Clinical Trials: Can We, the Nursing Profession, Change the Culture?

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1 Clinical Trials: Can We, the Nursing Profession, Change the Culture?

2 Agenda Why We Need to Change the Culture Why the Time is Right How We Plan To Do This Formative Research Results Next Steps Discussion

3 Project Team National Cancer Institute: Annette Galassi, Meredith Grady, Linda Parreco - OCE Elizabeth Ness CCR Ann O Mara - DCP National Institutes of Health Clinical Center: Clare Hastings Johns Hopkins University School of Nursing: Anne Belcher

4 Objectives Describe the implications of low accrual to clinical trials. Identify 2 initiatives successful in changing nursing curricula. Describe the current environment in nursing education and practice surrounding clinical research and clinical trials. Discuss ways in which nurses can affect accrual.

5 Definitions Clinical Research Patient-oriented Epidemiologic and Behavioral Outcomes and Health Services Clinical Trial One type of clinical research

6 Definitions Formative research Uses qualitative methods To help identify and understand the characteristics interests, behaviors, needs of target populations that influence their decisions and actions Provides insights on the individual and environmental level factors that should be considered in planning an initiative or program

7 Why We Need to Change the Culture Clinical trial participation is low Less than 6% of medically eligible adults with severe, life-threatening illnesses participate Less than 3% of the estimated 20% of medically eligible adults with cancer participate May be as low as 0.6%

8 Why We Need to Change the Culture Low accrual leads to: Delays Budget overrun Trial closure Trial Migration: ~ 50% of all FDA-regulated trials have migrated oversees

9 Why is clinical trial accrual low? Barriers to clinical trial participation Protocol Provider Patient Public mistrust of research Past medical abuses Current media coverage

10 Nursing s Influence Nurses have the public s trust Gallup Organization Honesty and Ethics survey results but may not have the necessary education.

11 A Question How many of you learned about clinical research and clinical trials in nursing school?

12 By educating nurses, we can Raise public awareness Increase patient knowledge Improve care Enhance accrual change the culture!

13 Why is this important to NIH? Clinical research the way we make progress NIH - the largest source of funding for medical research in the world Over 5,500 open clinical trials sponsored by NIH 2,035 of these are sponsored by NCI

14 NIH Budget

15 Why is this important for nursing? Clinical research settings have expanded and will continue to do so Comparative effectiveness research Patient-centered outcomes research Insurance coverage is becoming less of a barrier Patient Protection and Affordable Care Act (2010)

16 NCI s Cancer Program Today NCI-designated Cancer Centers: 66 CCOPs: 50 Minority-Based CCOPs: 13 NCCCP sites: 30 46,000 registered investigators

17 Academic Medical Centers Select Community Hospitals & Practices Private Practices All nurses must have a basic knowledge of clinical research.

18 Are nurses prepared to practice safely in care settings where clinical trials are being conducted? provide patient/family education related to clinical research/clinical trials? evaluate the evidence from clinical trials to provide evidenced-based care?

19 Nursing Education & Research 1970 s nursing research added to the baccalaureate curriculum 2003 IOM Committee on the Health Professions Emphasis on evidence-based practice 2008 AACN Essentials revised Essential III: Scholarship for Evidence-Based Practice

20 Nursing Education & Research Shift away from teaching research the traditional way Focus on generating the evidence Shift toward teaching evidencebased practice Focus on using the evidence

21 How can we teach about evidence-based practice without teaching about clinical research?

22 Our Premise Nurses need to understand clinical research and its relationship to evidence-based practice Nursing practice is informed by evidence Evidence comes from research; clinical trials are one form of research Research findings should guide our practice Research leads to improved health outcomes

23 Literature review Our Approach Other successful initiatives Perform environmental scan Draft concept paper Engage stakeholders Complete formative research Raise awareness / disseminate findings

24 Other Successful Initiatives Genetics Geriatrics End-of-Life and Palliative Care

25 Lessons Learned Evidence is mandatory Patience will be necessary Stakeholder buy-in is crucial Money will be required

26 Environmental Scan To assess the presence and extent of CR/CT content Baccalaureate, graduate and postgraduate programs 10 schools Key word search of course catalogs Clinical trials, clinical research, research

27 Environmental Scan Themes: Using research as theoretical basis for practice Appreciating research as a component of the scholarly process Developing skills reviewing and critiquing research articles Achieving basic knowledge of statistics and design Building competency as a consumer of research findings

28 Research Objectives The purpose of this study was to identify: knowledge and attitudes toward clinical research and clinical trials (CR/CT) in baccalaureate nursing education and nursing practice process/sources of information by which nurses learn about CR/CT current/potential opportunities for nurses in CR/CT

29 Formative Research Phases Phase 1: 60 minute in-depth interviews with practicing nurses, nurse executives, staff development directors and faculty (n=33) Phase 2: 90 minute, interactive, online session with deans of schools of nursing (n=28)

30 Formative Research Process Secured independent contractor Developed discussion guides Obtained IRB approval and OMB clearance Recruitment Data collection June, 2010 to December, 2010 Analysis

31 Results: Phase 1

32 Findings: Faculty Main drivers of curriculum change NCLEX AACN Baccalaureate Essentials Nurse employers CR/CT content not a priority by most schools Increased emphasis on evidencebased practice and finding the evidence

33 Findings: Faculty Consider CR/CT to be an important subject, although barriers are challenging: competing curricula priorities lack of faculty interest/skills low demand from employers low demand from students

34 Findings: Faculty New BSN graduates lack CR/CT skills not prepared to oversee care for patients on a clinical trial not prepared to educate patients about CR/CT Only half of respondents felt new nurses could take on a beginning role on a CR/CT team

35 Findings: Nurse Executives Note an expanding presence and importance of CR/CT Expect new BSN graduates to know how to care for patients on a protocol and where to get information about the protocol Mixed response on new BSN graduates preparation to educate patients about CR/CT

36 Findings: Nurse Executives Did not feel need to change BSN curriculum Half currently have CR/CT content in orientation Prefer employer-based CR/CT training; however barriers exist financial and time constraints level of interest from nurses

37 Findings: Staff Development Directors Support on-the-job training Limited need to enhance CR/CT content in BSN programs Inclusion in NCLEX is not needed New BSN graduates not prepared to educate patients on CR/CT

38 Findings: Nurses Most are interested in clinical research Varying levels of experience with CR/CT patients Limited exposure to CR/CT while in school Feel comfortable caring for CT patients, but want more training

39 Findings: Nurses CR/CT education opportunities often not a priority Support increased CR/CT content in undergraduate curriculum Lack of understanding of the roles nurses play in CR/CT

40 Results: Phase 2

41 Research Strategy: Phase 2 Conducted 90-minute Advanced Strategy Online (ASO) interactive session with deans of SONs 87 deans invited: 28 participants Facilitator guide IRB approval

42 Key Priorities for Content Changes Mean Importance # 10 s 1 Interprofessional collaboration Evidence based practice Patient safety Genetics and genomics Care for aging adults Clinical decision making in chronic illness Home and community based care The future of nursing Health literacy Cultural issues as related to nursing/care The issue of population health Ethics in the workplace Clinical research and clinical trials Healthy work environments Skills development Using a 10-point scale (1 = not important at all; 10 = great deal of importance) how would you prioritize each of these topics in terms of their importance for your institution in considering curriculum changes?

43 Why Clinical Research/Clinical Trials Is Lower Curricula Priority Clinical trials/clinical research was rated 6.8 on a scale of 1-10 when evaluating its importance for inclusion in undergraduate nursing programs. What are some reasons for why you think it was rated this way?

44 Is There a Need for More Education? Even though clinical trials and clinical research are found in a growing number of practice settings, undergraduate nursing students HAVE SUFFICIENT KNOWLEDGE to be safe practitioners. Because of the growing presence of clinical trials and clinical research in so many practice settings, undergraduate nursing students NEED ADDITIONAL KNOWLEDGE AND SKILLS to be safe practitioners. 4% Agree 0% Strongly Agree 4% Somewhat Agree 96% Agree 48% Strongly Agree 48% Somewhat Agree

45 ASO Additional Findings Variety of external factors influence curriculum content CR/CT content exists, but predominantly as part of nursing research and other courses Evidence-based practice (EBP) is mentioned frequently as instigating change, yet understanding and critically assessing the source of data is not specifically mentioned as integral to EBP Nearly all participants want to stay involved All are willing to advocate for changes to CR/CT curriculum content

46 Study Limitations Convenience sample Small sample sizes Lack of diverse settings represented Results are not generalizable

47 Common Themes CR/CT is seen in expanding settings CR/CT content is important, but not critical in baccalaureate curriculum Time constraints for including CR/CT content in academia and practice Few opportunities in school for exposure to CR/CT

48 Common Themes No need to include in NCLEX Employers are satisfied with new BSN graduates education New BSN nurses may not be prepared to educate about CR/CT CR/CT still thought of as a specialty Confusion about roles and career paths

49 Next Steps Disseminate findings / raise awareness Engage broader group of stakeholders Draft competencies and curricular guidelines

50 Next Steps Presentations: 2011 Oncology Nursing Society - Moderated poster session Association of Pediatric Hematology Oncology Nurses Poster presentation American Association for Cancer Education Oral presentation Sigma Theta Tau Oral presentation

51 Next Steps Publications: 2012 Journal of Nursing Scholarship formative research article American Nurse Today print and online series Begin dialogue with nursing community: 2011 Webinar with professional associations

52 Your Next Steps Become a cheerleader for clinical trials!

53

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