MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS) Matt Arnold, PharmD Site Investigator Genesis Quad Cities Family Medicine Residency June 18 th 2015 Study funded by NHLBI/NIH, 1R18 HL116259

Disclosures I have no financial or personal relationships with commercial entities that may have direct or indirect interest in the subject matter of this presentation

Background 1.National Institute of Medicine, CDC, & Cochrane Center calling for more research to evaluate use of pharmacists for management of cardiovascular disease 2.It is increasingly difficult to provide the necessary frequency and intensity of follow-up by PCPs 3.A centralized clinical pharmacy cardiovascular risk service (CVRS) at Kaiser Permanente of Colorado Successful implementation Mortality reduced compared to usual care Merenich JA, Olson KL, Delate T, Rasmussen J, Helling DK, Ward DG. Mortality reduction benefits of a comprehensive cardiac care program for patients with occlusive coronary artery disease. Pharmacotherapy. Oct 2007;27(10):

A Web-based Cardiovascular Risk Service to Improve Secondary Prevention: The ICARE study Application funded by NIH August 2013 Aim: To reduce CV events in patients needing secondary prevention using a CVRS managed by clinical pharmacists Research Question: Can “virtual” clinical pharmacists help support primary care physicians in small, rural offices that cannot financially support a clinical pharmacist?

A Web-based Cardiovascular Risk Service to Improve Secondary Prevention: The MEDFOCUS proposal Funded April 2014 Research Question: Even in FM residency offices with clinical pharmacists, there are many patients with chronic conditions Can a centralized CVRS help support on-site clinical pharmacists and physicians with much more intensive patient follow-up?

MED-FOCUS Aims 1) To determine if a web-based CVRS managed by clinical pharmacists will be implemented within diverse primary care offices 2) Evaluate barriers and facilitators to implementation and dissemination of CVRS 3) Demonstrate a favorable cost for the CVRS via robust cost effectiveness analysis 4) Reduce patient cardiovascular risk factors & risk of future CV events

MED-FOCUS Aims Primary Hypothesis: Adherence to guidelines for secondary prevention of CVD will be significantly greater in patients from clinics randomized to the CVRS group compared to the control group Secondary Hypothesis: Adherence to guidelines will deteriorate after the intervention is discontinued but still remain higher in the intervention group compared to the control group

Design and Inclusion Cluster, randomized trial –20 of highest enrolling CAPTION study sites –GFMC – randomized to intervention arm Offices have been stratified as High or Low percent minorities based on CAPTION enrollments Offices randomized to either intervention or usual care 400 patients, 240 will be racial or ethnic minorities (180 Blacks, 40 Hispanics)

Participating Locations You are here!

Design and Inclusion Primary Outcome is adherence to Guideline Advantage Criteria –Primary outcome: change in CVD risk score ≥55 years of age with a history of one of the following: –Coronary artery disease –MI –Stroke or TIA –Atrial fibrillation –Systolic heart failure –Peripheral vascular disease/claudication –DM with co-existing uncontrolled hypertension and/or uncontrolled hyperlipidemia

Examples of Guideline Advantage Criteria Diabetes −A1c in last 12 months −% age with LDL < 100mg/dl −% age with Dx of DM and LDL test in last 12 months −% age with BP <140/80 Peripheral Arterial Disease + tobacco use −% of smokers who have had a cessation intervention in last 24 months Preventative Care −% age 55 and older with Influenza shot −% age 65 and older with Pneumonia shot −% with controlled LDL OR prescribed at least 1 lipid lower med at max dose tolerated

Recruitment Study coordinator identification –Provider clinic schedule Physician referral –Study coordinator follow-up

Design Study Coordinator (SC) employed in each office screen and recruit subjects (ideally 25 per office) Only 2 study visits with SC: Baseline and 12 months, plus chart audit at 24 months –Lipids, A1c, CMP – baseline & 12 months SC in intervention offices will also collect medical record data at 4 and 8 months to provide data to the CVRS pharmacists –Exempt - pharmacists have Cerner access Data for the CVRS pharmacists downloaded to the Iowa Personal Health & Research Management (IowaPHRM) system Subjects in both arms have access to the IowaPHRM to upload and track there personal health data

Pharmacist dashboard – IowaPHRM Pharmacist interface to support tracking of: –Pharmacist-physician communication –Pharmacist-maintained conditions, medications, allergies, and pharmacies for each patient –Pharmacist-subject appointment scheduling –Contact tracking –Notes /SOAPs –Guideline Advantage Metrics Individual and mass messaging Repository of study documents

Activities of the CVRS Clinical Pharmacists Baseline assessment of medication and guideline adherence Assist patient with IowaPHRM to ↑ self-monitoring (e.g. BG, BP) Patient contacts: (based on pt choice) – s (secure), text msg, telephone –Every two weeks x 2 months  at least monthly Follow-up - medication adherence, side effects, life style modifications, etc. Make recommendations to PCP and on-site clinical pharmacist –Immunization, cancer screening, lifestyle modification and medication therapy recommendations

Clinical Implications Improvement in patient centered medical home status –Chronic care management –Care coordination –Quality improvement Improved management of patients with CVD or at high risk for CVD –↓ in CV event risk If successful, CVRS model may become an important strategy to markedly reduce CV events in US

Summary Team-based care is well established in many health systems like Kaiser, Group Health, VAs and academic centers One big challenge is how to most efficiently and effectively use each team member Combinations of self-management, face-to-face visits and telephone or internet encounters are likely the most effective and cost effective approaches

Study Progress

MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS) Thank You!

MEDication Focused Outpatient Care for Underutilization of Secondary Prevention (MEDFOCUS)