Mgh

Elissa Ladd “There’s No Such Thing as a Free Lunch….Or Dinner”: A Web-based Pharmaceutical Practice Program for Advanced Practice Nurses*

The overall goal of this program will be to improve advance practice nurse (APN) awareness of drug development and pharmaceutical marketing practices and to positively impact prescribing behaviors as a result of participation in an innovative web-based pharmaceutical education program to be implemented within the framework of a nationally recognized institution. 1) Objectives : 1. To develop an innovative multi-media interactive web-based pharmaceutical curriculum that targets an APN student and clinician audience from across the nation 2. To increase APNs knowledge and awareness of FDA drug approval, monitoring, and processes related to pharmaceutical research and development 3. To increase APN awareness and knowledge concerning the impact of pharmaceutical marketing on prescribing behaviors 4. To encourage an examination of the ethical dimensions of pharmaceutical marketing practices 5. To promote changes in prescribing behaviors that will enhance evidenced-based prescribing by APNs * Advanced practice nurse (APN) will be defined for the purposes of this grant as any advanced practice nurse that holds, by virtue of state practice acts, authority to prescribe medications, i.e. nurse practitioners, nurse-midwives and psychiatric nurse clinicians/nurse practitioners

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Elissa Ladd 2) Impact and Significance The process, extent and effect of pharmaceutical marketing that is directed to physician prescribers has been extensively documented in the medical literature (Avorn & Solomon, 2000; Chew et al., 2000; Goodman, 2001; Wazana, 2000). Overall, all of these studies describe the impact that pharmaceutical marketing practices have on the provision of appropriate cost-effective interventions in a health care climate of steadily rising costs. While there has been extensive empirical data reported on the effect that pharmaceutical marketing has on physician prescribing behavior, there has been an almost virtual paucity of empirical data on APN prescribing behaviors in relation to pharmaceutical marketing. Several authors have discussed the ethical implications of pharmaceutical marketing activities as it relates to APNs (Stokamer, 2003; Crigger, 2005; Kessenich, 2000). However, there have been only two empirical studies that have documented influence on nurse practitioner prescribing by pharmaceutical representatives (Blunt, 2005) or high rates of inappropriate use of highly marketed antibiotics (broad-spectrum) by nurse practitioners (Ladd, 2005). This dearth of data in the context of APN prescribing is striking considering that, in 2005, there are an estimated 115,000 practicing nurse practitioners (which is comparable to the total number of family physicians) and there will be an estimated 190,000 advanced practice nurse prescribers by the year 2015 (Cooper, 2001). In summary, advanced practice nurses have heretofore been operating in the sidelines or “under the radar” as they relate to programs that are focused on reducing non-scientific prescribing and awareness of pharmaceutical marketing techniques. Therefore, the purpose of this program will be to present and evaluate an online educational program to a national audience of APN prescribers and students that will detail the extent and effect that pharmaceutical marketing may have on APN prescribing behaviors. Moreover, it’s intent will be to increase nursing prescribers knowledge in order to effect behavioral change toward evidence based therapeutic choices.

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Elissa Ladd 3) Methods General Considerations: On-line education is an innovative and growing method that is used to offer continuing education to health care professionals (Cobb, 2004). There have been a number of studies that have documented that web-based technology is a viable and effective option for providing continuing education to post-degree students (Mills, 2000; Woo & Kimmick, 2000). Moreover, web-based continuing education has been used successfully to teach complex material and to disseminate evidence-based guidelines (Harris, Salashe, & Harris, 2001; LaBresh, Gliklich, Liljestrand, Peto & Ellrodt, 2003).

Phase I: Development Development of On-line Continuing Education Curriculum (Objective 1): Using the MGH Institute of Health Professions established on-line education program as a framework, an innovative multi-media interactive program will be developed in concert with our in-house information technology department and will be supervised by the Director of Information Technology Denis Stratford. Faculty from the MGH Institute of Health Professions (nursing, clinical research, information technology and curriculum development), in consultation with pharmacy professionals from the Massachusetts General Hospital will develop the on-line curriculum. The curriculum will be based on the MGH Institute of Health Professions’ pedagogical model of evidenced based practice in a multidisciplinary setting. The curriculum expert at our institution, Dr. Karen Wolf, will supervise curricular development. The format of the program will include four modules that will be enhanced by a multimedia presentation of on-line video, pod-casts, interactive case studies, downloaded clinical tools, and links to peer-reviewed literature. The video material will be presented in a documentary format and will include content interviews with experts and opinion leaders from the fields of medicine, nursing, pharmacology and marketing. The video documentaries will be presented in a visually appealing format that will include pertinent graphics, 3

Elissa Ladd film and commercial clips (when licensure is available) and will be produced by a professional production company with prior experience in this field (see Attachment F). In addition to the thirty-minute video documentary, each of the four modules will include the following components: •

Audio “pod-cast” (so that content can accessed in other venues)

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Links to related peer-reviewed journal articles

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Interactive case studies

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Downloadable clinical tools (check-off lists of questions or “talking points”) to be used when interacting with pharmaceutical company personnel. The content of each module will be supervised by the Program Director, Dr. Ladd and the program

members will make all decisions regarding final content. Each module will include the following subject matter: Module 1 (Objective 2) “Why and how are drugs approved?” :Overview of drug research and development in the United States; the FDA drug approval process. In consultation with the pharmacy content expert, as well as input from FDA personnel and other policy experts, a 30minute video will be produced in a documentary format. Specific content will include information on drug review and related activities by the FDA and interviews with physicians/policy experts with contrasting viewpoints. Appropriate visuals will be included. Module 2 (Objective 3). “There’s no such thing as a free lunch…or dinner”: Overview of pharmaceutical marketing practices, scientific evidence on the effect of marketing methods on prescribing behavior (drug samples, free meals, interactions with drug industry representatives, industry sponsored CME and lectures at national conferences, free gifts, office supplies). The thirty-minute documentary will include interviews with physician and nurse prescribers, pharmaceutical representatives, marketing experts, journalist, and policy researchers. Appropriate

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Elissa Ladd graphics and visuals of the marketing process, sample closets, pharmaceutical gifts, etc. will augment the content interviews. The development of this module will occur with input from the documentary’s producer, Ms. Slattery-Moschkau. Module 3 (Objective 4): “Is this the right thing to do?: Overview, discussion and presentation of opposing views regarding the ethical dimensions of pharmaceutical marketing and direct-to-consumer advertising; conflict of interest debate; effect on costs to patients and health care system as a whole. The thirty-minute documentary will include interviews with an ethicist, policy researchers with experience and knowledge of direct-to-consumer advertising, advanced practice nurse and physician prescribers, and pharmaceutical representatives. Module 4 (Objective 5): “How can I improve my practice?”: Overview of strategies to improve prescribing, i.e. evidence-based prescribing vs. market-based prescribing; cost-effective prescribing; strategies to improve interaction with representatives; critical evaluation techniques of pharmaceutical company information (data and claims). Based on input from our content experts Dr. Boepple, Dr. Mahoney and Dr. Ladd, the dimensions of evidence based prescribing will be developed in the video documentary. Interviews with pharmacy, nursing and medical content experts will be included.

Phase II: Marketing and promotion of the program: Staff will promote the Pharmaceutical Practice Program in a variety of venues i.e. national APN conferences across the country and direct web-links through advanced practice nurse organizations. Examples of conferences in which conference floor space will be rented to promote the program: American Academy of Nurse Practitioners, American College of Nurse Practitioners, University of Colorado, Keystone Conference, American College of Nurse Midwives, National Association of Pediatric Nurse Associates and Practitioners, National Association of Nurse Practitioners in Women’s Health, American Psychiatric Nurses 5

Elissa Ladd Association, Nurse Practitioner Associates for Continuing Education. Also, ads will be place in major US APN journals, and Google (and other search-engine) links will be hosted. Additionally, a letter with an accompanying brochure describing the program will be sent to graduate schools of nursing across the country. The letter will outline the online Pharmaceutical Practice Program as well as offer the content for use in their pharmacology education for advanced practice nurses. Free access to the web site will be reinforced. Finally, an in-kind monetary incentive of a $50 Amazon gift certificate plus free continuing education (CE) units will be provided to encourage participation in and completion of the program. Monetary and inkind incentives have been shown to yield significantly higher response in survey research (Ulrich et al., 2005). The MGH Institute of Health Professions Graduate Program in Nursing is accredited as a provider of continuing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Phase III: Implementation The on-line Pharmaceutical Practice program will be posted on the MGH Institute of Health Professions web site when curriculum is completed and sufficient marketing has taken place. The MGH Institute of Health Professions has an existing structure and process for offering continuing education credits on their distance learning platform. The existing continuing education template will be adapted by the information technology department to attract new users and ensure seamless completion and management of pertinent data. Information technology professionals will monitor the web site on a continuous basis.

Phase IV: Evaluation Pre and post test measurement (Objective 5): A modified version of Kirkpatrick’s Model of Summative Evaluation will be the primary measure to evaluate the objectives of this program (Curran & Fleet, 2005; Kirkpatrick, 1994). This model consists of four levels of evaluation: learner satisfaction (reaction), learning 6

Elissa Ladd outcomes (learning), performance improvement (behavior) and patient/health outcomes (results). The last level will not be evaluated in this project because of scope and time restrictions, however, it will be considered for future program and research planning. Learning outcomes will be tested with a four question multiple-choice format. Attitude/behavior evaluation and learner outcome (learning) questions will be designed with a Lickert five point scale format. Attitude/behavior questions will be adapted from the McMaster instrument (Agrawal, Saluja, & Kaczorowski, 2004) which measured attitudes of pharmaceutical marketing activities before and after an educational program directed at medical residents. . The goal of the program will be to enroll and receive completed surveys from 500 participants. Sample size is estimated based on having sufficient power to detect small changes in the primary outcome measure of knowledge, while having adequate power to address the secondary outcome of behavioral change at the 8week follow-up period, accounting for attrition. A pre-test survey will be completed by the participant prior to starting the Pharmacy Education Program. A post intervention on-line survey will occur immediately upon completion of the program and again after 8 weeks. The eight-week post intervention survey will contain questions that will evaluate performance improvement (behavior) measures. After completion of this final survey, an Amazon.com gift certificate access number will be automatically generated and emailed to participants. Continuing education units will also be generated for the participant to download. Data analysis: Mean scores for Learner Satisfaction measures and performance improvement questions (Lickert scale) will be calculated. For sets of Likert-scale questions, differences before and after intervention will be tested using multivariate analysis of variance. For analysis of single items, paired t-tests will be done and considered significant at a level p < .05. Univariate statistics will be used to analyze learning outcomes questions.

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Elissa Ladd Phase V: Long Term Sustainability: Upon completion of the program and loss of funding, it will be the goal of the MGH Institute to continue and modify the web-based program so that it can be targeted to a wider audience of prescribers. For a nominal fee to process CE and CME credits, the program could easily be offered to medical student and physician prescriber audiences. It is the intent of the MGH Institute of Health Professions to maintain the program in the public domain and it will remain on our distance learning platform for use by both nurse and physician prescribers and students of each field.

4) Anticipated Barriers and Challenges a) Potential Barrier: High intensity drug company marketing directed to advance practice nurses. Rationale: Advanced practice nurses have prescriptive privileges on some level in all 50 states and are an import and growing force of prescribers of medications (Kaplan & Brown, 2004). APNs frequently attend drug company sponsored events to obtain free CE credits, encounter pharmaceutical representatives in their practice settings, and receive free gifts and other embossed items. Strategy: As noted above, in order to compete with pharmaceutical company incentives for time and attention, monetary incentives will be used to encourage APNs to participate in the program. Also, participants will be offered free CE units in accordance to the hours that are completed. Participants, however, will not be included in the final data analysis if they have not completed the eight-week post program survey. b) Potential Barrier: Discomfort / lack of familiarity with on-line format Rationale: While the World Wide Web is ubiquitous in today’s heath care environment, some learners may not feel sufficiently skilled in the use of computer and web-based technology (Curran-Smith & Best, 2004).

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Elissa Ladd Strategy: Instructional design considerations will be based on the MGH Institutes successful online education program. In house information technology experts will be involved in the design and integration of the interactive and multimedia components of the program. Hundreds of new students each year are helped to use computer based learning programs at our institution and support will be available 24 hours a day, seven days a week. Overall, consideration will be taken for the wide range of demographics and technology skill levels of the participants.

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Elissa Ladd

Addendum to Proposal: April 27, 2006 Dissemination of Educational Program: The dissemination of the educational program will be implemented with the consultation and support of the National Organization of Nurse Practitioner Faculties (NONPF). NONPF is the only national nursing organization that develops competencies, curriculum guidelines, and program standards to promote quality educational preparation of nurse practitioners. They have significant content expertise within the organization relative to NP related curriculum, and have a broad network of collaborative relationships with nursing and other health care organizations. In general, NONPF is considered by many in the field to be on the forefront of the “diffusion of innovation” in terms of advance practice nursing education and practice trends. NONPF proposes to provide three types of services within the consultative relationship of the program. These services will include (but not be limited to):

1. Direct Consultation: NONPF will identify content and technical experts to provide review of the modules and other materials that are developed through the program and will provide feedback on the applicability to advance practice nurse education.

2. Dissemination: NONPF will provide services related to dissemination which may include links on their website to direct academic faculty across the country to the Web-based program, e-bulletin announcements of the release of modules and articles in the organization’s newsletter. They will continue to provide dissemination support after the grant period has ended. Additional dissemination strategies will be discussed during the two year grant period.

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3. National Conference or symposium: NONPF will organize and sponsor a pre-conference session, symposium or workshop on the dimensions of non-evidence based prescribing i.e. the potential effect of pharmaceutical marketing on prescribing behaviors, patient demand and ethical considerations.

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5) Timeline

MONTHS 2006/2007 Activity

Sept

Dec

Mar

1

3

6

2007/2008 June 9

PHASE I: DEVELOPMENT (Hire staff, instrument & curriculum development) PHASE II: MARKETING (dissemination, promotion) PHASE III: IMPLEMENTATION (enrollment, collect data) PHASE IV: EVALUATION (analyze data, present findings, write final report) PHASE V: Sustain/expand interdisciplinary content with MGHIHP as host

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Sept.

Dec.

March

12

15

18

June 21

Aug/Sept 24

Elissa Ladd 6) Bibliography/References Agrawal, S., Saluja, I, & Kaczorowki, J. (2004). A prospective before and after trial of an educational intervention about pharmaceutical marketing. Academic Medicine, 79, 1046-1051. Avorn, J. & Solomon, D. (2000). Cultural and economic factors that (mis)shape antibiotic use: the non-pharmacologic basis of therapeutics. Annals of Internal Medicine, 133 (2), 128-135. Blunt, E. (2005). Do Pharma perks sway patient care? Holistic Nursing Practice, 19, 242. Chew, L., O’Yeong, T., Hazlet, T., Bradley, K., Maynard, C. & Lessler, D. (2000). A physician survey of the effect of drug sample availability on physician’s behavior. Journal of General Internal Medicine, 15, 478 – 483. Cobb, S. (2004). Internet continuing education for health care professionals: an integrative review. Journal of Continuing Education in the Health Professions, 24, 171-80. Cooper, R. (2001). Health care workforce for the twenty-first century: the impact of non-physician clinicians. Annual Review of Medicine, 52, 51-61. Crigger, N. (2005). Pharmaceutical promotions and conflict of interest in nurse practitioners decision making: the undiscovered country. Journal of the American Academy of Nurse Practitioners, 17, 207-212. Curran, V. & Fleet, L. (2005). A review of evaluation outcomes of web-based continuing medical education. Medical Education, 39, 561-67. Curran-Smith, J. & Best, S. (2004). An experience with an online learning environment to support a change in practice in an emergency department. Computers and Informatics in Nursing, 22, 107-110. Goodman,B. (2001). Do drug company promotions influence physician behavior? Western Journal of Medicine, 174, 232-3. Harris, J., Salashce, S., & Harris, R. (2001). Can internet-based continuing medical education improve physicians’skin cancer knowledge and skills? Journal of General Internal Medicine, 16, 50-61. Kaplan, L. & Brown, M. (2004). Prescriptive authority and barriers to NP practice. Nurse Practitioner, 29, 28 -35. Kessenich, C. (2000). The garden of good and evil: pharmaceutical companies and the perspective practices of PNPs. Journal of Pediatric Health Care, 14, 324-326. Kirkpatrick, D. (1994). Evaluating Training Programs: The Four Levels. San Francisco: Berrett-Koehler.

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Elissa Ladd LaBresh, K., Gliklich, R., Liljestrand, J., Peto, R., & Ellrodt, A. (2003). Using “get with the Guidelines” to improve cardiovascular secondary prevention. Joint Commission Journal On Quality and Safety, 29, 539-50. Ladd, E. (2005). The use of antibiotics for viral upper respiratory tract infections: an analysis of nurse practitioner and physician prescribing practices in ambulatory care: 1997-2001. Journal of the American Academy of Nurse Practitioners, 17, 416-424. Mills, A. (2000). Creating web-based, multimedia and interactive courses for distance learning. Computers in Nursing, 3, 125-131. Stokamer, C. (2003). Pharmaceutical gift giving: analysis of an ethical dilemma. Journal Nursing Administration, 33, 48-51. Ulrich, C., Danis, M., Koziol, D., Garrett-Mayer, E., Hubbard, R., & Grady, C. (2005). Does it pay to pay? A randomized trial of prepaid financial incentives and lottery incentives in surveys of nonpysician healthcare professionals. Nursing Research, 54, 178-83. Wazana, A. (2000). Physicians and the pharmaceutical industry: is a gift ever just a gift? Journal of the American Medical Association, 283, 373 – 376. Woo, M. & Kimmick, L. (2000). Comparison of internet versus lecture instructional methods for teaching nursing research. Journal of Nursing Research, 3, 132-139.

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