Social and Behavioral Interventions to Increase Solid Organ Donation
Phase: NA
Conditions: Tissue and Organ Procurement
Sponsor: University of Hawaii

 
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Social and Behavioral Intervention to increase solid organ and tissue donation  
Clinical Trials Number: NCT02318849  
Unique protocol number: R39OT26993 from the Health Resources and Services Administration  
Document date:  May 27, 2023 
 
                              Study Design/Intervention Protocols and Statistical Analyses Protocols 
 
  The eHealth study used a cross-sectional design that included a sequential, multiple baseline survey design that was 
introduced  over two years at the three Hawaii university campuses. For example, undergraduate students at one site 
(University of Hawaii at Manoa-UHM) participated in three semesters of the DOD intervention and students at two sites 
(University of Hawaii at Hilo-UHH), Hawaii Pacific University-HPU) received two sequential semesters.  Figure 1 
shows the study design with  pre/post surveys and a sequential introduction of the intervention across three years (four 
semesters).   
 
Thus, either a baseline or post-test survey was administered at the start and/or the end of a semester depending on when 
the online intervention was introduced at a site.  All students at the site were recruited to take the surveys  regardless of 
whether or not they had completed a survey at any point in the past.  Therefore,  some survey analyses included cross-
sectional samples and some analyses included a cohort sample of students. Data collection protocols for online surveys 
from undergraduate students were approved by the University of Hawaii’s Human Studies Program in October 2014 
(CHS 22372) with Hawaii Pacific University’s Institutional Review Board ceding to the University of Hawaii’s IRB.   
 
Survey questions for primary outcomes:  
1. Status as a designated organ donor on Department of Motor Vehicles (DMV) issued driver’s license, state-
issued ID card or donor registry.  
 
2. Reported discussion about their choice to be (or not be) an organ donor on their DMV issued driver’s license 
with their parents or other family members. 
 
Protocol for Sample Size / Power calculations for surveys:  Simulations were run to determine the achieved power of 
our multiple baseline design resulting in an average of 240 participants per site for surveys collected at the beginning 
and end of four academic semesters at UHM and UHH and five academic semesters for HPU (20 data points, total n = 
4,800). We assigned 60% of the students at baseline to already be a DOD (prior to being exposed to the intervention), 
based on the proportion we observed in previous work.  Using an α=0.05 (two-sided) and a power of 80%, a simulation 
of 500 iterations found that the minimum detectable difference (MDD) in DOD prevalences comparing the 9 pre- and 11 
post- intervention assessments, using our analysis approach, was 4 percentage points for an average change overall (3 
campuses) and was 7 percentage points within a single campus; this was true assuming no change or a 3 percentage 
point drift in the pre-intervention prevalences over time.     
 
Protocol for recruiting students for Study Surveys and Intervention activities   Before taking the iDecide survey, 
students had to confirm they had read the consent form and actively consent (click yes). Eligibility was the verified. 
Only undergraduates enrolled at the three participating universities (UHM, UHH, HPU) were eligible, with enrollment 
verified by the respective university. Age was the only other eligibility criteria (18 years or older). Of the 8,001 online 
 Years:
 
 
 
 
 
      Months
9
10
11
12
1
2
3
4
5
6
8
9
10
11
12
1
2
3
4
5
6
7
8
9
10
11
12
 
1-1 = Site 1, Survey 1, etc.
 
Univ Hawaii Manoa- Site 1  
1-1
1-2
1-3
1-4
1-5
1-6
 
 
Univ of Hawaii Hilo- Site 2  
2-1
2-2
2-3
2-4
2-5
2-6
 
 
   Hawaii Pacific Univ: HPUSite 3  
3-1
3-2
3-3
3-4
3-5
3-6
3-7
3-8
Wave 1
 
Wave 2
Wave 3 
Wave 4 Wave 5 
Wave 6 Wave 7
Wave 8
Figure 1. Study Design  
 Baseline
Post-test
2015
2014
Sp2015
Online Intervention
2016
 Waves of Surveys:
Fa2016
Online 
Fa2015
Online Intervention
Fa2015
Online Intervention
Sp2016
Online Intervention
Sp2016
Online Intervention
Sp2016
Online Intervention

 
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consent forms completed, 853 (10.7%) reported enrollment at a nonparticipating university, and 2,073 (25.9%) didn’t 
finish the survey. After verifying enrollment status for the remaining 5,075 survey entries, 248 (4.9%) were excluded 
because the student was not currently enrolled or was a graduate student, or their survey was a duplicate within that 
assessment; 4,837 was the final count.  
 
Between November 2014 and December, 2016, undergraduate students were independently recruited to complete 
surveys (compensated for their time with a $10 Amazon gift code) and to participate in the social media contests during 
the intervention. That is, students who completed a survey were not informed by project staff about the contests, and 
students who entered a contest were not recruited by staff to complete a survey. The most commonly used method for 
recruitment was email with 14,868 emails sent to recruit for the surveys and 41,562 emails to recruit for contests. These 
emails were sent to faculty at the sites (asking them to inform students about survey), Registered Independent (student) 
Organizations (RIOs), survey respondents (if student agreed to receive future recruitment notices about surveys offered 
later in the semester). Previous contest entrants were emailed about remaining contests in that semester. Both print and 
online advertisements for the various different contests and different ads were used to recruit for the surveys resulting in 
467 print ads for surveys and 1,254 print ads for the contests. The ads were placed in campus newspapers, on napkin 
holders on cafeteria tables in dorms, and on bulletin boards around campuses. Two social media posts for the survey and 
282 posts for the contests were designed. They included posts for the contests on the project’s homepage /website, and 
on the project’s social media accounts/pages on Instagram and Facebook and on our YouTube channel. Students were 
also recruited in person via classroom presentations or tables set up periodically at campus centers at each university. 
Finally, students were recruited for the survey via departmental research websites that gave extra credit to students who 
participated in research studies. Figure 2 is the Consort Figure for recruitment protocols used for the surveys and 
contests across all sites/ years and survey accrual results.   
 
 
Ads (n=2,402) 
Emails to RIOs/SAB 
(n=18,974) 
SONA (n=20) 
Contact with Students 
(n=23,770) 
Emails to Faculty 
(n=13,693) 
Print (newspaper, 
napkin ads) (n=2,117) 
Online 
(n=285) 
Social Media 
(n=274) 
Newsletter 
(n=11) 
Survey 
(n=467) 
Survey 
(n=3,671) 
Intervention 
(n=15,303) 
Email 
(n=23,745) 
In person 
(n=25) 
Survey 
(n=5,778) 
Intervention 
(n=17,967) 
Intervention 
(n=274) 
Intervention 
(n=9) 
Survey (n=20) 
Consented to take survey 
(n=8,001) 
Prequalify by 18 yrs and eligible 
university (n=7,148) 
Failed to Prequalify with 
Ineligible University (n=853) 
Survey completed 
(n=5,075) 
Didn’t complete 
survey (n=2,073) 
Ineligible 
Completers (n=248) 
Eligible completers 
(n=4,827) 
Duplicates 
(n=8) 
Not enrolled 
(n=67) 
Enrolled at another 
campus in UH System 
(n=27) 
Graduate Student 
(n=146) 
Baseline 
(n=2,138) 
Recruitment 
Accrual 
Figure 2. Consort 
Intervention 
(n=8,292) 
Survey 
(n=5,401) 
Survey (n=4) 
Intervention 
(n=21) 
Survey (n=2) 
Intervention 
(n=1,650) 
Post 
(n=2,689) 

 
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   Leaders/officers from RIOs on each campus were recruited to serve on the project’s Student Advisory Board (SAB) 
each semester, resulting in a total of 40 RIOs participating. The SAB held up to 4 monthly teleconferences per semester 
where they provided input on recruitment for surveys and contests plus were informed about current and upcoming 
contests (for which only RIOs were eligible). At the end of a semester, RIOs that participated in the SAB received $100.    
 
eHealth Intervention’s Study Protocols: The protocols for staff who delivered intervention content were focused on 
the project’s website and  social media sites.  
  
Protocols for implementing the intervention: The University of Hawaii at Manoa core research team who designed 
the project’s website (and collected /wrote all the deceased organ donation educational content for it) also designed and 
conducted the social media based intervention and included the principal investigator, project supervisor, and a Graduate 
Research Assistant (GRA). A private website developer (Hedges Creative Company in San Diego) was contracted to 
develop and maintain the project website, its logo, with considerable input from the team and usability/navigation testing 
done by UH Manoa team. The Hedges Creative Company also took the surveys we designed and our consent form and 
programmed them into a separate website. After the website was developed and the social media pages created, the 
UHM team began to recruit students to take the online baseline surveys and enter contests on the study website via 
presentations in class, booths at the sites’ campus centers, posts on social media, print fliers on each campus, and weekly 
emails to student organizations and to faculty at all 3 sites. We also had two faculty members from the different sites 
(one from UH Hilo and one from HPU) who helped recruit students to participate in the contests and surveys. Students 
were involved as well: an unpaid student intern and 40 members of a Student Advisory Board (SAB) across all sites and 
all semesters. The student intern helped keep students engaged in the contests and informed them about surveys via 
campus fliers and provided continued awareness about the project during the summer months when the contests were 
not being held via posts on social media. The SAB consisted of RIOs at each site where at least one member from each 
organization attended monthly teleconferences to strategize and recruit their peers/members to enter contests and/or take 
a survey. The number of members on the SAB ranged from 2-4 per semester per site. In summary, there were 46 people 
involved in implementing the intervention throughout the study from Fall 2014 until the end of Fall 2016. 
 
Training protocols for intervention personnel: All staff on the core research team took IRB required online CITI 
training modules on Human Subjects Research. The Project Supervisor and GRA were both trained in OD issues by   
reading articles about deceased organ donation process, using the donor.gov website, and reading research articles 
written about educating adolescents and college students about the choice to be a DOD on their “adult ≥ 21 driver’s 
license.  In addition, the research team was trained by Dr. Thomas Feeley during a consultant meeting on how he had 
conducted pledge contests with college students/student organizations to increase student engagement in DOD.  
 
  Recruitment  protocols for study participants to complete surveys and/or enter study contests 
  The intervention’s was designed as open-access; thus, anyone with internet access could read its OD related 
information and view winning contest entrees. However, only undergraduates currently enrolled at a participating 
university, during periods when the intervention was active, were eligible to enter a contest. Entrants to all contests 
agreed to follow contests’ rules and regulations (clicked agree), entered their age (only ≥ 18 y/o eligible), selected 
university they were attending, and provided their university email.   
    Between January 2015 and December 2016, undergraduate students were recruited to enter social media contests 
during the active intervention periods at their site (see Figure 2). The primary recruitment method was email (n = 41,562 
across all contests/all years). Emails were sent to faculty at the sites (to inform students about contests), registered 
student organizations, and previous contests entrants. Both print and online advertisements (n= 1,254) were created for 
contests and appeared in campus newspapers, napkin holders on cafeteria tables, and printed flyers on bulletin boards 
around the campuses. Also, 282 posts were designed by intervention staff and posted on the project’s website and social 
media accounts (i.e., Instagram, Facebook, YouTube). Students were also recruited in person via classroom 
presentations or tables set up periodically at campus centers of active intervention sites.    
 
Design Protocols of eHealth Intervention website:  The home page of the website was designed with three main 
“links” related to Stage of Change and how users felt about organ donation or their reason for coming to the site. For 
example, the link “I’m uncomfortable” provided information for those who were Precontemplators or might be disgusted 

 
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by the thought of OD, while the “I’m interested, need resources” or “I want to win” links provided information for those 
in the action stage and came to the site for resources or to register for a contest.   See Figure 3 on next page:   
 
 
 
 Protocol for Social Media Contests  
   Along with the iDecide Hawaii website, project accounts / pages on various social media sites including Facebook, 
Instagram, and a YouTube channel were created. Facebook and Instagram pages were used to announce the contests, 
and these platforms, along with YouTube, were used to post the winning entries. Links to our social media pages were 
located atop each page of the project website. RIOs/SAB members were asked to “like” or “follow” our pages and 
“share” our posts, so they would be seen by their club members. In order to maximize our social media presence, 
students were asked to post their picture/video entries on their personal accounts and include our project hashtag (e.g., 
#idecidehawaiiphoto). This allowed their “followers” to see the video/picture and to be connected to others’ entries from 
the current and previous contests by simply clicking the hashtag.  
Protocols included total of 15 to 22 contests per site per semester were held during the intervention, with the largest 
number of contests (n=58) being held in the Spring of 2016 when all three sites were active in the intervention (see 
Figure 1). As an indicator of the dose for our gamification protocol, up to seven Instagram picture contests and six 
Instagram caption contests were held per semester, and five YouTube/Instagram video contests. Additionally, an essay 
(first person “reporter” story) contest and a pledge contest (members and any currently enrolled student could pledge on 
behalf of a specific RIO to become a DOD on next license renewal). In addition, two random drawings were held: one in 
the first week of classes at a campus center table, and another at the end of a semester for contest entrants who entered 
but did not win a contest. Finally, a referral program was created where those who won a contest more than two times in 
one semester (and, thus, were no longer eligible to enter that semester) could win a prize by referring another student to 
enter a contest if that student subsequently won. There were nine themes for the Instagram picture/caption contests, and 
five themes for Instagram/YouTube (15-60 seconds) video contests.  
 
Table 1 (see next page)  lists the specific intervention protocols /  themes for each contest on a social media site.   
 
Figure 3.  Website home page   

 
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4)  Statistical Analyses Protocols   
      Two types of data sets would be created: a  cross-sectional set and a longitudinal set. The cross-sectional dataset 
would include data from all surveys at each of the 20 assessment points (see Figure 1). The design allowed for students 
Table1:  Organ donation related themes for Social Media contests 
Theme 
Instagram picture 
contest
Instagram Caption 
contest
YouTube video 
contest
This is what a donor looks like
Sp2015
I’ll do it if YOU do it first! Be an advocate, tell 
someone you know THEY can save 8 lives and 
improve the quality for up to 20 more, just by 
being an organ donor. Spread the word!
Sp2016
Sp2016
Sp2015
Fa2015
Fa2016
Sp2015
Sp2016
Sp2015
Sp2016
Sp2015
Sp2016
Sp2015
Fa2015
Fa2016
Sp2015
Fa2015
Fa2016
Sp2015
Fa2015
Fa2016
Sp2015
Sp2016
What are the odds? You’re more likely to need 
an organ transplant than to be a donor when you 
die
Bust a myth! Find a myth about organ donation 
and expose the truth
Not as many as you think! Only 20% of Hawaii 
college students are designated organ donors
I’m gonna tell MOM! Talk to your mom (and 
other family) about your wishes to be a donor
Sp2015
Sp2015
Fa2015
Fa2016
Sp2015
Fa2015
Fa2016
Sp2015
Fa2015
Sp2016
Fa2016
Sp2015
Fa2015
Sp2016
Fa2016
Hug a Heart!
Go green… recycle yourself!
Sp2016
Sp2016
Be a SUPER HERO! Organ donors can save 8-
20 people
Sp2015
Fa2015
Sp2016
Fa2016
Sp2015
Fa2015
Sp2016
Fa2016
Sp2015
Fa2015
Fa2016
Sp2015
Fa2015
Fa2016

 
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to complete surveys at more than one assessment point.  Due to uniqueness of student email addresses, those with repeat 
surveys could be identified  Thus, students could complete one or more pre-intervention surveys, one or more post-
intervention surveys, or complete  both pre and post-intervention surveys. The longitudinal dataset would include  only 
those students who completed one or more baseline surveys and one or more post-test surveys 
    The primary hypothesis was that exposure to the intervention would increase the percentage of students who reported 
being DODs on license and/or who spoke to their parents about their choice to be (or not be)  a DOD on their license, 
and exposure would also improve knowledge and attitudes about OD. The primary analysis of the cross-sectional data  
used a logistic model of the outcomes DOD status or “talk to parents” regressed on a set of indicator variables reflecting 
each of the 20 assessment points (time by school combinations), adjusted for student’s age, sex, race, and religion. 
Predicted DOD status (or family talk status) was computed from the model for each assessment point and the predicted 
statuses were compared between pre-intervention and post-intervention assessments using a t-test to test the primary 
hypothesis. We also repeated the test within subgroups defined by school and by covariates, such as race, to determine if 
the intervention effect differed by subgroups. Linear models regressing knowledge and attitude scores on assessment 
indicator variables and adjustment factors were used to determine the intervention effect on these scores. 
    The primary analysis models were repeated in the longitudinal sample, accounting for repeated measures. Further, a 
logistic model of post-intervention DOD status was performed among the longitudinal sample where the students never 
reported being a DOD at any pre-intervention assessment. All post repeated measures for these individuals were 
included in one model (allowing for repeated yes answers) and all post repeated measures up until when the first yes 
reported for DOD was included in a second model. The independent variables included the assessment indicators, age, 
sex, ethnicity and religion. The predicted percentage adopting DOD would be obtained from the model and tested 
against 0 using a t-test. This comparison was repeated for each post-intervention time (e.g., 1st post-test) and for each 
school, as well as by subgroups defined by covariates. A similar analysis was performed for the “talk to parents” 
outcome in the subset who never reported having this conversation on any pre-intervention survey. 
     Lastly, in order to determine if the intervention was more effective in students less likely to be a donor, protocols  
stratified the statstical analyses using  a “propensity score” based on static student characteristics. We anticipated that 
students with characteristics making them less likely to become a DOD might be more influenced by our intervention. 
Propensity scores were developed for DOD status by using a logistic regression of DOD status using pre-intervention 
data to determine predictors from among demographic/sociocultural variables (e.g., age, sex, race, religion, place of 
birth, years lived in HI, college year, tuition source, college major, college credits, recruitment method, study site and 
time). The resulting DOD model based on 2129 surveys (Donor: Yes=1137, No=992) included significant factors of age, 
sex, race, college year, religion, and tuition source, using stepwise variable selection. The resulting logistic regression 
equation would then be applied to all surveys to obtain predicted probabilities that were used as “propensity scores.” The 
primary analyses for the cross-sectional data set was performed separately for surveys with a low propensity score < 
50% and for surveys with a high propensity score ≥ 50%. The analyses for the longitudinal data set were also stratified 
by low and high pre-intervention propensity scores, based on the average for students who provided ≥ 1 pre-test survey.