Radiation Therapy Oncology Group RTOG Semi Annual Meeting

Radiation Therapy Oncology Group (RTOG) Semi Annual Meeting Cancer Disparities Research Partnership Programs (CDRP) January 18, 2008 The Evolution of a Novel Radiation Oncology Cancer Disparities Research Program in an Indigent Los Angeles Community Urban Latino African American Cancer (ULAAC) Disparities Project Michael L. Steinberg, MD, FACR, FASTRO Principal Investigator David C. Khan, MD Co-Principal Investigator Nicole C. Harada, CCRC, CCRP Research Coordinator/Data Manager 1

Project Updates Navigator Training Program Patient Data Barriers to Care Clinical Trials Telesynergy Quality Assurance Instability of Health Care Delivery in South LA Publications Media Coverage 2

Patient Navigator Training Program The 9 -hour navigator training course emphasizes: – Investigating and implementing resources for patients in a timely fashion – Listening compassionately and non-judgmentally – Completing appropriate records of all interactions on behalf of the patient – Empowering patients to self-advocate in the healthcare realm 3

Training Program Improvements Prospective navigators are interviewed rather than oriented (effective 9 -05) Increased focus on clinical trial benefits and patient protection (effective 1 -06) Increased training time from 6 to 9 hours (effective 9 -06) Added patient/navigator dialogues (effective 9 -06) Added charting exercises (effective 9 -06) 4

Navigator Support More clinical trials in-services In-services on related health topics In-services on available resources Checking in by phone or note with “absentee navigators” One-to-one recordkeeping support Greater physician presence at meetings Four-page monthly newsletter starting June, 2007 Field trips every two months starting July, 2007 Birthday recognition ACS teleconferences 5

Navigation Process Overseeing and addressing immediate barriers to care (June 2005) Formalizing the process of offering navigation to patients (June 2006) Increasing navigators’ presence in Radiation Oncology (August 2006) Defining in-house navigator role (October 2006) ULAAC move adjacent to Radiation Oncology (April 2007) Including navigator input when clinical trials are offered (June 2007) 6

Training Program 22 active navigators – – – 18 Women 4 Men 11 cancer survivors 7

Patient Data 64% 36% Patients accepted navigation by gender: 208 Males 207 Females 8

Ethnicity of Patients Accepting Navigation To Date 9

Most Common Reported Barriers to Care of Patients Approached 10

Measuring the Effectiveness of Barrier Solution Identification Patient-specific barriers to care identified during the patient intake conducted by a navigator Records are maintained and audited to determine number of days to barrier solution identification Barrier solution includes assigning a navigator (psychosocial barriers) and identifying community resources (functional barriers) 11

Mean Number of Days to Barrier Solution Identification from April 2005 – November 2007 12

Trials Open for Accrual Name of Trial Name of Sponsor Prostate Patient Profiles Project (P 4) Louis Warschaw Prostate Cancer Center @ Cedars Sinai Medical Center RTOG 0413 National Cancer Institute RTOG 0232 National Cancer Institute RTOG 0526 National Cancer Institute 2003 -0414 (Petereit Prostate) National Cancer Institute SWOG S 0424 National Cancer Institute 13

Clinical Trial Accrual/Navigation 36 Enrollments (33 Patients) 20 13 Accepted Navigation Declined Navigation 14

Patients Accrued to Trial 15

Accrual to Trial by Ethnicity 16

ULAAC Health Services/Quality Instruments Patient Satisfaction Survey – Administered monthly via telephone Quality Assurance Patient Evaluation Survey – Administered monthly via telephone Cancer Post-Treatment Survey – Administered at first follow up visit 17

Health Services Instruments 18

Patient Pretreatment Condition Navigated Not Navigated X 2 p I had one or more family members who could be helpful / supportive. 32. 9% 35. 0% 1. 09 . 580 I had one or more friends who could be helpful / supportive. 24. 3% 24. 8% 1. 62 . 444 I had cancer treatment before. 4. 5% 3. 6% 1. 13 . 569 I helped a friend / family member through their cancer treatment. 5. 0% 5. 6% 0. 89 . 638 I had a good understanding of cancer treatment. 10. 6% 13. 1% 0. 16 . 410 I considered myself an independent person. 17. 2% 16. 2% 0. 74 . 239 I considered myself a spiritual / religious person. 13. 7% 16. 8% 1. 10 . 575 Pretreatment Condition • No statistically significant differences detected in measured baseline conditions between those who opted for / against navigation (n = 197). • No statistically significant differences detected in patient Education, Income, Marital Status. 19

Cancer Post-Treatment Survey During my cancer treatment… Quality of Care Navigated Not Navigated p n SD I felt supported. 87 2. 66 . 729 94 2. 78 . 490 . 187 I felt well informed. 86 2. 56 . 745 94 2. 68 . 572 . 215 I had adequate transportation to and from appointments. 87 2. 84 . 484 94 2. 93 . 302 . 131 I had someone to discuss my concerns and fears with. 87 2. 36 . 940 93 2. 58 . 742 . 076 I had someone to answer my questions. 87 2. 60 . 754 93 2. 62 . 641 . 803 I had someone to take care of me. 86 2. 29 1. 07 91 2. 44 1. 04 . 349 my basic financial needs were met. 87 2. 41 . 935 93 2. 63 . 719 . 077 I had good communication with my care providers. 87 2. 64 . 762 93 2. 77 . 513 . 177 Overall, I felt satisfied with the care that I received during my cancer treatment. 87 2. 82 . 518 93 2. 83 . 433 . 876 • 4 point Likert scale: 0 = Never… 3 = Always • No statistically significant differences between patient’s navigated / not navigated detected in retrospective self-report of cancer treatment phase. 20

FACIT-G – Functional Assessment of Chronic Illness Therapy (General) Metric Navigated Not Navigated p n SD Physical 87 20. 41 7. 87 95 22. 49 5. 81 . 043* Social / Family 87 20. 07 6. 47 95 21. 86 5. 44 . 044* Emotional 84 18. 44 6. 25 94 20. 17 4. 72 . 038* Functional 87 17. 18 8. 08 94 21. 00 6. 26 . 0005* Meaning / Peace 85 23. 02 5. 66 93 24. 98 5. 45 . 020* Faith 86 13. 63 3. 71 93 13. 97 3. 88 . 564 Total Spiritual 85 36. 67 8. 48 93 38. 94 8. 03 . 068 • Patients opting for no navigation faired better than those who were navigated on 5 of 8 metrics (*p <. 05). • Findings may be attributable to preexisting differences in social support systems, sense of personal independence, emotional robustness, prognosis, treatment methods, etc. • Corresponding qualitative investigation in progress to explore this issue in depth. 21

Patient’s Evaluation of Navigator Nav. CA Survivor Metric n Nav. Not CA Survivor SD n SD p The navigator was courteous. 55 4. 82 . 641 34 4. 76 . 554 . 688 The navigator was sensitive. 55 4. 82 . 512 34 4. 71 . 629 . 360 The navigator was respectful. 55 4. 84 . 501 34 4. 82 . 521 . 908 The navigator was friendly. 55 4. 93 . 363 34 4. 82 . 521 . 216 The navigator was thorough. 54 4. 81 . 585 34 4. 68 . 638 . 300 I valued working with the navigator. 54 4. 69 . 748 32 4. 66 . 701 . 860 The educational materials I received were helpful. 52 4. 50 . 828 34 4. 15 1. 019 . 082 The service referrals met my needs. 50 4. 08 1. 007 34 4. 47 . 825 . 065 I received financial information (if needed). 49 3. 80 1. 040 34 4. 12 . 913 . 150 I would recommend this service to others. 54 4. 82 . 711 34 4. 82 . 521 . 847 • Likert scale: 1 = Strongly Disagree… 5 = Strongly Agree • No statistically significant differences detected in patient satisfaction scores regardless of navigator’s cancer history. 22

Patient Overall Satisfaction with Navigation Service 23

Focus Groups Conducted by RAND Corporation by Project Year 24

RAND Patient Care Survey Purpose To assess patient experience with and elicit feedback about the Patient Navigator Program The information collected will be used to document aspects of the program and lessons learned to be able to share with other sites interested in having a Patient Navigator Program as well as to inform the current program The target number of 40 patients (both navigated and nonnavigated) Feedback will be presented to program at the end of data collection and analysis 25

RAND Patient Care Survey Methods Telephone survey Administered to patients who had a navigator and those that chose not to have a navigator Administered mid- and post-treatment Instrument Semi-structured Domains include: – Barriers – Self-Efficacy – Patient Satisfaction – Quality of Interaction – Demographics 26

Continuous Quality Improvement Process Deming and Juran – Quality Enhancement in Operations “Lean Thinking” Process to Improve Navigation – value as defined by patient – value stream care mapping processes – one piece flow Care Process Mapping 27

“Lean Thinking” to Improve Navigation Current State Future State Value Stream Standardization Elimination of inefficiencies Decreases number of steps for delivering services Ultimately improves quality and efficiency 28

Pre-Consultation Intake Patient Referral (Phone call from patient or referring physician) Appointment Made Information Gathered (demographics) Patient Records Requested Financial/ Insurance Authorization Day of Consultation (Patient arrives one-hour early to complete billing/medical paperwork) Oncology Nurse In House Navigator intake & assessment of barriers In House Navigator introduces, discusses, and offers navigation to patient Physician (H & P) In House Navigator discusses clinical trials If eligible for clinical trial, If not eligible for clinical trial, Accept Physician completes consultation Immediate barriers addressed Decline Undecided Radiation Oncology notifies ULAAC if barriers arise ULAAC follows up with patient 29

Initiation of navigation process Navigator Coordinator assigns/matches navigator to patient (taking into consideration preferences & skills) Navigator Coordinator notifies navigator of assignment (mails intake form) Navigator contacts patient Navigator reports to ULAAC Navigator & patient arrange face-to-face meeting when possible SOAP form documentation process initiated at initial call to pt SOAP Audit Welcome letter (including program brochure, and educational materials) 30

Ongoing Evaluation & Assessment of Patient Barriers (ULAAC) Comfort Calls SOAP Forms Navigator contacts patient 1 -5 times per week during treatment Coordinates with clinical staff Navigator Meetings Post treatment monthly follow up PRN Structured Interview PSS QASI CPTS Addressing Barriers CTQ RN/MD QA Ongoing Lay Navigation Navigator identifies difficult barriers & coordinates with ULAAC Professional staff assess barriers Barriers are addressed by immediate referral Barriers recorded in database: • Date • Resources identified • Date resolved • Resolution resource Barriers Audit 31

Instability of Health Care Delivery in the South Central Los Angeles Area 32

CFHS Service Area 33

Instability of Health Care Delivery 1995 - Tenet Health Systems purchases Centinela Medical Center 1996 - Centinela Community Foundation formed - $55, 000. 00 1997 - The money leaves the community, becomes part of California Foundations 34

Instability of Health Care Delivery 2001 – Daniel Freeman Memorial charts 11 th straight year in the red; Tenet comes to the rescue to purchase the financially distressed hospital 2002 – Tenet melt down…no capital expenditures for Centinela or Memorial campuses 2004 – Tenet divests Centinela and Memorial campuses 11/2004 – Robert F. Kennedy hospital closed 35

Instability of Health Care Delivery December 19, 2006 – CFHS abruptly closes Daniel Freeman Memorial campus (except Rad-Onc, ULAAC, Rehab Svcs) From 12/2005 – 10/2007 – CFHS promises to move Radiation Oncology and ULAAC Departments to Centinela campus…not forthcoming 11/2007 – Centinela campus sold site unseen to Prime Health Systems cancels Radiation Oncology Center Venture 36

Instability of Health Care Delivery Patients continue to need treatment & navigation Doctors migrated Periphery Decrease in number of cancer patients in hospital 37

California Hospital Medical Center Kaiser Foundation –West L. A. Da n ie l. F re em an M ar in a Ho s pi ta l Brotman Medical Center Centinela Regional Medical Center Memorial Hospital of Gardena 38 King Drew Medical Center/MLK Robert F. Kennedy Hospital Daniel Freeman Memorial Hospital

Down But Not Out Developing a free standing state-of-the-art Radiation Oncology Center in the community (12 -18 months) Continuing to provide radiation treatment to patients by transferring to nearby treatment center Transferring administrative responsibility of ULAAC grant to Partners in Care Foundation Maintaining radiation oncology services for the community by opening a satellite office for consultation, follow up care, and treatment planning 39

A new vision to changing the shape of health care 40

Partners In Care Foundation (Partners) Partners, charitable, non-profit serves as a catalyst for shaping a new vision of health care by partnering with organizations, families and community leaders in the work of changing healthcare systems, changing communities and changing lives. Partners nationally recognized leader promoting innovative community and home approaches in geriatric care management, health promotion, chronic disease management, end of life care, addressing ethnic health disparities and introducing positive practice change. Partners has an extensive history in testing, adapting and disseminating evidence-based models. 41

Community Partners Colleges and Universities Antelope Valley College, Boston University, California State University, Long Beach, California State University, Los Angeles, California State University, Northridge, Mount St. Mary’s College, Occidental College, University of California, Los Angeles, University of Southern California Hospitals and Healthcare Systems Antelope Valley Hospital, Alta. Med, Catholic Healthcare West, Cedars Sinai Medical Center, Children’s Hospital - Los Angeles, City of Hope National Medical Center, Henry Mayo Newhall Memorial Hospital, Huntington Memorial Hospital, Kaiser Permanente Memorial Care Medical Centers, Mission Community Hospital, Northridge Hospital Medical Center, Presbyterian Intercommunity Hospital, Providence Health System, SCAN Health Plan, St. Mary’s Medical Center Long Beach, Veteran’s Administration of Greater Los Angeles Healthcare System Social Service Providers Alzheimer’s Association, Healthcare Partners, Inglewood Senior Service Center, Jewish Family Service of Los Angeles, Joslyn Adult Center, Los Angeles Caregiver Resource Center, Meeting Each Need with Dignity (MEND Clinic), One Generation, Senior Care Network, St. Barnabas Multipurpose Senior Center Public Organizations U. S. Administration on Aging, California Department of Aging, City and County of Los Angeles – Area Agencies on Aging, City of Los Angeles Department of Aging, Los Angeles County – Public Health, Los Angeles County – Health and Human Services 42

Publications Inequities in Care: Explanations & Solutions for Disparities, Seminars in Radiation Oncology, July, 2008 Lay Patient Navigator Program Implementation For Equal Access To Cancer Care And Clinical Trials: Essential Steps And Initial Challenges Cancer, Volume 107, Issue 11 , Pages 2669 – 2677 Preliminary Results and Evaluation of Mammo. Site® Balloon Brachytherapy for Partial Breast Irradiation for Pure Ductal Carcinoma in Situ: A Phase II Clinical Study, The American Journal of Surgery, 192, p 427 -33, 2006 43

Abstracts Evolution of A Novel Radiation Oncology Cancer Disparities Research Program in an Indigent Los Angeles Community, International Journal of Radiation Oncology Biology Physics, 2007 Patient Navigators Tailor Interventions in Minority, Low-Income Populations, National Cancer Institute, NCI Cancer Bulletin, Volume 4, Issue 29, 2007 The Use of Lay Patient Navigators to Improve Quality of Care and Accrual to Clinical Trials for Radiation Oncology Patients Who Are Minorities or of Low Socioeconomic Status, International Journal of Radiation Oncology Biology Physics, Volume 66, Issue 3, p S 70, 2006 Using Telesynergy ® To Improve Access to Clinical Trials at an Underserved Community Based Hospital, International Journal of Radiation Oncology Biology Physics, 2007 Patient-Centered Satisfaction and Well Being Assessment in a Lay Patient Navigator Program for Underserved Populations, International Journal of Radiation Oncology Biology Physics, 2007 44

Presentations Experiences of an Urban Cancer Care Disparity Program: A Broadly Applicable Model for Quality of Care Enhancement ASTRO, Los Angeles, Ca. , October 30 th, 2007 Disparities in Healthcare: Medical Science Meets Socioeconomics, Politics, Race, Public Policy, and Poverty, Mid Winter Oncology Meeting, Los Angeles, Ca. , Jan. 21, 2007 The Use of Lay Patient Navigators to Improve Quality of Care and Accrual to Clinical Trials for Radiation Oncology Patients Who Are Minorities or of Low Socioeconomic Status, ASTRO 2006, Philadelphia, PA, Nov. 5 -9, 2006 Do Navigators Make a Difference in Acceptance of Clinical Trials? , ASTRO 2006, Philadelphia, PA, Nov. 5 -9, 2006 45

Presentations Preliminary results and evaluation of Mammo. Site® Balloon Brachytherapy for Partial Breast Irradiation for Pure Ductal Carcinoma In Situ: A Phase II Clinical Study, American Society of Breast Surgeons meeting, April 2006 Development of Lay Navigation Program in an Underserved Community, National Leadership Summit on Eliminating Racial Disparities in Health, January 911, 2006 Washington, D. C. Prophylactic Post-Operative Antibiotics for Prostate Brachytherapy, Prostate Cancer Symposium, ASCO, San Francisco, Ca. , 2006 46

Poster Presentations Patient-Centered Satisfaction Measures in A Lay Patient Navigator Program for Underserved Populations in Oncology, accepted for oral presentation, Western Regional Meeting, February 2008 Using Telesynergy to Improve Access to Clinical Trials at an Underserved Community Based Hospital, ASTRO, October 2007 Evolution of a Novel Radiation Oncology Cancer Disparities Research Program in an Indigent Los Angeles Community, ASTRO, October 2007 Patient-Centered Satisfaction and Well Being Assessment in a Lay Patient Navigator Program for Underserved Populations, ASTRO, October 2007 47

Poster Presentations Lean Thinking Process to Improving Navigation, Cancer Health Disparities Summit, July 16 -18, 2007 Lay patient navigator program for equal access to cancer care and clinical trials, ASTRO Health Services/Outcomes Research In Radiation Oncology, San Diego, CA September 15, 2006 A Lay Patient Navigator Program as Part of a Clinical Trials Infrastructure in a Community Hospital Serving Minority and Low Income Patients, Poster Presentation at the Cancer Health Disparities Summit 2006, Bethesda, MD, July 17 -19, 2006 48

Pending Articles Lay Patient Navigator Training Manual Efficacy of Navigation for the Indigent Cancer Patient Barriers to Care in Oncology: The efficacy of Lay Patient Navigators” Findings From the ULAAC Disparity Project: Navigator and Patient Characteristics Emerging Approaches for Identifying and Targeting Disparities: Utilization of Quality of Care Evaluation Metrics 49

Media Coverage Recent Coverage Past Coverage – Uprising Radio Broadcast, December 12, 2007 “Another Inglewood Hospital Threatened” – La Opinion article, November 11, 2005 – Ivanhoe Broadcast news, December 11, 2007 TV story on Patient Navigators (to air in March 2008) – Inglewood Today article, October 12, 2005 “To Navigate Services in a Health System: The Patient Navigator Program Helps Sort Through Obstacles that Make It Difficult to Treat Cancer” “Taking Care of Business: The Urban Latino African American Cancer (ULAAC) Disparities Project” – KCAL 9 news station (CBS) – December 7, 2005 2: 00 PM, 3: 00 PM, and 4: 00 PM news “ULAAC: New Cancer Program Helps Patients Navigate System” http: //cbs 2. com/video/? id=11126 Akcbs. dayport. com – On Target “Documentary 2005” 50

Definition of Success: going from failure to failure without significant loss of enthusiasm 51

Contact us: ULAAC Disparities Project Centinela Freeman Regional Medical Center, Memorial Campus 333 North Prairie Ave. , Inglewood, CA 90301 Telephone: (310) 674 -7050, x 4661 Fax: (310) 419 -8329 Email: mls@cccma. com Web: www. centinelafreeman. com Principal Investigator: Michael L. Steinberg, MD, FACR, FASTRO Project Administrator: Keith Andre, MA Keith. Andre@centinelafreeman. com 52