HEALTH SYSTEMS

2021, VOL. 10, NO. 2, 89–103

https://doi.org/10.1080/20476965.2019.1663974

ORIGINAL ARTICLE

Cloud-based multi-media systems for patient education and adherence: a

pilot study to explore patient compliance with colonoscopy procedure
preparation
a
Benjamin Schooley , Tonia San Nicolas-Roccab and Richard Burkhardc
a
Health Information Technology, University of South Carolina, College of Engineering and Computing, Columbia, SC, USA; bSchool of
Information, San Jose State University, San Jose, CA, USA; cBusiness/MIS, San Jose State University, San Jose, CA, USA

ABSTRACT ARTICLE HISTORY

Technology based patient education and adherence approaches are increasingly utilized to Received 18 April 2017
instruct and remind patients to prepare correctly for medical procedures. This study examines Accepted 6 August 2019
the interaction between two primary factors: patterns of patient adherence to challenging KEYWORDS
medical preparation procedures; and the demonstrated, measurable potential for cloud- Mobile computing;
based multi-media information technology (IT) interventions to improve patient adherence. endoscopy; colonoscopy;
An IT artifact was developed through prior design science research to serve information, medical procedure
reminders, and online video instruction modules to patients. The application was tested with preparation; instruction;
297 patients who were assessed clinically by physicians. Results indicate modest potential patient adherence
(43.4% relative improvement) for the IT-based approach for improving patient adherence to
CLASSIFICATIONS
endoscopy preparations. Purposively designed cloud-based applications hold promise for Consumer health
aiding patients with complex medical procedure preparation. Health care provider involve- informatics; ehealth; internal
ment in the design and evaluation of a patient application may be an effective strategy to medicine; mobile
produce medical evidence and encourage the adoption of adherence apps. applications; oncology;
quality and patient safety;
surgery

1. Introduction The focus of this study is to explore the feasibility

and potential effectiveness of a novel, cloud-based
1.1. IT-based e-health approaches for improving
software system to help assist patients in preparing
endoscopy preparation quality
for routine screening procedures and improving
Endoscopies, including both colonoscopies and endos- patient preparation such that the success rate of the
copies of the digestive tract, have become increasingly procedure can also be improved. More specifically,
common in the United States, Europe, and elsewhere. this research reports on a pilot study implementation
The technologies available to gastroenterologists to of a cloud-based instructional intervention to assist
accomplish endoscopies are improving every year, and patient compliance in a routine compliance context –
the procedures are becoming more routine. patient preparation for routine colonoscopy screen-
Colonoscopies, in particular, are strongly recommended ing. Since actual compliance is difficult to verify, we
for every adult in the United States and other countries in use a standardised, physician judged evaluation
order to identify precancerous or cancerous lesions in the instrument of colon evacuation as the most reason-
colon (Bechtold, Mir, Puli, & Nguyen, 2016). able and accurate proxy for patient compliance.
Colonoscopies have the advantage over other clinical As noted in (Saltzman et al., 2015), preparation for
assessment methods in that the endoscopic device allows endoscopies can often be inadequate, especially in
simultaneous use of surgical tools for removing suspi- older patients, leading to termination of the procedure
cious tissue. The endoscopic procedure itself is highly and a failed examination. Inadequate colon prepara-
information systems and technology (IT) dependent, tion has been reported in up to 30% of patients under-
relying on digital video visualisation devices, digital going colonoscopy (Hassan et al., 2013). Preparation
recording of endoscopic images, and other IT dependent for endoscopy is rigorous and is often described as
methods of assisting positioning of the gastroscope and unpleasant, involving fasting from food and consump-
evaluation of the gastrointestinal tract (see, for example tion of prescription solutions that force the evacuation
(Kiesslich et al., 2011)). It is no surprise that IT-based of the gastrointestinal tract over a period of 12 to
e-Health approaches are now being applied to help pre- 24 hours (Bechtold et al., 2016). If the patient delays
pare patients for the endoscopic procedure. or fails to follow the full preparation protocol, the
result can be a failed viewing of the gastrointestinal

CONTACT Benjamin Schooley bschooley@cec.sc.edu Health Information Technology, University of South Carolina, College of Engineering and
Computing, 550 Assembly St, Columbia, SC 29201, USA
© Operational Research Society 2019.
90 B. SCHOOLEY ET AL.

tract by the physician during the procedure. Patients Colonoscopies have become a standard-of-care test,
may not understand the rigorous timing of the pre- recommended for all adults in the United States,
paration protocol, or they may avoid consuming the largely because colorectal cancer is the second leading
bowel clearing solution, or they may contaminate their cause of cancer-related deaths. However, at least 41%
GI tract with food during the period of fasting (Sherer of patients do not receive adequate screening.
et al., 2012; Shieh et al., 2013). Apart from the expense Medical guidelines for colonoscopy are complex and
of a wasted procedure (Butterfly et al., 2016), an are not always easily recalled by non-specialist health
inadequate procedure provides limited or no benefit care providers (Lieberman David, 2016). Despite
to the patient and subjects the patient to subsequent, clear benefits, rates of non-adherence to scheduled
repeated procedures. Thus, medical teams have endoscopy/colonoscopy remain high (Blumenthal,
applied great emphasis on improving preparation Singal, Mangla, Macklin, & Chung, 2015; Kazarian,
rates as nonadherence to preparation instruction has Carreira, Toribara, & Denberg, 2008; Turner et al.,
been shown to predict a poor level of bowel prepara- 2008; Turner, Weiner, Yang, & TenHave, 2004).
tion (Chan, Saravanan, Manikam, Goh, & Mahadeva,
2011). This pilot study explores the potential for 1.2.2. Importance of successful bowel preparation
a cloud-based patient education and reminder system for adequate colonoscopy
to help improve these rates. Sufficient bowel preparation is essential for successful
In the following review, we discuss several relevant colonoscopy exams (Guo et al., 2017). Yet, bowel
themes from the background literature that can preparation is inadequate for >25% of patients
inform understanding of the sociotechnical context (Froehlich et al., 2005; Harewood et al., 2003; Ness,
of the current and potential use of IT to help prepare Manam, Hoen, & Chalasani, 2001; Sherer et al.,
patients for endoscopic procedures. These themes 2012). If the bowel preparation is inadequate, all
include the importance of patient adherence and measures of completeness of the exam are reduced
associated benefits and risks and the role of IT in and repeat exams are often needed, leading to
enabling or enhancing patient adherence. In addition, expected increases in overall costs and possible lack
we mention the role of IT in motivating patients of follow-up by patients (Fadel, Shayto, & Sharara,
more generally. The review looks at the possible role 2016; Johnson et al., 2014; D. Rex, Imperiale,
of digital IT tools in fear mitigation for patients. Latinovich, & Bratcher, 2002; Sharara & Mrad, 2013).
Following the review are discussion of the methods The endoscopy and colonoscopy exam preparation
and results of the study, and its usefulness for future process has many steps. It includes the time from the
efforts in improving the clinical results of endoscopic initial interaction between the physician or other
evaluation. healthcare provider and the patient until the actual
start of the exam, which proceeds with one of several
types of sedation and insertion of the endoscope,
1.2. Review of prior research
colonoscope or sigmoidoscope. Patients must be
1.2.1. Endoscopies are routine healthcare scheduled, and plans are made for the type of seda-
procedures that may benefit from e-health tion and other patient-specific requirements. In all
interventions cases, the medical team strives to reduce risks to the
Colonoscopy is widely used for the diagnosis and patient as much as possible (D. K. Rex et al., 2006).
treatment of colonic disorders. Properly performed The quality of colonoscopy preparation by patients
colonoscopies are generally regarded as acceptably is often evaluated formally at the time of colonoscopy
safe, accurate, and well tolerated by most patients procedure. Many large medical practices require doc-
(D. K. Rex et al., 2006). The quality of the pre- umentation of the adequacy of preparation, (Lai,
procedure preparation affects the ability of the physi- Calderwood, Doros, Fix, & Jacobson, 2009), both as
cian to perform a complete examination, the duration an effort to improve clinical quality and as a defence
of the procedure, and the possible need to cancel or against possible legal liability. In many cases, bowel
reschedule procedures. For example, the effectiveness preparation was found to be inadequate or poor (Lu,
of colonoscopy procedures in reducing the incidence Decker, & Connolly, 2015).
of colon cancer is dependent upon adequate visualisa-
tion of the colon (ideally, the entire colon), and careful 1.2.3. Fears of endoscopy lead to avoidance, and
and thorough examination by the physician of the non-compliance
intestinal mucosa (Fadel, Shayto, & Sharara, 2016; Surgeries often elicit patient fears. Endoscopies are
Froehlich, Wietlisbach, Gonvers, Burnand, & Vader, considered statistically safe procedures, but they are
2005; Harewood, Sharma, & de Garmo, 2003). medically classified as surgeries. A recent study of the
The consistent performance of quality colonosco- Mayo Clinic summarise some general attitudes about
pies is seen as key to improving health care quality fears associated with minor surgeries that did not
and reducing its long-term costs (D. Rex et al., 2014). require rigorous preparation, such as cataract surgery,
 HEALTH SYSTEMS 91

and found that roughly 10 to 25% of patients experi- recent study noted fear of pain, nausea, and needles as
enced significant fear in advance of the procedure primary sources of preoperative anxiety. Fear of anaes-
(Burkle et al., 2014). In the current study, fear of thesia was found among more than 80% of patients
the rigorous preparation may exceed fear of compli- (Mavridou, Dimitriou, Manataki, Arnaoutoglou, &
cations or difficulties related to endoscopy itself, Papadopoulos, 2013). In another study, authors found
resulting in a higher percentage of patients with fear that the best predictor of pre-procedure acceptability of
and possible avoidance or non-adherence behaviours. colonoscopy was anticipated pain (Condon, Graff, Elliot,
Fear of medical procedures has been associated & Ilnyckyj, 2008). Patients who undergo endoscopic
with negative outcomes of the procedure, although biopsy suffer anxiety until results are confirmed.
the extent of this effect is not well measured or Introducing written material post procedure has had
understood (Feuchtinger et al., 2014). In some situa- mild effects on patient anxiety (Kim et al., 2016).
tions, when general instructional methods of provid- In some areas of the world, lower income and
ing information and other cognitive approaches have education levels are associated with higher levels of
been tried with more extensive surgeries, the effec- fear and resistance to elective surgeries. A lack of
tiveness seems to be improved when it is focused on education about the surgical process itself may
the individual needs and questions of the particular engender avoidance behaviours and resulting lack of
patient (Burkle et al., 2014). A general theme of this adherence to medical recommendations (Kovai,
research stresses the importance of highly focused Prasadarao, Paudel, Stapleton, & Wilson, 2014).
messages such as those included in the online instruc- Instructional approaches are needed to help address
tional modules used in this study. these fears and anxieties.
Typical bowel preparation using propylene glycol
or other cleansing agents is expected to cause unplea- 1.2.4. IT approaches to improving colonoscopy
sant reactions in nearly all patients. Typical reactions outcomes
include nausea, bloating, diarrhoea, electrolyte imbal- Prior IT research contributions for endoscopy pre-
ances and possible dehydration (Scabini et al., 2010). paration have focused on computerised screening,
Patients looking for background on pre-endoscopy recommendations, and follow-up. For example, com-
preparation will certainly see this information online. puterised solutions have been studied for aiding pro-
Despite the widely available information on vider colonoscopy screening decisions and
unpleasant side effects of bowel prep, it is important recommendations. In one study, researchers devel-
that the patient accept the procedure and comply oped a guideline based clinical decision support sys-
with the rigorous preparation protocols. However, tem (CDSS) that made acceptable recommendations
patients have consistently expressed concerns about for colonoscopy screening in 48 of 53 cases, and
endoscopy procedures. Patient anxiety level has been helped the gastroenterologist revise the recommenda-
found to be a predictor of patient cooperation during tion in 3 cases (Wagholikar et al., 2012). In another
endoscopy exams (Mahajan & Johnson, 1997). study, a six variable model (based on patient demo-
Patient concerns and fears about endoscopy com- graphics and clinical information) was developed to
monly include fear of sensory/discomfort (such as predict colonoscopy patient non-adherence
pain, gagging, needles) (Drossman et al., 1996; (Blumenthal et al., 2015). In a separate study site,
Subramanian, Liangpunsakul, & Rex, 2005); fear of researchers found that an electronic medical record-
adverse outcomes (such as the possibility of finding based decision tool could safely and effectively tailor
cancer, leading to a need for surgery); fear of medical colonoscopy preparation recommendations and
mistakes and their consequences (such as not enough potentially improve colonoscopy efficiency and
sedation, procedural accidents, insufficient knowledge patient satisfaction (Imperiale, Sherer, Balph,
about the procedure, possibility of a need for addi- Cardwell, & Qi, 2011).
tional procedures) (Hagiwara et al., 2015); and other Other systems have aided in post endoscopy ana-
fears (fear of physicians, concern about others watch- lysis. The Parkland colonoscopy reporting system
ing the procedure). Patients often have multiple con- relates individual patient records with colonoscopy
cerns, identified in more than one category (Brandt, findings, providing follow-up recommendations for
2001; McEntire, Sahota, Hydes, & Trebble, 2013). patients. Endoscopists agreed the system was usable
In the development of a focused surgical fear scaling (83%), made their work easier (61%), and led to
questionnaire, researchers noted that presurgical fears improved practice (56%) (Skinner et al., 2016).
can arise from more than 20 objects of fear, including Electronic communication reminders have been
fear of anaesthesia, losing dignity, and pain or discom- used in endoscopy follow-up cases to address
fort. The endoscopy preparation regime is known to be patients’ short-term adherence to medication direc-
uncomfortable to many (Theunissen et al., 2014). These tions (Vervloet et al., 2012). As endoscopy is consid-
concerns contribute to ineffective bowel preparation and ered a medical test standard for making clinical
missed exam appointments (Bhise et al., 2016). One decisions, providers increasingly expect that related
92 B. SCHOOLEY ET AL.

patient communications, documentation, and report- attainment, and health literacy seems to be the key
ing be in electronic format. For example, emergency influence. Thus any method of intervention that
physicians noted their preference to receive endo- improves health understanding about colonoscopy
scopy reports via an electronic record whenever pos- preparation, including the online instructional mod-
sible (Shapiro, Kannry, Kushniruk, & Kuperman, ules used in this study, would be expected to favour-
2007). ably influence the quality of adherence to the
preparation protocol (Ojinnaka et al., 2015).
1.2.5. Patient education to improve adherence,
reduce patient anxiety, and improve bowel 1.2.6. Computerised or media enhanced
preparation instructions (EI) improves bowel preparation
Patient education is important to reducing patient A recent meta-analysis found a total of eight studies
anxiety and increasing adherence to scheduled endo- that set out to compare bowel preparation quality
scopy and bowel preparation for the exam. In several between patients receiving regular instructions (i.e.
studies, patient pre-procedure education has been verbal and/or written pamphlet) and enhanced
shown to reduce anxiety levels (Kutlutürkan, instructions (i.e. phone calls, videos, cartoons, 3D
Görgülü, Fesci, & Karavelioglu, 2010; Maguire, images) together with regular instructions. The
Walsh, & Little, 2004). In addition, a wide range of study found benefits from EI irrespective of purgative
education and communication interventions have medication types, instruction administration meth-
been found to improve patient comprehension ods, or diet restriction, leading to greater patient
(Schenker, Fernandez, Sudore, & Schillinger, 2010). willingness to repeat bowel preparation, concluding
Some educational modes used to communicate with that EI are an important factor in achieving adequate
endoscopy patients in prior studies include using preparation (Guo et al., 2017).
cartoon images (Tae et al., 2012), educational book- Telephone based re-education on the day before
lets (Spiegel et al., 2011), educational pamphlets colonoscopy has been found to effect the quality of
(Shaikh, Hussain, Rahn, & Desilets, 2010), simple bowel preparation and polyp detection rates (X. Liu
visual aids (Calderwood, Lai, Fix, & Jacobson, 2011), et al., 2014), while video based instruction has also
and telephone-based education and reinforcement on been shown to positively impact bowel preparation
the day before colonoscopy (X. Liu et al., 2014). relative to traditional preparation instruction (Park
These studies found these various educational meth- et al., 2016). In a clinical trial, researchers found that
ods reduce patient anxiety, may lead to reduced seda- computer assisted instruction before colonoscopy was
tive use during the procedure, and improve colon and at least as beneficial as standards-based nurse coun-
bowel preparation. Music has also been tested as an selling for achieving cleanliness of the colon.
intervention to decrease patient anxiety, pain, and Outcome measures included using the Ottawa
medication dosage (Martindale, Mikocka-Walus, Bowel Preparation Scale (OBPS) and the Boston
Walus, Keage, & Andrews, 2014). Bowel Preparation Scale (BBPS) (Veldhuijzen et al.,
Adherence to instructions is essential for adequate 2014).
bowel preparation. Better patient education prior to Several studies have looked at computer-based
colonoscopy improves adherence to instructions for education as a strategy for improving adherence to
bowel preparation and leads to cleaner colons exam prep instructions (Lewis, 1999). In one early
(Veldhuijzen, Klemt-Kropp, Noomen, Van Der study an interactive videodisc program with graphics,
Ploeg, & Drenth, 2014). In a recent meta-analysis of video, and audio was created to provide preproce-
randomised controlled trials of over a thousand dural education for patients who would be under-
patients, the adequacy of bowel preparation adher- going endoscopic procedures. The system appeared
ence was strongly influenced by educational interven- to assist comprehension for persons with limited
tions. Inadequate preparation due to noncompliance reading ability (Pernotto, Bairnsfather, & Sodeman,
was addressed in all nine of the studies in the meta- 1995). Similarly, a recent meta-analysis presented
analysis through non-computerised means such as a series of prior studies in which education videos,
telephone, phone message, and conventional mail. audio-visual, and enhanced mechanisms (e.g. text
None of the studies used advanced online instruc- messages, telephone, smartphone apps) demonstrated
tional modules of the type that are the subject of the positive effects related to educational understanding,
current study (Chen-Wang Chang1 et al., 2015). adherence, and bowel cleanliness (Z. Liu, Zhang, Li,
Health literacy has also been a clearly identified Li, & Li, 2017).
influence on cancer screening via colonoscopy. Lower In one mobile device focused study, an iPhone
educational levels are associated with lower health application was developed and used by a test group
literacy, which in turn is associated with lower rates (n = 108) to provide timed alerts for bowel prepara-
of colonoscopy screening. Colonoscopy screening tion, a text explanation of the procedure, dietary
rates are lower in those of low educational examples, tips for bowel prep, and an educational
 HEALTH SYSTEMS 93

video. The control group (n = 152) was provided Hypothesis: Patients who used and completed the
printed instructions with visual aids. Outcomes were study’s targeted IT-based training emails/video series
assessed using the Harefield Cleansing Scale. Modest for colonoscopy prep will have a higher rate of prep
improvements in quality of bowel cleansing were success, as measured clinically by physicians at the
observed in the smart phone application group vs time of procedure, than patients who have not received
the control group (100% vs 96.1%, p = 0.037). Mean the targeted IT package.
scores were similar in both groups. Patient accept-
ability was also higher in the test group (Lorenzo- The dependent variable in this study is a physician-
Zúñiga, Moreno de Vega, Marín, Barberá, & Boix, judged colon cleanliness score using a standard four-
2015). The app was only accessible to patients who point scale. The cleanliness score is the most feasible
used the iPhone and included just one video for and accurate proxy for patient compliance. The inde-
preparing patients for the purgative solution. pendent variable is patient membership in one of two
Social media application technologies were among groups: The intervention group, which viewed the
others tested on patients in China. Patients were timed, sequential multi-media cloud-based IT inter-
randomly assigned to groups that received standard vention, or the non-intervention group, which
education along with delivery of interactive informa- received the standard printed instruction routinely
tion via social media (n = 387) or standard education provided for colonoscopy patients. Thus, the depen-
only (n = 383). A higher proportion of patients in the dent variable and independent variable are the stan-
group that received social media instruction had 1) dardised, physician-rated cleanliness score and the
more adequate bowel preparation than those in the completion of the ICT intervention, respectively.
control group (82.2% vs 69.5%, P < .001), 2) Large numbers of medical studies (as opposed to
improved completeness indicators and identification this pilot study) address the complex issues behind
of problematic growths, and 3) higher subjective preparation adherence problems. The bowel cleans-
measures of bowel prep adequacy (Kang et al., 2016). ing agents were assigned by the physicians as part of
This study sought to deliver, and pilot test a more the standard medical protocol for routine colonosco-
widely accessible cloud-based mobile-web adherence pies at the clinic and are not a variable in this study.
application via an Internet browser than other studies
we could find. Second, our model provided for more
2.2. Setting
multi-media video-based instruction than other
mobile or app-based studies we could find. Further, The data for exploring and quantitatively evaluating
we provide a detailed explanation about the design the hypothesis for this study were collected in a large
and functionality of the technology intervention to Western outpatient gastrointestinal endoscopy clinic
provide essential knowledge about the integrated in the U.S. The hospital and clinic complex has 350
design and features of the artefact meta- acute-care beds and is staffed by more than 370
requirements – an important component for physicians.
a design research methodology and precursor to arte-
fact demonstration and evaluation (Peffers,
2.3. Patient population and screening
Tuunanen, Rothenberger, & Chatterjee, 2007).
Without understanding the scope of technologies or This was a prospective randomised controlled trial,
process used in prior intervention studies, it can be single-blinded (endoscopist). Patients aged 18 or older
difficult to assess the extent to which the technology receiving routine care at the outpatient clinic were
was a major factor in adherence. This study applies eligible for this study if their physician prescribed or
a software application that was designed, developed, the patient requested a regular routine elective colono-
and evaluated by the research team in prior studies scopy; could read, speak, and understand English; were
(San Nicolas-Rocca, Schooley, & Joo, 2014; Schooley, owners of a smartphone or home computing device
San Nicolas-Rocca, & Burkhard, 2015); and then pilot connected to the Internet; and were willing to partici-
tested in a live clinical setting for this study. pate in the study. Written informed consent to partici-
pate in the study was obtained from all participants.
Detailed study participation instructions were provided
2. Research approach by a well-trained medical staff member.
Participants were selected by convenience sample and
2.1. Hypothesis
randomly placed into study and control groups by the
To investigate the potential for IT-based systems to outpatient clinic medical staff from the routine patient
address the chronic problem of partial or inadequate stream for colonoscopy/endoscopy. All patients were
colonoscopy preparation, this study proposes the fol- pre-screened by the outpatient gastroenterology team
lowing hypothesis, which is evaluated in the study: for potentially inhibiting medical conditions, co-
morbidities or communication difficulties that might
94 B. SCHOOLEY ET AL.

inhibit their participation in the study. Symptom pre- (San Nicolas-Rocca et al., 2014) and assess the utility
screening by the medical staff excluded patients exhibit- and acceptance of the system (Schooley et al., 2015).
ing or reporting significant gastrointestinal bleeding, Prior phases of design followed a design science
diarrhoea, constipation, nausea, discomfort or pain. research framework that included artefact construc-
This was meant to exclude patients with acute or tion, implementation, evaluation and extension of the-
known chronic gastrointestinal diseases that might sig- ory (Hevner & Chatterjee, 2010). Field research
nificantly complicate the bowel cleansing process. involved qualitative interviews and focus group ses-
Specific known conditions screened out of the study sions with adult patients and clinicians. Once the
included colon cancer, gallstones, coeliac disease, crohn’s application reached a mature level of development, it
disease, ulcerative colitis, irritable bowel syndrome, was beta tested in a free clinic with medical staff
diverticulosis, cirrhosis, and other similar but more rare providing face-to-face, in-person patient education
conditions. No hospital inpatients were selected for this using the cloud-based application (Schooley et al.,
study, thus excluding a wide range of acute gastrointest- 2015). A qualitative evaluation then revealed addi-
inal diseases and conditions. As the focus of the research tional, new system features desired by users that were
was to conduct a pilot study to explore the feasibility of incorporated into the cloud-based system that was
an IT-based instructional program rather than assess the then pilot tested in a clinical setting with patients in
efficacy of a medical procedure, the study relied on the the study reported herein. The novel cloud-based sys-
medical expertise of the clinic for the screening of tem included the following features: a web-based user
patients to exclude medical conditions that are known interface for medical office staff and patients; medical
to complicate bowel preparation beyond the issue of office staff capability to select video instruction for
patient non-compliance with preparation procedures. each patient; staff-initiated email/text message invita-
The same exclusion criteria were applied to both the tions with links to online instructional videos for
study and control groups. Further, the intervention was patients; automated patient motivational reminders;
not assigned by the medical team to participants who and tracking of video watching (see Figure 1). Patient
could not easily view or listen to the video content and responses about the usability and satisfaction of using
the gastroenterologists were not aware of which type of the system were collected, summarised, and cate-
instruction patients received. gorised by recurring themes by medical office staff.
Independent risk factors that have been identified in Reported benefits to system use included patients
some prior studies to have significant effect on bowel reporting good understanding of instructions,
cleansing include male gender, age, and inpatient status improved visualisation and clarity of instructions,
(Hassan et al., 2013; Hsueh et al., 2014). A model based help with remembering and clarifying when and how
on these factors correctly predicted inadequate colon to proceed with instructions, and that system use
cleansing in 60% of patients (Hassan et al., 2012). As helped to ease concerns and worries with the proce-
such, gender and age data were collected and, as noted dure. Further, medical staff reported that patients
above, all patients were outpatient status. appreciated receiving videos specific to their needs
and procedures. Challenges to system use included
some annoyance with too many timed reminders,
2.4. Cloud-based IT intervention
occasional technical difficulties accessing videos from
Two prior studies by the research team documented timed reminders (e.g. from text messages), the need
the rigorous user-centred process to gather require- for staff to provide technical instruction for those with
ments, iteratively design the IT-based software system less computer device experience, and some patients

Figure 1. Cloud-based information technology package for patient education and reminder delivery.
 HEALTH SYSTEMS 95

still wanting to validate instructions with medical staff and, like the other modules, could be paused and
regardless of watching videos. Medical staff reported replayed part or in entirety as needed by the
that they experienced fewer phone calls requiring clar- patient.
ification of instructions from patients using the cloud- An additional module covered conscious sedation
based system. and procedural sedation. Conscious sedation involves
a small amount of anaesthesia and offers a faster
recovery time. This video includes discussion of
2.4.1. Digital, online, repeat-access videos a physician assigned to anaesthesia, who monitors
intended to improve endoscopy preparation patients’ vital signs and is prepared to quickly bring
All videos were prepared with a target reading, lan- a patient out of sedation, if needed.
guage, and comprehension level equivalent to The last online instructional module covered
a fourth-grade education in the United States. the very specific gastrointestinal prep procedures
Further, the videos were scripted and developed that all patients must follow to clean out their
with the intent to reduce patient anxiety and fear. digestive tracts prior to endoscopy. In addition,
Videos were scripted, filmed and composed with a video on conscious sedation was provided, so
extensive additional graphics to explain in simple that patients could learn about the procedure.
but clear terms the endoscopy pre-procedures and Thus, the planned sequence of instructional mod-
the preparation routine expected of patients. Audio ules included three to four modules, delivered as
delivery was presented by videos of physicians speak- links via email or text message over the days pre-
ing in reassuring tones about all aspects of the pro- ceding the procedure.
cedure. Three or four (as determined by the specific Digital video title screens visible to patients via the
medical procedure schedule) online instructional web application are shown in Image 1.
modules were introduced in sequence in the days
preceding the endoscopic procedure (see Table 1).
2.5. Participant procedures
Thus, the video choices were tailored to the needs
of the patient based on the planned procedure for For the study group, links to videos, reminders and
that patient. The online instructional modules cov- motivational emails, and text messages were com-
ered four topics: posed to be delivered to participants at specific
First, an online instructional module covering gen- times prior to the procedure to educate and remind
eral endoscopic purposes, procedures and methods patients to follow the preparation protocol. Each
was delivered to patients scheduled for a procedure. email included links to the sequenced set of three to
This initial instructional module could be paused and four videos (see Figure 2). Emails, text messages, and
replayed in part or in entirety as many times as video content were delivered via a cloud service as
necessary to satisfy the patient. a set of web-based applications and scheduled by the
Second, each patient was sent an online instruc- physician office staff via a physician office adminis-
tional module that was specific to his/her proce- trator interface (see Figure 1 for illustration).
dure, which would either be upper gastrointestinal The team was able follow the patient’s progress in
endoscopy or lower gastrointestinal endoscopy. viewing the videos by viewing the patients’ access logs
These modules were 1:58 to 3:52 minutes in length to the videos. The essential scenario for an interven-
tion patient will be a patient who successfully viewed
all the online instructional modules. Patients could be
Table 1. Digital video content. assigned to lower or upper endoscopy videos,
Duration
Topic (min) Primary objectives
depending on the procedure scheduled. Patients
Upper 3:28 Educates patients, answers major assigned to both upper and lower endoscopies
endoscopy questions, and is intended to reduce watched a total of four videos. Participant bowel
anxiety
Lower 3:52 Educates patients, answers major
cleanliness was assessed by the physician at the colo-
endoscopy questions, and is intended to reduce noscopy clinic at the time of the procedure (see
anxiety Figure 2 for study group procedure).
Conscious 1:58 Educates patients, answers major
sedation questions, is intended to reduce Since the feasibility and preliminary indicators of
anxiety, and alerts patients to effectiveness of this IT-based instructional interven-
possibility of problems in sedation and
the capability to immediately provide tion are intended to reflect a typical scenario for
an antidote to the sedation, if routine screening colonoscopy, the intervention was
necessary
Preparation for 3:04 Educates patients, answers major viewed by patients in their homes, and the procedure
colonoscopy questions, with a primary focus on preparation cleansing agent adherence behaviour was
instructions for the rigorous
preparation protocol and the
also performed by patients in their homes. Only the
importance of strict adherence to the colonoscopies were performed in the medical envir-
protocol onment in the presence of the physician.
96 B. SCHOOLEY ET AL.

Image 1. Digital video title screens.

Figure 2. Sequence of events in study procedures for study group.

The control group received written instructions If this procedure is followed only partially, or with
from medical office staff including visual aids explain- incorrect timing, or not at all, the endoscopic proce-
ing the procedure and when to begin self- dure may be impaired. As we have noted, many pre-
administration of the bowel cleansing solution. existing factors affect the understanding, motivation,
Phone call reminders were provided as a standard and fear associated with endoscopy and endoscopy
practice prior to the procedure. preparation that will affect patient actions at the time
of the preparatory procedure. When the endoscopy
(upper G.I. endoscopy or lower G.I. colonoscopy) is
2.5.1. Bowel preparation process
executed in the clinical facilities by the surgeon gas-
Since endoscopy procedures require rigorous pre-
troenterologist, the physician has the opportunity to
paration to be successful for the surgeon gastroenter-
evaluate the state of preparation of the patient G.
ologists executing the procedure, the surgeon requires
I. tract. If it is clean it is suitable, but if it is unclean
that the gastrointestinal tract, either upper G.I. or
it is difficult or impossible to proceed. For this study,
lower G.I. or both, be thoroughly clean so that the
physicians at the gastrointestinal endoscopy centre
surgeon can visualise the tissues with the endoscopic
rated G.I. tract cleanliness at the time of
devices. As noted, in many cases the preparation
a participants’ procedure using the standardi
procedures are not followed correctly. The result is
sed Boston Bowel Preparation Scale (BBPS)
that the ability to visualise tissue is impaired or made
(Calderwood & Jacobson, 2010; Lai et al., 2009).
impossible. The success of this preparation is almost
entirely dependent on the patient, who must follow
a disagreeable protocol for at least 24 hours prior to
3. Results – evaluation and findings
the procedure that requires fasting, drinking only
clear fluids, and ingesting a prescription solution Patients were identified, invited to participate, and
intended to evacuate the entire gastrointestinal tract. then assigned to a control group (n = 202) and an
 HEALTH SYSTEMS 97

intervention group (n = 95) as shown in Table 2. Table 5. Intervention and control groups – primary outcomes.
Mean ages for the Control and Intervention groups Acceptable Inadequate/
Adherence failed adherence
were 60 and 55, respectively, as shown in Table 3. Intervention Status – Groups n (%) (%)
Coding of the clinical outcomes by the examining No intervention (control 202 85.15 14.85
physician followed a four-point scale as shown in group) (P1)
IST-based instructional 95 91.58 8.42
Table 4. The coding scale is modelled after the stan- intervention (intervention
dardised Boston Bowel Preparation Scale (BBPS) used group) (P2)
in gastroenterology (Bechtold et al., 2016) having Test of proportions: z = −1.547; p = 0.0609 (α level 0.10,)
received good intra- and interobserver reliability
assessments in prior studies (Calderwood &
Table 6. Relative improvement in clinical outcome.
Jacobson, 2010). The scale coding and its relation to Percent Percent Percentage Relative improve-
the BBPS is shown in Table 4. As in other studies Group Success Failure ment in Clinical Outcome
noted above, the clinical coding scale was used to Control 85.15 14.85 n/a
IT Intervention 91.58 8.41 43.4
classify bowel preparation as adequate or inadequate
prior to data analysis.

3.1. Analysis – results of adherence. The overall result in this pilot study is
a 43.4% decrease in bowel prep failures in favour of the
There were 202 patients in the control group (P1) with intervention group (see Table 6). The left-tailed z-test
172 (85.15%) acceptable cases and 30 (14.85%) inade- of two proportions was used to test the following null
quate cases; and 95 patients in the intervention group (0) and alternative (a) hypotheses: H0: P1 ≥ P2; Ha: P1
(P2) with 87 (91.58%) acceptable cases and 8 (8.42%) < P2. The rejection region for this left-tailed test is
inadequate cases (see Table 5). The clinical results for R = {z:z < −1.28}. The results are tested at a preselected
the control group showed a 14.85% inadequate or 0.10 alpha level that is often used in preliminary stu-
failed preparation, suggesting failed adherence to the dies with smaller sample sizes (Mcdonald, 2014) and
protocol. The IT-based intervention group showed interpretable as suggestive of a significant effect in
a smaller 8.42% clinically assessed inadequacy/failure a preliminary study. For the H0 of this study, we
found z = −1.547 < zc = −1.28 and p = 0.0609 < .10.
Table 2. Control and intervention groups. It is then concluded that the null hypothesis is rejected.
Clinically Therefore, there is enough evidence in support of the
Qualified evaluated alternative hypothesis, to claim that the population
Group Qualification n n
proportion P1 is less than P2, at the .10 significance
Control No online instructional modules 202 202
Intervention Validated opening and access to 95 95 level. For the test of gender proportions, we found
all three online instructional z = 0.877 and p = 0.3803 (two-tailed test of two pro-
modules
Total n/a 297 297 portions), which is not significant at the 0.05 alpha
level. Analysis of age also showed no significant
differences.
Table 3. Demographics: Age and gender of control and
intervention groups.
4. Discussion and conclusion
Group Mean, Median Age Gender M, F (%)
Control 60, 61 years M 45%, F 55% This study explored the background and some
Intervention 55, 58 years M 43%, F 57%
important influencers of endoscopy/colonoscopy

Table 4. Coding of clinical outcomes as evaluated by physician in the clinical setting.

Physician- Interpretation in terms of Coding for
assigned code Clinical interpretation adherence analysis Boston Bowel Preparation Scale Code and Description1
G (Coded 4) Good preparation Patient adherence to protocol – Confirmed (3) Entire mucosa of colon segment seen well, with no
High adherence residual staining, small fragments of stool or opaque
liquid
A (Coded 3) Adequate Patient adherence to protocol – Confirmed (2) Minor amount of residual staining, small fragments
preparation Adequate adherence of stool, and/or opaque liquid, but mucosa of colon
segment is seen well
F (Coded 2) Fair preparation (less Patient adherence to protocol – Inadequate/ (1) Portion of mucosa of the colon segment seen, but
than adequate) inadequate Failed other areas of the colon segment are not well seen
adherence due to staining, residual stool, and/or opaque liquid
P (Coded 1) Poor preparation Patient adherence to protocol – Inadequate/ (0) Unprepared colon segment with mucosa not seen
poor – non-adherence Failed due to solid stool that cannot be cleared
adherence
1
From (Lai et al., 2009)
98 B. SCHOOLEY ET AL.

preparation adherence, including context-specific Thaweethai, & Phillips, 2011), while another study
motivation for patients, fear of medical procedures, found that diabetes self-management apps for treat-
patient memory, and related factors. A multi-media ment compliance do not conform to evidence-based
cloud-based system was designed through multiple recommendations (Breland, Yeh, & Yu, 2013).
prior phases of research to account for these influ- Further, most medical mobile phone apps lack expert
ences with the goal of improving patient education involvement in their design and development and do
and adherence. This study presented findings from not adhere to relevant medical evidence (Subhi et al.,
a pilot test of the cloud-based system for facilitating 2015). As such, it should not be surprising that few
preparation adherence that requires active participa- free and/or commercial adherence applications pro-
tion by medical staff and patients. The study also vide clinical evidence for their effectiveness.
provides preliminary effectiveness data that suggests A recent study that evaluated over 620 adherence
possible improved adherence to procedure prepara- apps found that just 66 were developed with health
tion requirements. care provider (HCP) involvement while an evidence
The study used two patient groups totaling 297 base for the apps were identified in only 5 apps. Just
individuals, with 95 in the study group with con- one app had both HCP involvement and an evidence
firmed use of the IT intervention, who were then base. The authors concluded:
evaluated clinically for the quality of their endoscopy
“The results demonstrate a concerning lack of health
preparation results using a standardised four-point care provider involvement in app development and
scale. The difference in group sizes is based on the evidence base of effectiveness. More collaboration is
results made available by the medical staff and is of required between relevant stakeholders to ensure
no significance other than that the larger development of high quality and relevant adherence
n strengthens the analysis. The results indicate support apps with well-powered and robust clinical trials
of the alternative hypothesis, and are suggestive of investigating the effectiveness of these interventions.”
(Ahmed, Ahmad, Ali, Ali, & George, 2018)
a modest effect from patient use of the IT intervention
on patient adherence to the protocol required for endo- According to the results from these authors, our
scopy preparation. research study provides an important contribution
This research provides several important contribu- in that its development included HPC involvement
tions. First, the role of information systems to in the design (as reported in prior published reports)
improve patient engagement and adherence to med- and in the clinical evaluation of the app, while also
ical instructions has gained a great deal of attention producing a modest evidence base for its use employ-
in practice and in the research literature. As noted in ing a patient centred pilot study and human trial.
the literature presented in this paper, patient adher- An important contribution of this study’s evalua-
ence to medical instructions poses a significant chal- tion is that patient adherence was evaluated clinically,
lenge for patients, providers and health systems alike. during and after the endoscopic procedure, by gastro-
Endoscopy preparation, inclusive of medication tak- enterologists who performed the procedure. Thus,
ing and other behavioural actions required (i.e. fast- this study evaluated associations between utilisation
ing), is one such context where adherence is often of the cloud-based application inclusive of comple-
low. This research addresses a critical need to develop tion of the online digital module bundles and success
accessible and practical information systems inter- of the visualisation of the gastrointestinal tract by the
ventions to improve adherence for use in outpatient doctor. The measure of outcome was a purely objec-
oncology settings where the majority of patients tive clinical evaluation of preparation effectiveness.
receive care. The methodology presented in this specific study
Second, this research addresses important gaps. was that of a randomised controlled trial, conducted
Prior research has found that the development of within the context of a larger, multi-year, multi-
most medication adherence apps may not include phase, design science research approach. We describe
important advances in the theory and practice of the suite of applications that were developed through
health behaviour change (Morrissey, Corbett, Walsh, prior phases of end-user participatory design research
& Malloy, 2016). We have considered behavioural, that included a set of integrated features for patient
psychological and memory-based inhibitors to education and adherence. We then extended our
patient adherence to endoscopy preparation in our results from prior phases of work to conduct the
app design. In addition, apps to motivate adherence pilot test implementation and evaluation reported in
and/or behaviour change relative to medical instruc- this manuscript. The results of this study provide
tions are often not designed rigorously as specified by some evidence that comprehensive information sys-
well-established design science approaches. For tems, designed rigorously following a design science
example, one study found that smoking cessation methodology, may aid patients in overcoming known
app designs rarely adhere to established guidelines anxieties and fears to comply with rigorous prepara-
for smoking cessation (Abroms, Padmanabhan, tion procedures. Thus, this study contributes to the
 HEALTH SYSTEMS 99

growing body of evidence that posits that using Slomski, 2018). Further, education alone has been
a clinical measure for the evaluation of a multi- found to be an insufficient intervention to promote
phase design science research effort may be an effec- adherence to medication regimens (Burhenn &
tive strategy for health information system research- Smudde, 2015). Rather, Burhenn and Smuddle
ers. Many evaluations provide technical validation, (2015) proposed that multicomponent, multi feature
human evaluation via surveys, observation, user app interventions provide improved adherence and
experiments, interviews, or focus groups. This paper that design and experimentation with various patient-
provides a much-needed contribution to the growing centred functionalities is important for discovering
number of design science research efforts that include successful digital engagement models. This study pro-
clinical oriented evaluations as part of a pilot study. vides evidence in support of such a proposition.
Applying a design science approach for multi-phase For health information systems researchers, this
studies such as the one presented herein may produce study also provides an example of how clinical
convincing evidence in support of their use. This oriented evaluations may be challenging to conduct
study supports such a notion. for health IT applications that have a breadth and
An important consideration for practitioners and variety of functionality bundled together. Although
researchers alike is the design and evaluation IT applications have been applied within patient edu-
approach of the artefact described and tested herein. cation settings for many years, the IT intervention
The system design included the following features: evaluated in this study offers some differentiation by
a web-based user interface for both medical office providing an integrated approach to planning, edu-
staff and patients; medical office staff capability to cating, motivating, reminding, and explaining to
select video instruction for each patient; staff- patients both visually and in text the nature of the
initiated email/text message invitations with links to preparation for endoscopy and its importance for
online instructional videos for patients; automated patient health for avoidance of subsequent do-again
patient motivational reminders; and tracking of procedures. As health IT systems continue to become
video watching (see Figure 1). Specific to endoscopy, more complex and integrated, evaluation methods
this study pilot tested a more widely accessible cloud- will need to address this complexity using a range
based mobile-web adherence application via an of methods and approaches. Using a clinical measure
Internet browser than other studies we could in a pilot study context may be one important way to
find. Second, our model provided for more multi- address such complexity. As of the date of this article
media video-based instruction than other mobile or submission, we have not found a published study that
app-based studies we could find. Further, we provide examines the effectiveness of a comprehensive infor-
a detailed explanation about the design and function- mation system such as the one described herein clini-
ality of the technology intervention to provide essen- cally for endoscopy preparation adherence. Yet, such
tial knowledge about the integrated design and comprehensive systems are becoming more prevalent
features of the artefact meta-requirements – an in the marketplace and thus a pilot evaluation in this
important component for a design research metho- regard represents an important and interesting con-
dology and precursor to artefact demonstration and tribution to the existing literature on health IT inter-
evaluation (Peffers et al., 2007). Without understand- ventions and may also provide some validation to
ing the scope of technologies or process used in prior practitioners currently using such systems. Future
intervention studies, it can be difficult to assess the work may separate out various user functionalities
extent to which the technology was a major factor in for independent testing and analysis.
adherence. This paper attempted to provide such The implications of this study for patients are of
contextual underpinnings. value. IT-based health interventions for improving
Unlike other studies noted in this paper that have human health has been a field of study for many
been aimed at improving colonoscopy education and years. Many of these studies target health and/or
adherence, our system provided personalisation of technology attitudes and behaviours, often with
multi-media content to the needs of the patient a focus on healthy eating, exercise, and other non-
based on the planned procedure for that patient. medical influences on improving health. Examples
Providers had the ability to customise content via also exist of IT interventions that test one or a few
their own interface. While the concept of personalisa- software functionalities in the field. Less common are
tion in information systems design is not new, this studies of comprehensive IT-based mHealth and
paper provides evidence that such a model may be eHealth applications that have been pilot tested in
beneficial for patient education, motivation, and live medical and clinical contexts with clinical results,
adherence. Simply providing reminders and content particularly utilising a set of cloud-based applications
to patients as a patient engagement strategy has not as described herein. Further, we selected a setting and
consistently demonstrated patient adherence out- patient population that is known to experience high
comes as reported in the literature (see for example levels of anxiety, fear, and uncertainty that has
100 B. SCHOOLEY ET AL.

traditionally resulted in high non-compliance with patients deemed healthy enough to undergo an out-
preparation procedures for a generally unpleasant patient elective colonoscopy were included. Thus,
medical procedure. The inclusion of integrated a wide range of known medical conditions were
eHealth multi-media educational delivery for this excluded from this study. While we considered some
context provides an example of the potential to of the independent factors that are important as indi-
further improve patient understanding and engage- cated in the literature including gender, age, and out-
ment with the health system. patient/inpatient status, we acknowledge that there are
While the study did not assess technology accep- potentially hundreds of comorbidities and demo-
tance by users, there are some indications of technol- graphic factors that could account for some of the
ogy appropriation – including that users whom were effects found in this study and thus should be consid-
provided a cloud-based system for endoscopy prepara- ered in future studies. Third, this study did not
tion used the system and its complete sequence of account for user perceptions of the technology, includ-
required tasks (to watch videos). Future studies may ing user acceptance and satisfaction. Fourth, the inter-
assess technology acceptance and appropriation in vention was conducted in a specific area of the
more depth using relevant instruments to determine Western United States with a local population that is
how patients interact with and find utility and usability characterised as having high literacy and employment.
in such applications. Combining such studies about These results cannot be necessarily extended to other
end user perceptions together with clinically evaluated areas of the world with different literacy, economic
results may provide stronger evidence for the effective- income, health, and eating patterns.
ness of the IT systems that are rigorously designed
through research and innovation efforts.
There are many areas in which future studies can Acknowledgments
validate and extend this research to other types of
The authors wish to thank Incendant, Inc. for their tech-
procedures. Future studies may strengthen the work nical assistance in developing this research. This research is
conducted herein by collecting and analysing a wide covered by Parkview Medical Centre IRB Number PIRB34.
range of possible demographic and medical/health
factors that we did not assess for this phase of pilot
research. Although the IT-based intervention was Disclosure statement
apparently usable and understood by the patients in No potential conflict of interest was reported by the
this study, this may not be the case with other popu- authors.
lations. Understanding of the digital communications
used in this study is one important area for future
analysis, especially among those who are non-native Funding
speakers of English or who have other limitations on
This research did not receive any specific grant from fund-
comprehension of the communications or technolo- ing agencies in the public, commercial, or not-for-profit
gies used for this study. Such research can lead to sectors.
adaptations in communications, such as language and
symbols that could benefit a variety of patient groups.
Finally, the research team is currently planning ORCID
studies on the effect of this class of IT-based inter- Benjamin Schooley http://orcid.org/0000-0002-6918-
ventions on patient motivation and patient fear miti- 9986
gation. This enhanced line of research promises the
possibility for use of this class of interventions for
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