Clinical Research Oriented Workshop (CROW) Meeting: March 14, 2013

Present: Abby Crocker, Kairn Kelley, Amanda Kennedy, Rodger Kessler, Charlie MacLean, Ben Littenberg, Connie van Eeghen (updated in a conversation with Peter Kreiner 3/15/13)

1.                  Start Up: New data sources out on health behavior and geo-locations available (driver license data – 18 states); Ben has the details.

2.                  Presentation: Charlie – Research Question

a.       Charlie reviewed the priorities that he, Liz, and Neil have:

                                                  i.      Opiates Pharmaco-epi

                                                ii.      Workforce snapshot: estimating efforts, locations, and distributions of providers throughout the state, based on claims.  To be used as a forecasting tool for AHEC, Blueprint, Green Mountain Care Board

1.      Licensure data has data problems: low response rate for survey data

2.      This clean-up process is a necessary precursor to using VHCURES for other analytical projects

                                              iii.      (Atypical antipsychotics – included in the request for opiate data, see i above)

                                              iv.      Back pain: Sharon Henry (RMS) for PT visits and costs

b.      Current operational

                                                  i.      Clean up provider data: next 4 weeks (plan for end of May)

                                                ii.      Patient data need to be cleaned?

c.       Opiate data:

                                                  i.      2 – 3 years of data, all VT insured patients including part D Medicare (no cash)

                                                ii.      Based on a claim for at least one opiate

                                              iii.      Data: drug claim, patient demographics, prescription and prescriber data

d.      Outcomes we could study:

                                                  i.      Natural history of acute opiate use converting to chronic – descriptive study

                                                ii.      Survival analysis: first fill of prescription to last

1.      What proportion of acutes become chronic users?

2.      What variables describe chronic users (age, gender, increase/decreased use, co-interventions: psych meds, nicotine replacements, heart disease…)

3.      May be able to develop a prevalence indicator, over years and seasons, compared to census data (zipcode, age, and sex adjusted) including median income

                                              iii.      Opiate intensity over time: morphine equivalence based on prescribed dose. 

Added after discussion with Peter Kreiner

                                              iv.      Cross-validate against EHR/Claims

                                                v.      Multiple interrupted time series by state of health outcomes (e.g. adverse events [deaths, overdoses…], questionable activity, red flags…)

                                              vi.      Multiple interrupted time series by state of prescribing changes (red flags)

                                            vii.      Get use data (FL?) as predictor and provider or patient level red flag data (future request)

e.       Future data request:

                                                  i.      Entire med list

                                                ii.      Diagnosis – from office visits or procedures; messier data

f.       Next steps:

                                                  i.      Workplan

1.      IRB approval – CM/pending

2.      Literature review: restrict to epidemiology – Amanda & Kairn/mid-May, to include the Introduction section to the manuscript

a.       Sources: CDC – MMWR, VPMS annual report

b.      Check MeSH headings for opioids, acute, chronic, longitudinal

c.       Develop a search strategy

d.      Original research and reviews… for the reviewers to decide

e.       Abby and Charlie have supplemental Endnote libraries

3.      Protocol and Methods, one for each research area (to define variables & statistical process)

a.       Charlie to provide data dictionary and field values

b.      Natural history: Charlie, Ben, Abby, & Rodger/Sylvie to set up 1^st meeting on or after April 8 for an hour; protocol outline done and methods section sketched by 3^rd week of April

                                                                                                                          i.      Consider developing the protocol for #3 at the same time (opiate dose/intensity)

c.       Prevalence of Opiate use by zip/census (consider clustering the data by region/primary care service areas)

4.      Data cleaning and creating variables – Charlie/mid-April

5.      Merging census (not needed for research areas 1 and 3) -

6.      Analysis – To be started at CROW May 9

a.       Intro and Methods sections need to be complete by this date

7.      Report writing – completed by end of May 2013

a.       Project coordinator/communicator and Lead Author: Abby Crocker

b.      Last author: Charlie (remainder of us will listed be alphabetically)

                                                ii.      NAPCRG annual meeting in Fall 2013 in Ottawa (North America Primary Care Research Group); deadline for abstracts is in April 17^th  

1.      Charlie to submit FAHC data

2.      Amanda to submit caffeine study – maybe?

3.      Connie to submit Opiate Rx Management QI study results

g.      Peter Kreiner update meeting (3/15/13)

                                                  i.      His data bases include 3 states: CA, FL, and ME (more history), going back several years (at least 2011 on)

                                                ii.      HID is the vendor for two of these states (same as VT)

                                              iii.      Data are in different formats but all are SAS readable; could generate a SAS transport data set.  CDC has asked for an on-line portal to access the data.

                                              iv.      A request for data would go through an oversight committee of federal and state partners (they meet monthly by phone) who would review the protocol.  The data could be transferred through the UVM FTP site.  Brandeis IRB protocol already in place.

                                                v.      All records have patient identifier, year of birth, zip, NDC, provider identifier, provider zipcode, quantity, refills, pharmacy identifier, pharmacy zipcode, payment source

1.      CDC has provided a red book (2011); to be replaced with a broader set of NDC codes for 2012 (subscription is ~$15,000/year) to translate the NDC code into drug and drug category

2.      DAWN data set is another possible source with NDC data

                                              vi.      Peter will share the elements of the standard reports with Charlie and Ben

1.      Multi-state studies would require HID support, as the DEA number is not available in the data set

                                            vii.      Possible research topics discussed from CROW meeting above.  Possible work plan:

1.      Conduct study using VHCURES all payor data set on the Natural History of Acute Opiate Use (Peter indicated that this is high in the Novel part of FINER.  Peter has seen only one such research paper [from Maine] which involved the loss of the PDMP for a short period of time.)

2.      Request for similar data from Brandeis.  No cost estimate at this time; may be part of collaborative work done jointly.  May result in a fundable grant submitted jointly.

3.      Follow up plans could include cross-state comparisons, selection of likely interventions resulting in RO1 proposal.  Peter was interested.  Some research funding is currently available, depending on the proposal.  Other states are coming along: Delaware, TX, …

3.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard South Level 4. 

a.       Mar 21: Kairn: F31

b.      Mar 28: Abby: Dissertation Dry Run (will start at 2p, on schedule – new location?)

c.       May 9: Charlie: Exploration of analytical plan for Natural History of Acute Opiate Use (and perhaps more)

d.      Future agenda to consider:

                                                  i.      Christina Cruz, 3^rd year FM resident with questionnaire for mild serotonin withdrawal syndrome?

                                                ii.      Peter Callas or other faculty on multi-level modeling

                                              iii.      Charlie MacLean: demonstration of Tableau

                                              iv.      Journal article: Gomes, 2013, Opioid Dose and MVA in Canada (Charlie)

Recorder: Connie van Eeghen

How to change patterns of behavior

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Clinical Research Oriented Workshop (CROW) Meeting: March 7, 2013

Present: Amanda Kennedy, Charlie MacLean, Connie van Eeghen

1.                  Start Up:   Civilization starts with a tea pot; see Alan Rubin for proof of this.

2.                  Presentation: Connie van Eeghen – Poster Presentation on Opiate Rx QI

a.       Connie shared her first draft of a poster presentation planned for the annual conference of the Society of General Internal Medicine (end of April in Denver).  Although the number of workshop participants was low this week, this had no effect on the number of suggestions made to improve the poster, which were so substantial it is almost impossible to capture them all.  Some of the more significant changes:

                                                  i.      Include references in small print in a corner of the poster.  This material draws from several other researchers, some of whom will be attending the conference.

                                                ii.      Add more data to the background.

                                              iii.      Use the headers as the thread on which the future article will be based – lead the reader through the study.

                                              iv.      Integrate all text into the poster as text; don’t try to make some of it behave like an illustration.

                                                v.      Replace reports of the results with tables/charts.

                                              vi.      Switch to 3 columns (from 4) to give wide diagrams the space they need.

                                            vii.      Link like items together: number the best practices and reference the numbers in the table and diagram.

                                          viii.      A table that shows what each practice did and didn’t accomplish (traffic light indicators of red/yellow/green) is more compelling that a simple bar chart that shows only which best practices were used most.

                                              ix.      Include the funding source.  And include the final poster in an appendix to the final report for the funding source (VDH).

3.                  Presentation: Charlie MacLean – Poster Presentation on Pharmacoepidemiology

a.       Charlie was invited to participate in a FAHC quality improvement symposium, and asked at the last minute to provide a poster.  The poster provides the rationale for why pharmacoepi-studies are valuable and illustrates with two examples.  Suggestions made included eliminating a general illustration on the conceptual relevance of pharmacoepi and exchanging report samples for report results. 

4.                  Plans for VHCURES Project

a.       Next week we will start developing our VHCURES project, with the general goal of studying:

                                                  i.      Opiate naïve patients

                                                ii.      Natural history of opiate use

                                              iii.      Progression of drug use

                                              iv.      Progression of provider involvement (and order of involvement)

                                                v.      ED utilization

b.      Our goal for next week is to develop a research question.  Additional steps after that include:

                                                  i.      IRB approval

                                                ii.      Data clean-up for individual providers records (Charlie)

                                              iii.      Plan to triangulate data in PRISM or IRIS (validation paper)

1.      VHCURES: the FAHC doctors and practices; the drugs that were paid for

2.      PRISM: the drugs that were ordered

3.      VHCURES: the unseen prescribers and drugs; time from ordering to fulfillment

c.       Charlie will lead the workshop next week.

5.                  Next Workshop Meeting(s): Thursday, 2:00 p.m. – 3:30 p.m., at Given Courtyard South Level 4. 

a.       Mar 14: Charlie: Development of VCHURES Research Question (everyone will be here!)

b.      Mar 21: Kairn: F31

c.       Future agenda to consider:

                                                  i.      Christina Cruz, 3^rd year FM resident with questionnaire for mild serotonin withdrawal syndrome?

                                                ii.      Peter Callas or other faculty on multi-level modeling

                                              iii.      Charlie MacLean: demonstration of Tableau

                                              iv.      Journal article: Gomes, 2013, Opioid Dose and MVA in Canada (Charlie)

Recorder: Connie van Eeghen