The KS clinic operates within a large urban multispecialty medical organization comprising 21 clinics and over 325,000 diverse patients comprising primarily white (55%), African-American (23%), and Hispanic (19%) ethnicities who are mainly middle-class, employed, and with private insurance coverage primarily through HMO- or PPO-type plans. Patients with epilepsy are referred to the centralized KS neurology clinic. HCPs include general neurologists (n = 5), an epileptologist, and a nurse epilepsy specialist. The neurology department has an annual epilepsy case load of approximately 400 patients. The Epilepsy Education and Research Program was established at KS Clinic in 1987 with the goal to demystify epilepsy through patient and family education and training about epilepsy, its treatment, and management, and to develop and conduct research to improve the clinical management of epilepsy through participation in multicenter clinical drug trials and academic collaborations (3, 40, 41).

The Smith Clinic at Harris Health provides care to patients who are primarily Hispanic (40%), low-income, uninsured, and covered by Medicaid, and are referred from community health centers (n = 12) operated by a large public hospital system. Medical residents and students rotating through the clinic see up to 40 patients per clinic day under the supervision of attending faculty.

The UT clinic is a large urban multispecialty neurology clinic. Patients with epilepsy comprise white (56%), black (14%), Hispanic (4%), Asian (0.2%), and other/unknown (27%). Economic status and financial coverage for health care is diverse, predominantly commercially managed care (58%), and Medicare (31%). The clinic is a tertiary care referral center for neurological disorders, including the diagnosis of epilepsy and the management of difficult epilepsy.

A PPAG was formed with representation from patients and HCPs from the three clinics and incorporated into the MINDSET research and planning team. The PPAG was consulted to review content (e.g., constructs, scales, and threshold scores for identifying “at-risk” patients); assess functionality, flow, and “look and feel;” test usability; and review evaluation plans. Patients for the advisory group were invited to join the PPAG by co-investigator clinicians and nurses on the basis of their being representative of the patient population, over 18 years of age, English speaking, engaged in epilepsy management issues, and interested in contributing to the field. The PPAG included three neurologists, one nurse educator, and eight patients with epilepsy. The PPAG met in a conference room at the KS Clinic. Patient members received an incentive payment of $30 per meeting.

A decision support tool for identifying patient S-M needs based on clinical, behavioral, and psychosocial variables requires identifying S-M behaviors and the clinical, behavioral, and psychosocial antecedents related to poor S-M as well as to identifying what other instruments/tools might be available in the field. To develop a logic model of the problem, the literature review addressed the medical management of epilepsy, epilepsy S-M behaviors, determinants of S-M behavior, and environmental factors associated with S-M. Data on the S-M interventions, DSSs in support of epilepsy management, and perceptions of PWE toward technology-based applications were also reviewed to understand the empirical and clinical context. Theories and models applicable to chronic disease management amenable to, or applied to, epilepsy were also reviewed, as were practice guidelines for epilepsy management. The research team developed problem statements, identified relevant electronic publication databases of Medline, PubMed, and PsychINFO, formulated database search strategies, and recommended an approach to synthesizing the literature. Data abstraction forms were developed and pilot-tested before they were used to abstract data from the identified relevant studies. Abstracted data were used to create evidence and information tables for expert review. We considered articles published in peer-reviewed journals, including review articles and surveys as well as practice guidelines. Abstracts, poster presentations, and editorial publications were excluded.

As with many chronic diseases, patients with epilepsy may undergo benign or malignant courses, but all will be affected significantly in some way (21, 42). Most patients with epilepsy undergo basic serological tests, EEG, and imaging studies, and have treatment initiated with a single anti-seizure medication (referred to, henceforth, by the common term anti-epilepsy drugs or AEDs) appropriate for the type of seizure, and age and gender of the patient. If the first agent does not control the seizures or has unacceptable toxicity, switching to a second or third appropriate agent occasionally provides better results. Some patients have seizures incompletely controlled with a single agent, but the addition of a second medication only allows a further 15% seizure control. The choice of a specific AEDs for a given patient is a fairly complex process, which needs to consider the individual’s tolerance for medication in general, seizure type, etiology of seizures, co-morbid conditions, concurrent medications, as well as non-medical factors such as employment and medication costs. Despite optimal pharmaceutical treatment, approximately 30% of patients will have recurrent seizures, and as many as 50% of patients with partial seizures will not attain complete seizure control with medication regimens. Patients who do not respond adequately to AEDs may be candidates for surgical treatment or other alternative regimens, including the ketogenic diet, vagal nerve stimulator, and control of precipitating factors (43). The pathophysiology of epilepsy varies between individual patients who may experience a number of different seizure types (e.g., generalized tonic-clinic seizures characterized by convulsions; absence seizures characterized by abrupt beginning and end, blank stares, and only a few second in duration; and complex partial seizures that are characterized by altered consciousness where there is no memory of the misplaced behavior demonstrated during the seizure) and varied stimulus onsets (43).

For PWE, S-M comprises a number of adaptive behaviors that may assist in lowering seizures (44). S-M for PWE refers to a number of adaptive behaviors that may assist in lowering seizures. In recent years patient S-M has received more attention (2, 20). Behavioral risk factors contributing to seizures and co-morbidities include lack of adherence to AEDs, failure to monitor and protect against seizure triggers, lack of safety management to minimize the adverse consequences of seizures, failure to adhere to clinical visit regimens, and failure to adjust lifestyle behaviors to minimize risk of injury (2, 6, 45) (Figure 1). Epilepsy co-morbidities are associated with poor S-M and include cognitive dysfunction, depression, suicidal ideation, death resulting from a seizure or status epilepticus, and sudden unexpected death in epilepsy (SUDEP). Medication management (adherence), safety behaviors (e.g., cessation of driving), and daily activities (e.g., maintaining sleep and reducing stress and exposure to triggers of seizure triggers) may lower seizure frequency. The focus of seizure control is management of AEDs. AEDs require strict adherence and, even with this, may not completely control seizure activity in 30% of epilepsy patients (46). Compounding this is low AED adherence. Review data for claims indicates 39% of patients do not take their prescribed regimen (47). Failure to adhere to prescription is associated with increased likelihood of hospitalizations and ER visits (47). Poor adherence is related to significant adverse health effects and increased mortality (48, 49). Uncontrolled seizures place “challenging demands” on PWE and their family and strongly predict low quality of life (50), being related to injury, limits on driving, and restrictions on sporting and recreational activities. Other S-M activities, apart from AED adherence, can increase mood and quality of life. For example, self-monitoring can increase awareness of prodromal (early) features of seizures (e.g., “mood and premonitory triggers of blurred vision, hunger, thirst, tiredness”) (44). Such self-prediction is associated with favorable mood and increased confidence in one’s ability to accurately predict seizures (51).

A range of factors provide antecedents for S-M behavior (Figure 1). Poor S-M could be due to the patient’s low levels of knowledge (declarative and procedural) and skill regarding epilepsy S-M behavior and goal setting, low self-efficacy or confidence to perform S-M behaviors, low outcome expectations (both in terms of causality of seizure onset as well as causality of treatment), and lack of attribution of S-M success to self-effort (particularly as this relates to patient control); lack of acceptance or denial of the diagnosis of epilepsy; fear of stigma related to epilepsy; perceived barriers to managing epilepsy, as well as unrealistic perceptions of how other PWE self-manage (2, 7–9, 11, 16, 52–62). Epilepsy is often associated with cognitive dysfunction, behavior problems, depression, and anxiety (12). Furthermore, seizures in epilepsy may be precipitated by psychological triggers such as stress and emotions such as anxiety and anger (12). Patient’s perceptions of, and satisfaction with, health services and clinical care are associated with health care utilization, an important aspect of S-M (2). Many PWE lack the behavioral capability to monitor and self-regulate behaviors that affect seizure susceptibility indicating a need for effective S-M programs (2). Such behaviors include AED adherence, exposure to environmental stimuli, overuse of drugs and alcohol, stress reduction, and ensuring adequate sleep (2).

Interpersonal, organizational, and community factors impact PWE. Personal determinants of environmental factors involve HCPs, families, and the community (Figure 1) (2). Epilepsy management is compromised when families lack knowledge and skills for providing support for S-M, and HCPs lack the skills to effectively communicate with patients and families to train them on, and reinforce them for epilepsy management behaviors (2, 12). This is compounded by the general community’s misguided beliefs about epilepsy, lack of knowledge and skills to assist with seizures and support management, and lack of awareness of policies and guidelines regarding supporting PWE in important life functions, including employment, driving, sports, and housing (2).

Until recently, there were few evidence-based epilepsy educational programs (63). Reported results were encouraging. In a study among 100 adults with epilepsy with a two-day psycho-educational program (Sepulveda Epilepsy Education) significant effects were demonstrated that included greater serum AED levels (indicating better drug adherence), decreased use of hazardous medical S-M practices, greater understanding of epilepsy, and decreased fear of seizures in treatment group compared to the comparison group (64). A study among adult Nigerian patients, a two-day modular didactic psycho-educational program focused on adjusting to epilepsy and related psychoneurotic traits, depression, and stigma demonstrated significant improvement in knowledge of epilepsy, neurotic disorders, and depression, in the treatment group compared to the comparison group (65). A modular didactic educational program (MOSES, Modular Service Package Epilepsy) evaluated on a sample of 242 participants, demonstrated greater tolerance of AEDs, fewer side effects, improved knowledge and coping, and greater satisfaction with therapy in the treatment group compared to the comparison group (56). Interventions were mainly psycho-educational with minimal focus on S-M as previously defined. Recent evidence-based interventions that target S-M behaviors and/or co-morbidities for adults (≥18 years) include WebEase (Web Epilepsy Awareness, Support, and Education), UPLIFT (Using Practice and Learning to Increase Favorable Thoughts), PEARLS (Program to Encourage Active Rewarding Lives), HOBSCOTCH (HOme Based S-M and COgnitive Training CHanges lives), and PACES in Epilepsy (Program of Active Consumer Engagement in S-M) (66). WebEase is a self-paced online website where PWE can choose from among medication, stress, sleep, and personal tracking diary modules that provide tailored activities for learning, self-assessment, and goal setting (assessed at 1-week intervals). A national RCT (n = 148) demonstrated significant improvement in self-efficacy and medication adherence for those using WebEase (67). Other interventions have greater focus on co-morbidities of depression [UPLIFT (68), PEARLS (69)] and subjective memory complaints (HOBSCOTCH) (70) or a niche priority population consumers with active epilepsy (with seizures occurring within the last year) (PACES) (71). Tools to optimize decision-making for S-M for patients and providers within the clinic visit had not been reported.

The Centers for Disease Control and Prevention (CDC) Epilepsy Program supported the development of e-Tools as one of several approaches to address the gap in available epilepsy S-M tools (1). This vehicle has the potential to overcome barriers to care that PWE face such as lack of transportation and stigma (1). Despite this, a review of the literature on informatics applications for epilepsy management revealed an only recently emerging research effort (25). Of the 68 studies reviewed in the domains of patient monitoring and prevention, education, and therapy or guideline application most were descriptive (describing models, system development, or system installation) with only eight studies testing effectiveness (the impact on patient or provider behavior) using prospective design (25). PWE are well positioned to use emerging eHealth applications in epilepsy S-M. Over 50% of PWE have access to the Internet in a variety of settings (i.e., home, work, school, library) (72–74) and a recent cross-sectional study (19) with adult PWE (n = 183) indicated that most participants had access to computers and the Internet (95 and 60%, respectively) and used them to find health information (99 and 57%, respectively). Participants reported “searching for general information on epilepsy (43%), medication (30%), specific types of epilepsy (23%), and treatment (20%)” and most reported that they “likely would use an Internet-based S-M program to help control their epilepsy” (19). Counter-balancing this is needs assessment survey data of adults with epilepsy in the Pacific Northwest (n = 165) (75, 76) indicating that a majority of patients prefer in-person (individual or group) program delivery, reinforcing the importance of this over purely distance delivery (phone or Internet).

While the patients in the PPAG were veteran self-managers and mostly exhibiting good seizure control they expressed frustration regarding their relationship with their HCP. This applied particularly to patients from a large inner city community health clinic where brief “face time” with clinicians and frequent and consistent turnover of fellows hampered the development of an ongoing therapeutic relationship. They considered a tablet-based DSS within the context of a clinic visit as a positive addition. Many were using the internet to acquire information on epilepsy and most wanted greater communication with their HCP. There was general agreement for the potential of the epilepsy DSS as a clinical tool in facilitating patient-provider communication.

Social cognitive theory (SCT) and self-regulation models (77–79) were consistently reported in the literature in the context of S-M of epilepsy and other chronic diseases (80, 81) and associated with key psychosocial determinants, including knowledge, outcome expectations, and self-efficacy and skills previously described. A tenet of SCT is that behavior is determined by the interaction of personal, environmental, and behavioral influences (77). Personal influencers include cognitions, such as personal values, beliefs, skills, outcome expectations, and self-efficacy. Environmental influencers include social or physical factors (e.g., influential role models, social or normative support). Self-regulation is a potent SCT concept for organizing health education in the management of chronic health disorders (82, 83). It comprises primary sub-functions of behavior self-monitoring (including antecedents and consequences); judgment of one’s behavior in comparison to optimal personal standards and environmental circumstances; and self-reaction (behavior to rectify drifts from optimal S-M) (84). The categorization of S-M behaviors in Figure 1 are informed by this self-regulation framework (Figure 1). The term self-regulation refers to both the patient’s management of his/her own care and the transfer of S-M tasks to the patient by the HCP as appropriate. Self-regulation has the potential of improving the patient’s autonomy and increasing adherence to medical regimens, which can improve medical outcome. Self-regulation necessitates a more prominent role of the patient in first determining, and then monitoring, behaviors and environment, and then modifying therapeutic regimens accordingly in collaboration with the HCP. Self-efficacy and outcome expectations have been described as determinants of epilepsy S-M behavior (10, 16).

The 5-A’s model of behavior change (81), quality-of-care criteria, and clinical guidelines for epilepsy (13, 31, 32, 85); informed MINDSET’s scope, components, and relevance within a clinical context (described in Step 3). Motivational enhancement therapy protocols (86) provided a means of eliciting decision-making within an mHealth program. Both motivational interviewing and shared decision-making supports the ethical principle of self-determination (87) Motivational enhancement protocols used to elicit movement toward behavioral change had been used in previous decision-support studies (88, 89).

To collect additional data on determinants of poor epilepsy S-M in their priority population, the planning team conducted surveys with PWE receiving care at two clinics in the Houston area (n = 238) (10). The objective was to examine variation in S-M across diverse patient populations and explore the association between personal psychosocial factors (knowledge, self-efficacy, depression, and stigma) with S-M. A cohort of 437 patients previously enrolled in the CDC-funded Epilepsy Care and Outcomes Study (41) completed a 45-minute S-M survey within the context of their regular clinic visit. The survey comprised scales previously reported in epilepsy-related research, including the Epilepsy S-M Scale, Epilepsy Knowledge Scale, Epilepsy Self-efficacy Scale, Outcome expectations, Shared Control portion of the Multidimensional Desire for Control Scale, Personal Resource Questionnaire 85 Part 2, Center for Epidemiologic Studies Depression Scale, and Modified Parent Stigma Scale, and Patient Satisfaction Questionnaire-III. The justification for these scales was recent research that had focused on assessing the association of these factors and epilepsy-related S-M behaviors. DiIorio et al. (90) determined the association of the assistance aspect of social support with regimen-specific support (41). Self-efficacy was significantly associated with outcome expectancy and anxiety in the predicted directions and anxiety was significantly negatively associated with S-M (90). DiIorio et al. determined that self-efficacy and patient satisfaction explained the most variance in medication management (16). Self-efficacy was associated with social support, stigma, outcome expectations, and depressive symptoms. Stigma was associated with depressive symptoms (16). The overall fit of the model was improved by adding the direct association between stigma and outcome expectations for seizures to S-M (90). DiIorio et al. (91) identified depressive symptoms and seizure severity as significant antecedents of self-efficacy for epilepsy S-M. Also significant were predictors of social support and stigma (91). Self-efficacy, social support, depression, and perceived stigma were significantly related to S-M regardless of demographics, seizure frequency, or socio-economic status (p < 0.05). These findings suggested that the difficulties with S-M faced by many patients with epilepsy are similar irrespective of a patient’s background or characteristics and that the types of strategies to improve S-M appear similar regardless of population heterogeneity.

Management Information Decision Support Epilepsy Tool was designed to positively impact S-M behavior for epilepsy that encompassed three domains: Medication management, seizure management, and lifestyle management.

The expected behavioral outcomes for PWE related to each domain were as follows:

Take AEDs as prescribed by the physician (medication management).

Targeted health and quality of life outcomes included decreased seizures (number and duration) and AED side effects and improved daily functioning resulting in improved work productivity, less injury, and reduced ER visits, hospitalization, or death attributable to epilepsy (Figure 1).

Management Information Decision Support Epilepsy Tool was designed for use in the clinic visit so S-M assessment and intervention needed to become a minimally invasive component of the clinic flow. Rather than manipulate varied clinic environments (which would be prohibitive when considering future dissemination), the environmental outcome focused on the interpersonal level of the HCP (neurologist and nurse educator). Therefore, the environmental outcome was focused at a personal level:

HCP and/or nurse educator will support PWE to self-manage their condition.

Performance objectives were described for each S-M outcome: medication management, seizure management, and lifestyle management. These are listed in Figure 2 and were drawn mainly from review of existing literature and S-M measurement instrument domains (7). MINDSET and the patient action plan alert both the patient and HCP when change in S-M behavior is needed and cues them to decide on S-M priorities or goals based on available evidence and to agree on how best to achieve these S-M changes. The action plan provides the patient with an ongoing resource outside of the clinic visit on priority S-M performance objectives and strategies to achieve them (described further in Task 4.3 below).

The environmental focus for MINDSET was for the HCP to support S-M awareness raising and skills training (Figure 2). This included identification and review of S-M problems, and discussion with the patient to develop agreed upon S-M behavioral goals. The HCP’s behaviors were structured in accordance with the 5 A’s model and included requesting the patient complete data input into MINDSET, reviewing their epilepsy management profile, and acknowledging status (ASSESS); reviewing the patient’s epilepsy profile, reinforcing past management successes, and discussing personally relevant, specific recommendations for behavior change (ADVISE); reaching agreement on treatment goals with the patient (AGREE); reviewing barriers to achieving goals and agreeing on strategies to overcome them, and providing the patient with an action plan (ASSIST); reviewing epilepsy S-M change at each visit by comparing MINDSET epilepsy profile with that of the previous visit, arranging referrals appropriate to existing co-morbidities in the patient profile, and linking patients to appropriate community resources to provide the support needed (ARRANGE). The briefness of clinic encounters made it challenging to adequately review S-M and such assessments had lacked formality. There was opportunity for relative improvement in the HCP modus operandi as it pertained to S-M intervention.

Theoretical and empirically based methods for S-M education, included chunking of information into a meaningful framework of S-M domains, self-assessment of S-M behaviors, feedback of a S-M profile to the patient to give an assessment of their S-M status, reinforcement for behavioral successes, goal setting to address those behaviors that were a problem for S-M, tailoring of goals based on the patient’s individual profile, advance organizers and cue altering for S-M using behavioral strategies, self-monitoring of behaviors and environment, and facilitation and linkage to care/support as needed (Table 3). The research team selected methods based on (1) our previous work in decision support of chronic disease (96) and technology-based behavioral change interventions founded in self-regulation frameworks within varied health domains (97–99), (2) empirical evidence for use to impact the target determinants (exemplified in Table 3), and (3) the pragmatics of use in a tablet-based program. 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. Their operationalization within MINDSET is described in Task 4.1 below.

Guidance on how MINDSET could align to existing guidelines, recommendations, and clinic flow was informed by the 5 A’s model, quality assurance guidelines, and clinic task analysis. The 5 A’s Behavior Change Model. The 5 A’s Behavior Change Model (used with the Improving Chronic Illness Care Chronic Care Model) provided a framework for developing the scope, contextual fit, and application of MINDSET at the interpersonal (patient-provider interaction) level (81). A tenet of the model is that chronic illness patients have a S-M Action Plan covering the 5 A’s 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 counseling protocols representing the best practice recommendations (33, 34, 100). 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 it 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 (101) (Figures 3 and 4). This involved shadowing patients through their clinic visit in each of the participating neurology clinics, examining data flow within the clinic for each patient, decision-making by HCP, interaction points between the patient and provider, and duration in each location.

Scales were embedded in MINDSET to provide assessment of the critical behaviors and determinants previously identified (Tables 1 and 2). A design specification was that MINDSET be minimally intrusive of clinic flow and patient burden. Therefore, an assessment battery was designed that collected information based on theory and empirical relevance, 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. Furthermore, 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 frequency), described in Task 4.2 and Figure 5 below.

Self-assessment was an important method applied within MINDSET (Table 4). Assessment of S-M behavior was collected using the 38-item Epilepsy S-M Scale (7, 8, 16, 55) 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 S-M behaviors was assessed using a 33-item Epilepsy Self-Efficacy Scale (7). Responses were entered on a sliding scale (slider bar) adapted from motivational enhancement protocols (86) with a response set ranging from 0 to 10 with 0 being not at all confident (I cannot do at all) and 10 being extremely confident (Sure I can do) (8, 56). 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 to 10 with 1 indicating not important and 10 indicating extremely important (86).

Medication side effects represent an important clinical parameter to inform AED 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) (34, 103–105). 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 (103). Barriers to AEDs were assessed using a list of 18 barriers to medication adherence (adapted from previous studies) and provided to patients reporting missed doses (Table 5) (88).

Depression is a common co-morbidity of epilepsy that can compromise S-M practice. MINDSET was not initially designed to intervene on depression directly and S-M matrices were developed for patients who were physically and cognitively capable of S-M 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 (NDDI-E) Screening Tool that assesses the degree of depressive symptoms in the last week (106–108). 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 (102).” “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) (102, 107, 108).

Immediate feedback is an important method applied in MINDSET (Table 4, #3). A profile is produced by MINDSET. The patient can review this in the waiting area and then share it with the HCP (Figure 3). The profile 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, the patient rates his/her self-efficacy (confidence) and perceived importance to perform any S-M behavior that is flagged (Table 4, #4). Based on programmed benchmarks for behavior (frequency), self-efficacy (degree of confidence), and perceived importance, 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 S-M behaviors. If the patient reports no problems with S-M 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 sharing MINDSET, both the patient and HCP can tab to a list 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 (102).” 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).

Providing patients with a decision aid to document S-M behaviors and guide future S-M goals is consistent with other approaches to chronic disease management (e.g., asthma) (109). For epilepsy S-M, such tools have focused on acute seizure management and not broader S-M domains inclusive of medication or lifestyle behaviors (110). 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).

An in-house alpha test was conducted by 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”). Research team members each completed MINDSET, simulating a patient with particular epilepsy S-M profiles. They completed logs recording any problems encountered that included incorrect logic, program bugs, syntax errors, or interface design problems. They completed the problem log by recording their location in the program, the user initiated events that preceded the problem, and a description of the problem (including screen captures where appropriate). Problems were collated and sent to the programming team for further troubleshooting and revision prior to usability testing.

Patient Provider Advisory Group patients from three clinic sites (36–53 years of age, prescribed at least one AED, mainly female and ethnic minority) and 4 HCP from the planning 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. Hypotheses for usability testing were that patient ratings on usability parameters (measured on a usability survey) would exceed an a priori benchmark of 70% agreement and that HCPs would rate MINDSET features (measured on a features checklist) as providing improvement to their current practice. After an orientation, 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. Any problems (as previously described for alpha testing) were recorded and collated. Patients 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 patient’s 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 S-M needs. Patients rated MINDSET favorably on usability parameters, providing 80 to 100% agreement that it was easy to use, likable, credible, understandable, and appealing. This exceeded a priori success criteria of at least 70% agreement (94, 95). Patients 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 S-M domains (“seizure history and management, medication management, lifestyle management, and providing an epilepsy action plan”) (102).

Reported barriers to use of MINDSET 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. The usability data indicated that MINDSET showed initial promise in facilitating the operationalization of S-M constructs for screening, management, and education; the application of clinical guidelines; and was feasible for clinic use. The HCPs rated MINDSET favorably on thoroughness; but also rated it as requiring more time for the clinic encounter.

A total of 60 patients from the KS clinic (n = 20), BT clinic (n = 20), and UT clinic (n = 20) (previously described) would be invited to participate. Participants would include patients with a diagnosis of epilepsy who are 18 years of age and older, who can speak English, who are willing and able to complete MINDSET, and who have no other medical disorders that could inhibit their ability to use MINDSET or practice S-M activities. Participation would be based on clinician and nurse educator referral and ideally reflect the diversity of gender and race-ethnicity, average age and SES for the respective clinic populations.

Each clinical site would recruit 20 patients to participate in the randomized pre–post treatment and comparison group study. Once enrolled the patients would participate during three regular clinic visits that would be scheduled three months apart. They would be randomly assigned to one of two groups (30 in each group, 10 from each site) for receipt of the treatment (MINDSET plus usual care) or comparison (usual care only) condition.

At the first visit, a MINDSET research staff member would meet the patient at the clinic to confirm participation, answer questions, and, if they agree to participate, obtain signed consents. Consent and study protocols are subject to approval by human subjects internal review boards at the contributing university and clinical organizations. All patients would then complete a contact sheet, and a demographic survey. They would then input data into the assessment section of MINDSET (My Profile) prompted by screening questions. This would include data on seizures, AEDs, and lifestyle, as well as S-M behaviors (Epilepsy S-M Scale) and self-efficacy (Epilepsy Self-efficacy Scale) related to these domains. Data input would take place in the waiting room and clinic room while waiting for the clinic appointment.

Group 1 patients would use MINDSET to review their epilepsy S-M patient profile (My Plan) that indicates S-M challenges (“risk”), provides behavioral goals and associated advice about content, provides recommendations for discussion with the HCP, and also provides information on associated S-M resources (e.g., available through the American Epilepsy Society, Epilepsy Foundation, and MEW Network). During the clinic encounter, the provider and patient would refer to MINDSET. The HCP would be provided suggested action items based on the patient’s profile, could access the patient profile (My Plan) data and could confirm or modify these data after interviewing the patient. The patient and provider would have the opportunity to review recommended discussion points, goals for management, and the action plan. The provider will have the opportunity to provide the patient with a tailored printed action plan that reiterates the priority management goals discussed in the clinic encounter.

After completing initial assessment items in MINDSET, Group 2 patients would provide MINDSET back to the research staff member and continue their regular clinic visit in which they would meet with their providers as usual without the benefit of MINDSET information and prompting on discussion points and the action plan, and without the receipt of a printout of the action plan. Following the clinic visit both group 1 and group 2 patients would complete process measures of the clinic visit interaction checklist and clinic visit communication scale. All patients will then be provided $15 for their participation.

During the second visit, patients in Group 1 and Group 2 would again complete the assessment (My Profile) component of MINDSET. Group 1 patients would again use MINDSET to review their epilepsy S-M patient profile and recommended management goals (My Plan) and both HCP and the patient can use MINDSET to review and confirm data and develop the action plan. The HCP would also have access to any change in the patient data since the last clinic visit. Group 2 patients would again only complete initial assessment items in MINDSET, and then will provide MINDSET back to the research staff member and continue to the regular clinic visit. Again, following the clinic visit, both Group 1 and Group 2 patients would complete process measures (described below). During the third visit, both Group 1 and Group 2 patients would input their profile data using the assessment screening tool in MINDSET (My Profile). They will then return MINDSET to the research staff, complete a short exit interview.

Comparisons of changes in scale scores on S-M and self-efficacy from O₁ to O₃ will be made and t-tests and one-way analysis of covariance of the changes will be used to address the evaluation hypothesis. The independent variable of interest in all cases will be group assignment: treatment or comparison. Measures of mediating factors including depression and pre-test scores will be used as covariates.

This study represents a modest trial designed to be accomplished with available resources. While loss to follow-up is often an issue in such trials the small sample and previous success of the clinics in tacking and maintaining these patients indicates that a 20% attrition is realistic. A per-protocol analysis is planned in this efficacy trial to determine impact of the MINDSET intervention if received. Furthermore, because a limited number of providers (neurologists) are involved in the trial there is expected to be limited turnover and the capability of targeted training by the research staff. Despite this, any findings need to be interpreted in the light of acknowledged study limitations. We expect minimal between-patient contamination because the patients are not typically interacting with each other in these clinics. However, the study is subject to within-provider contamination because a limited number of providers will encounter both MINDSET (Group 1) and usual care (Group 2) patients. It is not possible to blind the provider in this type of trial because they are using MINDSET and the action plan with their patients. It is, therefore, possible that providers will be more attentive to lifestyle issues with all their patients, above what they might originally have been. The contamination will work against a Type I error, making any findings more robust. Further, the time constraints of a busy neurology clinic will likely limit providers to patient-specific cues (from the Action Plan) and not unduly influence general discussion. This remains to be determined. The trial has not been registered in a public trials registry.