2/22/13

RWJ Challenge

I. Background

Pearl Leaves is a health information technology company designing software and services to enhance medical adherence. We are here to make engagement in healthy medical regimens easier and more enjoyable and we intend to extend this reach to all populations. Over half of the American public is now on chronic medications and chronic medication usage extends across all demographics. For instance, 26-28% of children under 19 and up to 30% of women aged 20-44 are on chronic medications. Lack of adherence to medical regimens is ubiquitous and the resulting consequences both in terms of clinical outcomes and financial losses are huge. These losses extend across multiple community segments and include patients, hospitals, third party payers, and pharmacies. Increased death rates and decreased quality of life can be directly attributed to lack of medical adherence, the severity and time course of these consequences varying per disease entity. In diabetes, decreased adherence results in an increased incidence of complications such as limb loss and end organ failure. In HIV+ individuals, increased conversion rates to AIDS can be attributed to failure to adhere to prescribed medical regimens. There are significant financial losses associated with nonadherence, the estimates ranging from 100 to 300 billion annually for the pharmaceutical industry alone. Other associated financial losses can be attributed to increased complication rates, increased readmissions to hospitals, and decreased productivity of the workforce. Increased medical adherence would significantly decrease health care costs to the community. Within this proposal, we intend to build on the existent Pearl Leaves platform and use further development in gaming and gamification to enhance our engagement platforms. Our programs will improve health care outcomes and healthcare quality, reducing overall spending on community health, and improve overall community health.

Pearl Leaves’ existent platform focuses on addressing nonadherence to medical regimens with the full complement of digital media resources: smart phone apps, eBooks, games, and web worlds. We have developed a system that will allow for the customization of our content and approach based on the needs, tastes, and skill levels of a patient, a system we feel will allow us to approach and engage patients more effectively. Pearl Leaves has also identified a critical and missing link in other approaches to adherence. The medical system currently lacks the resources and capacity to monitor, analyze, and continuously update the information necessary to provide optimal support to improve adherence to medical regimens. Pearl Leaves is developing a system to provide these services. Though the mainstay of the system is an automated component, these services are backed by significant clinical expertise. Data demonstrates that one of the highest risk populations for nonadherence is lower income individuals, and many have feared that the use of IT in adherence efforts would broaden the economic divide. Ironically, however, it may be possible to use information technology to bridge this divide more effectively than ever before. Data from the news business sector is showing that news is now reaching lower socioeconomic groups more effectively than ever before, and the channel for this reach has been through smartphones. We believe that the medical industry should leverage this same access channel to reach previously poorly accessible groups. It is critical, however, that in so doing, we devise engagement methods tailored to the tastes and needs of these populations, in order that the success of these efforts are optimized. In this grant, Pearl Leaves is refining the medical gaming platform that they

have developed to create a system that would be optimally engaging for all socioeconomic groups. Indeed, at risk populations will have different needs, tastes, and skill sets, and these factors should be taken into account in both the activity elements and visual elements of games. The overall mission of Pearl Leaves is to induce a culture change in reference to the integration of medical behavior into our lives, beginning with the young, and establishing patterns that should last a lifetime. Within this mission, Pearl Leaves intends to leave no population behind.

For this challenge, we describe the development of a new game, that will allow collection of data critical to optimizing digital media approaches to health outcomes. We show a community deployment program that will be piloted in Kansas City, one of the 16 AF4q areas, but that is easily scalable across the diverse geographies of the US.

The CEO of Pearl Leaves has a significant history in academic medicine, is chairman of committees in international organization, and has far ranging contacts in diverse fields, both in terms of mentors and trainees. She works for Pearl Leaves full time. The Director of Software Architecture has over 15 years of experience in medical IT systems, including software design and project management and is working for Pearl Leaves full time. Our director of Creative has over twenty years of high level experience in the creative arts, including 12 years of experience at Hallmark and over 10 years of experience as a successful freelance artist and works for Pearl Leaves 35-40 hours a week. We have extensive contacts within the business community. Notable among these contacts are those through the Kauffman Center and the addition of Blake Williamson, past VP and CMO of Blue Cross Blue Shield Kansas City, to our advisory board.

There is approximately $150,000 invested in the development of our systems to date. We are currently in the final stages of due diligence with a group of angel investors for an ask of $500,000. Funds from this ask will be used to drive further development, the investment dollars have not been apportioned to development further development of strategies for the disadvantaged. Pearl Leaves will continue to actively seek additional funding for this goal.

II. Software Development

A). Established Software Infrastructure. Pearl leaves has already developed a smart phone multicomponent application called Plan-it MedTM that approaches adherence upon the platform of addressing four components that have been shown in meta-analyses to be important in adherence. A central element of the application is customizable reminder functions for multiple medical elements including meds, appointments, labs, and educational milestones (Figure 1). When a patient does not make a medical milestone, they are given the option of providing data as to why this milestone was not met (Figure 2). The educational/motivational elements made available with this program include facts (pearls), motivational quotes, and ebooks. With each educational fact, there is also an multiple choice question that will allow for educational assessment and the ability to decrease the chance that the patient clicked that they read the fact without processing the data. (Figure 3). There is also a section that allows the import of customizable content from individual health groups/ institutions or import of data in other formats which may be important for education in a specific disease state. There is a component called “Team” that allows for facilitated contact with individuals the patient has

designated to be on their team (Figure 4). Finally, points are tracked within the app and are used to cash in on rewards within our system. This system was developed for native iOS (in beta testing) and development for native android systems is in process (Scheduled to be completed by May).

There are several gaming schema that have already been developed under the name Play-it MedTm. These schema are centered around strategies in which patients are allowed to move through a game after a medication or series of medication administrations or a task is completed. These games,

included under the name of “Play-it MedTM” are intended for release to the general public in April and are currently targeted at kids aged 2-5. They were designed with medication administration for acute conditions in mind such as the treatment of urinary tract infections and ear infections and were conceptualized by the CEOs daughter.

B). Expanded Functionality/Features Specific for this Project1). A New Game Schema. A masculine game schema is described. The scheme of this game will be to design an engine. We intend to develop multiple levels of this game.

The first level is shown, and involves the assemblage of a standard car engine. Some of the technical art developed for this project is shown. When a patient reaches various milestones within their treatment, they are allowed to proceed with creation of an engine. it is also of note that the game is designed with an educational component. Each engine part is named and its functionality described. When pieces of the engine are missed, construction of the engine cannot proceed. Multiple gaming goals can be monitored with this game including the number of steps required to create the engine and

the speed with which the engine is created. These elements can be used to allow very basic social gaming. In the second level, multiple different engine types are possible. It will require knowledge of these parts and compatibilities to proceed with engine design and development. There will be learning modules to prepare for this development. Elements of not only engine capabilities, but body design and aerodynamics will come into play. When construction is completed, preset algorithms will be used to determine the speed capacity or energy efficiency of the engine.

STEP 8CORRECT PIECE HIGHLIGHTS IN GREEN

STEP 3

STEP 14

CRANKSHAFT AND PISTONS:The pistons go up and down, they transfer this power to

the crankshaft through the piston arms. They do this with special joints that encircle the crankshaft. The

crankshaft sends power forward to the fan belt. The rotational energy is then transferred to the wheels via

other systems

FAN AND FAN BELT:The fan belt is connected to the cam shaft on the engine and uses the power of the engine to turn

di!erent devices on the car such as the Water pump to keep the engine cool. The fan draws air through the radiator to cool the engine when the car is stopped

and when driving.

ENGINE COMPLETE

STEP 1-ADD OIL PAN STEP 1-ADD ENGINE BLOCK

BUILDING THE CAR ENGINE

STEP 3-ADD CRANKSHAFT AND PISTONS

STEP 4-ADD CAM SHAFT AND VALVE SPRING

ENGINE PIECES BELOW MAIN SCREEN

STEP 5-ADD CRANK CASE STEP 6-ADD CAM COVER

STEP 7-ADD WATER PUMP STEP 8-ADD FAN BELT AND FAN STEP 9-ADD OIL FILTER

STEP 10-ADD SPARK PLUG STEP 11-ADD EXHAUST MANIFOLD STEP 12-ADD GAS PUMP

STEP 13-ADD DISTRIBUTOR AND LINES STEP 14-ADD AIR FILTER

(These functionalities will be further developed with a mechanical engineering group) The ability to create differential capacities within these parameters will serve as the basis for gamification. Patients will be allowed to compete based on these qualities. Team competitions will also be facilitated.

In the third level, constructed vehicles will be allowed to race. A given patient may have a variety of different vehicles, and may pick different vehicles to engage in different types of races. There will be cross country races over rugged terrain, cross country road races, and races along circular racetracks of various lengths. Ideally, racing through various terrains can be portrayed in animation on devices.

In the forth level, races will be conducted with drivers allowed to pick their pit teams. Scenarios will be created that will required racing and engineering knowledge and will need to be addressed as members proceed. Patients can contact other members for advice.

A minimal viable product will be developed as Level 1. Interest, potential, and available funding for the project will be assessed. The components necessary for progression to level two will be in large part more content based. By the time that we move to Level 3 and Level 4, however, significant additional programming and design will be involved.

2). Blood Glucose monitoringFurther Development of Points for: Completing educational components, Performing Blood Glucose measurements,Having blood glucose measurement that are: Good for a given patient (these can be tailored by the caregiver) or improving. Will follow standard blood glucose measure and HgA1c, a more chronic marker of compliance.

3). Simulated Situations Added to the Pearl (Fact) A DaysChallenges will encourage quick thinking, thorough thinking, empathy, concentration, and logic. Examples of simulated situations that will be added include: I can’t afford to buy my meds; I have not insurance; I don’t know if I have insurance; They want my insurance card. I have no idea what or where it is. What do I do?; My mom or dad is sick, where do I go?; My phone is not working?; My phone plan ran out?.

4). Further Development of Rewards Strategies when gamification seems to be inadequate for a given patient. The gamification will become more enjoyable for individuals better at gaming or at higher levels in the game process. Additional elements that will be added to increase engagement include: a). Audio positive reinforcement components: Maybe some fun, silly voices when meds are taken: “You rock”, “Congratulations”, “Good Job”, “Great Job”, “sick”, other idioms, musical choices, etc; b). Random motivators to allow the element of surprise; c). Material rewards. Additional partnerships with vendors in the area that have national counterparts to assess what material elements may actually prove to be good motivators (iTunes point, etc).

Software Development Resources. We have spent the past year evaluating and developing relationships with software development resources. Initial programming was performed by a group in Milwaukee called Awesome Fat. Further development efforts will proceed with a combination of the following groups: Creative Capsule (have designed GoMeals, ranked in some listings as one of the top 10 medical apps), Propaganda3 ( a high end gaming outfit with

extensive experience in gamification and accommodation to large numbers of users) Bazillion pictures (a highly developed animation and visual arts studio in Kansas City, 27 Global (a local software development group that has recently developed FrontFlip), and Bodeefit ( a local fitness start up that has developed an online fitness program that requires no gym memberships and equipment and may benefit our populations immensely. Members of the design team, the legal team, the clinical collaborators, the software development teams, and the legal teams are well versed in COPPA.

III. Data Collection

All data collected will be very complementary to the current Alligning Forces for Quality data set. These potential for data collection is vast and unique.

Engagement data will be collected on these populations that would otherwise not be collected. The data is designed to be collected in a de-identified manner. At presents, patients are enrolled through a third party, and PL does not have access to their names, though we do have access and collect demographic data that we use to personalize the approached. Pearl Leaves will have access to this data, but will make any data collected through programs developed through these grants available to RWJ and if desired to the general public. We would also actively seek partnerships with RWJ for continuous and unrestricted access to the data accrued in the Pearl Leaves Database, even beyond that accrued through the apps developed with this challenge.

The data that will be available from the Pearl Leaves Database is huge and could have tremendous community benefits. Not only will we have access to personal daily habits data and its correlation with health behaviors in a more detail than previously available, but we will have access to the way such data affects medical education.

Examples of data than can be collected include but are not limited to: Demographic and personality factors that correlate with showing up at the engagement center, Factors (behaviors and demographic data) that correlate with continuing engagement, Rewards that this population prefers, Diet patterns, Diet patterns and ability to influence/change diet patterns, How various diet patterns affect and more knowledge of the effects of these diet patterns affect behavior, What methods of communication with caregivers they prefer, What sources patients use to ask for help, What methods of communication with caregivers they prefer, Activity levels and methods of influencing activity levels, How involvement in a Health Engagement Center can improve Health.

Educational data Additionally, a whole range of unique data points can be collected in reference to patient medical education. Up to this point, very little data has been accumulated in the targeted patient population with medical education, and little, if any has been accumulated with the

provision of medical education with mobile devices. Types of data that can be collected include but are not limited to: What educational data is affective in changing behavior patterns, What educational methods are effective in transmitting education, How “gaming” and “gamification” affects, encourages, and reinforces educational targeted behaviors. III. Community Deployment Approach

Pearl Leaves will leverage its knowledge of medical disease and treatment, knowledge of the data on the components that are necessary for adherence, and its connections to the strengths of the Kansas City community to complete this project.

Initial deployment efforts will be conducted at Hope Family Care Center on Prospect in Kansas City, Missouri (http://hfcckc.org/). This site will serve as the primary beta testing site for the roll out our system. These systems will also be rolled out with a group called Pediatric Associates in Kansas City Missouri, the largest group of general pediatricians within this metro area, to assess pertinent issues to a different socioeconomic demographic. A critical member of the latter team is Natasha Burgert, who has recently been named one of the top five physician experts in social media in the US. She will be a valuable resource as we continue to gauge all safety issues as we move forward with the gamification aspects. All patients ages 13-30 with a new or old diagnosis of diabetes will be given the “Create: NGN” app, provided with an instructional video on app usage, and given 30 minutes of free play time if time permits in the office prior to departure, during which questions will be addressed. After usability and feasibility piloting at these sites, the system will be tested at wider locations throughout the city. A larger and more long-range approach will be called KC Health Engagement and we intend to bring in the support of the community with this effort. The intent is to eventually develop an “engagement” assessment center, the Kansas City Health Engagement Center or KCHEC (domain registered as KCHEC.org), where remote monitoring can guide patients through the process right after they have been given their hardware and software. Patients at risk for nonadherence will be referred for follow up at the KCHEC. The details of eligibility for this recommendation will be determined after funding sources are assessed. There are a variety of screening tools that can be used to determine those most at risk for nonadherence. The Merck Health Adherence Estimator is one such tool. Others are emerging (reference to start up just mentioned yesterday). Once a patient is referred to the center, they will either be taken through an automated process in which Pearl Leaves designs a customized adherence system for them. We estimate that up to 15-25% of patients will be at risk for not showing up to this first appointment. We hope that the offering of yet another game upon their arrival will be an incentive to overcome this barrier of entry. We also will have the phones to provide reminders about the necessity of attending the nonadherence center. Eventually, we do hope to have funds to allow patients to meet with a health adherence counselor. When this is possible, we will even contact patients through Facetime, to encourage more attendance.

Then the gaming begins. The patient begins to engage in their medical regimen, and is rewarded for good behavior both through the social engagement components, and the other incentives that a given community can provide. We are in the early stages of developing partnerships to support these programs. Initial efforts will focus strictly on the rewarding process of the gaming itself.

We are engaging multiple resources within the community to help address the program. We are a member of the KC start up village, and as such, have access to many programs that are being developed within the city under the guidance of the Kauffman Foundation and the Big 5 initiative of Kansas City for support of entrepreneurship. As part of this relationship, members of the start up village are eligible for reduced rate programs for phones and phone plans from Sprint. Pearl Leaves will utilize this opportunity to make sure that our population has access to mobile medical hardware and services. We also have contacts with an organization within our community called the Archer Foundation that is supporting entrepreneurship in the community. We will be using their advice as we furtherer define our business models and search for funding sources.

Outreach/ScalingThis center could have multiple impacts upon our community. First of all, it would be key for these kids to participate in designing something that is effective for their demographic. Secondly, it could be a source of positive feedback that these kids get to see that their thoughts and ideas do indeed feedback into the design of certain products that will be useful to both themselves and their community. Finally, it will be a spring board into encouraging IT education in a group that may normally not have access to all of the motivational elements that may push someone to this space to which others may have access.

The scenarios described above related have been designed with an eye towards diabetes management. It is of note, however, that programs can be designed with these tools to address a wide variety of medical conditions. Distinct adherence packages can be designed to take into account specific characteristics of various diseases, and unique characteristics of given patients. For instance, “packages” could be designed as followed for the following disease stages:

Parents or clinicians can select from prepackaged reward solutions that Pearl Leaves has suggested. 1). Diabetes package This adherence package would be tailored around diet, monitoring, and activity.2) Childhood obesity package This adherence package would be tailored around fitness and diet components.3). Mental health package (Geared towards depression and ADD) This package would be tailored around exercise, pursuit of positive behavior, and in some cases medications.