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Study Confirms Intranasal Abuse of Hydrocodone/Acetaminophen by Adolescents & Adults may be a Significant Public Health Issue CORALVILLE, Iowa, Aug. 08, 2017 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the publication of the results from a study conducted by Inflexxion, Inc. evaluating the patterns of abuse and how immediate-release hydrocodone acetaminophen combination products are administrated in the peer-reviewed journal Pharmacoepidemiology & Drug Safety. Titled “Patterns of Abuse and Routes of Administration for Immediate-Release Hydrocodone Combination Products,” by Cassidy, et al., the peer reviewed manuscript examined prevalence of abuse of immediate‐release (IR) hydrocodone combination products as compared to other classes of opioids.  While prescriptions for hydrocodone combination products have recently decreased, they remain the most widely prescribed opioid products in the United States and are subject to frequent abuse among adults and adolescents. Few data existed to understand the contribution of IR products to the problem of prescription opioid abuse. This epidemiological study sought to better understand abuse patterns for IR hydrocodone combination products among adult and adolescent substance abusers. “Our findings suggest that frequently prescribed opioids, such as hydrocodone IR combination products, may contribute substantially to the overall problem of prescription opioid abuse,” stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm and co-author. “The data from this study of the epidemiology of abuse of opioids in the United States confirm a prevalence of intranasal (IN) abuse of IR hydrocodone combination products among about 23% of adults and 43% of adolescents assessed for substance abuse treatment in the sampled from the Addiction Severity Index – Multimedia Version/ Comprehensive Health Assessment for Teens (ASI-MV/CHAT) database. Considering that hydrocodone is the most widely prescribed opioid in the US, these figures translate into a large absolute number of individuals abusing these products intranasally. KemPharm believes this represents a significant public health risk that requires a multimodal mitigation approach, including abuse deterrent technologies.” “This result adds important substance to the general understanding of IN abuse of hydrocodone/ acetaminophen products among adolescents and adults who misuse prescription opioids,” added Theresa Cassidy, Ph.D., Vice President of Health Analytics at Inflexxion and lead author of the study.  “Our study showed in absolute terms, given the approximately 90 million prescriptions issued as recently as 2015, IN abuse of these relatively easily available opioid products equaled or exceeded the abuse of extended release opioid products.” A cross‐sectional study examined abuse prevalence (including abuse adjusted for prescription volume and morphine milligram equivalents) and abuse characteristics for IR hydrocodone combination products and other prescription opioids among separate samples of adults and adolescents assessed for substance abuse problems or entering treatment from January 2012 through June 2015. Results indicated higher abuse for IR hydrocodone combination products than other opioid categories per 100 assessments but lower per prescriptions dispensed. IR hydrocodone combination products had similar abuse prevalence to all extended‐release and long‐acting opioids when considering abuse measured per morphine milligram equivalents dispensed. An upward trend in IR hydrocodone combination product abuse was observed among adult substance abusers comparing the period prior to and after Drug Enforcement Administration rescheduling from Schedule III to Schedule II of these products in October 2014. Most individuals reported oral abuse of IR hydrocodone combination products, but snorting, reported by 23% of hydrocodone IR combination product abusers, also appears to be a route of abuse that may have public health relevance. KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LAT™ (Ligand Activated Therapy) platform technology.  KemPharm utilizes its LAT™ platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release profiles for the treatment of ADHD, and KP201/IR, an acetaminophen-free formulation of the company’s immediate release abuse deterrent hydrocodone product candidate, KP201.  For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com. Inflexxion helps healthcare organizations, provider communities, pharmaceutical companies, and regulatory authorities to improve patient care and inform public policy.  Through their strategic approach and depth of expertise, Inflexxion analyzes and disseminates health-related data for surveillance, risk management, epidemiological studies, quality improvement, and outcome measurement.  Inflexxion’s unique data collection includes multiple data streams at the point-of-care, Internet Monitoring technology, and web-surveys with hard to reach populations. For more information visit www.inflexxion.com. Caution Concerning Forward Looking Statements This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected features and characteristics of KP201 and Apadaz™, and the anticipated timelines for any IND or NDA submission or the availability of clinical trial results.  These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; obligations to third parties regarding the potential commercialization or sale of KP201 and Apadaz™; and the FDA approval process, including without limitation any timelines for related approval. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm's Quarterly Report on Form 10-Q for the period ended March 31, 2017, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | September 20, 2017
Site: www.prnewswire.com

Developed in part with support from the National Institutes of Health (NIH), grants (Grant No. R44DA026359, PI S.F. Butler and Grant No. R44DA015617, PI S.F. Butler), PainCAS is a scientifically validated web-based, patient self-report clinical tool for assessing pain and opioid misuse risk in patients with chronic pain. "Participating in the Allscripts Developer Program allows us to help Allscripts clients by providing a scientifically validated tool to assess for pain and opioid risk for patients suffering from chronic pain and assist in determining treatment planning," said Bruno Lempernesse, CEO, Inflexxion.  "Our mission is to provide clinically relevant tools and data to improve patient outcomes and assist in combatting the opioid epidemic." The Allscripts Developer Program (ADP) offers both proprietary and FHIR® enabled APIs to connect third-party applications, devices and other innovative healthcare technologies with Allscripts products. Allscripts has been supporting API integration since 2007 and is enabling over a billion data exchanges each year ­– the largest documented utilization of APIs in healthcare. Find more information about PainCAS on the Allscripts Application Store.  Health IT developers can create a free Allscripts Developer Portal account to access the Allscripts Open APIs and start building or connecting new innovations for Allscripts users. Inflexxion helps healthcare organizations, provider communities, pharmaceutical companies, and regulatory authorities to improve patient care and inform public policy.  Through their strategic approach and depth of expertise, Inflexxion analyzes and disseminates health-related data for surveillance, risk management, epidemiological studies, quality improvement, and outcome measurement.  Inflexxion's unique data collection includes multiple data streams at the point-of-care, Internet Monitoring technology, and web-surveys with hard to reach populations. For more information visit www.inflexxion.com.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 322.56K | Year: 2011

DESCRIPTION (provided by applicant): Substance abuse treatment is often complicated by problems such as depression, family and interpersonal conflicts, and legal issues. When these issues are addressed with effective, evidence-based treatments (EBTs), outcomes improve. To improve the quality of addiction treatment, experts have called for the adoption of a continuing care management approach, involving a more comprehensive integration of EBTs in the treatment process. However, it is often difficult to integrate EBTs into the clinical workflow, so clinicians rely on old patterns of care. EBTs are most likely to be implemented if information about them is available to the clinician at the point of service. The expansion of electronic health record (EHR) use offers an important opportunity to overcome this problem. Although CDS systems are generally not available within behavioral health settings, SAMHSA has encouraged the integration of behavioral health into EHRs and is wants to increase the number of behavioral health providers who use EHRs. The next step is to build CDS capabilities that will be available as EHRs inevitably expand across behavioral health settings. This proposal will address this gap through a partnership between two companies that have developed a national standing in substance abuse treatment. Inflexxion has developed a computerized version of the Addiction Severity Index called the ASI-MV, now used in over 600 treatment centers nationwide. FEI's flagship product is the Web Infrastructure for Treatment Services (WITS), a web application that captures extensive client-level treatment data, and is used in 22 states, by more than 1,000,000 clients. Inflexxion and FEI will develop a CDS component that will plug into the WITS user interface. Applying advanced statistical and data mining techniques to the extensive WITS data set (that includes ASI-MV data), we will assess the relationships among client profiles (key predictive variables), services, and outcomes, to provide recommendations about treatment services that will yielded the best outcomes (e.g., successful recovery and decreased depression, increased duration of employment, fewer legal/judicial problems). Rather than rely on static algorithms, they system will gain intelligence as the number of cases increases. The advantages of this approach are: (1) it utilizes statistical analysis and data mining to match effective interventions with client profiles; (2) assists clinicians in identifying the best service combinations, EBTs, resources fortheir clients at the point of service; and (3) assists organizations in identifying EBT implementation and outcomes. The public health potential of this is very significant, and will shift the paradigm away from an asynchronous, training-based EBT implementation model to a data-driven, continuing care model. The current proposal represents a significant innovation that addresses the traditional barriers to EBT implementation. Because FEI and Inflexxion have both attained a significant collective presence in substance abuse treatment field, there will be an opportunity to implement the system in a large number of treatment settings. We envision a commercial model that initially sells subscription access to the proposed system within the WITS application and,eventually to users of other EHR systems, to facilitate broader healthcare integration. PUBLIC HEALTH RELEVANCE: When co-morbid issues are addressed in substance abuse treatment, via evidence-based approaches, patient outcomes improve. Evidence-based treatments (EBTs) are most likely to be used if information about them is available to the clinician at the point of care. However, the use of EBTs in substance abuse treatment continues to lag. We propose developing a system to: (1) match effective interventions with client profiles; (2) identify the most effective combinations of service and (3) make the data available to the provider at the point of care by integrating the system in an electronic health record. This would represent a significant innovation that addresses major barriers to EBT implementation, and enhances the use of electronic health records in substance abuse treatment.


Grant
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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.58M | Year: 2011

DESCRIPTION (provided by applicant): The majority of adolescents struggling to avoid substance use during early recovery are also coping with many other issues (e.g., peer relationships) for which they require consistent support. We propose to develop an online relapse prevention program for adolescents called Staying Off Substances (SOS). Specific content in the program will be recommended to counselors based on their client's a) age, b) current motivation level, and, when available, c) reported needs andstrengths on the Comprehensive Health Assessment for Teens (CHAT(R)), a Web-enabled interactive adolescent self-report assessment for use in treatment settings. Whereas current online programs for adolescents are geared for primary prevention, CHAT(R): SOSwill be an intervention for use in clinical populations. Counselors will assign the client's user name to access privileges for that content and/or other content per their clinical judgment. We expect that CHAT(R): SOS will ultimately have six modules corresponding with the CHAT(R) subscales (i.e., Psychological Health, Family Relationships, Peer Relationships, Tobacco Use, Alcohol Use, Drug Use). CHAT(R): SOS will include opportunities to reinforce the skills and philosophies that adolescents learn in treatment through online interactive exercises, writing activities, and access to a supportive, online community. This resource will be available to them during treatment and post-treatment to help them navigate challenges in early recovery. Adolescents willreceive tailored recommendations and an individualized user experience because CHAT(R): SOS will utilize an innovative content management and logic solution called Ektron. CHAT(R): SOS will also provide counselors with guidelines on how to use this programwith their clients (e.g., in sessions, during aftercare) and custom user reports. To demonstrate the feasibility of the program concept, the Phase I study focused on the Peer Relationships 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 programwas 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 a) produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program and b) determined the necessary technologies to produce the complete program in Phase II. In Phase II we will develop the program then test its efficacy in a field trial. The field trial will examine the primary hypotheses that, relative to the control condition (CHAT(R) only), CHAT(R): SOS will be associated with significantly higher motivation, higher self-efficacy, more relapse coping, and lower substance use. PUBLIC HEALTH RELEVANCE: Adolescent substance abuse is a significant public health issue. Unfortunately, the 2005 federal Treatment Episode Data Set indicated that less than 150,000 adolescents received treatment. Typically, 75% of those who receive treatment relapse within the following year. To address the need for cost-effective assessment, Inflexxion, Inc. developed the Comprehensive Health Assessment for Teens (CHAT(R)), a Web-enabled interactiveself report assessment for use in treatment settings. We propose developing a supplemental online relapse prevention program called CHAT(R): Staying Off Substances (SOS). CHAT: SOS will use an adolescent's 1) age, 2) motivational level, and, when available, 3) responses to the CHAT(R) assessment to recommend Web-based relapse prevention content to address the adolescent's individual needs. This resource will be available to adolescents during treatment and post-treatment to help them navigate challenges inearly recovery.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.37M | Year: 2011

DESCRIPTION (provided by applicant): In the current economic climate, community colleges are playing a more vital role than ever in educating the workforce. Enrollment at community colleges has grown by 17 percent since fall 2007 to a total enrollment of 8million (AACC, 2010a). Moreover, President Obama has called on community colleges to produce five million more graduates by 2020 (Gonzalez, 2010). However, community college students have a number of psychosocial and health behavior risk factors for failing to meet their academic goals. Among first-time students who start at a four-year college, approximately three-quarters persist to the second year, compared to roughly half of first-time students who start at a two-year college (McIntosh and Rouse, 2009). The objectives of the proposed research are to create the first comprehensive wellness and alcohol and other drug (AOD) intervention prevention program specifically for community college students. The following Phase I specific aims were successfully completed: (1-3) Interview students, health staff, and institutional decision makers; (4) Produce Content, Design, and Development Plans; (5) Create a demonstration; (6) Conduct usability and acceptance testing with students; (7) Conduct acceptance testing with institutional decision makers and health staff, and (8) Complete the Phase II research design. Results indicate that the MSB-Community College program has feasibility as an intervention and as a technical project. The specific aims of the Phase II are to: (1) Convene an advisory board of community college presidents and health professionals to inform implementation strategy; (2) Produce the online program, and (3) Conduct a randomized controlled trial to test the efficacy of the online program. We hypothesize that, compared to students in the control group, students exposed to MSB-Community College will demonstrate: (1) decreased stress; (2) increased use of protective behavioral strategies; (3) decreased substance use negative consequences; (4) decreasedsubstance use, and (5) increased college adjustment. Secondary hypotheses are that students will report: (1) increased likelihood of reaching a personal academic goal and (2) increased likelihood of attainment of a degree/certificate, or persistence witha program of study. The innovation of the current Phase II application is in adapting to a new population theoretical approaches that have been successful in research with four year students. This will be achieved by creating a program that is informed byadvances in four-year college health programs while incorporating findings from research with community college students to create appropriate content, features, and a delivery method. Successful completion of the aims of this Phase II application will expand the field of college health by acknowledging and addressing the needs of a large and diverse, yet underserved, population. If the program is successful, it will have a significant public health impact in terms of improving the health of almost half ofall undergraduates (AACC, 2010a), with the secondary goal of also increasing retention. PUBLIC HEALTH RELEVANCE: The objectives of the proposed research are to create the first comprehensive wellness and alcohol and other drug (AOD) intervention prevention program specifically for community college students. The innovation of the current Phase II application is in adapting theoretical approaches that have been successful in research with four year students to a new population. If the program is successful, it will have a significant public health impact in terms of improving the health of almost half of all undergraduates (AACC, 2010a), with the secondary goal of also increasing retention.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 194.84K | Year: 2014

DESCRIPTION (provided by applicant): Pain management including the use of opioid analgesics is recommended for adolescents who are suffering from recurrent or chronic pain associated with a specific etiology such as cancer, cystic fibrosis, sickle cell anemia, hemophilia or organ transplants (see citations by etiology in letter of support from CO-I, Dr. Solodiuk). Preventive screening tools provide information that can be used by the provider to inform prescription choices (use of opioid versus another medication) and subsequent monitoring (e.g., urine screens, pill counts), resulting in safe and effective pain management. Pediatric hospitals are currently using screeners developed and tested with other populations because there is no validated tool for this specific patient population. The primary aim of this application is to begi development of a screening tool called the Adolescent Screener and Opioid Assessment for Patients with Pain (A-SOAPP) for use with adolescent-aged patients with secondary, r


Grant
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.


Grant
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.


Grant
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.

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