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Newton, MA, United States

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.10M | Year: 2010

DESCRIPTION (provided by applicant): One of every five adults in the United States (46.4 million people) is affected by arthritis. Increasing the number of days individuals are free of arthritis pain is one of the Healthy People 2010 objectives. Although there are a variety of medical treatments and medications available, self-management is a critical component in helping arthritis sufferers learn how to identify, avoid, and help manage their pain. Unfortunately, clinicians face significant time pressure, leaving little time for desired patient-provider education and collaboration. This is an important omission as tailored advice (e.g., specific exercises to reduce pain) from health providers could enable behavior change and improve outcomes. Therefore, widely accessible and tailored interventions that address motivational issues are needed to facilitate self-management education among arthritis patients. Because of its reach across demographic groups, the Internet is an excellent vehicle for offering a self- management program to arthritis sufferers. We propose to develop an interactive, online pain self- management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977, 1997). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self- management strategies. Moreover, it will be designed to complement and connect to our other SBIR- supported pain online health interventions (chronic back pain, migraine pain, neuropathic pain) to be a more comprehensive resource for those seeking pain management assistance. The most unique aspect of painACTION: Arthritis is that it includes three technological innovations -- a Web 2.0-enabled platform, a Custom Recommendation Engine, and Dynamic Lessons - to help people self manage their arthritis pain. In Phase I we accomplished two important objectives: 1) established the feasibility of painACTION: Arthritis as an intervention and a technical project and 2) generated preliminary plans for the content, design, and technical development of painACTION: Arthritis. In Phase II we will produce the program and test its efficacy. PUBLIC HEALTH RELEVANCE: One of every five adults in the United States (46.4 million people) is currently affected by arthritis and this number is expected to continue to grow to 67 million over the next twenty years. In 2003, 128 billion was spent on arthritis treatment in the United States alone. During the Phase I project we worked with consultants, people with arthritis pain, health professionals, and technical staff to: a) establish the feasibility of creating an online self management program for people with arthritis pain and b) develop plans for content, design, and features for a fully functional painACTION: Arthritis program. In Phase II, we propose to create painACTION: Arthritis then conduct a study to find out if it helps people with arthritis pain to increase their self management skills and functioning.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.17M | Year: 2010

DESCRIPTION (provided by applicant): This Phase II application proposes to continue development of the ASI-MV-CAT, a Computer Adaptive Testing edition of Inflexxion's popular Addiction Severity Index-Multimedia Version (ASI-MV). Built on the ASI, probably the most widely used adult assessment for substance use problems in the US, the ASI-MV provides a reliable, valid and cost-effective version for all clinical and research purposes. The Internet connectivity of ASI-MV Connect allows automated collection of data in a manner that is compatible with clinical and administrative systems. The ASI-MV is currently used at more than 500 sites throughout the country and is administered nearly a hundred thousand individuals annually. Despite its substantial commercial success, the current version of the ASI-MV suffers from some of the psychometric problems inherent in the ASI itself. Developed more than quarter century ago, concerns have mounted about the psychometric performance of the ASI, particularly as evaluated in light of modern thinking. Furthermore, profound changes in the nature of the substances abused, patient populations, and treatments have occurred during the past 25 years. Thus, the ASI and, by extension, the ASI-MV do not meet all critical assessment and treatment needs of administrators, researchers, and clinicians. The ASI-MV-CAT is intended to update the ASI and to provide the option for brief, but state-of-the-art, assessment. The ASI-MV has amply demonstrated the feasibility of using computer- mediated administration of the ASI. Based on principles of Item Response Theory (IRT), a computer adaptive testing (CAT) version of the ASI-MV will permit improvement in several, related measurement concepts: (1) scaling and dimensionality of derived scores, (2) interval measurement of clients' problem severity, (3) overall adherence to scientific measurement principles and hence, (4) applicability of measurement data to statistical analyses. CAT also permits a quick ASI screening or follow-up assessment that could potentially reduce administration time 50% to 80%. In Phase I, the Specific Aims were accomplished utilizing a large database of ASI-MV Connect assessments (N = 23,400). A comprehensive examination of the psychometric (classical test theory-CTT and IRT) status of the existing ASI items for all ASI domains was conducted. While some domain items performed better than others, each domain was found to require updating and improvement. Two pools of potential new items were generated for the employment and psychiatric domains. Phase II will see the completion of four Specific Aims: (1) development and qualitative evaluation of new pools of items for the remaining ASI domains (medical, alcohol, drug, legal, and family/social), (2) comprehensive psychometric analyses of the entire item bank on a large number of clients in treatment for substance use disorders and a community, non-clinical sample, (3) creation of a fully functioning prototype of an ASI-MV-CAT, and (4) empirical tests of validity and sensitivity to change of the ASI-MV-CAT. These steps will result in a new and more powerful version of the ASI that will represent a significant advance in the evolution of this important tool. PUBLIC HEALTH RELEVANCE: The ASI is the gold standard assessment for individuals in substance abuse treatment. Since its creation, changes in the substances abused, patient populations, treatments, and psychometric standards suggest the need for an updated version. The proposed ASI-MV-CAT would address this need and permit flexible and efficient administration options, updated content, and could be rapidly disseminated. The ASI-MV-CAT will have major public health importance and significant commercial potential.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.76M | Year: 2010

DESCRIPTION (provided by applicant): This Phase II proposes the development and testing of an online CME program for primary care physicians called Managing Addiction and Pain in Primary Care (MAP-PC). Multiple studies have supported the utility of opioids in the treatment of acute pain and pain related to cancer, but they continue to be under-prescribed by physicians for chronic pain. Many physicians are concerned about possible abuse by patients, potential liability, and censure by regulatory agencies. The reluctance to prescribe opioids is particularly evident among primary care physicians (PCPs), who treat a high proportion of pain patients. An improvement in the ability of primary care physicians to adopt pain management and addiction medicine principles would lead to more appropriate use of opioids, along with more successful pain treatment outcomes in patients, especially those with potential or past substance misuse/abuse. The promotion of Risk Evaluation and Mitigation Strategies (REMS) for opioids by the FDA will likely require further development of continuing education programs for physicians. Unfortunately, there is a lack of such training for physicians treating chronic pain patients. With the advent of the Internet and business logic (decision branching) software, there is technology available to engage and educate physicians seeking to build pain treatment skills. Using this technology, MAP-PC will help physicians: (1) increase pain management and addiction medicine skills with pain patients at risk of opioid abuse or misuse; (2) make informed decisions about the appropriate use of opioids for their patients; and (3) manage clinical challenges that arise during the course of pain treatment with opioids. In Phase II, we will complete the development of MAP-PC and the study measures. The efficacy study will involve randomization to two conditions: (1) Experimental (MAP-PC) and (2) Control (online text-based CME). The Experimental and Control groups will undergo a baseline assessment, post-intervention, and three-month follow- ups. Phase II involves testing the hypotheses that, relative to the control condition, physicians exposed to MAP-PC will: (1) improve expertise in managing opioid risk in chronic pain patients, (2) enhance self-efficacy in managing opioid risk in chronic pain patients, and (3) improve clinical practice behaviors with respect to identifying and addressing opioid risk issues in pain patients. We will also test the secondary hypotheses that, relative to the control condition, physicians exposed to MAP-PC will perceive significantly: (1) fewer barriers to prescribe opioids for chronic pain patients, and (2) reduced reluctance to prescribe opioids for chronic pain (changed beliefs). Finally, we will test user satisfaction with and acceptance of MAP-PC. PUBLIC HEALTH RELEVANCE: Pain is often under-treated due to primary care physicians' ambivalence about prescribing opioid medications for fear that the patient might abuse or become addicted to the medication. This is particularly true for patients with potential or past substance misuse/abuse. This research project will culminate in the development and testing of an interactive Continuing Medical Education (CME) course, Managing Addiction and Pain in Primary Care (MAP-PC), that teaches primary care physicians about pain management and addiction medicine skills with pain patients at risk of opioid abuse or misuse. If successful, this program can enhance public health by helping physicians to offer needed treatment to chronic pain patient while managing the risk of opioid misuse/abuse more effectively.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2010

DESCRIPTION (provided by applicant): Substance abuse research indicates that: (1) addressing medical and psychosocial problems associated with substance abuse and dependence leads to better outcomes; (2) treatments are now shorter due in part to rising healthcare costs, and it is difficult to address these issues effectively during treatment, making medical and psychosocial ( wraparound ) services following treatment essential; (3) counselors may lack the knowledge to effectively integrate these services; and (4) referrals to these services have been underutilized and clients may lack the motivation, knowledge, or skills to follow up with the referrals when they are made. To address these deficits, we are proposing the development of ASI-MV Solutions, which will provide tailored motivational feedback and skill-building lessons to clients to address specific psychosocial and medical problem areas. We expect that ASI-MV Solutions will have seven modules (Alcohol, Drugs, Medical, Psychiatric, Legal, Employment, and Family) corresponding to domains of the ASI-MV, a Web-enabled interactive version of the ASI administered in treatment settings. Substance abusers who have high severity scores on ASI-MV subscales will be directed to corresponding interactive lessons and local resources on ASI-MV Solutions. To demonstrate the feasibility of the program concept, the Phase I study focused on the Employment domain. All feasibility criteria were met and findings indicated: (1) Proposed content was based on highly positive findings from concept mapping, as well as usability and acceptance testing with clients and experts. Ratings of potential effectiveness and appeal were high. (2) Usability testing indicated that the program was usable by the target audience, the skills and outcomes were relevant to the target audience, and the program was regarded as potentially very helpful to the treatment process. We surpassed feasibility benchmarks for both clients and experts. (3) Our technical/design team produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program, as well as determining the necessary technologies to produce the complete program in Phase II. In Phase II we will develop ASI-MV Solutions content, complete the ASI-MV Solutions program, field test the program, and conduct satisfaction and acceptance testing of the program with clients and counselors. PUBLIC HEALTH RELEVANCE: Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients. Inflexion is proposing the development of ASI-MV Solutions, which will educate clients about employment, legal, psychiatric, relapse prevention, medical, and family issues, as well as include resources and strategies for counselors. By linking learning modules to client results on the ASI-MV, an online interactive version of the ASI administered in treatment settings, we will be able to offer clients important tools to address key recovery issues and encourage counselors to make appropriate referrals to medical and psychosocial services.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.34M | Year: 2011

DESCRIPTION (provided by applicant): This Phase II application continues development of the Pain Assessment Interview Network - Clinical Advisory System (painCAS), a systematic and tested computer-administered assessment of chronic pain patients. Initial Assessment and Follow-up modules assess relevant health and functioning information of patients as they enter or continue treatment for chronic pain. Provider Initial and Follow-up Reports organize patient information in a convenient way that brings to theprovider's attention notable health and functioning issues. The assessment includes an evaluation of risk for misuse and abuse of prescription pain medication. painCAS also generates a report specifically intended for patients. Finally, painCAS includes provider-focused tools for uploading and analyzing aggregate data for patients who have taken the painCAS assessments, as well as a Decision Support resource that can help guide treatment. Such a pain management resource would allow a physician to maximize the available time in a clinic encounter while minimizing potential adverse impacts of treatment, such as abuse or misuse of analgesics. A convergence of factors suggests the time is right for a clinical tool like the painCAS: (1) increasing pressure from healthcare policy makers and payors to systematize care, documentation, risk assessment, and prescribing; (2) public demands for adequate pain treatments; (3) public, industry, and regulator concerns about prescription medication misuse and abuse; (4) increasing acceptance of computer assessment and tools (including EMRs) in clinical settings; (5) increasing interest in clinical pathways and disease management to improve the efficiency and quality of care, and (6) an increasing recognition of the importanceof understanding certain chronic conditions from a multidimensional perspective. Despite the need and several prior efforts to develop electronic pain assessments, the American Academy of Pain Medicine (AAPM) notes that no system has yet been widely adopted. Building on our prior work developing and disseminating electronic assessments as well as an innovative combination of features that add value to the system, a strong case can be made that the painCAS will be adopted. During Phase I, the groundwork waslaid for a system design that will fit into the flow of clinical activities, meet important assessment and reporting needs, and provide relevant information directly to patients. Phase II will see the completion of remaining components of the assessments and design and the building of the completed painCAS system to be tested in a field trial. In Phase II, a multilevel, controlled, randomized clinical trial of patients in pain specialty clinics will test the impact of painCAS on treatment process and outcome against a painCAS assessment only condition and a treatment-as-usual condition. The tested hypotheses are that the painCAS will: 1) standardize documentation of chronic pain assessments, 2) increase the likelihood of discussion of appropriate topics andissues during the medical visit, and 3) improve the patient's satisfaction with treatment. Secondary analyses will examine the extent to which painCAS use is associated with improvement in pain functioning, mood, and misuse/abuse of medications. The proposed painCAS potentially addresses limitations of existing efforts to enhance assessment and practice in the treatment of chronic pain. PUBLIC HEALTH RELEVANCE: As society increasingly demands that medical professionals address the complex clinicalpresentations of patients with chronic pain, it is increasingly important that providers have the benefit of standardized computer- administered assessments along with computerized treatment recommendations. Successful development and dissemination of a comprehensive, integrated Pain Assessment Interview Network - Clinical Advisory System (painCAS) will go some distance toward enhancing assessment and treatment of chronic pain and be perceived as highly valuable to stakeholders. We believe this product hasenormous commercial viability and public health importance and that its innovative combination of features will overcome obstacles to adoption that have plagued other electronic pain assessment systems.

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