Running head: AN IMPROVEMENT IN PRACTICE 1

An Improvement in Practice:

Utilization of a Web-Based Informational Tool in Obtaining Informed

Consent

Adison Pusateri

University of South Florida

AN IMPROVEMENT IN PRACTICE 2

Abstract

Clinical Problem: Standard informed consent procedures utilized prior

to outpatient procedures do not ensure patient understanding of the

education provided. Patients who provide consent for a procedure

without being adequately informed are at risk for postoperative

complications and an increased recovery time.

Objective: To provide statistically significant data that supports the

hypothesis that a web-based informational tool in addition to current

standard informed consent procedures is an effective way to increase

patients level of informed consent.

Results: Fraval, Chandrananth, Chong, Tran, and Coventry (2015) have

shown that in patients who underwent an elective orthopedic

procedure, the use of a patient education website increased the level

of informed consent compared to patients who were not provided the

use of the website (p<0.01). In a similar study, Yin, Goldsmith, and

Gambardella (2015) provided patients undergoing a knee arthroscopy

for the first time with a multimedia online education program. Those

who utilized the program were shown to have a greater understanding

of their surgery both preoperatively (p<0.001) and postoperatively

(p<0.05). Shelton, Freeman, Fish, Bachman, and Richardson (2016)

showed that the use of an online education module increased

healthcare surrogates understanding of the process of informed

consent compared to those who did not access the module (p=0.001).
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Conclusion: The utilization of a web-based educational tool improved

patient levels of informed consent before undergoing a procedure.

However, additional research would be useful in order to strengthen

the findings for web-based educational modules before becoming a

part of standard informed consent procedures.

Utilization of a Web-Based Informational Tool in Obtaining Informed

Consent

Many hospitals utilize web-based educational tools for inpatients;

however, those who are not inpatients do not often receive said

opportunity. For people in the hospital for an outpatient procedure,

clinical trial, as a healthcare surrogate, or any reason other than an

inpatient stay, the standard forms of patient education such as

informative pamphlets and education provided verbally by the

healthcare provider are predominantly used. In people who visit the

hospital on an outpatient basis, how does the utilization of web-based

patient educational tools compared with standard informed consent

procedures affect the patients level of informed consent before

undergoing a procedure? With the use of web-based informational

tools, patients should have a greater understanding of what they are

agreeing to and therefore a higher level of informed consent.

Literature Search

The literature reviewed in order to provide the research

presented was found using the search engines PubMed and CINHAL.
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The studies utilized were found by searching the following terms:

patient education, informed consent, web-based, and multimedia. The

search was further narrowed by including only randomized controlled

trials that have been published within the last five years. After

reviewing relevant sources, a total of one guideline published by the

Agency for Healthcare Research and Quality, and three randomized

controlled trials were reviewed and synthesized for the purposes of this

paper.

Literature Review

Three randomized controlled trials and one guideline were

selected to evaluate the effectiveness of the utilization of a web-based

educational tool to improve the level of informed consent in people

who visit the hospital on an outpatient basis before undergoing a

procedure. One study, conducted by Fraval, Chandrananth, Chong,

Tran, and Coventry (2015), set out to test the hypothesis that utilizing

a patient education website in addition to standard informed consent

procedures improves the level of informed consent, satisfaction, and

anxiety in patients undergoing an elective orthopedic surgical

procedure. They did so by conducting a randomized controlled trial

including a sample of 211 patients. In this study, participants were

randomly assigned to either a control group (n=108) or an intervention

group (n=103). The participants were recruited from one orthopedic

clinic and were scheduled to undergo one of five common orthopedic

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procedures. Patients in the intervention group were instructed to read

information regarding their procedure from an educational website

following the standard discussion regarding the procedure with their

healthcare provider. Patients in the control group only received the

benefit of the standard discussion. Both groups then completed several

surveys pertaining to the outcome measures discussed previously.

Participants in the intervention group exhibited a clinically significant

increase in the level of informed consent when compared to

participants in the control group (p<0.01). Satisfaction levels in the

intervention group were also higher than in the control group

(p=0.043). However, there was no significant difference between the

groups in regard to how they rated their anxiety (p=0.195). There were

several strong points of this study. Its randomization and

appropriateness of the control group, concealment of the

randomization, the fact that reasons why patients did not participate

were given, the use of reliable and valid instruments to measure

outcomes, and the fact that participants in each group were similar in

terms of demographics all strengthen the data collected. Also the fact

that the study included more than one elective orthopedic surgery and

utilized instruments to measure the outcomes specific to each

procedure included improves its generalizability. A large weakness of

this study was the lack of any form of follow up with the participants to
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determine whether or not the improvement in patient education was

sustained.

In the study conducted by Yin, Goldsmith, and Gambardella

(2015), a goal was set to determine the effectiveness of a multimedia

online education program for patients who were to undergo a knee

arthroscopy for a meniscal tear for the first time. The outcome

measures included were patient knowledge recall at the preoperative

visit, confidence on the day of surgery, and knowledge on their specific

procedure at the postoperative visit. 64 patients scheduled to undergo

the aforementioned procedure were recruited from one orthopedic

clinic and randomly assigned to either a control group (n=29) or an

intervention group (n=26). Participants in the intervention group

completed a web-based multimedia educational program in addition to

standard informed consent procedures, which were the only

interventions offered to the control group. Both groups then completed

surveys pertaining to the outcome measures. Participants in the

intervention group were shown to have a greater understanding of

their surgical procedure both preoperatively (p<0.001) and

postoperatively (p<0.05). Participants in the intervention group were

also significantly more likely to answer questions regarding their

surgery correctly than those in the control group (p<0.03). On the day

of their procedure, the results of the survey given showed patients in

the intervention group as being more confident regarding the quality of

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the education received than the patients in the control group (p=0.03).

Strengths of this study include its randomization, the appropriateness

of the control group, the fact that reasons why patients did not

participate were given, and the fact that participants in each group

were similar in terms of demographics. Also, the fact that patient

knowledge was assessed multiple times strengthens the significance of

the findings. Several hindrances of this study include the fact that

seven different surgeons were included, making it difficult to measure

the quality and quantity of education provided verbally. Also, the fact

that the patient questionnaire on their level of confidence was created

specifically for this study, therefore it was not previously validated, can

be viewed as a weakness. The fact that the intervention group was

informed of the purpose of the study may indicate possible bias on

their part.

In the study conducted by Shelton, Freeman, Fish, Bachman, and

Richardson (2016), the hypothesis was tested that an online education

module regarding the process of informed consent for genomics

research in addition to standard informed consent forms for healthcare

surrogates is more effective than standard informed consent forms

alone. The primary measure of the study was the healthcare

surrogates understanding of the process of informed consent for

genomics research. One hundred and thirty four participants were

recruited from two ICU waiting rooms from the same medical center
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and randomly assigned to either a control group (n=69) or an

intervention group (n=65). Participants in the intervention group were

provided with an online education module in addition to the standard

genomics research informed consent form, which was the only

intervention made available to the control group. Both groups were

then given a questionnaire rating their understanding of the process.

After review, it was shown that participants in the intervention group

had a higher level of understanding regarding the process of informed

consent for genomics research than the participants in the control

group (p=0.001). Strengths of this study include its randomization, the

appropriateness of the control group, the fact that reasons why

participants dropped out or did not qualify were provided, the fact that

instruments used to measure outcomes were reliable and valid, and

the fact that participants in both groups were similar in terms of

demographics. Also, the online module was designed to include people

from different cultural backgrounds, making it more generalizable. A

weakness of this study is the fact that the online module was only

presented in English. It was unstated whether or not participant

randomization was concealed from the individuals who recruited them.

According to Cordasco (2013), the process of obtaining informed

consent encompasses seven steps to be completed by the healthcare

provider, which are as follows:

1. Informing the patient of their role in the process

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2. Explaining to the patient what the issue is and what the

proposed treatment is
3. Describe possible alternatives to the proposed treatment,

including the option of forgoing treatment all together

4. Describing the risks and benefits of the proposed treatment

along with those of the alternative treatments

5. Discussing questions the patient might have
6. Determining the patients understanding of what has been

discussed
7. Confirming the patients preference and gaining consent.

All of these steps must be completed in order for informed consent to

be considered valid (Cordasco, 2013). While the Agency for Healthcare

Research and Quality does recognize the availability of web-based

tools for obtaining informed consent, among other methods, there is

currently no guideline on their recommended use (Cordasco, 2013).

Synthesis

Fraval et al. (2015) showed in patients scheduled to undergo an

elective orthopedic surgery that those who were provided access to a

patient education website regarding their procedure were significantly

more informed than those who were not provided with the website

(p<0.01). It was also shown that patient satisfaction with the teaching

was higher in the group that was able to use the website (p=0.043).

Yin et al. (2015) showed in patients scheduled to undergo a first time

knee arthroscopy for a meniscal tear, those who were provided with an

online multimedia education program had a greater understanding of

the procedure both preoperatively (p<0.001) and postoperatively

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(p<0.05) when compared to those who werent. Patients who were

provided with the online program were also shown to be significantly

more likely to correctly answer questions regarding their surgery

(p<0.03) and to be more confident regarding the quality of the

education provided (p=0.03). Shelton et al. (2016) showed that

healthcare surrogates understanding of the process of informed

consent for genomics research was higher when exposed to an online

education module compared to when the surrogates were not provided

access to the module (p=0.001).

Each of these three studies compared a web-based educational

tool to standard informed consent procedures. However, the outcome

measures used by each of these studies differed. While all three

utilized the level of informed consent as an outcome measure, some

went further than others. The study conducted by Shelton et al. (2016)

used informed consent as its primary outcome measure. However, the

study conducted by Fraval et al. (2015) measured outcomes based not

only on patient knowledge, but also on satisfaction and anxiety. The

study conducted by Yin et al. (2015) took it one step further and

included patient knowledge at both the preoperative and postoperative

visits, along with patient confidence on the day of surgery, in their

outcome measures.

Although the randomized controlled trials presented indicate that

the utilization of web-based educational tools in addition to standard

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informed consent procedures are superior to standard informed

consent procedures alone, further research should be conducted before

requiring this be incorporated into clinical practice. There are several

gaps that research has yet to address regarding the topic, including

what population of patients would benefit most from online educational

tools and if there are procedures in which online educational tools are

not helpful.

Clinical Recommendations

Considering the evidence presented supports the hypothesis that

web-based educational tools improve patients level of informed

consent for outpatient procedures, further studies should be conducted

to determine if there is a specific population of patients, whether it be

in regards to age, diagnosis, or some other factor, who would benefit

most from this method of obtaining informed consent. Research should

also be conducted regarding whether or not there are specific

procedures in which the patients might benefit more from this method.

Clinical practice should be revised to include a web-based educational

option when obtaining informed consent for outpatient procedures.

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References

Cordasco, K. (2013). Obtaining informed consent from patients: brief

update

review. In P. Shekelle, R. Wachter, & P. Pronovost (Eds.), Making

health care

safer II: an updated critical analysis of the evidence for patient

safety

practices (Ch. 39). Rockville, MD: Agency for Healthcare Research

and

Quality.

Fraval, A., Chandrananth, J., Chong, Y., Tran, P., & Coventry, L. (2015).

Internet based

patient education improves informed consent for elective

orthopaedic

surgery: A randomized controlled trial. BMC Musculoskeletal

Disorders, 16, 14. doi: 10.1186/s12891-015-0466-9

Shelton, A., Freeman, B., Fish, A., Bachman, J., & Richardson, L. (2016).

A computer-

based education intervention to enhance surrogates informed

consent for

genomics research. American Journal of Critical Care, 24(2), 148-

155. doi:

10.4037/ajcc2015983
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Yin, B., Goldsmith, L., & Gambardella, R. (2015). Web-based education

prior to knee

arthroscopy enhances informed consent and patient knowledge

recall. The

Journal of Bone & Joint Surgery, 97 (12), 964-971. doi:

10.2106/jbjs.n.01174