[EP-110.624]
National survey results of care burden:
focusing on 567 families whose children require advanced and complex medical care in domiciliary settings in Japan
Hirotoshi Maeda, M.D. 1), Izumi Iikura 2), Masahiro Ikari 3), Ikuko Tomomatsu, Ph.D. 4)1), 2), 3) Medical Incorporated Foundation Harutaka Kai
4) TOMO Lab LLC
COI: This study was funded by the Ministry of Health and Labor Sciences Research Grants. [2018-2019]

Objectives

Background１）Neonatal mortality is sharply declining in Japan
Neonatalmortality rate
30

Changes of neonatal mortality rate over the past 70 years in Japan・Physicians and nurses have empirically known the amount of care burden for the ‘not-bedridden C-NAMC'.
・However, as the methodological framework to measure the care burden for the ‘not-bedridden C-NAMC' has not been
established, there was no quantitative data to create a public support systems.

25

neonatal mortality rate = number of neonatal death / 1000 live births

20
15
10

2017=0.9

5Figure#10
1950

1960

1970

1980

1990

2000

2010

（year）

２）Increasing number of the children who need advanced medical care
【Reference：Health and Labor Sciences Research Grants：201918009A】(C-NAMC) in Japan
Figure#2

Figure#3 Changes in the number of children who require ventilator

Changes in the number of the C-NAMC(by age group) (estimate)management (by age group) (estimate)

Doubled over the past 14 years

17-fold over the past 14 years

Methods３）2 types of C-NAMC

Notbedridden
children
They are not bedridden, or notBedridden
children

They are conventionallyconsidered as severely disabled.

Existing concept of severelydisabled children

intellectually disabled, and arein the category of new types ofdisabled 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.

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 tube
by themselves.)
In addition, the number of respite facilities forthem is low.

・1,162 paediatric home-based patients from 18 medical institutions in Japan (including childhood onset transition cases).
・Data collection period：from September 2019 to February 2020
・Survey contents:
Major caregivers of the patient✓basic data including profile of the patients and their major caregivers (mainly family caregivers)✓a time study about medical care at home (max. 24 hours)✓time needed to each type of medical care✓subjective sense of care burden for above medical care
Physicians✓a risk assessment from a clinical perspective【Procedure for measuring time】
i. The time (duration) needed for each medical care was measured using a stopwatch. The measurement was performed by the caregivers
for every medical care event conducted at home.
ii. The duration was multiplied by the frequency of each care to calculate the total hours of medical care provided per day.

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

４）Social support systems for C-NAMC have not established【Procedure for measuring the risk level】
i. The physician in charge fills out a survey form regarding the medical devices and medical care used by the patient.
ii. The physician estimates the level of risk on a 4-point scale in terms of medical equipment and medical procedures.
iii. For certain medical devices and medical cares, risks become higher depending on child’s condition, then the physician adds evaluatedrisk factors.

PICU
government

Care giver•

Consultation/visit•

Community
Hospital△Day CareDay Service
Short stay××△
clinics＜Evaluation criteria of the sense of care burden＞

Extinction between medical care and welfare×△C-NAMCAt Home△
pharmacy

Rehabilitation
facilities•

Difficulties among C-NAMCs and their families

Consultation/visit△
Visitingnurse

Figure#4

It is supposed that C-NAMCs are in a hospital, not in acommunity.
There are no schemes to connect between medical
professionals, welfare and care professionals, andeducational professionals,
nevertheless it is the key to support C-NAMCs
Lack of social resources and human resources.

•••••

Excessive burden of mothers
Difficulties to go to school
Lack of day-care service
Without respite care, mothers cannot rest. Oncethe mother got sick, no one can treat the childLess cares for brothers and sistersNo criteria in place for the assessment of care burden for the C-NAMC and determine the amount of support needed.

3

Physicalability
bedridden /able to move legs andarms

Time duration ofVideo recordings

Medical devices

tracheostomy＋ventilator + tube feeding

bedridden /able to move legs and tracheostomy＋ventilator + tube feedingarms
bedridden /unable to move legs and tracheostomy＋ventilator + tube feeding
arms
peritoneal dialysis + tracheostomy＋ventilator + ED tubeﾞ+

Total hours

Maximum time without medical careduring daytime

Maximum time without medical care during
nighttime

5-mins frame

total hours

5-mins frame total hours

Time duration

16:00～16:00 (next day)

24 hours

945 mins

24

2 hours

3:30～5:30

16:00～16:00 (next day)

24 hours

12

1 hour24

2 hours

3:30～5:30

16:00～16:00 (next day)

24 hours

1050 mins

71

5 h 55 mins

1:05～7:00

16:00～12:00 (next day)20 hours

12

1 hour34

2h 50 mins

3：00～5：50

2bedridden /able to move neck2

bedridden /able to move legs andarms

bipapﾞ+ nasogastric tube

20:00～8:05 (next day)

12 h 5 mins

525 mins42

3 h 30 mins

1：30～5：00

8bedridden /able to move legs andarms

tube feeding

16:00～16:00 (next day)

24 hours

15

1 h15 mins

63

5 h 15 mins

1：45～7：00

4bedridden /able to move arms

tracheostomyﾞ+ nasogastric tube

16:00～16:00 (next day)

24 hours

25

2 h 5 mins

70

5 h 50 mins

1：10～7：00

3able to stand up

Oxysian ＋ tube feeding

8:30～17:30

9 hours

945 mins

―

―

―

1

able to stand up

tracheostomy＋ventilator ＋nasogastric tube feeding

11:10～18:45

7 h 35 mins18

1 h 30 mins―――4

able to stand up

tracheostomy＋ventilator ＋nasogastric tube feeding

15:30～20:35

5 h 5 mins

14

1 h 10 mins

―

―

―

6

able to stand up

tracheostomy＋ventilator + tube feeding

9:30～17:05

7 h 35 mins26

2 h 10 mins

―

―

―

3

able to stand up

tracheostomy＋ventilator + tube feeding

17:20～22:35

5 h 15 mins

33

2 h 45 mins

―

―

―

11

able to stand up

tracheostomy＋ventilator + tube feeding

9:00～19:05

10 h 5 mins

12

1 hour―――2

able to crawl

tracheostomy＋ventilator + tube feeding

5 h 30 mins

12

1 hour―――

2ablle to stand up

9 hours15

1 h 15 mns―――

nasogastric tube

10:30～14:30
16:00～17:30

tracheostomy＋ventilator + tube feeding + IVH

8:30～17:30

Table#3２）Time study by caregivers

This study NOT prove an increase in care burden with improvement of child’s physical ability, which physicians and nurses are empiricallyfeeling.
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).

score
0

＜Evaluation criteria of the risk level＞

Evaluation criteria

score

Figure#6

Figure#7

I don't feel any burden at all.

1

I feel a little burdened.

2

I feel a little burden.

3

I feel a great burden.

4

I feel extremely heavy burden

0

Not life-threatening

1

Can become serious

2

Can become serious in a short time3

Directly life-threatening on the spot

Table#1◆◆Data collection results
Caregivers’ response rate in the survey: 567/1162 (48.8%)
Number of responses of the self-reported 24-h Time-Study Samples: 552-Number of valid Time-Study Samples: 497/552 (total)- Valid estimations of risk level by physicians: 986/1162 (total) (84.9%)

90.0
80.0
70.0
60.0
50.0
40.0
30.0
20.0
10.00.01)
1) bedridden2) unable2)to stayin sitting position

3) stay3) able toin sitting position

1) bedridden2) unable to stayin sitting position

3) able to stayin sitting position

３）Risk evaluation by physicians
The average risk score of 2 (could become serious in a short time) or higher was for tracheostomy (2.5) andperitoneal dialysis (2.3). The average risk score of 1 (could become serious) or higher was for ventilator (1.8),
Intravenous hyperalimentation IVH (catheterization: 1.2), oxygen (1.2), and drains (1.4). (1.2), oxygen (1.2),
and drains (1.4).

Discussion
1. The actual status of medical care for C-NAMC provided at home was quantified.
2. In Japan, most medical care for C-NAMC is provided by families, in particular mothers. Under the situation, the time
to complete medical care was significantly longer than our assumption, and subjective sense of the care burden andrisk control of medical care were significantly greater than our assumption.
3. Based on the knowledge shared among the physicians and nurses and the analysis of video data collected in the firstperiod, we hypothesized that the duration of the medical care and subjective sense of care burden increase alongwith the increase of child’s motor function.
However, there were no correlations of the time to complete the care and subjective sense of the care burden with achild’s level of bodily function.
4. The degree of medical care risk assessed by physicians depends on the type of medical care provided. The risk ofsuction and ventilators was significantly higher than that associated with other types of medical care.
5. With the medical care required for tube feeding, both the amount of time required for medical care and subjective
sense of the care burden increased with the improvement motor function.
⚫ The time-based study using the video data and self-reported questionnaire were not sufficient enough to demonstrate
the increasing care burden with the improved child’s motor function.
⚫ The development of new methods is necessary in order to demonstrate the correlation between the time for themedical care and subjective sense of the care burden and child’s motor function.
⚫ The new approach is presented 「[2905-HP-QA.174] Development of a methodology to assess the care burden forthe children with high motor function who require advanced medical care」

Conclusion
The burden of medical care included “the burden of the amount of care required to be implemented” and“the burden of increased risk with improved bodily function in children.”In the case of medical care via tube feeding, the time for care became longer and the burden became
greater with the increase in the child’s bodily function.

1) bedridden2) unable to stayin sitting position

3) able to stayin sitting position

1) bedridden2) unable to stayin sitting position

3) able to stayin sitting position

In the case of medical care via tube feeding, the time for care became longer and the burden
became greater with the increase in the child’s bodily function.
In terms of the care burden by medical care, tube feeding ranked second. In terms of the time required, tube feeding ranked third after
peritoneal dialysis and central venous feeding.
We performed cross-correlation analysis between care burden and motor function of children, and between time (duration) needed for
medical care and motor function of children in terms of categories of medical care. The result showed both care burden and time (duration)needed for medical care of tube feeding increased as the child’s motor function increased.

Evaluation criteria

Figure#10

Average Time （minutes)◆ 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.

【Procedure for measuring the subjective sense of care burden】
i. Participants provided responses regarding their subjective sense of care burden (SSCB) for each medical care event on a 5-point scale.
ii. The number of times of each medical care (NTMC) was implemented was calculated for each participant.
iii.Calculate SSCB x NTMC for each patient. (e.g., e.g., SSCB of tube feeding=1, NTMC involving tube feeding was implemented 5 times aday=5; ESTIMATE of care burden of tube feeding is: 1 × 5 = 5).

Discharge and post-discharge follow-up
Major Hospital

Figure#9

The video recordings were analyzed separately during daytime (all 15 participants) and during
nighttime (7 participants). Time without medical care during daytime ranged from 25 min(minimum) to 2 h and 45 min (maximum) and that during nighttime ranged from 2 h (minimum) to
5 h and 55 min (maximum).
The result shows that it is difficult for caregivers to take adequate rest and sleep.

2２）Time study by caregivers and risk assessment by physicians

・The data was published by the Japanese Ministry of Health, Labor and Welfare.
・Medical services in Japan are fundamentally conducted by the national health insurance. Medical institutions file a medical claim foreach patient. The data is estimated from the number of medical expenses claimed by the medical institutions. （* Since the number isbased on monthly claim data in June each year, the yearly based chronological trend is not a smooth curve.）
・The targets are patients living at home under the age of 19.
* Statistics of the C-NAMC do not include children with insulin injections.

This study revealed the impact of medical care on the daily rhythms of caregivers.

6・Participants: 15 C-NAMC and their families(informed consents were obtained beforehand)・Data collection period:① November, 2018 – February, 2019② February, 2020 – June 2020.
Movements of children and their families were recorded inFigure#5
various duration from 5h and 10 min to 24h.
・ Up to 8 cameras were set and simultaneous recordings were performed from different angles. The camera
used in this study is Sopak-C made by Kobayashi Manufacture Co.Ltd. This was specially developed forprocess analysis.
・ Primary caregivers (mostly mothers) filled out time-study sheet in which 24hr was divided into 5min (288frames x 5 min). Each 5 mins frame was marked either “care conducted” or “no care conducted”
・Video data and the time-study sheet for each children are compared.

1) bedridden, 2) not bedridden but unable to stay in sitting position, 3) not bedridden and able to stay in sitting position

１）Video analysis

Age1) Video Analysis

For each category of medical care, the correlation coefficient was calculated between the level of burden andthe level of motor function, and between the time required for medical care and the level of motor function.
The result showed that only for the category of tube feeding, both care burden and time required for medicalcare increased as the child’s motor function increased.

Results⚫ To assess quantitatively the medical care provided at home for non-bedridden C-NAMC.
⚫ To determine the amount of expenses for supporting these children.
This is the first basic research required to create a public support system for such children in Japan.

Results

The time-based using the video data and self-reported questionnaire solely could not prove SSCB
increased as the child’s motor function increased which physicians and nurses are empirically feeling.

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 aProfessional 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

Table#2

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

Figure#8“Questionnaire survey on Pediatric Home Mechanical Ventilation Abroad”
Thank you for your cooperation !