Clinical Research Oriented Workshop (CROW) Meeting: July 19, 2012

Present: Kairn Kelley, Rodger Kessler, Connie van Eeghen

1.                  Start Up:  Interesting fact from Rodger – when NIMH study section participants finish their review of a grant application that they just finished discussing and make up their minds about the final score, they must self-declare if they are going “out of range,” or giving a score that is higher than or lower than any of the scores given by the in-depth reviewers.  Not many do this, so the “sale” of the application has to be made with those three reviewers in mind.  Why is this relevant?  Connie and Rodger’s application didn’t get to full section review, so all we have to work with are the comments from the three reviewers, which we’re hoping is enough feedback to make it all the way to the finish line.

2.                  Presentation: Connie and Rodger’s R03 Critique

a.       This grant application is being rewritten for resubmission in October.  The one page introduction should address all issues raised by the reviewers and all changes to the draft should be identified by italics or underline. 

b.      Much of the discussion centered on or kept returning to the aims.  Simplify the aims, so that they are easy to read and remember.  Specify the aims really well:

                                                  i.      Aim 1: Make the preliminary toolkit roadworthy so it can be disseminated.

                                                ii.      Aim 2: Confirm that process measures, which is what the toolkit addresses (such as treatment initiation rates, referral rates), are improved.  Characterize this aim as “Reach” and an indication that we should continue to develop and disseminate the toolkit.

                                              iii.      Aim 3: Demonstrate whether outcome measures, which is what BHI addresses, improve using a prospective cohort study.  This study will measure whether patients who received BHI services in the clinic (as developed by the Toolkit) also had changes in symptom scores for depression at 3 and 6 months after screening.  The study will also measure the same data on patients who were screened but, for some reason, did not get BHI services, to determine whether their symptom scores change over time.  Characterize this aim as “Effectiveness.”

                                              iv.      Notes on the aims:

1.      There is not enough space in the aims to explain the mixed methods approach, so don’t.  Explain this in the methods section and expect the researchers to look for it there.

2.      It will also be possible for us to measure utilization of hospital admissions, PCP visits, and ER visits using our source of data.  This may be another perspective on “effectiveness.”  The focus of the grant is on toolkit development, not efficiency, so we had a short debate on whether to include this in the third aim statement and didn’t come to a conclusion on this.  It can certainly be included as work we can do in future studies.

c.       The approach section received the lowest scores from the reviewers and was the focus of the remainder of the discussion.  We focused on the first comment and came up with the following plans:

                                                  i.      State a model that links the toolkit to BHI integration to care.  Use Peak’s 3 world model to support the need for alignment of operations with financial and clinical processes. 

1.      Example statements: The success of BHI is determined by its operational implementation.  The purpose of the toolkit is to provide the operational details that lead to successful implementation and a strategy to customize each operational element to the individual practice. 

2.      Cite Gawande’s WHO article to support the use of a checklist in refining clinical practices by using operational processes.  Also, check Rodger’s application for the Simulation Lab for references related to the relationship between operations and clinical outcomes. 

                                                ii.      Clarify that this study is providing an initial test of the previously developed toolkit to confirm its acceptability (refer to the TAM model) and to improve it as needed.  While the method has already been developed, the toolkit (manual, checklists, examples, etc.) has not been developed.  The value of doing this will be measured in clinical outcomes and, later, in efficient use of health care resources.  

d.      Next steps: Connie to send draft to Rodger by Monday morning.

3.                  Workshop Goals for 2012:

a.       Journal club: identify UVM guests and articles; invite to CROW ahead of time

b.      Research updates: share work-in-process

4.                  Next Workshop Meeting(s): Thursday, 11:00 p.m. – 12:00 p.m., at Given Courtyard Level 4. 

a.       July 26: Connie: R03 draft (no Ben)

b.      Aug 2: Abby – “How we picked the predictive model for the NAS article”

c.       Aug 9: (no Abby)

d.      Aug 16: (no Abby)

e.       Aug 23:

f.       Aug 30: (new schedule?)

g.      Future agenda to consider:

                                                  i.      Ben: budgeting exercise for grant applications

                                                ii.      Journal Club: “Methods and metrics challenges of delivery-system research,” Alexander and Hearld, March 2012 (for later in the year?).  UVM authors who have published interesting design articles (Kim, Osler)

                                              iii.      Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished); drug company funding.  Also: discuss design for PCBH clinical and cost research.

                                              iv.      Amanda: presentation and interpretation of data in articles

                                                v.      Sharon Henry: article by Cleland, Thoracic Spine Manipulation, Physical Therapy 2007

Recorder: Connie van Eeghen