2013 CTSI Annual Pilot Awards to Improve the Conduct of Research

To facilitate the development, conduct or analysis of clinical & translational research

Partnering with Patients: Novel Data Sources for Comparative Effectiveness Research

Proposal Status: 


The Randomized Controlled Trial (RCT) has long been the gold standard for proving efficacy.  However, RCTs suffer from lack of generalizability to the broad population not merely because of strict patient inclusion/exclusion criteria, but because patients in these trials generally receive closer care than patients in the “real world.”  Observational and Phase IV studies were created to capture additional data in “real world” populations; however, they were not designed to elucidate comparative effectiveness of different treatments.  As a result, there have been limited tools to conduct medium to long-term comparative effectiveness research (CER) in real populations. However, with the concurrent evolution of electronic health tools and the concept of Patient Reported Outcomes (PRO) espoused by such organizations as the NIH and the Patient Centered Outcomes Research Institute, unprecedented opportunities in CER have emerged.  Orthopaedic Surgery, including Spine surgery and Arthroplasty represent compelling arenas for implementing pilot research modalities for several reasons.  First, a significant care gap continues to exist following elective orthopaedic interventions.  For example, in spine surgery,laminectomy and spinal fusion is the procedure with the highest costs associated with potentially preventable readmission, and among the highest rates of readmission.1 The Institute of Medicine in a 2009 report, targeted spine surgery as a top priority for CER.2,3  Readmission for arthroplasty is also highly variable between and within centers, and an evidence-based approach to reducing readmissions would have significant value in improving quality of care for elective joint replacement procedures. Despite this spotlight, there remain no widely accepted modalities for developing or implementing PRO measures in CER.4   The purpose of this proposal is to implement a mechanism for structured follow-up of patients after discharge to capture data, and detect potential complications early, at a stage that may permit treatment without readmission.


UCSF’s Department of Orthopedic Surgery has made significant strides in advancing the quality of patient care and safety following spinal surgery and arthroplasty, receiving the 2012 designations as a Center of Excellence for both services.  However, we continue to seek opportunities to innovate in this area and to become a national model of excellence.  The department has identified an innovative technology that can be scaled and generalized to all surgical specialties, that can open up a new arena in clinical research, and that is “shovel ready,” already in clinical use in several Bay Area orthopedic practices.  The tool captures rich data on signs/symptoms, health outcomes, and quality of life by engaging patients post-discharge, and allowing them to participate in their own outcome reporting. The specific aim of this proposal is to implement a pilot project that extends care beyond discharge by engaging patients in self-reporting of their health status at regular intervals during their own recovery.  Information from the resulting dataset may identify early signs of complication that will enable treatment in an outpatient setting rather than as a readmission.  The infrastructure for patient follow-up will begin with spine and arthroplasty services, and extend to surgical procedures throughout the UCSF campus.



We propose a pilot study using a novel HIPAA compliant SaaS platform called HealthLoop that is presently being piloted for clinical purposes by a large health plan.  Through a library of configurable electronic follow up protocols, orthopaedic surgery patients will be sent recurring automated email check-ins from their physicians after discharge with structured queries pertaining to their surgery.  A research database and a clinical dashboard will capture structured signs/symptoms, health outcomes, functional status, and impending complications using validated PRO tools. These will enable researchers to analyze a continuum of data throughout recovery and clinicians to intervene at any sign of impending complication.


Criteria and Metrics for Success

Metrics for success will include: Identification of practice patterns and/or follow up regimens that lead to superior outcomes; Reduction in complication rates; Reduction in ED visit and readmission rates; Reduction in total costs; Improved functional outcomes.


Approximate Cost and Justification

$50,000 is required for UC customization of clinical templates, provider training, implementation of the HealthLoop platform, execution of the pilot, as well as data analysis and reporting.



University of California Spine Surgery Consortium

Clinical and research staff at HealthLoop (Mountainview, CA) 


  1. Qasim M, Andrews RM. 2009. HCUP Statistical Brief #142. Sept 2012. AHRQ, Rockville, MD. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb142.pdf.
  2. IOM (Institute of Medicine). Initial National Priorities for Comparative Effectiveness Research. Washington, DC: The National Academies Press. 2009.
  3. Numerof, Rita. Comparative Effectiveness Research in Spine Care in Defining the Value of Spine Care, Jeffrey A. Rihn, M.D., Alexander R. Vaccaro M.D., Ph.D., Todd J. Albert, M.D. and David B. Nash, M.D., editors, 2012.
  4. Basch et al, JCO December 1, 2012 vol. 30 no. 34 4249-4255.


Though interesting, this proposal is focused on advancing a particular area of research. To be eligible projects need to show generalizability and scalability in advancing the conduct of translational research. You're welcome to amend the proposal to address how the solution is generalizable or decide its a mismatch for the funding mechanism.

We have amended the proposal for review.

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