10/31/2014

Clinical Research Coordinator Time Utilization Data: Does it Describe the Clinical Research Nursing Specialty Domain of Practice?

Debra L. Henninger, MHSA RN CCRC Associate Director, Office of Research Compliance Geisinger Health System |1

Clinical Research Nursing Background NIH Clinical Center, Nursing & Patient Care Services CRN Specialty – Clinical Research Nurse (care of research patients) – Research Nurse Coordinator (study coordination and management)

CRN Domain of Practice – Five Dimensions • • • • •

Study Management Clinical Practice Coordination of Care & Continuity Human Subject Protections Contributing to the Science

*National Institutes of Health Clinical Center, Nursing and Patient Care Services, 2009

Clinical Research Nursing Domains of Practice

CRN 2010 Domain of Practice Committee 2009. Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. 2009. National Institutes of Health Clinical Center, Nursing and Patient Care Services. Available at http://www.cc.nih.gov/nursing/crn/DOP_document.pdf

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Research Purpose • Describe the CRNC role and differentiate skills required for CRNC responsibilities • Examine the applicability of the five dimensions identified within the NIH domain of practice for the specialty of clinical research nursing to the actual experience of nurses working as clinical research coordinators*

*National Institutes of Health Clinical Center, Nursing and Patient Care Services, 2009 |4

Study Aims 1. Describe how self-reported time utilization data obtained from Geisinger CCS Clinical Research Nurse Coordinators (January 1, 2011 through December 31, 2011) fits into the five dimensions of the NIH domain of practice for the specialty of clinical research nursing. 2. Explore applicability of the five dimensions of the NIH domain of practice for the specialty of clinical research nursing to the actual experience of the Geisinger CCS CRNC.

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Study Design • Retrospective; Exploratory • Small convenience sample • • • • •

16 Geisinger Clinical Research Nurse Coordinators Operational time utilization data - Time Track© January 1, 2011 – December 31, 2011 Data abstracted by administrative research staff De-identified data only

• 2011 CRSS Study data – CRNC demographics • Aggregate data re-purposed • Provided by PI - Liza Behrens, MSN RN CCRC • De-identified data only |6

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Time Track “Buckets” ADMIN

Study start-up regulatory work and management throughout the study such as: sponsor regulatory document preparation; budget review, approvals and signatures; preparation of study aids, such as inclusion/exclusion pocket cards, study visit checklists; site initiation preparation; communication with the sponsor & study staff

VISIT

All work related to patient visits, including patient scheduling, visit preparation (i.e. lab kit prep), travel to visit, time with patient, Epic & Study Manager documentation, sending MRIs, scans, etc to sponsor

RECRUITMENT Any activities related to subject recruitment, such as development of patient letters, phone script, ads and flyers; educating call center; review of Epic clinic schedules; prescreening patient records; discussion with patients re) trials (phone, mail, email, in person); management of recruitment database

Time Track “Buckets” IRB

IRB activities throughout the study including all work related to initial IRB submission, Amendments, Protocol Deviations, Continuing Review, all IRB communication

FEASIBILITY

All work related to feasibility, such as work on protocol, sponsor questionnaires; population & budget assessments; feasibility reports; site selection prep & visit

SAE

Time spent on Geisinger pt SAEs, including EHR review & data collection; SAE reporting to sponsor – initial & followup; eCRF completion & queries related to SAE; communication with providers, investigators; IRB report

CLOSE-OUT

Study closeout activities involved with closing out the study with the sponsor, including close-out monitoring visit; sponsor-required documents; packing up the study for storage; disposing of unused study supplies

Task Distribution: Administration Billing Reconciliation Closeout/ Archiving

CRNC Activity Distribution as recorded in Time Track© (Example)

Case Report Form (CRF) Completion EPIC Smart Tools

Hours: 600.00 20.00 76.00 170.00 5.00

IND Safety Reports

12.00

IRB

64.00

Meeting

18.00

Monitor Visit Meeting Time

76.00

Recruitment

63.00

Serious Adverse Event (SAE)

16.00

Travel Visit

12.00 660.00

January 1, 2011 - December 31, 2011

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NIH Dimensions of Clinical Research Nursing

Dimensions of Clinical Research Nursing and Corresponding Time Track©

Time Track© Activity Categories

Study Management

Administration Billing Reconciliation Budget Chart Review Close-out/Archiving Confidentiality Disclosure Agreements Contract CRF Completion Document Development Feasibility IND Safety Reporting IRB Meeting Monitoring Visits On-Call Recruitment

Care Coordination and Continuity

Epic Smart Tool Development Visits (25%)

Clinical Practice

Serious Adverse Events Visits (50%)

Human Subject Protections

IRB Member Visits (25%)

Contributing to the Science

Special Projects (50%) Orientation (50%) Unscheduled Mentoring

Overhead – Not attributed to any Dimension

Education General (no Time Track© activity selected) Meeting (Department, GHS, etc.) Orientation (50%) Personnel Management Special Projects (50%) Time Off Travel

Clinical Research Nurse Dimension Time Track© Activity Category

Distribution of CRNC Hours per Clinical Research Nurse Dimension and Time Track© Activity Category

Percent of Total Time

Total Hours

13%

2468.09

Study Management

Administration

Study Management

Closeout/Archiving

0%

83.79

Study Management

Feasibility

2%

405.99

Study Management

Meeting

3%

583.43

Study Management

Monitor Visit

2%

280.62

Study Management

IRB Submissions

1%

206.54

Study Management

Recruitment

1%

145.24

Study Management

CRF Completion

5%

965.85

Study Management

IND Safety Reports

0%

Study Management

Budget

0%

Study Management

Contract

0%

10.95

Study Management

Billing Reconciliation

1%

213.01

Study Management

Document Development

0%

Study Management

START-UP

0%

0.18

Study Management

Chart Review

14%

2511.02

Clinical Practice

Serious Adverse Events

3%

566.56

Clinical Practice

Visit 50%

8%

1543.83

Human Subject Protections

IRB MEMBER

0%

39.25

Human Subject Protections

Visit 25%

4%

771.92

Care Coordination & Continuity

Visit 25%

4%

771.92

Care Coordination & Continuity

Epic Smart Tools

1%

153.09

12.22 65.55

14.00

Contributing to the Science

Unscheduled mentoring

1%

178.40

Contributing to the Science

Special Projects 50%

4%

751.76

Contributing to the Science

Orientation 50%

2%

403.62

Overhead

Special Projects 50%

4%

751.76

Overhead

Education

2%

455.94

Overhead

Orientation 50%

2%

Overhead

Meeting

5%

Overhead

Personnel, Admin

1%

226.50

Overhead

Time Off

11%

1963.02

Overhead

Travel

2%

302.14

Overhead

BLANKS

1%

208.46

403.62 949.30

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Distribution of % CRNC Hours per Dimension of Clinical Research Nursing Domain of Practice

Series: (1) Study Management; (2) Clinical Practice; (3) Human Subject Protections; (4) Care Coordination & Continuity; (5) Contributing to the Science; (6) Overhead | 12

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Distribution of Study Types

Series: (1) Clinical Trials and (2) Data Collection | 13

Discussion / Limitations Population – – – –

Convenience sample Small number Employees Nurses only

Data – – – –

Self-reported Accuracy / timeliness Activity definitions / operational Applied demographic data

Future Research • Expand to non-nurse coordinators, other staff • Expand beyond central core research service • Enhance descriptive demographic data • Survey • Longitudinal design • Explore relationships • Explore impact on cost of clinical research

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So What? • Real-world context • Contribute to body of knowledge for CRN specialty • Nursing specialty certification • Role definition • Delegation of responsibilities • Training programs • Career ladder development

• Implications for conduct of research • Maximizing efficiencies • Reducing costs

Acknowledgements Liza Behrens, MSN RN CCRC Sub-investigator Secondary use of CRSS Study data Mentor

Adele Spegman, PhD RN Sub-investigator Mentor

Geisinger Cardiovascular Center for Clinical Research Administrative Staff De-identification of operational Time Track© data

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Contact Deb Henninger, MHSA RN CCRC Associate Director Office of Research Compliance Geisinger Health System 100 North Academy Avenue Danville, PA 17822-3069 570-214-9096 [email protected]

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