CROW NOTES 5/24

Present:   Marianne Burke, Levi Bonnell, Justine Dee, Juvena Hitt, Kairn Kelley, Ben Littenberg, Connie van Eeghen

Guest: Rodger Kessler

1.                   Rodger Kessler & Connie van Eeghen: PRECIS evaluation of IBHPC study on a pragmatic vs. and explanatory continuum

a.       Background: Rodger Kessler, Stephanie Brennhofer, and Connie van Eeghen are working on a manuscript to describe the PCORI Integrated Behavioral Health in Primary Care study from a research study management perspective: the inherent complexity of large pragmatic trials using IBHPC as a starting point, supplemented with results from a literature review.  They have come to CROW to conduct an exercise in re-evaluating IBHPC on the PRECIS continuum of pragmatic/explanatory trials.

b.       One key issue: in using this continuum, discussion focused on who the participants are (recipients of the intervention) and who the practitioners are (those who deliver the intervention).  IBHPC has two kinds of recipients: patients and practice members.  It has two kinds of practitioners: practice members and “the practice.”  The group used both perspectives in evaluating the study. 

c.       Ratings

                                                   i.      Eligibility

1.       Patient as participant: 10; was 9, because the sites that agreed to do this may have patients that are selected different than the general population of sites

a.       Rodger: “In the study that you are engaging in…” not “the issues outside the study that may relate to the study” Audience is not the Secretary of Health but the kinds of practices engaged in this study

2.       Practice as participant:  8, these practices were not pulled from a national random sample, but were Friends of Rodger, or identified through professional networks.  Not a perfectly generalizable set of practices; a convenient sample. But we didn’t restrict; we did do cold calls – random selection is not a criterion. 

a.       Rodger: common study section complaint: “you are biased towards early responders.”  Yes, that is the basis of being involved in the study.  This trial had to select in that way. 

b.       Ben: 14 states with 43 clinics (but not 213, as in the CLASP trial in Table 2)

c.       Gail: there were a lot of hoops to jump through: providing data, convince IRB, completing surveys – some sites could not get organized to participate in the study

d.       Juvena: PIP eligibility was pragmatic;

                                                 ii.      Experimental intervention – flexibility:

1.       Patient as participant

2.       Practice as participant: 7 – monitoring, suggestion, not CONSIDERABLE flexibility

a.       Rodger: having to function within the study is not a pragmatic issue

d.       Current Radar Charts:

e.       Future CROW sessions: focus on 2-3 domains (4-6 evaluations) per 1-hour session.