CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

Mobile Study Support Pilot Project

Proposal Status: 

Rationale: UCSF and the Benioff Children's Hospital have been selected by the national Children's Oncology Group Consortium (COG) of the National Cancer Institute (NCI) to conduct new Phase I Pediatric Oncology studies. Patients enrolled in these studies who are not admitted to the Pediatric Clinical Research Center (PCRC) Inpatient Unit, will require evening and weekend support for study procedures, including timed blood draws, sample processing and EKGs. We propose a “Mobile Study Support” (MSS) Pilot, under the CTSI/Clinical Research Services-PCRC to improve the conduct of translational research. MSS services would assist in providing research procedural care to oncology inpatients participating in clinical trials on the 7-Long Oncology Floor, as well as other UCSF investigator studies. We anticipate the MSS model will become widely utilized as we transition to our new pediatric hospital at Mission Bay.

Plan: A PCRC research nurse, 60% FTE, will become an Administrative Nurse (AN) I and will increase her effort to 90%, to include MSS nursing, PCRC outpatient unit clinical care, and administrative duties. The nurse in this position will be familiar with related study procedures, since procedures for Oncology protocols to be supported, mirror the 70 current active research studies in the CTSI/CRS-PCRC. Immediate benefits of this pilot are continuity with knowledge of investigator studies and teams, clinical research nursing expertise to these teams, and expert care to patients participating in these phase I trials. The new AN I position of the MSS PIlot is an innovative role that will add value to the growing demand for pediatric Outpatient and mobile visits. Because this position contains an administrative component, the hours will be flexible to meet the demands of the clinical care and administrative needs without requiring to pay for on call time for mobile visits. The MSS pilot design will dedicate maximal effort to protocols approved under the COG Consortium while accommodating variability in protocol volume as this new service line grows. Sustainability will be measured by the increase in investigators supported and the expansion of site locations beyond the Benioff oncology unit on 7 Long. (see collaborators below). Six active Oncology studies are requesting immediate support: ADVL0912, ADVL1112, ADVL1013, ADVL1011, ADVL0921, NANT0702. Three additional, new leukemia phase 1 studies in various stages of development are also strong candidates: AALL1121, ADVL1114, TACL0903.

Criteria and metrics for success: Measures of success will include number of studies, number of patient locations, number of patients served, patient contact hours, investigator satisfaction with nursing and study support, and cost per patient vs. alternative costs (such as admission to PCRC beds). Challenges and barriers to success will be presented to the CTSI CRS leadership to improve the pilot design. Funding contributions to support this pilot will be sought from investigator grants to ensure the pilot's success and sustainability. Alignment with CTSI Strategic Goals includes responsiveness to; 1) "CRS-without-walls" model to increasingly support investigators outside the current eight CRS sites, 2) Creating cross-cutting initiatives with consortium partners, thus increasing new and potential collaborations to accelerate research, 3) Work with CTSI's Program Evaluation Unit to apply dashboard/metrics methods to monitor and report on progress. This MSS Pilot can also serve as a model for the national COG-NCI group, other CTSA sites, and is in alignment with the model of the National Center for Advancing Translational Sciences (NCATS/NIH).

Cost and sustainability: Administrative Nurse I salary and benefits at 60% are as follows:

$147,394 (salary base) x 60% (effort) = $88,438 (salary) + $20,438 (benefits) = $108,876. $100K is requested for this pilot. After initial start-up cost, cost recovery is anticipated for services to offset 20-30% costs in YR1, with further increases in out years. As MSS demand increases, service providers other than RNs may be included to perform research procedures not requiring RNs, such as performing EKGs and processing specimens during non-business hours.

Collaborators: NCI Children’s Oncology Group (UCSF investigators Drs. Kate Matthay, Steven DuBois, Robert Goldsby, and others), UCSF Intensive Care Unit Research Team, UCSF Cancer Center, UCSF Benioff Children’s Hospital at Mission Bay.


A much-needed service that will enhance our ability to provide complex phase 1 therapies to complex patients with relapsed cancer. Steven DuBois

Steven The CTSI-CRS PCRC looks forward to supporting your unique research needs at UCSF via our innovative new model. We are delighted to have you be our partner in this proposal. Thanks again

This seems like something very useful to pilot--I think you could highlight the potential for other services (beyond oncology, on both the adult and pediatric sides) to use what is learned from piloting this service to potentially adapt it for other types of studies that take place in a variety of settings in the medical center, such as the infusion centers in ACC and the ED. Probably oncology studies do not have unscheduled study visits, but it would be interesting to think about how this model could be adapted to studies of treatments for conditions that do happen on an unscheduled basis (e.g. status epileptics).

Amy Thank your for your very helpful comments. This "Mobile Study Support Pilot" falls under the CTSI-CRS "scatter model" initiative to extend CRS services to investigators and research participants outside the confines (and constraints) of a traditional discrete inpatient/outpatient hospital-based unit. With an average of 300 active CRS studies per year across UCSF sites and the EBay, and 59 supported disciplines, the success of the MMS pilot will allow the CRS to support researchers across the spectrum of research and in diverse settings. Your request to respond to treatements occurring on an unsheduled basis is a great suggestion. Thanks again

I do not think we should lock ourselves into stating what percentage will be for each role. Demands from each area will determine needs.The way it is written the AN I will have to be available 24/7 for MSS which will be a limiting factor in hiring.

Excellent point. Because the prospect of an increase from 6 to 9 COG funded studies is likely, the MSS suppport will likely increase as well and should not be restricted by functional roles. Thanks

This proposal not only advances the goals outlined in the proposal, it brings the added benefit of creating another significant point of partnership with the HDF Comprehensive Cancer Center. The UCSF CTSI and Cancer Center relationship has attracted the attention of the NIH program officers and appears to be in alignment with the new NCATS model. The success of the Phase I unit at Mount Zion has demonstrated that the arrangement has mutual benefits for the two organizations and the opportunity to greatly improve the patient experience. Providing standard of care and research services in one location promotes a patient focused, cost-effective approach to providing services that makes the unit attractive to industry sponsors. We have seen increased patient enrollment at Mount Zion and have every reason to believe that this family friendly model can have the same impact for pediatric studies at UCSF.

UCSF is one of 17 sites in California (of a 220 national/international consortium) selected by the Children's Oncology group (COG) to conduct this unique research. The COG explores the entire clinical-translation research spectrum of childhood cancers, from the molecular basis of disease, through phase 1 to 3 clinical trials, biomarker discovery, extending into survivorship issues, but also the critically important challenges that pediatric cancer patients confront, including neurobehavioral consequences of disease and therapy. Support for this CRS-PCRC pilot will further translate into advnaces in these key areas of research as well as for patients and families.

This is a cutting edge proposal developed by Dr. Pock, the medical director of the PCRU CRS and organized by Mario Moreno. This is a logical extension of our "scatter model" and represents a bold new collaboration with the Cancer Center. The return-on-investment will be high in terms of efficiency and revenue generation.

Thank you for the insightful commentary. This collaborative initiative with the Cancer Center also clearly aligns with UCSF Chancellor's key mission, 1) Provide unparalleled care to our patients, 2) Improve health through innovative science, 3) Be the workplace of choice for diverse, top-tier talent, 4) Create a financially sustainable enterprise-wide business model.

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