Elizabeth Eisenhauer v2 - IACRN · Nurses as Research Participants: Ethical Considerations Margo...

Information Behavior of Clinical Research Participants

Elizabeth R. Eisenhauer, RN, MLS Doctoral Student

School of Nursing University of Michigan

Prepared for presentation at The International Association of Clinical Research Nurses (IACRN) 5th Annual Conference San Diego, CA. October, 23-25 2013

Copyright Elizabeth Eisenhauer 2013 1

Disclosure

Copyright Elizabeth Eisenhauer 2013

§  Elizabeth Eisenhauer has no conflict of interests to disclose.

§ Thank you to The Rackham Graduate School at the University of Michigan for the Rackham Travel Grant to

defray the costs of attending this conference.

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Background and Significance


*We need clinical research volunteers

*Often cited that < 5% of eligible cancer patients enroll in CTs (Murthy, Krumholz, & Gross, 2004)

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Background and Significance


* Over the last decade the deaths of several healthy volunteers in clinical research studies have been well

publicized

* Impacts the public’s view of clinical research in general

* We need to understand the experience from the participants’ perspective: Holistically

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Purpose


*To help understand the clinical research experience from the participants' perspective through the lens of

information behavior

*To help inform researchers of participants’ needs

*In turn, to help participants receive the (information) they need

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Research Questions

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1)  How do clinical study participants find a study to join or determine which study to join?

2)  What information do they need, or seek, to decide to enroll?

3)  What was the extent of information seeking before they made their decision to participate?

4)  How confident are they about their decision to enroll?

Methods


*  Study was approved by the Health Sciences and Behavioral Sciences Institutional Review Boards (IRB- HSBS) at the University of Michigan (U-M).

*  Recruitment: Flyers and website posting

*  Qualitative: 10 semi-structured interviews

Methods


*  Brenda Dervin’s Sense-Making methodology, Micro-moment timeline interviews

*  Open coding, content and narrative analyses, based on Dervin’s work, were used to find themes emerging in the data

*  Schamber (2000) discusses the strengths of combining time line interview techniques with inductive content analysis

Findings and Discussion


1) How do clinical study participants find a study to join or determine which study to join?

* None approached by a clinician

* 60% found the study electronically

* 40% found the study by noticing a posted, paper flyer

Explained well by Bates (2007) work on browsing and Saracevic (1996) work on the relationship between cognitive relevance and interest



2) What information do they need, or seek, to decide to enroll? 3) What was the extent of information seeking before they made their decision to participate?

* Short answer is “lots”

* Questions best answered by personal interaction (not paper) with coordinator or research assistant (FTF, Phone, E-mail)

* Prompt response cannot be emphasized enough

* “play within a play”



Based on qualitative comments from P3:

1)  where would the study be held? 2)  what would be the duration? 3)  what would I have to do as a participant 4)  what are the criteria? 5)  I am eligible? 6)  what do I need to do?



Themes regarding motivation for participation Interest (relevance)

Compensation Altruism

Convenience

(level of physical/emotional invasiveness and/or time commitment/level of involvement)

Content (study content, level of convenience or invasiv eness)


PROCESS (t ime, cha nging pa rticip ant (inf ormation) needs and emotions)

Motivation (interest, altruism,comp ensati on)

Implications


System / Study design issue: automated e-mails

Engaging Health Sciences Librarians and informationists

Use of Clinical Research Nurses

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Theoretical Framework


Hildegard. E. Peplau Interpersonal Relations in Nursing,1952

Describes nursing: “therapeutic, interpersonal process” Common themes of trust, goals, needs, uncertainty, anxiety (see summary: http://currentnursing.com/nursing_theory/interpersonal_theory.html)

Implications


Nurses best situated to be Clinical Study Coordinators Unique skills Trust

Focused on participants motivation/goals/understanding: natural Patient Advocates

Attending to spoken and unspoken participant needs, concerns, uncertainty/anxiety

Links between caring and information provision Advanced Practice Role (CRN)

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Conclusions


McDonald, M., & Cox, S. (2009). Moving Toward Evidence-Based Human Participant Protection. Journal of Academic Ethics, 7(1-2), 1-16.

“…health research ultimately depends on the participation of human volunteers as research subjects...Under these circumstances, searching for evidence of what happens to these volunteers…is ethically mandatory….The onus is on the research community to collect and use that evidence to good effect.”

Be grateful to your research participants!

Key References


§  Bates, M. J. (2007). What is browsing—really? A model drawing from behavioural science research. Information Research, 12(4), Paper No. 330. Available at:

http://Informationr.net/ir/12-4/paper330.html §

§ Bornstein, D. (May 16, 2012). The Power of Nursing. New York Times, [Online Commentary] Available from: .http://opinionator.blogs.nytimes.com/2012/05/16/the-

power-of-nursing/ §

§  Case, D. (2007). Looking for information: A survey of research on information seeking, needs, and behavior (2nd ed.). Boston, MA: Elsevier/Academic Press.

Chapter 7: Perspectives, paradigms, and theories. Pp. 141-190.

§  Cox, K., & McGarry, J. (2003). Why patients don’t take part in cancer clinical trials: an overview of the literature. European journal of cancer care, 12(2), 114-122.

Key References

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§  Davidoff, F., & Florance, V. (2000). The informationist: a new health profession?. Annals of internal medicine, 132(12), 996-998.

§  Dervin, B. (1992). From the mind's eye of the user: The sense-making qualitative-quantitative methodology. In J. Glazier & R. Powell (Eds.),

Qualitative research in information management, (pp. 61-84), Englewood, CO: Libraries Unlimited.

§  Dervin, B. (1999). Chaos, order, and Sense-Making: A proposed theory for information design. In R. Jacobson (Ed.), Information design (pp. 35-

57). Cambridge, MA: MIT Press.

§  Frankl, V. (1959/2006). Man’s search for meaning. Boston, MA: Beacon Press.

Key References


§  Getz, K., Borfitz, D. (2002). Informed consent: a guide to the risks and benefits of volunteering for clinical trials. Boston, MA: CenterWatch.

§ Hastings, C. E., Fisher, C. A., & McCabe, M. A. (2012). Clinical research nursing: A critical resource in the national research enterprise. Nursing Outlook, 60(3), 149-156. doi:10.1016/j.outlook.2011.10.003.

§  Henwood, F., Harris, R., & Spoel, P. (2011). Informing health? Negotiating the logics of choice and care in everyday practices of ‘healthy living’. Social Science & Medicine, 72(12), 2026-2032.

§

§  Kuhlthau, C. C. (1993). Seeking meaning: A process approach to library and information services. Norwood, NJ: Ablex Publishing.

Key References

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§ Maslow, A. (1943). A Theory of Human Motivation. Psychological Review, 50, 370-396.

§ McDonald, M., & Cox, S. (2009). Moving Toward Evidence-Based Human Participant Protection. Journal of Academic Ethics, 7(1-2), 1-16.

§  Murthy, V. H., Krumholz, H. M., & Gross, C. P. (2004). Participation in cancer clinical trials. JAMA:the journal of the American Medical

Association, 291(22), 2720-2726.

§  Penckofer, S., Byrn, M., Mumby, P., & Ferrans, C. E. (2011). Improving subject recruitment, retention, and participation in research through Peplau’s theory of interpersonal relations. Nursing Science Quarterly,

24(2), 146-151.

Key References


§  Peters-Lawrence, M. H., Bell, M. C., Hsu, L. L., Osunkwo, I., Seaman,P., Blackwood, M., ... & Minniti, C. P. (2012). Clinical trial

implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial. Contemporary clinical trials, 33(2), 291-

297.

§  Pettigrew, K. E. (1999). Waiting for chiropody: contextual results from an ethnographic study of the information behaviour among attendees at community clinics. Information Processing & Management, 35(6), 801-

817.

Key References


§  Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999). Barriers to participation in randomised controlled trials: a

systematic review. Journal of clinical epidemiology, 52(12), 1143-1156.

§  Saracevic, T. (1996). Relevance Reconsidered ’96. In P. Ingwersen, & N.O. Pors (Eds.), Proceedings of CoLIS 2, second international

conferenceon conceptions of library and information science: Integration in perspective, Copenhagen (pp. 201–218). Copenhagen: Royal School of

Librarianship. See reprint accessed online 9/6/2013 at: http:///www.comminfo.rutgers.edu/~tefko/CoLIS2_1996.doc

Key References


§  Schamber, L. (2000). Time-‐line interviews and inductive content analysis: their effectiveness for exploring cognitive behaviors. Journal of

the American Society for Information Science, 51(8), 734-744.

§  Tomlin, A. (2002): Hospital librarians and the Johns Hopkins tragedy, Journal of Hospital Librarianship 2(4), 89-96. doi:

http://dx.doi.org/10.1300/J186v02n04_07

Acknowledgments


§ Thank you to: All of the study participants and Dr. Soo Young Rieh, Dr. Marcelline R. Harris, Dr. Richard W.

Redman, Dr. Jesus M. Casida, Sarah Fox, Elizabeth (Elsie) Nolan, Dr. Janet Larson, Catherine Meldrum, Dr. Carolyn

Sampselle, Keri Kirk, Dr. Kelley Kidwell, Allen Flynn, Dr. Dave Uddin, and an anonymous reviewer.

Questions?


§  Please contact: [email protected]

Nurses as Research Participants: Ethical Considerations

Margo Moore BSN, RN, CCRP Stephanie Sealschott BSN, RNC-NIC

IACRN 2013

NNCQ Study Neonatal Nursing Care Quality

This presentation is based on research funded by a Research Scholars in Patient Services Grant, Cincinnati Children’s Hospital Medical Center

PI: Heather Tubbs Cooley, PhD, RN

Objective

Background:

•  Major Healthcare system changes •  Nurses are frontline caregivers in patient

care •  Research on care delivery practices •  Protections for nurses as vulnerable human

subjects

The Belmont Report Basic Ethical Principles

Respect For Persons

The principle of respect for persons divides into two separate moral requirements: •  Individuals should be treated as autonomous

agents •  Persons with diminished autonomy are

entitled to protection.

Recruitment Strategies

NNCQ

Neonatal Nursing Care Quality Study

Join us for an Information session about the study, ask questions, and receive a $5 meal ticket for your time.

Information Sessions:

3/13 Wednesday 18:30-‐20:00 NICU Classroom

3/14 Thursday 6:30-‐8:00 NICU Classroom

3/18 Monday 6:30-‐8:00 NICU Classroom

03/19 Tuesday 18:30-‐20:00 NICU Classroom

03/21 Thursday 18:30-‐20:00 NICU Classroom

03/22 Friday 6:30-‐8:30 NICU Classroom

3/11 Monday 6:30-‐8 Outside Breakroom

3/15 Friday 6:30-‐8 Outside Breakroom

3/19 Tuesday 6:30-‐8 Outside Breakroom

3/20 Wednesday 6:30-‐8 Outside Breakroom

3/21 Thursday 6:30-‐8 Outside Breakroom

Beneficence

Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. •  do not harm •  maximize possible benefits and minimize

possible harms

Certificate of Confidentiality

Social Justice •  The burdens and benefits of research

should be justly distributed.

Enrollment

•  All registered nurses in CCHMC NICU •  Primary position includes direct patient care •  Permanent NICU employees •  Completed orientation

Data Collection 6 week quarterly cycles over 1 year Each Nurse receives:

•  Questionnaire(s) for each baby cared for on each shift worked

•  Assessment of shift workload form

How to keep the data safe during collection?

•  Each nurse has their own special 4 digit number they created, no names

•  Questionnaires are given directly to nurses and collected prior to their shift ending

Data Collection Hurdles

Data Entry and Storage

•  Over 120 pieces of paper to be entered daily into the protected data base

•  All forms are in a locked cabinet and office in a separate building from NICU

•  Further de-identification

Summary

•  End of Cycle 3 •  Best Research Practices •  Careful planning=high quality research data

and outcomes.

Questions?

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