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Clinical Research
Time Consuming and LaboriousMultidisciplinary Team
Principal InvestigatorResearch NurseClinical Research CoordinatorPharmacistRegulatory Specialist
Highly Specialized
What do research teams do?
Paperwork, paperwork, paperworkRegulatory workCorrespondence with the IRBEnroll and manage study participantsHighly technical requiring a broad expertise and skill set
Identifying Tasks
Gwede: Role IdentificationCanada Clinical Trials GroupMoffitt
→ high burnout→ high turnover
Gwede 2000, 2001, 2005, 2008; Roche 2002
How To Quantify Workload?
Inherent TasksProtocol Acuity Scoring System“workload is an ever evolving municipality that requires flexibility, especially within clinical trials”Activity Based Costing (ABC) methodology
Soenen 2006; Fowler 2003
ABC in Healthcare
FlexibilityABC in Clinical SettingsABC for Research in Africa
Soenen 2006; Fowler 2003; Demeere 1992; Chou 2007
ABC in Clinical Trials
Clinical Trial TasksComplex Factors
DiseaseAcuity of Underlying Illness Related to DiseasePhase of StudySponsorStudy Team Structure
Team Member Roles: The Oncology Research Nurse (ORN)
Ehrenberger 2004; ONS 2010; Castro 2009; Gwede 2001; Roche 2002
Oncology Research Nurse
Research NurseResearch CoordinatorClinical Research CoordinatorOncology Research NurseOncology Research Nurse Coordinator
Gwede 2001, 2008; Roche 2002; Schmidt 2008; Ocker 2000; Thompson 2005
Defining the Role
CTN SIG 2004: Dimensions of an Oncology Research Nurse2010: Clinical Trials Nurse CompetencyCastro and NIH
Ehrenberger 2004; ONS 2010; Castro 2009; Biron 2007
Nursing Role Effectiveness Model
Structure-process-outcomes
Role delineation
Irvine 1998
PatientOrganizational Variables
Nursing
OncologyResearch
Nurse
OncologyResearch
Nurse
ORN-WAT (Oncology Research Nurse – Workload Assessment Tool)
Itemize TasksQuantify Time for TaskFlexible ToolBudgetWorkload OrganizationWorkload Allocation
Objectives
Test the feasibility of completing the ORN-WATMeasure how much time respondents were spending on identified tasksTime to completion of survey
What’s in the ORN-WAT?
94-item questionnaire 1) Non-identifiable Demographics (5 questions)2) Protocol Management (40 questions)3) Eligibility and Entry (13 questions)4) Treatment (22 questions)5) Follow-Up and Final Stage (7 questions)6) Time to Complete (1 question)7) Acceptability E-Scale (6 questions)
Tariman 2009
Pilot test of the ORN-WAT
Dana-Farber/Harvard Cancer Center (DF/HCC)70 Oncology Research Nurses at Dana Farber/Harvard Cancer Center InstitutionsSurvey methodology utilizing Survey Monkey®Time and Task48 Responses (69% response rate)
Respondents:
Survey Participation by Institution
10%
50%9%
31%
Beth Israel DeaconessMedical Center (BIDMC)Dana Farber CancerInstitute (DFCI)
Massachusetts GeneralHospital (MGH)
Nonresponder
Level of ExperienceRe se a rch Exp e rie nce
0 2 4 6 8 10 12 14 16
Number of yearsas a research
nurse
Number of yearsas oncology
research nurse Less than 2 years
2-5 years
6-10 years
11-15 years
Greater than 16 years
Protocol Management (40 questions)
> 90% do not do any Regulatory WorkOnly 10% Budget Review/Negotiation> 60% do not spend time working on correspondence with SRC/IRB 80% spend < 5 hours on Drug Order Templates25% of time: Sponsor Required MeetingsResearch Team SupervisionLow % Preparing for Audit
Eligibility and Entry (13 Questions)
Assessing Participant Eligibility: 11-20 hoursConsenting: ~10 hoursEducation of Participant/Family: 50% greater than 10 hours per month
Treatment (22 Questions)
Scheduling Research Related Exams and Visits: 89% reported 5-40 hoursEducation of Clinical Care Staff: 66% 1-10 hoursProviding Research Related Care: 53% 1-10 hoursToxicity Assessment/Management: > 60% more than 20 hoursViolations/Deviations/Adverse Events: 65% spend less than 5 hours
Follow Up and Final Stage (7 Questions)
Minimal Involvement80-90% respondents did nothing in this categorySurprising
Acceptability E-Scale (6 Questions)
Number (N) Average
How Easy 37 1.9
How Understandable 37 1.6
How Much Enjoy 37 2.9
How Helpful 36 2.7
Time Acceptable 37 1.8
Overall Satisfaction 36 2.3
How Long Did it Take?
Surve y Co mp le tio n T ime
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
less than 15minutes
15-30 minutes 30-45 minutes 45-60 minutes greater than 60minutes
The Next Step:
Test ReliabilityBroaden the Sample SizeSimpler Tool
Special Acknowledgement
Donna Berry, PhD, RN, AOCN®, FAANPaul Catalano, SCDHallie Kasper, RN, MSN, PNP-BC, AOCNPKaren Schulte, MSN, ANP-BC, OCN
Questions…
?? ??
Thank You
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Chapter 4, Workload Determination and Resource Allocation; p. 21-29.Roche K, Paul N, Smuck B, Whitehead M, Zee B, Pater J, Hiatt M-A, Walker H. Factors affecting workload of
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References Continued…Ehrenberger HE, Lillington L. Development of a measure to delineate the clinical trials nursing
role. Oncology Nursing Forum. 2004; 31(3):E64-E68.Oncology Nursing Society. Oncology Clinical Trial Nurse Competencies [Internet]. ONS eNews:
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Castro K. Building the foundation for clinical research nursing: domain of practice for the specialty of clinical research nursing. Presented at: CRN 2010 Domain of Practice Committee, November 2009. Available: http://www.cc.nih.gov/nursing/crn/DOP_document.pdf
Biron AD, Richer MC, Ezer H. A conceptual framework contributing to nursing administration and research. Journal of Nursing Management. 2007:15:188-196.
Schmidt CR. ONS Manual for Clinical Trials Nursing. 2nd ed. Pittsburgh: Oncology Nursing Society; c2008. Chapter 11, Clinical Research/Interdisciplinary Team; p. 69-75.
Ocker BM. Plank P, Darlene M. The research nurse role in a clinic-based oncology research setting. Cancer Nursing. 2000 August:23(4):286-292.
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Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the acceptability e-scale for web-based patient-reported outcomes in cancer care. Applied Nursing Research. Forthcoming 2009
