. . . 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

Northeast 14 7/21 33% 5.68

Site 2 16 38/54 70% 3.51

Site 3 12 0/12 0% .77

Site 4 7 3/10 30% .88

Site 5 16 13/29 45% 2.57

Site 6 18 8/26 30% 1.36

Site 7 13 24 54% 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?