Clinical Research Oriented Workshop (CROW) Meeting: December 17, 2015

Present:  Marianne Burke, Kairn Kelley, Ayodelle LeBruin, Ben Littenberg, Gail Rose, Adam Sprouse-Blum, Connie van Eeghen

Start Up:  Welcome to Adam! Adam is a Family Medicine MD; headache fellowship; trained in the Bronx.

1.                  Discussion: Specific Aims for STTR grant application due Jan 5 2016 (Small Business Technology Transfer Research)

a.       The focus is on using medical record data (biomarkers in lab values) to predict alcohol problems in the absence of the AUDIT by an honest responder.  There may be an opportunity for a private company (PES) to use these data in support of care management for primary care practices.

b.      STTR has two phases:

                                                  i.      Phase 1: concept, development over 6 months to a year

1.      More time to develop Phase 2, less risk of rejection

                                                ii.      Phase 1 and 2 (fast track): feasibility and implementation, including commercialization of product, with commitment letters and preliminary data

                                              iii.      Good funding source; SBIR is an avenue for many small businesses – more competition (note that 3% of NIH must go to small businesses)

c.       Diagram: process flow of how the data are used to develop a PCP letter, website, and mobile app

                                                  i.      Algorithm to identify at risk patients based on lab values – to be developed by this project

1.      Generates both false positives and false negatives

2.      First draft exists; to be fine-tuned with NHANES data (a sample of data were held out while developing the initial algorithm)

3.      To be validated with PRISM data

4.      Includes: SGOT, MCV, hemoglobin, HDL cholesterol, LDH, … is a self-teaching algorithm (via recursive partitioning)

                                                ii.      Well-developed process for generating letter to PCP

1.      Consider accessing email address instead of postal address, with link

2.      Or text for link to app

                                              iii.      Web-site (AUDIT) is not yet developed and will not be funded by this project – easy to do

1.      If this were to be the first step, the percent positive is about 30%

2.      Must have sufficient security to ensure that the person completing the AUDIT is genuine

3.      Might this be eliminated and made part of the app?  The letter from the PCP can say something like “due to information from lab data in your chart, you are at risk for the following health issues…” Provide link and security sign on. Front load with a disclaimer such as “this is a trial for our office to see if this helps you…”

a.       Can also include other questions: workplace abnormalities, diet (vegan),…

b.      Branch to a reassuring message if all is negative

c.       Provide text or phone number option for live follow up for problems

d.      Check with Damon: can security protection be set up without the web stop?

                                              iv.      Mobile app – to be developed by this project

1.      Need expert developer/evaluator for mobile app prototype

d.      Benefit: when SBIRT and other interventions are used, alcohol consumption goes down and medical costs, absenteeism all improve

2.                  Next Workshop Meeting(s): NOTE NEW TIME: Thursdays, 1:30 p.m. – 2:30 p.m., at Given Courtyard South Level 4.   

a.       December 24: UVM closed

b.      December 31: UVM closed

c.       January 7, 2016: Kairn updated draft of test/retest reliability manuscript

Recorder: Connie van Eeghen