Clinical Research Oriented Workshop (CROW) Meeting: July 21, 2011

Present: Amanda Kennedy, Rodger Kessler, Connie van Eeghen

1. Check in: Newly available – policies for the CTS PhD program; see Amanda if interested.

2. Rodger: R01 redesign

a. Note – this is part of two projects underdevelopment, the other of which is an R03 that Connie is working on. Partners for the R01 (likely to be submitted to NIMH) besides Rodger: Ben, Connie, and others, possibly including Amanda. There are other strategies (besides an R01) to consider whether other grant mechanisms and institutes are appropriate but as an R01, it needs external (to VT) partners, of which Rodger has two candidates (NJ and San Diego).

b. The R01 announcement is not about improving clinical care but about evaluation and research, testing, for example, the consistency of implementation across settings, staff, and time. It is also about studying dissemination and implementation; it does not require a RCT design.

c. Scope needs to be narrowed from original plan. Rodger’s study goal is to compare the effectiveness of a set of alternatives in collaborative care, not to prove causality, but to evaluate how they stand with respect to RE-AIM criteria and to explore variation. The design to support this question may be cross-sectional (no time series) or cohort (over time). Choices from Rodger’s handout were reviewed (see below, with discussion notes interspersed).

i. Possibility 1 Q: Does a systematically developed and implemented collaborative care intervention improve clinical, organizational and financial processes and outcomes compared to regular care? Not really novel, does not have much chance of considerably impacting on the field. Not personally exciting to Rodger.

ii. Possibility 2 Q Does systematically defined and implemented collaborative care improve clinical, organizational and financial processes and outcomes compared to practices that have implemented cc with no attention to formal intervention design or implementation? More interesting - could impact the field moderately - not sure that study section will get it. May be difficult to recruit.

iii. Possibility 3 Q Does systematically defined and implemented collaborative care (to be relabeld ~integrated care) in a set of primary care practices including FA PC practices and outside of Vermont practices who are interested in but have not yet moved to implementing collaborative care who agree to implement the FA PCBH intervention- improve clinical, organizational and financial processes and outcomes compared to practices that have adopted the Katon/Unutzer IMPACT nurse care manager with psychiatric oversight model of primary care treatment of psychiatric conditions (the gold standard in research but which, so far, has low uptake). Novel, Interesting, feasible large impact on field- Not sure it is implementation research- rather comparative effectiveness.

1. Not randomized: leaves open the question of bias; a design issue related to subject selection. May need to collect an “interest cluster” and randomize within the cluster.

2. Timing of grant implies a 2012 start or later. Likely, the projects will start before the grant is approved using EMR data retrospectively and prospectively, sampled repeatedly over time.

3. Consider a pre/post design; each subject serves as their own control. Start ups can be staggered.

3. Next Workshop Meeting(s): Thursday, 9:30 a.m. – 11:00 a.m., at Given Courtyard Level 4

a. July 28: cancelled (No Ben, Abby, Rodger)

b. Aug 4: Rodger: Implementation planning for next Integrated BH site at FA (No Abby)

c. Ben is on vacation July 16 – 30 and out Aug 4; Abby is on vacation August; Amanda is teaching Tues & Thurs 1 – 4 from July 1 – Aug 26

d. Future agenda to consider:

i. Rodger: Mixed methods article; article on Behavior’s Influence on Medical Conditions (unpublished)

ii. Future: Review of different types of journal articles (lit review, case study, original article, letter to editor…), when each is appropriate, tips on planning/writing (Abby)

Recorder: C. van Eeghen