126390-144

The clinical trial assessment of infrastructure matrix tool (CT AIM) to improve the quality of research conduct in the community.

Category: 
Health Services Research
Session Type and Session Title: 
Clinical Science Symposium, Optimizing Access to Clinical Trials in Community Practice
Abstract Number: 
6512
Citation: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 6512)
Author(s): 
Eileen P. Dimond, Robin Zon, Diane C. St. Germain, Andrea Denicoff, Angela Carrigan, Kandie Dempsey, Worta J. McCaskill-Stevens, Maria Magdalena Gonzalez, Mitchell Z. Berger, Lucy Jean Gansauer, James D. Bearden, Kathy Wilkinson, Donna M. Bryant, Maria Caroline Bell, Beth Lavasseur, Phil Stella, Marjorie J. Good, Kathleen Igo, Octavio Quiñones, Stephen S. Grubbs; National Cancer Institute, Rockville, MD; Michiana Hematology Oncology PC, South Bend, IN; Leidos Biomedical Research, Inc.(Formerly SAIC-Frederick, Inc.), Frederick, MD; Helen F. Graham Cancer Center, Newark, DE; St. Joseph Hospital, Orange, Orange, CA; The Cancer Program of Our Lady of the Lake and Mary Bird Perkins, Baton Rouge, LA; Spartanburg Regional Medical Center, Spartanburg, SC; Billings Clinic, Billings, MT; Sioux Valley/University Hospital, Sioux Falls, SD; St. Joseph Mercy Hospital, Ann Arbor, MI; Leidos Biomedical Research Inc. (Formerly SAIC-Frederick, Inc.), Frederick, MD; DMS Inc, Frederick National Laboratory for Cancer Research, Frederick, MD; Helen F. Graham Cancer Center at Christiana Care, Newark, DE

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: ASCO described minimum standards and exemplary attributes for CT sites to improve research quality (Zon et al JCO 2008, JOP 2011; Baer et al JOP 2010). Based on these attributes, the NCI Community Cancer Centers Program (NCCCP) developed and piloted the CT AIM Tool to facilitate research program improvements through self-assessment and benchmarking. The tool identified 9 attributes (see Table) each with 3 progressive levels for research sites to “score” their program from less (Level 1) to more (Level 3) exemplary CT infrastructure (e.g. Level 1- only phase 3 treatment trials open vs. Level 3 – Phase 1/2/3, cancer control and prevention trials open). Methods: From 2011-13, 21 NCCCP sites self assessed their CT programs annually using the tool. Results: See Table. Conclusions: Statistically significant increases (p < 0.0001) occurred in Level 3 (more exemplary) infrastructure ratings from 2011 to 2013 across all 9 attribute categories assessed at the 21 sites. Statistically significant gains were seen in two attributes: CT Portfolio – increases in site early phase and cancer control trial implementation; CT Communication /Awareness - shifts observed from institutionally focused CT education to broader community outreach/engagement. The tool showed utility across the sites for promoting quality improvement, benchmarking research performance, progress reporting and providing metrics for communicating infrastructure needs. Use in research beyond oncology and outside the community setting is plausible. NCI Contract HHSN261200800001E.

Attribute and year Level (1-3) and No. of sites (n=21)
1 2 3
CT communication/awareness* p 0.0281
2011 6 11 4
2012 2 10 9
2013 1 10 10
Accrual
2011 5 10 6
2012 4 6 11
2013 4 5 12
Education standards
2011 3 12 6
2012 3 7 11
2013 3 5 13
Multidisc. involvement
2011 2 8 11
2012 3 3 15
2013 2 4 15
Participation in CT process
2011 1 11 9
2012 2 6 13
2013 2 6 13
Physician CT engagement
2011 1 10 10
2012 1 5 15
2013 1 3 17
CT portfolio * p 0.0228
2011 1 12 8
2012 1 6 14
2013 1 3 17
QA
2011 4 11 6
2012 3 8 10
2013 3 4 14
Community outreach/underserved accrual
2011 8 6 7
2012 6 6 9
2013 4 7 10
Level 3 scores for ALL attribute categories from 2011 to 2013* p < 0.0001
67 107 121

* Significant p value for change over time.