

Ventilator x move hands and arms (remove)
Ventilator x move hands and arms (change settings ventilator)
Ventilator x walk or stand holding on to things-Video data analysis (confirmation/evidence)
Advantages• Grasp individuality and details• Visually confirm what happened, and minimize the variety of the quality of data obtained• Grasp events in objective and accurate way• Especially when it comes to understanding new events："Seeing is believing"• Data is not influenced by researchers’ ability of interview or the relationship between a
researcher and a participant.
Disadvantages• The number of samples could not be greatly increased, and it takes time to collect data
• Equipment is required.
• Burden on participants is high.
• Data may not be obtained depending on the installation conditions of the camera.

tube feeding138

nutrition injection x act violently

gastrosoma x crawl

nutrition injection x refusing / resisting

nutrition injection x turning overnutrition injection x move hands and arms (pulling tubes)

ED tube x turning overnutrition injection x walkED tube x refusing / resisting

Table#1３）Questionnaire survey: Not-bedridden C-NAMC-Interview (data coding)-Questionnaire survey
Advantages• Grasp individuality and details• By using seｍi-structured interview technique, interview data iscollected in terms of a same framework.
• Individual narratives are datalized, while retaining individuality.
• Grasp chronological changes• Grasp worries and burden of the subject which cannot be quantified.
Disadvantages• Interviewee may focus on his/her interests, interviewee’s subjective
perspective may be emphasized.
• Data is influenced by researchers’ ability of interview or therelationship between a researcher and a participant.
• The number of samples could not be greatly increased, and it takes
time to collect data.

2 axes codes for Hypo 2

tracheostomy cannula x pull

Ventilator

Qualitative/Quantitative Study

Figure#3

Prior to the coding of interview transcripts, the tentative findings of the video data analysis were referenced to set the following
hypotheses:
Caregiver needs additional moves, time, and effort to complete medical care caused by child's moves and behaviors
C-NAMC's moves and behaviors increase the risk to complete medical care. By this, caregiver's burden to prevent therisk occurs or increases.

Hypo 2“C-NAMC care burden” Triangle Assessment Model

Qualitative Study
1) bedridden

Results

the sum of the basic score plus the 'Mimamori'score. A score of 8 or higher is a requirement for
additional nursing staff in welfare facilities.

This kind of "calming the child or constant watching-over burden" was difficult to evaluate using only quantitative survey data. By
combining the qualitative approach of interviews, this became possible. In addition, we were able to corroborate the content ofinterviews by questionnaire survey results and by video data which was collected using multiple cameras installed in households.
By combining these data, a more solid evidence has been generated to demonstrate their benefits.

(The perfect match between the results of the time of care and the video data provided a major revelation for the system revision.)

４）Time study by caregivers for medical care and care burden

Figure#1

OldResults
They are conventionallyconsidered as not severein the level of disability
and supports for them
are insufficient.
The number is rapidlyincreasing.

Medical Care

Medical Care

Qualitative study: Interview survey, Video data analysis, Questionnaire survey••

As the reality of "Mimamori: Watching-Over" was revealed, medical care (previously difficult to assess at home and in the community)
became assessable. As a result, a new disability welfare system was established. The system starts in April 2021.
Specifically, tube feeding, which had been assessed lower as an object of support in the past, was assessed higher. 'Mimamori' score
which evaluates the risk level of each medical care were newly set.
⚫
In the new score system, decision is made by■Extract narratives that correspond to the hypothesis and coded in２-axis = medical care x child’s behavior

Data collection period: November, 2018 – January, 2019
Participants: 7 participants from 6 families (See the Table#3 of [EP-110.624] for detail)Up to 8 cameras were set for the fixed point observation.
Primary caregivers (mostly mothers) filled out care procedures and measured the time.

Quantitative study: Time study by care givers and risk assessment by physicians•••••４） A new disability welfare system (new medical care assessment score)
was established.

Quantitative Study-Time study by caregivers

ComplementationAdvantages• Possible to collect a big data samples• Grasp the trend over all
Disadvantages• Less objective• Limitation to collect the precise data
• Difficult to grasp the individuality• Cannot control irregular event• Cannot be coded

Questionnaire (subjects: caregivers who have experienced cares both of bedridden C-NAMC andnot-bedridden C-NAMC)

In response to a question about the change in the burden of medical care, 83.2% of the total
respondents answered that the level of burden “remained the same” or “became more difficult” after
the child became “not-bedridden,” compared to when they were bedridden.

became easier
16.8%
became more difficult
33.8%２）Interview (data coding)■Hypothesis based on the tentative analysis of time study, video data andinterview data
【H 1】Caregiver need additional moves, time, and effort to complete medical care caused bychild's moves and behaviors【H 2】Depending on combinations of C-NAMC's behavioral characteristics and types of medicalcare, medical risk increases as well as caregiver's burden to prevent risk from occurring orincreasing.

N=79

N=79

remained the same
49.4%Figure#5

Figure#4

This study has made medical care (traditionally been difficult to evaluate at home and in the community in Japan's disabilitywelfare system) assessable. As a result, a new scheme was established, which is enforced from April 2021. Specifically, tube
feeding (assessed lower as an object of support in the past) was highly assessed. “Mimamori” score which evaluates the risk levelof each medical care was newly developed.

Conclusion★This study proved the increase in the burden on caregivers along with the improvement of children's bodyfunction which physicians and nurses empirically perceive.
★This study revealed behavioral characteristics of children that increases the burden of caregivers for each
medical care.
- Medical device and children's behaviors which impact on the care burden and risk were classified (e.g.
"tracheostomy cannula x pulling").
- The classification made it easier to understand the characteristics and risks of each medical care.
- The necessary support for each of medical care was clarified.
In summary, we were succeeded in providing the data and rationale for creating a scheme more in line with theactual situation of C-NAMC and their caregivers.

Key References
Jessica T. DeCuir-Gunby, Patricia L. Marshall, Allison W. McCulloch (2010) ‘Developing and Using a Codebook for the Analysis of Interview Data: An Example from a
Professional Development Research Project’, Field Methods, pp. 1-20
Joy D. Bringer, Lynne Halley Johnston, Celia H. Brackenridge (2006) ‘Using Computer-Assisted Qualitative Data Analysis Software to Develop a Grounded TheoryProject’, Field Methods (18), pp. 245-266
Hsiu-Fang Hsieh, Sarah E. Shannon (2005) ‘Three Approaches to Qualitative Content Analysis’, Qualitative Health Research (15), pp. 1277-1288
Alan Bryman (2007) ‘Barriers to Integrating Quantitative and Qualitative Research’, Journal of Mixed Methods Research, (1), pp. 8-22
Jori N. Hall and Katherine E. Ryan (2011) ‘Educational Accountability: A Qualitatively Driven Mixed-Methods Approach’, Qualitative Inquiry, (17), pp. 105-115

Acknowledgement

We would like to express our gratitude to the families and physicians who cooperated in the questionnaire survey, as
well as to the researchers and collaborators of the MHLW "Research to establish criteria for judging children withmedical care in the reimbursement for disability welfare services".

“Questionnaire survey on Pediatric Home Mechanical Ventilation Abroad”
Thank you for your cooperation !