... for our health Wisconsin Research and Education Network and the University of Wisconsin Department of Family Medicine Collaboration Among Pharmacists & Physicians to Improve Outcomes Now (CAPTION) WREN Research Support for a Multi-Site National Study

Outline Overview of CAPTION Study Coordinator Role What WREN brings to CAPTION Progress to Date/Lessons Learned

What is CAPTION? 5 year, prospective, cluster-randomized multi-center trial in 31 clinics across the US (13 states) Funded by the National Heart, Lung and Blood Institute (NHLBI), a division of NIH (RO1HL091841) PIs at University of Iowa

PPCM: Intervention Physician-Pharmacist Collaborative Model (PPCM) for managing hypertension and asthma Pharmacists meet with patients and can make treatment recommendations to physician over time Physician and patient make final decisions about treatment

Research Questions Do patients who receive PPCM achieve better health outcomes compared to patients who do not receive PPCM? Does the effect spread to clinic patients who do not receive the intervention? Will PPCM be adopted in clinics with high minority populations? Cost Effectiveness?

Study Design Clinics randomized to 1 of 3 study arms: 1)HTN PPCM Intervention (9 mo) 2)HTN PPCM Extended Intervention (24 mo) 3)HTN Usual Care/Asthma PPCM

Two Madison Clinics Participating Wingra Family Medicine Clinic ▪ Assigned to Arm 1: HTN PPCM Intervention (9 mo) Northeast Family Medicine Clinic ▪ Assigned to Arm 3: HTN Usual Care/Asthma PPCM

Northeast Family Medicine Clinic Local Principal Investigator ▪ Louis Sanner, MD Study Pharmacist ▪ Carrie Stoltenberg, RPH Study Coordinator ▪ Kate Judge, MSSW. ▪ WREN Regional Research Coordinator.

Enroll 24 subjects with HTN to the Active Observation Group Monitor BP for for 24 months following enrollment (6 visits) Retrospective Chart Audits on a Passive Observation group (9 subjects). Begins 2 years after the first subject was enrolled Study Coordinator Role (HTN)

Enroll 15 subjects with persistent asthma Asthma subjects will receive PPCM for 9 months. Subjects are followed for 18 months (3 study visits with coordinator) Chart review to document asthma control in the 9 month period prior to enrollment Study Coodinator Role (Asthma)

Coordination: Behind the Scenes Write IRB application for local site Chart review identify eligible pts to recruit Recruitment Study visits with participants Data entry

WREN Contributions to CAPTION WREN assumes study coordination responsibilities in January 2011 WREN submits new IRB application to modify study procedures ▪ submitted 2/11/11; approved 4/6/11 First study participant enrolled! 5/17/11

WREN Procedure Modifications KEY MODIFICATIONS … Added COMPENSATION for study participants Added WREN team as personnel Modified Screening Procedures

Screening Modifications Electronic Query: DFM Database Administrator identifies patients to exclude based on study exclusion critiera ▪ Advantages: Decreases incidental observation of PHI, and saves study coordinator time Phone Screening: Ask screening questions over phone ▪ Advantages: Less likely to waste participant time with appointment if not eligible

Northeast Enrollment Success Northeast has enrolled 15 eligible HTN patients to date. Target: 24 33% Screen Failure Rate ▪ 21 patients brought in for baseline ▪ 7 patients did not meet bp requirements. ▪ Uncontrolled BP: 140/90 OR 130/80 if have CKD or DM Enrollment Rate per 30 Days: 5.68 patients

# enrolled# screen failures % screen failures Enrollment Rate per 30 Days Northeast147/2133%5.68 Site 21638/5470%3.51 Site 3120/120%.77 Site 473/1030%.88 Site 51613/2945%2.57 Site 6188/2630%1.36 Site %3.96 Enrollment Numbers Comparison

Enrollment Rates Per 30 Days

Screen Failure Across Sites

Conclusions Fine-Tune Pre-Screening for BP ▪ Current Report: Identifies pts without good bp reading in 2 years. Most have at least 1 good bp in 2 yrs. Still have to review EHR ▪ Better: Identify pts who have not had a good bp in last 3-6 months Enrollment Success ▪ Compensation Attracts Participants ▪ WREN Team Approach is KEY

CAPTION QUESTIONS?