Received Date : 27-Feb-2016

Revised Date : 20-Aug-2016

Accepted Date : 02-Sep-2016
Article type : Brief Communication
Accepted Article
Effects of structured education program on organ donor designation of nursing students and
their families: A randomized controlled trial

Minoru Murakamia,b, Shingo Fukumaa,c,d, Masaya Ikezoeb, Chizuko Iizukae,

Satoshi Izawae, Yosuke Yamamotoa,c, Shin Yamazakia and Shunichi Fukuharaa,d

a
Department of Healthcare Epidemiology, School of Public Health in the Graduate
School of Medicine, Kyoto University, Kyoto, Japan.
b
Department of Nephrology, Saku Central Hospital, Nagano, Japan.
c
Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University
Hospital, Kyoto, Japan.
d
Center for Innovative Research for Communities and Clinical Excellence (CIRC2LE),
Fukushima Medical University, Fukushima, Japan.
e
Saku Central Hospital Nursing School, Nagano, Japan.

Running head: Changing behavior toward organ donation

Corresponding author:

Prof. Shunichi Fukuhara, MD, DMSc

Department of Healthcare Epidemiology

School of Public Health in the Graduate School of Medicine, Kyoto University

Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan

Tel: +81-75-753-4646

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1111/ctr.12845

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 Fax: +81-75-753-4644

E-mail: fukuhara.shunichi.6m@kyoto-u.ac.jp
Accepted Article
Minoru Murakami, Shingo Fukuma, Masaya Ikezoe, Chizuko Iizuka, Satoshi Izawa,

Yosuke Yamamoto, Shin Yamazaki and Shunichi Fukuhara

Effects of structured education program on organ donor designation of nursing students

and their families: A randomized controlled trial

Clin Transplant

Abstract

Introduction: Little is known about the effect of education programs on changing attitudes
and behaviors of participants and their families towards deceased organ donation.

Methods: The subjects of this randomized trial were Japanese nursing students who were
not previously designated organ donors. They were randomly assigned to either the
education program or information booklet group. The program comprised a lecture
followed by group discussion and information booklet. The primary outcome was
self-reported organ donor designation. Outcomes were assessed by questionnaire.

Results: Data of 203 (99.0%) students were analyzed. At study end, 7 of 102 students (6.9%)
of the program group and 1 of 101 students (1.0%) of the booklet group consented to
donate organs (proportion ratio 6.93 [95% CI 0.87-55.32]). There were significant
between-group differences in willingness to consent for donation (54.9% vs. 39.6%;
proportion ratio 1.39 [95% CI 1.03-1.87]), family discussion (31.4% vs. 15.9%; 1.98
[1.16-3.38]), and organ donor designation of family members (11.8% vs. 2.0%; 5.94
[1.36-25.88]). No group differences were found in willingness for organ donation by
students and family members.

Conclusion: Although there were no significant between-group differences in organ donor

designation, the program seems to indirectly promote consent to organ donation by their
families.

(199/200 words)

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 Key words: education program, group discussion, organ donation, organ donor designation,
transplant recipient.
Accepted Article
*Corresponding author:

Prof. Shunichi Fukuhara, MD, DMSc

Department of Healthcare Epidemiology

School of Public Health in the Graduate School of Medicine, Kyoto University

Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan

Tel: +81-75-753-4646

Fax: +81-75-753-4644

E-mail: fukuhara.shunichi.6m@kyoto-u.ac.jp

Introduction

Substantial efforts have been made worldwide to promote deceased organ donation
through education and public campaigns. Organ donation is especially important in patients
with end-stage kidney disease (ESKD) since kidney transplantation provides longer survival
and better quality of life than dialysis (1-3). Unfortunately, the shortage of organs for
transplantation remains a serious global problem (4-6). Japan is in the most serious situation
among the developed countries; the kidney transplant rate from deceased donors in 2013
was less than one thirtieth of that in the United States (7).

One potential solution for alleviating the shortage of donor organs is to close the gap
between willingness to be an organ donor and actual registration (8, 9). One study reported
that while 66% of Japanese university students, including nursing students, were willing to
donate their organs after death, only 31% had provided consent for organ donation (10).
Since education about organ donation and transplantation is not routinely incorporated into
the nursing education curriculum (11), additional and systematic education of nursing
students is required.

Two systematic reviews have shown that education on organ donation and
transplantation effectively influenced participants’ knowledge, attitudes, and behavior (12,
13). However, little is known about the effect of education programs on changing attitudes

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 and behaviors of participants and their families towards deceased organ donation. The aim
of the present study was to assess whether an educational program designed for nursing
students was effective in changing the attitudes towards deceased organ donation and
Accepted Article
promoting family discussion and organ donor designation in both nursing students and their
families, compared with information booklets.

Materials and Methods

Study design and setting

Our study was a parallel-group, non-blinded, randomized controlled trial (RCT) conducted at
Saku Central Hospital Nursing School (Saku Nursing School) located in Nagano Prefecture,
Japan. The number of registered nursing students in the school is 253, divided into three
grades, with two classrooms per grade. This was the first time for all students to receive a
systematic lecture on organ donation and transplantation and also the first classroom
lecture delivered by a patient. To evaluate the impact of our education program, we asked
the students to participate in our study.

Ethical declaration

All study procedures were approved by the Institutional Review Boards of Kyoto University
(E2286) and Saku Central Hospital. All participants provided written informed consent.
Participation was voluntary and without any form of incentives or coercion. The study
protocol was registered at UMIN Clinical Trials Registry (#UMIN000014507).

Japanese organ donation and transplantation system

Japan has a clear consent system for deceased organ donation (14). Consent for organ
donation in Japan can be made through four avenues: online internet registration, organ
donor designation on a donor card, driver’s license card, and health insurance card.
However, post-mortem organ procurement in Japan requires both organ donor designation
and family approval (15).

Participants

Students who were not previously designated organ donors were eligible for study
participation. Students were excluded if they were absent at the baseline questionnaire
survey.

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 Randomization and masking

With the use of computer-generated random numbers, we randomly assigned eligible

Accepted Article
nursing students in a 1:1 ratio to either the intervention or control groups (Figure 1).
Randomization was stratified by grade and gender. Outcome assessors, analysts, and all
authors other than MI, a lecturer of the program, were masked to group assignment.

Intervention group

Students randomized to the intervention group received an educational program on day 17.
The educational program was developed based on the transtheoretical model of Prochaska
and coworkers (16, 17). The model suggests that a change in health behavior involves
progress through five stages: pre-contemplation, contemplation, preparation, action, and
maintenance. The model integrates important constructs, such as decisional balance and
self-efficacy. To include progress to the next stage in our model, we incorporated two
components into our program: a classroom lecture and a small group discussion (Table 1).
The lecture was provided by two lecturers: a transplant nephrologist and a kidney transplant
recipient. Finally, the students received a brief information booklet, The Gift of Life, which
was prepared for the general population by the Japan Organ Transplant Network (18).
Although a donor card was included in the booklet, we did not encourage students to
distribute donor cards at home. No information about religion was included in the program.

Control group

Students randomized to the control group received three information booklets on the same
day. One was the same booklet handed to the intervention group. This ensured that all
participants of both groups received a donor card. The other two were Current Status of
Transplantation in Japan and Kidney Failure: Treatment Options and Practice. Both of them
were written in lay terms for easy understanding by patients with ESKD.

Outcomes

The primary outcome was organ donor designation. We described all the above mentioned
modalities as “organ donor designation” in the present study, indicating consent to donate
organs after death, regardless of modalities. The secondary outcomes focused on the
proportions of students: 1) who obtained approval of the family to the student's consent for
organ donation, 2) who expressed willingness to provide consent for organ donation, 3) who
expressed willingness to donate organs after brain death, 4) who expressed willingness to
donate organs after circulatory death, 5) who expressed willingness to approve organ
removal from a deceased family donor with organ donor designation, 6) who expressed
willingness to approve organ removal from a deceased family member with unknown

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 donation status, 7) who discussed deceased organ donation with their family, and 8) whose
family member(s) provided consent for organ donation.
Accepted Article
Outcome measures

We measured all outcomes using an anonymous, self-reported questionnaire. The survey

included 21 questions, with options of, “Yes”, “No”, and “I don’t know”. We counted the
number of students with respect to all outcomes. Thus, if at least one family member
consented to donate organs, we defined it as organ donor designation of family members.
We also asked about the modality selected by the student to indicate consent for organ
donation and which family member(s) consented to organ(s) donation when the student
responded “Yes” to the question. We measured intervention-related adverse effects and
contamination rate using the follow-up questionnaire. We defined obtaining information
about the intervention from the students in the other group as contamination.

The survey was conducted on day 1 and repeated on day 39. School teachers
explained its contents to all students on day 1. However, teachers did not discuss the
primary and secondary outcomes in the present study. Students placed the completed
questionnaires in sealed opaque envelopes. Students who did not agree to participate in the
study were permitted to return a blank questionnaire. All envelopes were opened at Kyoto
University, and thus all the staff of Saku Nursing School were blinded to the results of the
questionnaires.

Statistical analysis

All analyses were performed on the modified intention-to-treat population, which included
all enrolled participants who received the intervention and completed the follow-up
questionnaires.

For our primary analysis, we used Fisher’s exact test to compare the proportion of
students who provided consent for organ donation between the program and booklet
groups. The proportion ratio was reported with 95% confidence interval (CI) without
adjustment. In the secondary analysis, we used log-binomial regression models to adjust for
potential confounders. For secondary outcomes other than family consent for organ
donation by the student, unadjusted and adjusted proportion ratios were reported with
their corresponding 95% CIs, as with the primary outcome.

We also conducted posthoc analysis to assess the impact of the program on nursing
students with and without contamination. Statistical analyses were performed with STATA
statistical software, version 13.0 (STATA Corporation, College Station, TX). All tests were
two-tailed, and P<0.05 was considered significant.

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 Results

Participants
Accepted Article
The study was conducted between August 25 and October 3, 2014. Of the 253 nursing
students, 205 students who consented to participate were randomized to receive the
allocated intervention and 203 completed the study (program group: n=102, with 2
excluded for absenteeism, booklet group: n=101) (Figure 1). The baseline characteristics of
the two groups were similar (Tables 2 and 3).

Primary outcome

In the program group, 7 of 102 students (6.9%) provided consent for organ donation,
compared with 1 of 101 students (1.0%) in the booklet group (proportion ratio 6.93 [95% CI
0.87-55.32]; P=0.07) (Table 3). Of the 8 students who consented to donate organs, 4, 2, and
1 students of the program group selected driver’s license cards, organ donor cards, and both
the driver’s license card and health insurance card to indicate consent for organ donation,
respectively. On the other hand, the single student of the booklet group selected the
driver’s license card. The result remained the same even after multivariate adjustment for
potential confounders (adjusted proportion ratio 6.94 [0.86-55.65]; P=0.07).

Secondary outcomes

Of the 8 students who consented to organ donation, 4 in the program group obtained their
family’s approval, while the single student in the booklet group did not. Interestingly, the
proportion of students whose family consented for organ donation was significantly higher
in the program group than in the booklet group (11.8% vs. 2.0%; 5.94 [1.36-25.88];
P=0.010). In the program group, the mothers, parents, fathers, older brother, and older
sister of 6, 2, 2, 1, and 1 students, respectively, provided consent for organ donation. On the
other hand, the father of 1 student provided consent for organ donation and the mother of
1 student did the same in the booklet group. All students whose families provided consent
for organ donation discussed organ donation with their family.

Adverse effects and contaminations

Although there were no reported adverse effects, contamination occurred in 53 students

(52.0%) of the program group and 43 students (42.6%) of the booklet group.

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 Posthoc analysis

Among the students who reported contamination, 3 of 53 (5.7%) students of the program
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group and none of 43 (0%) students of the booklet group provided consent for organ
donation. Among students who did not, 4 of 49 (8.2%) students of the program group and 1
of 58 (1.7%) students of the booklet group did so.

Discussion

Our study showed that among Japanese nursing students who had not previously consented
to organ donation, the educational program did not encourage organ donor designation
compared with the booklets. However, the program promoted family discussion and organ
donor designation among the family members of the program group. To our knowledge, this
is the first trial to show the indirect effects of an educational program in encouraging the
families of participants to provide consent for organ donation through family discussion.

To remove barriers to organ donation and promote organ donor designation, we

incorporated both narrative storytelling (19-22) and group discussion (23) into our
educational program. However, only 6.9% of the students in the program group progressed
to the action stage, with no significant difference between the two groups. This is probably
due, at least in part, to the religious and cultural differences between Western countries
and Japan. Because in Shinto, the most common religion in Japan, the dead body is
considered impure and dangerous and thus quite powerful, it is difficult to obtain consent
from bereaved families for removal of body organs immediately after death (24). Therefore,
we need to improve educational programs to become more suited for the prevailing
religious and cultural backgrounds.

The main aspect of our study is that participants can potentially be advocates of the
primary outcome and promote organ donor designation of their family members through
family discussion. To our knowledge, only one RCT has previously assessed the effect of an
educational program on organ donor designation by family members as a secondary
outcome and reported that there was no significant difference between the two groups
(17% vs. 14%) (25). However, it has been reported that the “child-to-family” approach is
effective in promoting healthy lifestyles of the family members. School-based randomized
trials reported the effect of educational programs for students on the reduction of salt
intake and blood pressure among adults of their families (26), on the decrease in body
weight of their mothers (27), and on the improvement of Framingham cardiovascular risk of
their parents (28). Because all students whose families consented for organ donation
discussed organ donation with their families, our educational program might indirectly
encourage their families to consent for organ donation through family discussion.

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 Apart from the above strong point, the study has several limitations. First, the
outcomes may not precisely reflect actual behavior change due to social desirability
response bias among nursing students. Although we did not know the modality selected by
Accepted Article
the family that indicated consent for organ donation, we asked the students the modality
selected by themselves and the family member(s) who consented to organ donation when
students responded “Yes” to those questions. Second, although both organ donor
designation and family approval for the decision to remove organs are needed in Japan, the
primary outcome in our study was simply organ donor designation. However, the primary
endpoint of many previous studies was organ donor registration or designation (12, 13), as
is the case with our study and three weeks seemed to be too short for students to obtain
family approval. Third, contamination occurred in about half of the students in both groups.
We considered any contamination only ensured underestimation of the effect of the
program since the program included the main contents of all information booklets delivered
to the students in the booklet group. Fourth, we could not collect detailed information
about the families of the two groups due to ethical considerations. However, we would
anticipate similar distributions of baseline donor designation rates among the families of the
participants due to the randomization. Finally, another limitation is related to external
validity, in particular, the single-center design and lack of non-nursing students.

In conclusion, among Japanese nursing students who were not previously designated
organ donors, our educational program did not increase organ donor designation, compared
with information booklets. However, the program seems to have indirectly motivated the
families of the students through family discussion to consent to organ donation.

Acknowledgments

Our study was supported by the Yukiko Ishibashi Foundation. We thank the two kidney
transplant recipients, Fusako Saito and Hideko Takahashi, for the lectures provided to the
nursing students.

Authors’ contributions

MM, S Fukuma, and S Fukuhara participated in the research design, writing of the
manuscript, and data analysis. YY and SY participated in the research design and data
analysis. MI, CI, and SI participated in the performance of the research. All authors read and
approved the final manuscript.

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