Clinical Research Oriented Workshop (CROW) Meeting: September 12, 2013

Present:  Marianne Burke, Kat Cheung, Ahmed Hamed, Kairn Kelley, Amanda Kennedy, Ben Littenberg, Connie van Eeghen

Start Up: Ben’s experience in setting up an internal medicine service resulted in desegregating part of St. Louis in the 1990s – one for the history books.  See the social history: “American Nations” to explain the diversity of cultures in this country. 

1.                  Discussion: Kairn - IRB application

a.       Much of the IRB narrative related to design may (and should) be pulled from the methods section of the proposal.  Detail is important and should reflect the work as planned, but should be focused on the questions asked and only at the level of detail that is necessary.

b.      In objectives: brief explanation of the problem

c.       Study design: extract from methods section

d.      Procedures: Use research protocol, if it already exists.  Review with the CVMC Privacy Officer to ensure that the requirements of the clinical setting will be met. 

                                                  i.      Consider completing the research protocol, to reduce the volume of later amendments. 

                                                ii.      Steps in the process MUST include consent, and the education process underlying consent (and the consent form).

                                              iii.      Incentives can be referenced, e.g. “consistent with standard clinical practice, such as a pencil, an eraser, or a lollipop.”   

                                              iv.      Include a plan for dissemination of results to subjects.  For example, share the results of the hearing sensititivity test with the parents, with appropriate references for follow up care if needed.  Also include a plan for sharing results with pediatrician (include in the consent form).

                                                v.      Including a plan for a registry must appear in one of the objectives of the study and in the consent form.  Or, collect the students’ contact information and address the development of a registry later.

e.       Risks and benefits: there are benefits: each student gets a free hearing sensitivity test

f.       Data Safety and Monitoring has 2 objectives:

                                                  i.      Does there need to be an outside reviewer that will stop the study in case harm is being done?  No.

                                                ii.      Is there the possibility of unexpected events that would need to be reported?  Yes.  “The PI will assess all adverse events and report them to the IRB”

                                              iii.      Plan for review of adverse events with committee

2.                  Next Workshop Meeting(s): Thursdays, 11:45 a.m. – 1:15 p.m., at Given Courtyard South Level 4.   

a.       September 19: CANCELLED

b.      September 26: Abby (and Sharon Henry?) – practice presentation about VHCURES data base

c.       October 3: Abby - Update on Natural History of Opioids projects

d.      October 10:

e.       October 17: SPECIAL GUEST: Jay Piccirillo is an ENT from Wash U in St Louis who is expert in prediction models in cancer. He and Ben did a lot of work together many years ago about how to incorporate functional status measures into cancer staging to improve prognosis. Now he is working on how to develop personalized prognosis estimates and share them with patients.  A top-notch researcher and collaborator to meet and talk with.  10:30 – 12:00

f.       October 24:

g.      Future agenda to consider:

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

                                                ii.      Charlie MacLean: demonstration of Tableau; or Rodger’s examples of Prezi

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

                                              iv.      Ben: Tukey chapter reading assignments, or other book of general interest

Recorder: Connie van Eeghen

Clinical Research Oriented Workshop (CROW) Meeting: September 5, 2013

Present:  Abby Crocker, Kairn Kelley, Rodger Kessler, Ben Littenberg, Connie van Eeghen

Start Up: Rodger received formal notice that the SBIRT grant was approved – congrats!

1.                  Discussion: Abby – Natural History of Opioids projects

a.       New opportunity: examine opioid prescriptions by region or age, based on data availability and novelty.  Abby shared an article in Pediatrics, 2010; 126:1108-1116 “Prescribing of Controlled Medications to Adolescents and Young Adults in the US,” which uses ER and office visit data regarding controlled medications (not just opioids, although these are broken out on pgs 11-12.)  These NAMCS data end in 2007, whereas we can now access data up to 2010.  Also, this article did not focus on children under the age of 15 or discriminate between newly prescribed controlled medications and ongoing controlled medications.  Another new area of study is region, or urban vs. rural area of care delivery.  No published study has followed up on this study.

b.      Consider:  

                                                  i.      Separate studies for each kind of controlled medication: pain, sedative-hypnotic, and stimulants. 

                                                ii.      Separate the data by source: ED vs. office visit. 

                                              iii.      Analyze the incidence and prevalence of controlled substance prescription

c.       Plan:

                                                  i.      Review article carefully (Abby)

                                                ii.      Detailed literature review of the this topic, including more recent publications from this author-Fortuna (Abby)

1.      Assistance in reviewing journal articles: Rodger and others

                                              iii.      Develop skill with NAMCS and NHAMCS data sets

1.      Access the codebook and make it available (Abby)

2.      How were the data collected, sampling frame (Kairn)

3.      What are the variables (Abby, Kairn)

4.      Historical scope: what have we learned already from these data sets (Abby)

                                              iv.      Next step:

1.      Set up GIMR site for sharing documents (Abby)

2.      Research question

3.      Included population

4.      Design: predictors and outcomes

5.      Future possible topics

a.       Stimulant use in transition from adolescents to young adulthood (Rodger)

2.                  Literature Management: Ben shared Dr. David Craig’s (surgeon specializing in sentinel node detection) interest in an automated tool for organizing literature, which is connected to a search engine.  Anyone interested in trialing it should contact Dr. Craig with the introduction: “Ben sent me.” 

3.                  Next Workshop Meeting(s): Thursdays, 11:45 a.m. – 1:15 p.m., at Given Courtyard South Level 4.   

a.       September 12: Kairn: IRB application (no Rodger; Amanda late)

b.      September 19: (no Ben, Connie, or Rodger)

c.       September 26: Abby (and Sharon Henry?) – practice presentation about VHCURES data base

d.      October 3: Abby - Update on Natural History of Opioids projects

e.       October 10:

f.       October 17: SPECIAL GUEST: Jay Piccirillo is an ENT from Wash U in St Louis who is expert in prediction models in cancer. He and Ben did a lot of work together many years ago about how to incorporate functional status measures into cancer staging to improve prognosis. Now he is working on how to develop personalized prognosis estimates and share them with patients.  A top-notch researcher and collaborator to meet and talk with.  10:30 – 12:00

g.      Future agenda to consider:

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

                                                ii.      Charlie MacLean: demonstration of Tableau; or Rodger’s examples of Prezi

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

                                              iv.      Ben: Tukey chapter reading assignments, or other book of general interest

Recorder: Connie van Eeghen

Quality Symposium coming up

Hello All,
I'm looking forward to attending FAHC's quality symposium on Friday. I am sharing the details below for others who may be interested.
Kairn

http://www.uvm.edu/medicine/cme/?Page=2013quality.html

James M. Jeffords Institute for Quality and Operational Effectiveness

presents:

Engineering Risk Out of Health Care: The Journey to High Reliability

September 6, 2013

Sheraton Hotel and Conference Center, South Burlington, VT

Overview

We are pleased to present the fifth annual Quality Symposium, sponsored by the James M. Jeffords Institute for Quality and Operational Effectiveness at Fletcher Allen Health Care in partnership with the University of Vermont. This year’s program will explore the concept of high reliability in health care and will offer strategies aimed at improving patient safety and quality.

Objectives:

1. Introduce the concept of “high reliability” and “ultrasafe” in health care.
2. Discuss the strategies and tools for enhancing team communication.
3. Learn how simulation is used to optimize processes and redesign systems to increase patient safety, enhance outcomes and achieve reliable health care delivery.
4. Share the learning experiences associated with optimizing re-engineering principles.

Who Should Attend

This conference is designed for health care providers, hospital and other health care administrators, quality improvement and patient safety professionals, government personnel involved in health care system oversight, and members of the community interested in creating high-reliability health care organizations.

Clinical Research Oriented Workshop (CROW) Meeting: Aug 29, 2013

Present:  Marianne Burke, Kat Cheung, Abby Crocker, Kairn Kelley (by phone), Rodger Kessler, Ben Littenberg, Connie van Eeghen

Start Up: Ben provided a sneak preview of Rodger’s and Connie’s data re: behavioral health integration in an early case study….  Looking good!

1.                  Discussion: Rodger is developing an assessment for primary care offices based on Peak’s Lexicon to evaluate the level of integration of behavioral health services in primary care (see previous meetings’ notes) that can be send to CJ Peak for his first review. 

a.       Feedback on language is of interest but not the primary goal.

                                                  i.      Group the questions consistently throughout the assessment (single format)

                                                ii.      Consider breaking down the first domain into smaller “bites” for future evaluators

                                              iii.      Language around “how often” a characteristic appears may need to be sensitive to whether there are some populations that have been focused on, and others that have not

b.      Focus is the tool, overall, to evaluate how well a practice is meeting the expectations of integrated behavioral health in primary care, to compare among practices, and to support decisions about future development of BH in a practice.

                                                  i.      Seven domains (from Peak’s manuscript), which contributed to the language used to develop the assessment questions, the results of which should be reproducible and reliable, either by self-assessment (eventually) or outside evaluator.

                                                ii.      Domains need to be clearly specified, for example:

1.      #5: protocol for care is the presence of a tool that is used practice-wide (a characteristic of the practice)

2.      #6: the use of that tool in a customized fashion for specific patients, which must be shared with either the team, the patient, both, … (a characteristic of the provider-patient team)

3.      #7: “follow up” may be part of a protocol and be part of a care plan, and may include follow up services received (e.g. treatment initiation and maintenance); therefore, it is a characteristic of the care plan.  This domain could become an “achievement” indicator – that the follow up is carried out.  The fact that follow up is part of care plans would belong to Domain #5 and that specific care plans include follow up belongs to Domain #6.

c.       How to operationalize the scoring

                                                  i.      Consider adding choices for “Don’t Know” and “Not Relevant”

                                                ii.      Consider adding comments (at least in early versions of the assessment)

                                              iii.      Consider a Gutman scale: increasing inclusion of elements that are all true or not

                                              iv.      Consider averaging the answered questions of each domain, so Domain #1 does not outweigh all the other domains.  These averages can be averaged or summed into a total score.

                                                v.      Be prepared for two limitations in early phases of this assessment:

1.      Lack of data in some domains

2.      Domains that do not wind up predicting outcomes, which will still be important as a focus for aspirations

2.                  Next Workshop Meeting(s): Thursdays, 11:45 a.m. – 1:15 p.m., at Given Courtyard South Level 4.   

a.       September 5: Abby – Natural History of Opioids projects (no Amanda)

b.      September 12: (Amanda late)

c.       Future agenda to consider:

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

                                                ii.      Charlie MacLean: demonstration of Tableau; or Rodger’s examples of Prezi

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

                                              iv.      Ben: Tukey chapter reading assignments, or other book of general interest

Recorder: Connie van Eeghen