1. ASPIRE Workshop 1: Conceiving the Research Idea
Sheila Botts, PharmD, FCCP, BCPP Chief, Clinical Pharmacy Research & Academic Affairs

2. What to Expect from this program
Just-in-time structured instruction on research principals
Professional and peer feedback on your project
Accountability assistance

3. What is Expected of you? Come to workshops prepared
Participate in the large & small group workshops
Post-class meeting with local preceptor(s)
IRB training +/- IRB attendance

4. What to Expect Today Large Group Workshop Small Group Workshop
Session Evaluation
November 14, 2018
| © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.

5. Resources ASPIRE website ASPIREKPCO.weebly.com Small Group Mentor
Local Research Preceptor

6. http://www.ASPIREKPCO.WEEBLY.COM November 14, 2018
| © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.

7. Conceiving a Research Question
Background:
Per the Heart Protection Study (HPS), statin therapy in patients with DM and TC >= 135mg/dL reduced major cardiovascular events by 22%
There are hundreds, maybe thousands of DM patients in our system who meet this criteria and are NOT on a statin

8. Conceiving a Research Question
Can a population management strategy involving patient letters get eligible DM patients onto statin therapy?

9. PICO
Population
Intervention
Comparison
Outcome(s)

10. Population* DM TC >= 135 in past year
No statin therapy in past year

11. Intervention*
Send eligible patients a letter explaining benefits of statin therapy
Ask patient to pick up Rx for a statin (already ordered)
Include a phone number to ask a pharmacist any questions

12. Comparison*
Patients not receiving this intervention

13. Outcome*
Purchase of a statin Rx within 3 months of letter mail date

14. Refined study question
Among DM patients likely to benefit from statin therapy, will an intervention involving a letter, a pre-ordered statin prescription, and pharmacist counseling significantly increase statin initiation compared to no intervention?

15. FINER Feasibility Interesting Novel Ethical Relevant
F: postage, ordering Rx, letter, availability of CPS, what about f/u lab tests? I:
N: Population-based strategy—quite novel in 2007/2008
E: Is it fair to only do this for half the patients?
R: Still relevant in 2014

16. Objectives
Primary: Quantify the effect, if any, of the intervention on the rate of “statin starts” within 3 months of letter mail date (=index date)
Secondary:
Among statin-starters, compare persistence at 1 year
Among statin-starters, compare proportion with an elevated CK or ALT during the 6-mo post-index

17. Hypotheses/ Outcomes: Primary Objective Compare short-term efficacy…
(Alternative) Hypotheses: Patients in the intervention group will have a higher statin-start rate
Outcome: statin-start=purchase of a statin Rx within 3 months of index date

18. Hypotheses /Outcomes: Secondary Objectives Compare longer term efficacy…
Hypothesis: Statin starters in each group will have similar rates of statin persistence at one year
Outcome: statin persistence=statin purchase at one year post-index +/- 45 days

19. Outcomes /Hypotheses: Secondary Objectives Compare safety…
Hypothesis: The incidence of abnormal CK or ALT levels will be similar between the two groups
Outcome: CL>600 IU/L or ALT>200 IU/L during 6 months post index date