Case study 2 mindset: a mobile Health (mHealth) Management Information Decision-Support Epilepsy Tool Ross Shegog and Charles Begley University of Texas Health Science Center at Houston School of Public Health Acknowledgement
Figure 2. PRECEDE Logic Model of Change for MINDSET
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F  igure 2. PRECEDE Logic Model of Change for MINDSET
IM STEP 3: PROGRAM DESIGN In this section we describe the generation of MINDSET’s scope and sequence, the choice of theory and evidence-based methods, and the design of practical applications to deliver change methods. Task 1: Generate Program Themes, Components, Scope, and Sequence The theoretical framework for MINDSET is based in Social Cognitive Theory (Bandura, 1986), self-regulation models (Bandura, 1986; Clark, 2003), the 5-As model of behavioral change (Glasgow et al, 2004), motivational enhancement therapy (Velasquez et al., 2001), quality-of-care criteria and clinical guidelines for epilepsy (Fountain et al., 2011; American Epilepsy Society, 2003; Pugh et al., 2007, 2011), and formative studies (The Center for Managing Epilepsy Well, 2010; Begley, 2010). It was designed in collaboration with a patient–provider advisory group (PPAG) comprising patients with epilepsy and their HCPs. The literature review of decision support and self-management in epilepsy from the needs assessment phase (Step 1) was particularly helpful in informing methods (Harding, 2011; Shegog, Begley, Iyagba, Harding, Dubinsky, Newmark, Ojukwu, Friedman, 2011a; Shegog, Begley, Harding, Dubinsky, Newmark, Ojukwu, Friedman, 2011b; Begley, Shegog, Iyagba, Chen, Dubinsky, Newmark, Ojukwu, Friedman, 2010). The challenge was to develop a program to be able to fulfill five functional objectives involving both the patient and provider, without disrupting the flow of a typical clinic visit:
We attempted to contain the scope of MINDSET to only relevant data required for the visit so as to not unduly intrude on the timing of events in the clinic flow and to not over-burden the patient. These objectives and our observation of the natural clinic flow suggested the scope and sequence of MINDSET. It was possible for the patient to enter and review their data in MINDSET in the waiting room prior to their visit, and then to provide this profile and the tailored action plan to the HCP for review and discussion in the clinic visit. MINDSET’s scope and sequence are more fully detailed in Step 4.2 below. The original working title for the program was “Brainstorm.” While the notions of epilepsy as a brain-related disorder and thinking about management are apparent in this title, the term “brainstorm” also has connotations with the erratic neural activity of a seizure and was considered too provocative by patients and providers. The MINDSET acronym, Management Information and Decision Support Epilepsy Tool, offered two contextually related meanings, that of the cognitive profile of the patient explored in the retrospective data input phase, and of “setting” one’s mind which relates to the prospective action plan phase. Task 2: Choose Theory and Evidence-Based Change Methods Individual Behaviors Theoretical and empirically based methods for self-management education included chunking of information into a meaningful framework of self-management domains, self-assessment of self-management behaviors, feedback of a self-management profile to the patient to give an assessment of their self-management status, reinforcement for behavioral successes, goal-setting to address those behaviors that were a problem for self-management, tailoring of goals based on the patient’s individual profile, advance organizers and cue altering for self-management using behavioral strategies, self-monitoring of behaviors and environment, facilitation and linkage to care/support as needed. These methods and their related practical applications (Task 3.3) could all be delivered through repeated exposure to the MINDSET intervention in clinic visits over time. These methods were operationalized in MINDSET to impact learning objectives as exemplified in Table 3. Table 3. Example of Methods and Practical Applications used in MINDSET to Impact the Determinants (Knowledge, Self-efficacy, Perceived Importance, and Skills) for Adhering to Prescribed Medications.
Clinic Environment Guidance on how MINDSET could align to existing guidelines, recommendations, and clinic flow was informed by the 5As model, quality assurance guidelines, and clinic task analysis. The 5 As Behavior Change Model: The 5 As Behavior Change Model is intended for use with the Care Chronic Care Model (CCM) and provided a framework for thinking about the scope, contextual fit, and applications of MINDSET at the interpersonal (patient-provider interaction) level (Glasgow et al., 2002). A tenet of the model is that chronic illness patients have a Self-Management (SM) Action Plan informed by and including all the 5 As elements (Assess, Advise, Agree, Assist, and Arrange). Quality of Care Measures: Quality of care measures for epilepsy management include an array of assessment, treatment, and counselling protocols representing the best practice recommendations (Hoch DB, Norris D, Lester JE, Marcus, 1999; Pugh et al., 2007, 2011). Published quality care measures for the clinical management of epilepsy were consulted to determine the context of use for the practice of medicine. Aligning MINDSET function within these protocols positioned MINDSET for ready acceptance for clinic use. Clinic Task Analysis: Task analysis was conducted to examine the clinic flow in each of the participating clinics to understand the on-site operation and to determine logical opportunities for intervention without compromising that clinic flow (Figure 3). 3. Example Flow Diagram and Notes from the Task Analysis for the Kelsey Seybold (KS) Neurology Clinic 
Task 3: Select or Design Practical Applications to Deliver Change Methods As described in Section 3.2 above, the planning team selected specific practical applications to operationalize the theory-based change methods in ways that fit the population and setting for the intervention. We decided that a PC tablet-based tailored self-assessment approach would be feasible for intervention delivery. We designed MINDSET to be easy to use by physician and patient and portable to be able to accompany the patient through the clinic visit. Inclusion of data familiar and important to HCPs (e.g., seizure frequency and history, medication missed doses, and side effects) were included with the less familiar data on self-management behaviors for seizure, medication, and lifestyle management to provide added salience for use in the clinic setting. Clinic visit time constraints further suggested the advantages of tailoring data input such that patients would only enter their perceived self-efficacy and importance for “flagged” self-management problem behaviors. IM STEP 4: PROGRAM PRODUCTION In this section we describe the refinement of the program’s structure and organization, planning for program materials, drafting of messages and materials, and pretesting, refinement, and production of materials. Task 1: Refine Program Structure and Organization MINDSET is a tablet-based program to provide real-time self-management decision support to patients (over 18 years of age who are diagnosed with epilepsy) and HCPs in the context of their clinic visit (Shegog, Begley, Dubinsky, Harding, Goldsmith, Hope, Newmark, 2013). Originally mounted on an Archos 101 Android tablet platform (and subsequently on a Windows-based Dell platform), the use of MINDSET comprised three steps: patient data entry, patient and provider data review, and patient and provider discussion of issues, goals, and strategies. We envisaged that MINDSET would prompt the patient in the waiting room prior to seeing their HCP to input data in three epilepsy self-management domains: medication, seizures, and lifestyle. The method of chunking (Table 4, #1) informed us in distilling the complexity of epilepsy self-management into questions assessing 3 management domains and 13 self-management sub-domains including medication self-management (current anti-seizure medication prescriptions, medication adherence, adherence barriers, side effects, and medication, self-management behaviors), seizure self-management (the patient's recent seizure history, including frequency and type, and seizure self-management behaviors), and lifestyle self-management (including mood, social life including sexual relationships, child care, employment, and driving, physical activity, safety, record keeping, social support, and clinic visits). Patient Data Entry for Assessment Assessment instruments were embedded in MINDSET to provide assessment of the critical behaviors and determinants previously identified (Tables 1 and 2). A design specification for MINDSET was that it be minimally intrusive of clinic flow and patient burden. We therefore designed an assessment battery that collected priority information based on theory and empirical evidence, availability of a comprehensive and psychometrically valid scale, and clinical practice needs. For this reason the determinant of knowledge was not assessed in MINDSET, though addressed in tailored messaging and action plan feedback. Further, in response to the need for utility for use, assessment was tailored such that data were collected only when necessary for a given patient. For example, data on perceived self-efficacy and importance were only collected on a behavior if that behavior was flagged as “at-risk” (less than optimal adherence). This is discussed in more detail in Task 4.2 and Figure 7 below. Assessment of Self-Management Behaviors Self-assessment was an important method applied within MINDSET (Table 4). Assessment of self-management behavior was collected using the 38-item Epilepsy Self-Management Scale (DiIorio et al., 1992a, 1992b, 1994, 2004) that delineates behaviors regarding medication adherence, seizures, information, safety, and lifestyle. Responses were entered using a button selection on a 5-point Likert scale ranging from “never” to “always.” Perceived self-efficacy to perform self-management behaviors was assessed using a 33-item Epilepsy Self-Efficacy Scale (DiIorio et al., 1994). Responses were entered on a sliding scale (slider bar) adapted from motivational enhancement protocols (Velasquez, 2001) with a response set ranging from 0–10 with 0 being not at all confident (I cannot do at all) and 10 being extremely confident (Sure I can do)( DiIorio et al., 1992a, 1992b). Self-efficacy items were completed for those behaviors flagged as “at-risk.” Also adapted from the use of decision rulers from motivational enhancement protocols was the assessment of importance. Responses were based on a sliding scale from 1–10 with 1 indicating not important and 10 indicating extremely important (Velasquez et al., 2001). Table 4. Examples of Theoretical Methods and Practical Applications used in MINDSET
Assessment of Medication Side Effects and Barriers to Adherence Medication side effects represent an important clinical parameter to inform anti-seizure medication prescription as well as motivation for medication adherence. Side effects were assessed using a 19-item Epilepsy Adverse Events profile assessing reported problems during the previous four weeks from a list of 19 adverse effects (Table 5) (Panelli, Kilpatrick, Moore, Matkovic, D'Souza, O'Brien, 2007; Perucca, Carter, Vahle, Gilliam, 2009; Gillman, Fessler, Baker, Vahle, Carter, Attarian, 2004; Pugh et al., 2011). The scale assessed reported problems during the previous 4 weeks from a list of 19 adverse drug effects (Table 5). The original instrument used a 4-point Likert scale response set: 1. Never a problem; 2. Rarely a problem; 3. Sometimes a problem; 4. Always a problem (Panelli et al., 2007). Barriers to anti-seizure medication were assessed using a list of 18 barriers to medication adherence (adapted from previous studies) and provided to patients reporting missed doses (Table 5) (Markham, Shegog, Leonard, Bui, Paul, 2009). Table 5. Items Assessing Medication Side Effects and Barriers
Assessment of Depression Depression is a common comorbidity of epilepsy that can compromise self-management practice. MINDSET was not initially designed to intervene on depression directly and self-management matrices were developed for patients who were physically and cognitively capable of self-management practice. However, the MINDSET planning team saw the potential of MINDSET providing neurologists with the benefit of rapid assessment. Depression was assessed using the 6-item Neurological Disorders Depression Inventory for Epilepsy (NDDIE) screening tool that assesses the degree of depressive symptoms in the last week (Friedman, Kung, Laowattana, Kass, Hrachovy, Levin, 2009; Gilliam, Barry, Hermann, Meadow, Vahle, Manner, 2006; Epilepsy Foundation, 2013). Patients were prompted to provide the answer that best described them over the last 2 weeks for “everything is a struggle,” “nothing I do is right,” “I feel guilty,” “I’d be better off dead,” “I feel frustrated,” and “I had difficulty finding pleasure.” The response set was a 4-point Likert scale ranging from never to always or often. NIDDI-E scores of above 15 were considered positive for depression, with specificity of 90%, sensitivity of 81%, and positive predictive value of 0.62 based on the mini international neuropsychiatric interview (MINI) (Gilliam et al., 2006; Epilepsy Foundation, 2013). Patient Review of the Self-management Profile Immediate feedback is an important method applied in MINDSET (Table 4, #3). A profile is produced by MINDSET for the patient to review in the waiting area and share with the HCP (Figure 4) that summarizes responses on medication, seizures, and lifestyle, and flags at-risk behaviors based on a comparison of the frequency of the behavior to benchmarks. As previously described, for any behavior that is flagged, branched tailoring is applied where the patient is asked to rate his/her self-efficacy (confidence) and perceived importance to perform the self-management behavior (Table 4, #4). Based on programmed behavioral (frequency), self-efficacy (degree of confidence), and perceived importance benchmarks, the profile provides a prioritized list of behavioral issues for discussion, goal setting, and action. The profile has accompanying tailored advice boxes to increase awareness about strategies to improve self-management behaviors. If the patient reports no problems with self-management behaviors (i.e., he/she has no flagged behaviors), reinforcement is provided in a text-based congratulatory message (Table 4, #5). The advice boxes are also available to provide anticipatory guidance (or advance organizers) in the form of specific behavioral strategies to consider in the future (Table 4, #6). When the patient shares MINDSET with the HCP, the provider and patient can tab to a series of recommended action items and discuss the items and set goals (Table 4, #7). The process of using MINDSET is designed to promote shared decision-making where a patient and HCP can assess the need for improvements (both medical and psychosocial) and make subsequent informed treatment and behavioral change decisions. The applications, messages, and cues for discussion (Table 4, #8) are designed to impact determinants of knowledge, self-efficacy, perceived importance, and skills (Table 1). HCP-patient Review and Discussion of the Self-management Profile and Action Plan Providing patients with a decision aid to document self-management behaviors and guide future self-management goals is consistent with tools used in other chronic diseases such as asthma (USDHHS, 2007). For epilepsy self-management, such tools had been confined to acute seizure management and not inclusive of a broader set of self-management domains such as medication or lifestyle behaviors (Le, Shafer, Bartfeld, Fisher, 2011). MINDSET flow and function provides the HCP with an intuitive scaffold to progress through the management steps of assess, advise, agree, assist, and arrange (Table 2), allowing a rapid review of a patient’s status, reviewing strategies to plan coping responses (Table 4, #9), to alter behavioral cues (Table 4, #10), to institute self-monitoring (Table 4, #11), and to link to family and community support as needed (Table 4, #12). The process of using MINDSET is reiterated at each clinic visit (Table 4, #13). Figure 4. MINDSET Use within the Clinic Visit and Top-level Flow 
Figure 5. MINDSET Upper-level Flow 
Task 2: Prepare Plans for Program Materials A program design document provided the blueprint for MINDSET, informed by our understanding of patient characteristics including knowledge, educational background, cognitive capacities and limitations, age-related skills, cultural background, and time available for learning and training in the clinic setting (Begley et al., 2008, 2010). The team developed flowcharts to establish the function of MINDSET for the programmer, depicting the steps in the development of a tailored self-management action plan focused on anti-seizure medication adherence, seizure management, and lifestyle management (Figure 5). Flow charts and screen map mock-ups were developed as PowerPoint slides to depict MINDSET content, function, position of menu options, data entry components, patient profile display screens, and tailored feedback (bullets and cues). These “proof-of-concept” layouts illustrated what the patient and provider would see (the look and feel of the program). Initial mock-ups depicted (1) screening assessment and (2) decision support for intervention on self-management (Figure 6). The screening assessment consisted of computer-based prompts for the patient to input data (based on the data acquired from the screening tool, see Section 4.1 above) (Begley et al., 2010). The decision support was designed to provide feedback to both the patient and the provider in the form of confirmation of the patient’s profile on clinical and psychosocial variables, cues on discussion points during the clinic visit, and self-management goals and an action plan for after the clinic visit. The algorithm for prioritizing the self-management goals on the basis of patient self-report is illustrated in Figure 7. The development of flowcharts and screen maps was an iterative process and an essential one that helped guard against serious error or logical flows in the finished product. The design of an intuitive user interface was essential so that someone unfamiliar with the program could easily use it. A dedicated formative PPAG meeting provided a review and feedback on the design documents including content, design (interface) features, navigation, functionality, language, logistics of use and implementation in the clinic, orientation needs, and evaluation specifications. Figure 6. Evolution of MINDSET user interface 
Figure 7. MINDSET decision flow to produce a tailored action plan 
Task 3: Draft Messages, Materials, and Protocols To produce MINDSET components we executed production activities in an iterative manner, conducting formative evaluations of the program with the PPAG during development. Programming followed a stepped sequence. At each developmental step all components of the program were taken one draft further toward completion, building upon the review of previous developmental steps. This process ensured that all elements of the program had been developed with the benefit of multiple reviews. Structured programming techniques were used to develop the program and reduce needed refinements. The Archos 101 Android tablet platform provided the first MINDSET hardware platform, later superseded by the Dell Latitude (Figure 8). Patients and providers interact with MINDSET using a stylus or touch screen. The program was button and menu driven and designed for intuitive, easy navigation for both patient and provider with a limited depth of screens, ensuring providers could review the patient’s entire profile in two stylus button presses and not need to drill down for data deeper than 2 screens. F  igure 8. Dell Latitude tablet
Data input was in the form of pre-existing items from the previously validated surveys embedded in MINDSET (see Section 4.1 above). Messages provided to the patient in MINDSET and on the Action Plan confirmed the patient’s self-management profile (including flagged behaviors, perceived self-efficacy and perceived importance), reinforced self-management success, and provided strategies and recommendations specific to flagged behaviors. A series of message tables was created to organize the tailored messaging on the basis of possible permutations. For example, a different message would be presented to a patient to confirm their self-efficacy (low/high) and perceived importance (low/high) for managing their anti-seizure medication (Table 6). The 5-As model informed message construction that delivered strategies for flagged behaviors. Messages advised on goals (Agree), listed behavioral strategies, and cued discussion with the HCP (Assist) (Table 7). Table 6. Example Tailored Messages Based on Confidence and Importance Feedback for Medication Management
Table 7. Example MINDSET Messaging for a Patient who Reports Forgetting to Take Seizure Medicine
Task 4: Pre-test, Refine, and Produce Materials To pre-test and refine MINDSET components we (1) conducted an in-house alpha test of the program components on completion of programming activities, (2) conducted a usability analysis of the program, and (3) modified the program based on feedback obtained. MINDSET Alpha Test for Functionality. Alpha testing refers to a trial of software produce carried out by the developer before the produce is made available for usability or beta testing. An in-house alpha test was conducted among the MINDSET research team to ensure all program components and functions conformed to the intentions of the designers, functioned appropriately, and presented no anomalies (bugs). Any revisions indicated in the alpha testing (e.g., incorrect logic, program bugs, syntax errors, or interface design problems) were made prior to usability testing. MINDSET Usability Testing with PPAG. PPAG patients from three clinic sites (36–53 years of age, on one or more epilepsy medications, two-thirds female, and two-thirds from an ethnic minority) and 4 HCP from the development team were asked to use the MINDSET prototype in “laboratory” conditions (a dedicated conference room at Kelsey Seybold clinic) not associated with their regular clinic visit. Patients were asked to access all elements of MINDSET (the screening tool, patient profile, recommendations, and action plan) and to verbally describe and interpret what they were seeing and doing. They then completed a usability survey assessing the functions of MINDSET and were interviewed on how MINDSET could be improved in terms of content, function, and interface design. Data were gathered on the patients’ satisfaction with the user interface, ease of use (usability), acceptability, credibility, and applicability of the system to their needs using previously validated usability measures. HCPs were provided with a MINDSET tablet that had pre-loaded data on a patient whose profile indicated clinical and psychosocial self-management needs. Patients rated MINDSET highly on most usability parameters: ease, likeability, credibility, understandability, and appeal. They appreciated the opportunity to thoroughly review their epilepsy management: “It makes me look @ problems in my lifestyle/mood,” and to receive advice: “I love the advice sections”; “the advice sections were really useful for me”; and to organize their thoughts prior to the clinic encounter “… opportunity to remember everything to discuss with doctor”; “the information and seizure history for the doctor is great”; and “Helped condense my thought and organized any questions I might have.” HCPs rated MINDSET as increasing the ease, thoroughness, accuracy, and communication in each of the self-management domains (seizure history and management, medication management, lifestyle management, and providing an epilepsy action plan). Reported barriers to use included that the questions (behavior and self-efficacy) seemed repetitive; that patients required assistance due to technical difficulties with the tablet that delayed system responsiveness (distinct from a need to clarify data input questions); and that, while patients advocated the use of MINDSET, they suggested the need for patience for data entry due to the extensive data input in the My Profile section. Modifications were made in response to these issues. These focused on technical/functional fixes, on adjusting clinic expectations on the time commitment for data entry, and alerting patients to the apparent repetition of data input items. Sufficient time for modifications was included in the development and testing timeline to ensure the program specifications would be sufficient to conduct a feasibility study. The usability data indicated that MINDSET showed initial promise in facilitating the operationalization of self-management constructs for screening, management, and education; the application of clinical guidelines, and was feasible for clinic use. The HCPs rated MINDSET favorably on thoroughness; they also rated it as requiring more time for the clinic encounter. IM STEP 5: IMPLEMENTATION PLAN In Step 5, program planners describe potential program implementers, state the outcomes and performance objectives for implementation, construct matrices of change objectives for implementation, and design implementation interventions. Given that MINDSET is still in the efficacy trial phase (see Step 6 below), we have not fully completed all tasks for Step 5. An implementation intervention for wide-scale adoption, implementation, and maintenance of MINDSET will be developed pending the intervention’s demonstrated efficacy to enhance epilepsy self-management behaviors. Task 1: Identify Potential Program Implementers MINDSET was designed for use by HCPs in specialty neurology clinics managing outpatients with epilepsy. Thus, potential adopters included specialty clinic directors or upper level administrators; potential implementers included HCPs such as neurologists, epileptologists, and nurse educators. Task 2: State Outcomes and Performance Objectives for Implementation Performance objectives for adoption include that the clinic director will: Assess the need for an epilepsy self-management program among clinic patients; review MINDSET and note objectives and relative advantages; obtain feedback from clinic staff on potential barriers to/advantages of adopting MINDSET; solicit experiences from other clinics that have used MINDSET; agree to adopt MINDSET by signing a memorandum of understanding for its use. The outcomes and performance objectives for MINDSET implementation will be finalized pending evaluation activities. Task 3: Construct Matrices of Change Objectives for Implementation Critical opportunities for MINDSET implementation within the clinic flow were identified from clinic task analysis of collaborating clinics to intimately understand the environmental constraints of the use of MINDSET (Figure 3) as well as PPAG review of the implementation plan (in the context of review of the feasibility study protocol). MINDSET was designed for stepped use during the patient’s regular clinic visit that followed generic steps that could be applied across clinic settings (Figures 4 and 5): The patient inputs self-management data into MINDSET and receives a patient self-management profile that includes flagged behaviors, recommended strategies, and cues for items to discuss with the HCP; the patient presents MINDSET to the HCP who reviews and confirms the profile with the patient; the patient and HCP discuss recommended strategies; the HCP gives the patient a printed action plan tailored to the patients self-management needs based on the discussion. Matrices of change objectives for clinic directors, HCPs, and clinic nurses to adopt and implement MINDSET are pending results from evaluation activities. Task 4: Design Implementation Interventions The development of an implementation intervention for MINDSET is pending determination of its effectiveness. IM STEP 6: EVALUATION PLAN In this section we describe writing effect and process evaluation questions, developing indicators and measures of assessment, and specifying an evaluation design. Task 1: Write Effect and Process Evaluation Questions MINDSET was designed to increase patient and provider awareness of the patient’s epilepsy self-management behavior (i.e., medication adherence, seizure history and management, and the physical and social interactions related to lifestyle), enhance the quality of communication between them during the clinic visit (with focus on important self-management goals and strategies consistent with patient needs), and to increase the patient’s confidence to achieve those goals. The primary question to be addressed in the evaluation of MINDSET was: Does the use of MINDSET by a patient with epilepsy and their HCP to identify self-management needs and develop a plan to address them during multiple clinic visits over a 9 month period improve the self-management behaviors and confidence of the patients? Stated as an alternative testable empirical hypothesis: Patients with epilepsy who use the MINDSET self-management decision-support system in the context of their usual clinic visit for three consecutive clinic visits over a nine-month period will report at least three fewer “at-risk” self-management behaviors (assessed by the Epilepsy self-management scale) compared to patients who do not use MINDSET. Process evaluation questions included assessment of the amount of exposure patients had to MINDSET, the quality of the patient and provider clinic encounter when MINDSET was used, patients’ and HCPs’ perceptions of MINDSET and their experience using it in the clinic visit, and whether MINDSET prompted further information seeking regarding epilepsy self-management
From the outset the development of MINDSET focused on instruments and scales to assess patients’ self-management status and to provide indicators of self-management success over time. For this reason measures for evaluation closely corresponded to those embedded in MINDSET. Impact measures include the epilepsy self-management scale, epilepsy self-efficacy scale, Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), and adverse effects scale previous described (refer to Step 4: Program Production above and Table 8). Table 8. Sample Measures for Pilot Test
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