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engage: University of Michigan Clinical Research Comparative Evaluation Report Team Envolve (Pratibha Bhaskaran, Liz Blankenship, Tammy Greene) SI 622 • Assignment 4 • February 7, 2008

Team Envolve • Engage U - M Clinical Research!


Table of Contents

Overview!

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Comparative Evaluation Methodology!

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Comparative Evaluation Sites!

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Comparative Evaluation Findings!

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Discussion of Features!

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Recommendation"

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Conclusion"

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Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research

“Engage: Your Gateway to Clinical Research throughout the University of Michigan”

Overview Clinical research faces many obstacles, not the least of which being recruiting participants. They must be able to recruit the right type of participants in the right amounts to have a study be effective. This includes recruiting specific demographic groups such as racial minorities, pregnant or postmenopausal women, the elderly, and other groups. Recruitment must take into account variance in available free time, literacy, and preference for in-person interaction over written, telephone, or computer interaction. Although a website cannot fulfill the needs of every potential participant, websites like Engage increase the efficiency of recruitment by giving easy access to many individuals to the vast numbers of clinical research trials available, and empower them to search for the studies for which they qualify (Lovato, Laura C, et al 1998). Engage is a gateway to clinical research throughout the University of Michigan. The purpose of Engage is to provide "one-stop shopping" for people who want to help medicine move forward by participating in clinical research. The site has several features such as a study database, public search tool, a secure registry and general information about clinical research. The original study database feature allows study teams to post their clinical research trials for the public to view. The public search tool allows for easy searching based on queries that search the database by condition, keyword, studies seeking healthy volunteers, and date posted. The registry is a feature that allows interested volunteers to enroll in a registry as well as be matched to potential studies so that researchers can contact them as a potential candidate. General information resources are also posted so the public can learn about research.

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engage: U - M Clinical Research Our project will mainly focus on the features used to complete the following tasks: • Finding General Information • Finding Studies • Registering as a Volunteer

Comparative Evaluation Methodology For this portion of our project, we looked at five sites that are similar to Engage in that they provide information about clinical research and specific studies in which people can participate. These sites all serve local communities in different parts of the United States and thus are not direct competitors. However, researching comparable sites was insightful for gaining a better understanding of what could be more effective for achieving Engage's goal and what to avoid while planning to restructure the site. The first step in our comparative evaluation was to identify some sites with similar functionality to Engage. Molly Dwyer-White, our Engage contact, gave us a list of 10 sites that she had compiled as sites providing similar functionality to Engage or having some desired feature. We reduced this list to only five, eliminating the sites that did not have comparable features or would not offer any additional information to our analysis. With these five sites, we looked at each and determined the audience and objective of the site. We also identified several positives and negatives about each site. Finally, we came up with a matrix of recommendations for Engage based upon our comparison to the other systems.

Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Comparative Evaluation Sites Website Name

Website URL

Duke University Clinical Trials

http://www.dukehealth.org/clinicaltrials

John Hopkins Clinical Trials Unit

http://www.hopkinsclinicaltrials.com/

Indiana University School of Medicine

http://www.medicine.iu.edu/body.cfm?id=1725

Office of Clinical Research Vanderbilt Clinical Trials Center

http://www.mc.vanderbilt.edu/root/vumc.php?site=ctc

Washington University

http://vfh.wustl.edu/

Volunteer for Health

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engage: U - M Clinical Research Comparative Evaluation Findings Engage - University of Michigan Clinical Research http://www.umengage.org

Description: Engage is a University of Michigan initiative to facilitate and further research within the university. It provides a secure online registry for people to register as participants for clinical research, and matches them to clinical studies. It also provides general information to the public about research. Audience Profile: People affiliated with the University of Michigan, or residing near it, who would be interested in volunteering as participants for clinical research. Summary: Engage is a vast site, with a large number of studies the user can search for, however, there is a fair amount of text that is unnecessary for the user. Coupled with the lack of a quick, direct way to get to major links like enrollment, this makes the process of using Engage tedious for someone unfamiliar with the site. Features such as the ability to be matched to studies, and decide whether to be contacted by a study team or contact them directly give the user more flexibility and options than the other clinical research websites studied. Positives: • Allows volunteers to decide if they wish to be contacted if their profile matches a study, or whether they wish to directly contact study teams they're interested in • Allows users to do a filtered search by age, sex, and other characteristics to reduce time wasted viewing studies for which they are ineligible Negatives: • Too text-heavy, difficult to navigate directly to information of interest • Registration process is long with no clear indication of how many more pages need to be filled in or where you are in the process Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research • No provision to save entered information and return later to complete the rest • Navigating to major pages (such as enrollment) involves having to go through extraneous pages with little relevant information

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engage: U - M Clinical Research Duke University Clinical Trials

http://www.dukehealth.org/clinicaltrials

Description: DukeHealth.org is a website by Duke Medicine, which integrates the Duke University Health System, the Duke University School of Medicine, and the Duke University School of Nursing. It is a patientoriented site offering several services for patients such as scheduling appointments and registering for clinical trials. The clinical trials portion of the site offers a directory, search of current studies and contact information for each study. There is no other information regarding clinical research or registering to participate. Audience Profile: Patients in the Duke University Health System and other community members in the Duke University area. Summary: The DukeHealth.org site is effective for the small number of studies available in the Duke University Health System. Although the site could benefit from additional information about clinical research and search features that find only studies relevant to the user, the site is visually appealing, uses simple language, and serves its users well. Positives: • Clear language without excess medical terminology • Clean, simple, visually appealing site layout • Clear categories of navigation Negatives: • No general information about clinical research • No way to register online

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engage: U - M Clinical Research John Hopkins University Clinical Trials Unit http://www.hopkinsclinicaltrials.com/

Description: The John Hopkins University School of Medicine Clinical Trials Unit serves as a gateway to foster the growth of clinical research within the School of Medicine by means of the highest ethical and scientific standards in a time sensitive and cost effective manner. The primary function of the site is to find clinical studies and sign up to request information/notification about future trials, as well as main be the main general information resource regarding clinical trials. Audience Profile: Anyone interested in clinical trials research at John Hopkins University. Summary: Overall, the John Hopkins University School of Medicine Clinical Trials Unit site is a great resource for clinical research information and has an easy registry process. But the site lacks a matching system that allows the participant to see the studies that match their profile and track current or requested studies. The site is closely branded like the School of Medicine site, but not exactly. The best feature of this site is its search feature that is visually prominent on the site and immediately draws the readers attention. Positives: • Clear visual layout/navigation (information pertaining to trials on the left navigation and information pertaining to the organization on the top) • Search feature prominent on screen • Search results allow sign-up for specific study • Study description is clear giving the most important information relevant to the study: goal, participant requirements and time investment. • Registration process is clear • Site search to search the site, medical literature using pubmed and the web using altavista Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research • Most requested pages box • Not text heavy or a lot of links Negatives: • No listing of current available studies (and currently there aren’t many open studies, so search results are all empty) • When search terms are misspelled, there are no suggestions for terms and the search term is not repeated on the results page to indicate it was misspelled. • Registration does not match participant to studies online. Instead the information is reviewed and you are contacted at a later date. • Participant has no way of tracking studies that he/she is interested in or have requested information for.

Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Indiana University Office of Clinical Research http://www.medicine.iu.edu/body.cfm?id=1725

Description: The Office of Clinical Research at Indiana University serves research investigators, volunteers and industries. Potential volunteers may download the required forms from the office's website, and mail them back completed (there is no online registry). A list of studies currently seeking volunteers in maintained online, with details such as eligibility, compensation and contact information. Resources are also provided for researchers and study coordinators. Audience Profile: People affiliated with Indiana University, or residing near it, who would be interested in volunteering as participants for clinical research. Summary: The website of the Office for Clinical Research at Indiana University is neatly divided into the three audience profiles it caters to - volunteers, researchers/study coordinators and sponsors. It is thus easy for the user to navigate through the website and know where they are within it. The lack of an online registry puts the onus on the volunteers to obtain the forms, complete and mail them, though certain types of users (those not very comfortable working with computers) might prefer this system. Positives: • Clear left navigation allows the user to easily ascertain their location within the site • Division of the website into three sections based on audience type makes it easier for the user to find information relevant to the section they belong to • Visual layout and color scheme is aesthetically pleasing, while conveying a feeling of trust, authority and credibility • Not too text-heavy, while still providing relevant information in a succinct manner

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engage: U - M Clinical Research Negatives: • Descriptive titles provided as labels for links in the list of currently enrolling studies tend to be verbose • Use of medical terms in the list of studies makes it difficult for the layman to understand what the study is about • Lack of an online registry puts the onus on the volunteers to obtain, complete and return forms in order to participate

Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Vanderbilt University Clinical Trials Center

http://www.mc.vanderbilt.edu/root/vumc.php?site=ctc

Description: The Vanderbilt Clinical Trials Center and the General Clinical Research Center have developed a web application to provide research subjects a method to self-register personal information for inclusion in a recruitment database. Submitting information for the recruitment database in no way obligates you to participate in research studies, but may result in one or more contacts by phone or email assessing your interest and suitability for research trials. The main purpose of this site is to register for access to the recruitment database and find general information. Audience Profile: Anyone interested in clinical research studies. Summary: The Vanderbilt Clinical Trials Center and General Clinical Research Center site is a bland example of a clinical research site. Lacking visual appeal is the first of many flaws with the site. There are also three volunteer for research links off the home page that link to three different pages, which include a blank page. But the site is also closely branded to the Vanderbilt Medical Center site with a few variations. It is clear because of the tag-line what the purpose of the site is but this is eliminated by the registration process that generates outside links to clinical research sites. Positives: • Clean visual layout and navigation • Not text heavy or a lot of links • Tag line explains the purpose of site Negatives: • Visually unappealing with very small font

Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research • Registration does not match participant to studies online. Instead the information is reviewed and you are contacted at a later date. • Participant has no way of tracking studies that he/she is interested in or have requested information for. • Participant must go to another site, listed after registration, to look for current studies. It's not clear how these sites are associated with Vanderbilt University.

Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Washington University’s Volunteer for Health http://vfh.wustl.edu/

Description: Volunteer for Health is a website sponsored by the University of Washington School of Medicine. The site features ways to connect volunteers to studies, including searching for studies, browsing by condition, and way to create an account. With an account, you fill out more detailed personal information including medical history and can save studies that interest you. Registering for an account also gives you the opportunity to have VFH contact you in the future about studies for which you qualify. Audience Profile: This site has a primary audience of public in the community surrounding the University of Washington in St. Louis, Missouri. Summary: This site prominently displays "Copyright 2000" on the bottom of many of its pages and indeed, the site feels a bit like something from the 1990's. Although it may not be as visually appealing or user-friendly as sites designed more recently, this site functions reasonably well for its target audience. The best feature of this site is that all you need to initially sign up is your name and e-mail address - all other details can be filled in at your leisure. Positives: • The types of information listed on each study detail page is consistent including the headers which helps the user know where to look • Allows user to create an account, then come back later to fill in their profile and medical history Negatives: • Visually unappealing, with a gray background and boring serif fonts • Inconsistent page design is disorienting (page width, font size) Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Discussion of Features General Information: New users of clinical research study sites are often first-time visitors seeking further information prior to participating in a clinical study or trial. So, one of the goals of the clinical research sites is to inform the user. It is imperative for the success of the site that this information be easy to access and understand to encourage participation.

Engage’s Home Page In comparison to other clinical research sites, the Engage site provides an overwhelming amount of information and navigation options that is often confusing and a hindrance for the user. Some of the barriers to the ease of accessibility or understanding are organization, labeling, and navigations systems that do not make sense to users. These systems should categorize and represent information in a way that users understand. Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research

Engage’s Content

Engage’s Navigation Content on the Engage site is organized by topic and by task to provide answers to the user's questions about clinical research at the University of Michigan. These categories of content are labeled appropriately to represent the topics to be viewed such as "About Research" or tasks to be completed such as "Volunteer for Research." The navigation systems on the Engage site is the most difficult system for browsing or moving through the site. Repetitive links within the text offer the users multiple options for getting to the same content, but are at times divert the users attention. This is primarily due to its attempt to address multiple audiences such as potential participants and researchers.

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engage: U - M Clinical Research

Duke University’s Site

Indiana University’s Site

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engage: U - M Clinical Research

Washington University’s Site The Duke University, Indiana University, and Washington University clinical research sites provide the best structure for presenting and accessing information about clinical research studies. Each of these sites has a clear and consistent structure that supports the users ability to browse, search and find general information about clinical research without being distracted by excessive in line links or content. The Indiana University site segments its content based on the audience type such as patients, investigators and sponsors. The information presented on the Engage site is often clear and helpful information for the users. But the obstacle to finding it is the extraneous information not specifically for potential participants located everywhere on the

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engage: U - M Clinical Research site and the confusing navigation to the get to the information. Contextual navigation systems embedded within the text bombard the content of the site, especially on the home page where direction is needed. These links should be carefully chosen so as not to add clutter or confusion and important navigation should be included within the major navigation categories that are easier for the user to see and choose.

Search Capabilities: Finding studies that interest you is an important part of using websites like Engage. On the sites we examined, users could generally search by typing something in a keyword search box or select a condition. Hidden amongst the conditions on some sites was "Healthy Volunteer." Engage, on the other hand, has a clearer option to view only studies looking for Healthy Volunteers.

Engage’s Find Studies Page When users click on the link for healthy volunteers, they may select from male, female, child, or all studies. After that, the results are displayed, which often includes studies the individual still doesn't qualify for, such as studies seeking participants only in a certain age range. Similarly, when viewing the studies added to the system recently, there is no filtering by user characteristics. Only by selecting "Search by Keyword" can the user narrow down search results to only those relevant to him or her.

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engage: U - M Clinical Research

Engage’s Search by Keyword Page Of the sites we looked at, Engage is the only one that has this ability to filter out results that are not relevant to users. An important part of recruiting subjects is to make it easy for them to find studies for which they are eligible. Engage should leverage this unique ability by making the option easier to find. Another factor in the success of search features is the display of the results. Engage does poorly in this respect, always sorting results by condition and showing no details about any studies unless the user expands one of the condition categories shown. Other sites are only slightly better, showing the title and description of the search, and even sometimes highlighting the occurrences of the keywords searched for, but not offering any additional functionality.

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engage: U - M Clinical Research Registration Process: The process of enrolling as a volunteer in the Engage registry includes four pages of a consent form and five pages of information about the applicant, including demographic and contact information. Though the consent form lets the user know where they are in the process (e.g. "step 2 of 4"), this information is not available for the main registration form. Consequently, the user is compelled to enter pages of information without knowing how many more are still left to be filled.

Indiana University’s Registration Form Indiana University does not have an online registry; instead, forms may be downloaded from the website, completed and mailed back. The forms are between one to three pages long. The link to the registration section is easily accessible from the top navigation, similar to Engage, but Engage includes an extraneous page with another link to click to actually start the registration process. Team Envolve • Engage U - M Clinical Research !

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engage: U - M Clinical Research Washington University does not have a prominent link to their registry, however, the registration process does not require the user to complete the process in one session. Users create an account by providing their name, date of birth and email address. They may then either proceed to complete their enrollment by entering demographic and medical information or return later to complete it. Information required is divided into sections - profile and medical history - that further simplifies the procedure for the users.

Washington University’s Registration Process John Hopkins University has a short form on their website requesting contact and medical information. Vanderbilt University combines the consent, contact and medical information on one lengthy page, and the link to enroll is not easy to navigate to quickly. Both universities require the information to be entered in a single session.

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engage: U - M Clinical Research Recommendations Feature

Engage Usage

Recommendation

Contribution to Site Design

Visual Layout

The Engage site is visually unbalanced. There is a lot of content and navigation within a small visual space. As a result, nothing is prominent on the site to direct the user.

Alter the visual layout of the site to increase the Aesthetics, Usability amount of space, reduce the amount of content and highlight important sections on the site to increase their prominence and 'findability' on the site.

Overall

The Engage site is overall a presentable site. The branding is consistent with the University of Michigan Health Systems site and works well for the branding of the clinical research site. But the flaws of the visual layout diminish the value of the overall presentation.

Correct the visual layout flaws so that it complements the design of the site.

Aesthetics

The Engage site's top navigation is clear and concise. But the other options of navigation on the right, left and within the text distract the user. The links buried within the text are often repetitive to the major navigation above it.

Remove some of the text links and provide consistent navigation only where needed. Divide the site into sections by audience or task, similar to Indiana University's site.

Usability

Presentation

Navigation

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engage: U - M Clinical Research Feature

Engage Usage

Recommendation

Text Balance

The Engage site is very text-heavy. Though it aims to provide extensive information, some of this is often unnecessary and a hindrance to potential volunteers when attempting to complete major tasks like enrolling.

Indiana University's site provides information that is adequate for the users to perform their tasks without overloading them with unnecessary text. Engage could possibly remove the unnecessary content that it has, and highlight the major entry points like enrolling.

Usabililty

Search

The Engage site allows many types of search, more than the other sites we compared it to. The "Search by Keyword" option is misleading in name; it is not a simple keyword search. "Studies Seeking Healthy Volunteers" option leads to many studies which the participant still may not qualify for. Search results are cumbersome to navigate.

Have a single search page that allows the user to type in a keyword, select a condition from a pulldown menu, or fill in information about him or herself such as age and sex. This page could contain a sidebar on the right side with the most recently added studies, with a link to see all studies added in the last 30 days.

Functionality, Usability

The Engage registration process is lengthy, with four pages of consent forms to read through, five pages of information to fill out, several redundant pages to click through, and a long process for registering for an UM-friend account if you are not affiliated with the University of Michigan.

Simplify and break up the registration process. Eliminate redundant click-through pages and relocate extra information to help pages accessible via links. Make it possible to create an account in one session, then come back to fill in information and sign consent forms during another session, similar to the Volunteer For Health site.

Functionality, Usability

Capabilities

Registration Process

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engage: U - M Clinical Research Feature Help or Support

Appropriate Language for Audience

Engage Usage

Recommendation

Contribution to Site Design

While help is provided in some parts of the site, other times no guidance is available.

Move wordy text guidance from within pages to a help page. For each page where there might be any question about what a user should do next, provide a help link that gives guidance for that particular page. This could be in the format of Frequently Asked Questions.

Structure of Content, Usability

The studies listed on Engage often use medical terminology in the titles and descriptions that many users may not understand.

Set clear guidelines about what language should be used for medical staff posting study information to the site. If funds permit, have someone screen all new studies and request rewording for descriptions that sound too technical. Make sure the most important information regarding the goal, participant requirements and time investment of the study are included in the description.

Usability

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engage: U - M Clinical Research Conclusion Conducting a comparative analysis was valuable in terms of viewing Engage in relation to its contemporaries, rather than as an absolute. One thing we observed, was that amongst the websites surveyed, Engage is the most vast with a much larger number of studies listed. Some of the content is, however, unnecessary and verbose and tends to result in information overload, acting as a hindrance to users when they perform their tasks. A reduction of this would allow users to find what they're looking for much quicker. Engage caters to different sections of users - volunteers, researchers, and study coordinators. Redistributing the content so that it is easier for each audience group to find would allow the vast amount of valuable information to be channeled better, as was observed in Indiana University's website. Providing indicators of progress during the registration process, and permitting users to save information and return later to complete it, would make the lengthy registration process easier to accomplish. Overall, Engage performs relatively well, considering the vast amount of content it houses. This vastness may be a little overpowering for the user, but by redistributing content and making it easier for the user to access quickly, Engage will simplify the process of registering for, and finding studies.

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engage: U - M Clinical Research References Lovato, Laura C.; Hill, Kristin; Hertert, Stephanie; Hunninghake, Donald B. and Probstfield, Jeffrey L. (1998). Recruitment for controlled clinical trials: Literature summary and annotated bibliography. Controlled Clinical Trials, 18 (4) 328-352.

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SI 622 Comparative Evaluation  

A comparative analysis of Engage and similar clinical research recruitment systems, Winter 2008, SI 622: Evaluation of Systems and Services

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