Clinical Research Oriented Workshop (CROW) Meeting: Sept 1, 2011

Present: Amanda Kennedy, Rodger Kessler, Ben Littenberg, Connie van Eeghen

1. Check in: All present survived the flood waters pretty well; a grateful and lucky group

2. Calendar for Fall Semester: the Workshop will change its meeting schedule this year to Thursday afternoons, from 12:30 – 2:00 in the fourth floor conference room in Given South. Connie will notify Jen, who will make sure that CTS students are aware and know that they are invited.

3. Connie: R03 Grant Preliminary Outline

a. Connie and Rodger described a grant outline in response to the “implementation and dissemination” announcement by NIH, which is, unusually, not housed in a single, specific institute. This application will be directed to NIMH, with deadlines in October or February. Connie reviewed the 16 elements of the grant proposal and received specific feedback on the following sections:

b. Project Summary: a critical piece of the application, this is like the abstract and requires attention. State here, and throughout application, that “by completing this pilot, the researchers intend to widen the application of the toolkit to implement and disseminate successful methods of integrating mental health, substance abuse, and health behavior services into medical practices through continued research in an R01 grant”

c. Project Narrative: a “low stress” section, read by the lay public when listed. Sections typically include:

i. Statement of the problem

ii. Solution

iii. Relevance

d. Personnel: Based on the size of the grant, must include Rodger and Connie (15% each) and may include a qualitative faculty expert (2.5%)k and a senior researcher (Ben at 2.5%). Connie will contact Nick Brightman at Sponsored Project Administration to arrange for a spreadsheet with the requested personnel.

e. Research Plan:

i. Specific aims – limit to two but Connie has three to start with:

1. Refine existing manual (short time frame; few resources needed)

2. Implement manual

a. Identify the two FAHC sites (identify with Rodger’s help: Milton, S. Burlington…)

b. Prepare sites/staff

c. Execute (list tasks; see dissertation procedural manual which will also be attached as an appendix)

3. Evaluate results: what was learned

ii. Research strategy – six page limit organized as follows:

1. Significance: half to ¾ page, not more than full page of lit review, references, problem (e.g. gap in literature), why important, conceptual model, use of qualitative (or mixed) method including basis (e.g. grounded theory). This is effectively a marketing plan; think about referencing Larry Green with “mental health, substance abuse, and health behavior serving as a lab for QI” (Rodger)

2. Innovation: 1 or 2 paragraphs indicating why this is novel; why this is a contribution. Explain why the field is changing; reference Larry Green’s call for collaborative care implementation as a means to informing the diffusion of newly proven techniques, accelerating and winnowing the most effective methods of uptake in practice.

3. Approach: two paragraphs presenting:

a. Preliminary studies done at GHC, effectively piloting this methodology to produce what has been learned so far (explain this); also implemented at DVHC in a prior study at a primary care site for a medical QI project

b. Overview of study design: subjects, method, time line, etc. in support of stated aims. Reference Rodger’s circular on mixed methods approach. Anticipate and respond to problems, e.g. practices may drop from the study but there are backups, staff may not consent but the practice may still participate, the toolkit will undergo adjustment in the course of implementation and changes will be noted.

iii. Inclusion enrollment report is needed; Rodger will send Connie an example

iv. Human subjects section is needed; may be able to use an existing protocol or state that a new protocol is pending approval and that similar protocols currently active have been approved

v. Budget – annual (double these for 2 years)

1. Include key personnel and obtain Nick’s spreadsheet, which includes his routing worksheet and budget (5 tabs)

a. Rodger, 15%

b. Connie, 15%

c. Ben, 2.5%

d. Cynthia C-P, 2.5%

2. Supplies (printing - $500)

3. Practice incentive ($500)

4. Travel to sites ($500)

5. Conference ($1500)

f. Letters of support – write these letters for them and ask them to modify/sign:

i. Tom Peterson, MD, Family Medicine

ii. John King, MD, Family Medicine

iii. Medical directors of each site participating

iv. Claudia Berger, MD, Given – support of past work

v. Ben Littenberg, MD, CTS – support of past and future work

vi. Connie van Eeghen (Rodger is the applicant, remember) – how delighted she is, how well prepared Rodger is to conduct this study, and how important the implications of its results

vii. John Brumsted, MD, Interim CEO of FAHC – support

viii. Craig Jones, MD, Blueprint – support

g. Appendix: Procedural manual for Connie’s dissertation, which forms the ground work for the toolkit

h. Draft narrative sections above, without regard to page length, and return for more feedback. It would be helpful to accomplish this in time for a Friday seminar presentation, at which the participants will be asked to take the role of Study Section.

4. Next Workshop Meeting(s): Thursday, 12:30 p.m. – 2:00 p.m., at Given Courtyard Level 4

a. Sept 8: Kairn Kelley – specific project planning and communication plan for next 3 months (Ben late, Connie out)

b. Sept 15: (Rodger out)

c. Sept 22: (Rodger out

d. Sept 29: Rodger – ???

e. Future agenda to consider:

i. Ben: budgeting exercise for grant applications

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

iii. 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