UPMC McKeesport Hospital
McKeesport, PA

UPMC McKeesport Hospital
1500 Fifth Avenue
McKeesport, PA 15132
http://mckeesport.upmc.com
PI: Dwight E. Heron, MD

UPMC McKeesport was founded in 1894 and is a nonprofit acute care community hospital that serves the 200,000 residents of McKeesport and the surrounding area. The Hospital offers 216 beds for acute care patients and 56 beds for patients who need skilled nursing care. The hospital offers an array of health care services including intensive care, cardiac care and ongoing rehabilitation and educational programs for patients with cardiac, neurologic, and orthopaedic diagnoses. UPMC McKeesport is a teaching hospital, with residency programs in both family practice and internal medicine. The hospital's merger with UPMC Health System in April 1998 provides access to UPMC's state-of-the-art diagnostic and interventional capabilities and its extensive roster of specialists. The resources of UPMC have allowed UPMC McKeesport to enhance its care services to the community. This commitment is visible through the health care services the hospital provides as well as through the community-focused programs sponsored by the McKeesport Hospital Foundation.

UPMC Cancer Center at UPMC McKeesport
The University of Pittsburgh Medical Center and the University of Pittsburgh Cancer Institute (UPCI) have partnered with community-based hospitals throughout the region to develop UPMC Cancer Center, one of the largest integrated community networks of cancer physicians and health care specialists in the country. UPMC Cancer Center at UPMC McKeesport allows patients to receive the highest level of cancer care without having to leave their communities. UPMC Cancer Center at UPMC McKeesport offers an array of cancer care treatment services, diagnostic services, and cancer care services, including, but not limited to: Biological Therapy Administration, Chemotherapy Administration, Radiation Therapy administration, Magnetic Resonance Imaging, Computerized Tomography, Medical Sonography, Nuclear Medicine, Bone Marrow Aspiration, Bone Marrow Biopsies and Bone Marrow Smears.

UPMC McKeesport - ROCOG II - Sustained community clinical trial phase

Our experience has demonstrated that a key element to successful accrual to therapeutic clinical trials in a community setting is availability of an on-site clinical research coordinator and the associated infrastructure.  We have found this to be the case upon receipt of supplemental funding received in 2006 and 2007 when accruals at UPMC McKeesport increased at a rate of 300% (n=3 to n=31).  However, since accruals have leveled off over the past year it is necessary to consider other possible success indicators for accruals in the community setting.  Other key facilitators for accruals include availability of appropriate trials suitable for the population served as well as physician “ownership” of the trials by way of designation as the principal investigator on the study.  Section II will further test these possible facilitators by comparing an established successful community hospital accruals rate to UPMC McKeesport accruals.  We hypothesize that these indicators may not only be related to patient base variables but to the physician cultures at these hospitals.

Cancer remains one of the leading causes of death in the United States each year and account for >550,000 deaths in the United States (1).  Disparities in outcomes have been extensively reported and are frequently attributed to and exacerbated by geography, availability of services, socioeconomic status, race/ethnicity, education level amongst others. A number of solutions have been proposed to address these clear disparities which include participation on clinical trials.

Patients enrolled on clinical trials have been shown to receive “better” care predominantly related to more accurate assessment of stage, co-morbidities, more consistent treatment and routine follow-up post completion of care.  Furthermore, clinical trials form the basis upon which existing standards of care are refined or improved.  Our experience in the UPMC McKeesport Radiation Oncology Community Outreach Group (ROCOG I) funded through the NCI Radiation Research Program , Cancer Disparities Research Partnership (CDRP, U56 CA105486) has provided us great insight into the challenges of cancer health disparities in the rural and urban poor, elderly, urban African Americans and the Amish in Western Pennsylvania.  In ROCOG I, we established a novel and highly successful patient navigation model, extensive and sustainable community outreach partnership with the McKeesport State Health Improvement Plan (SHIP) and consumer advocacy groups.

These were vital steps in implementing and establishing a culture of clinical trials investigation that was heretofore nonexistent in the five communities served by ROCOG I.  Key to this success was a trial and error process and dedicated resources to establish a clinical trials infrastructure with population-specific clinical trials offerings.  By establishing a culture of clinical trials investigations in the community setting, we are now confident that investigator-initiated clinical trials that are population-specific may now be realized.  We believe that our experience to date makes us uniquely qualified to respond to this RFA (CA-09502) of the Cancer Disparities Research Partnership.

In this proposal, we have leveraged our previously described patient navigator program, outreach through community groups and professional education/development through the use of TELESYNGERGY™ into a model that is suitable to maximize the goals of clinical trial creation, implementation and accrual into our new proposal entitled, ROCOG II.  Each of the sub-programs of ROCOG I has been evaluated (see Section I) and modified to sharpen its focus for ROCOG II.  The Patient Navigator Program has evolved into the “Patient-Centered Informed Decision Coach” (PCIDC) who will have a more immediate and extensive contact with the patient alongside the clinical team. The PCIDC will provide decision support for the patient and their family members who are often critical in the participation of the patient in a clinical trial.  The clinical trials working groups consisting of the PI, co-investigators and other clinicians will continue to expand the cadre of multi-disciplinary, multi-modality clinical, symptom management and prevention trials. This group of investigators will also identify populations specific clinical trials needs and will implement investigator-initiated clinical trials which are one of the hallmarks of the maturation of a clinical trials program.

As in ROCOG I, we found that social/fiscal policies can have a significant impact on clinical trials accrual (see Clinical Trials Progress Report and impact of Medicare HMO on clinical trial participation).  In partnership with the leadership of the University of Pittsburgh Cancer Institute (UPCI), we are evaluating the extent and impact this obstacle and anticipate the acquisition of data detailing the extent of the problem in time for the Director’s testimony to Congress in February, 2009.  Given the population we serve, the liability for Medicare HMO patients who will have to pay for 20% of the cost of their care if they enroll on a “Medicare Qualifying” trial versus limited or no cost if they choose standard of care remains a major barrier to accrual in our community.  We anticipate that the correction of the infrastructure failure should further enhance our performance on achievement  of our goals.  ROCOG I has led the way in detailing the growing significance of this CMS policy.

Professional development and continuing medical education (CME) is vital to maintaining quality, modern cancer care. Via the use of the TELESYNERGY® system, we propose to continue both intramural and extramural collaborations with our partners and non-partner institutions through tumor boards, CME offerings, as well as for clinical trials management (e.g. DSMB for joint protocols).  We have shown in 3 sites that TELESYNERGY® can be used as a vital tool around which a number of core support programs can be maintained.

ROCOG II will focus on:

1. Building on our experience of our U56 award
2. Maximizing our accrual to therapeutic, symptom management, behavioral and prevention trials
3. Creating a long-term, sustainable clinical trials infrastructure at each site
4. Enabling transformation of the clinical sites to a more sustainable culture of clinical investigation through CCOP or similar model
5. Sharing our findings and experience with the greater oncology