A centralized cardiovascular risk service to improve guideline adherence in private primary care offices

Abstract

Background Many large health systems now employ clinical pharmacists in team-based care to assist patients and physicians with management of cardiovascular (CV) diseases. However, small private offices often lack the resources to hire a clinical pharmacist for their office. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in primary care medical offices in rural and small communities. Methods This study is a cluster randomized prospective trial in 12 primary care offices. Medical offices were randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. Primary outcomes will include adherence to treatment guidelines and control of key CV risk factors. Data will also be abstracted from the medical record at 30 months to determine if the intervention effect is sustained after it is discontinued. Conclusions This study will enroll subjects through 2015 and results will be available in 2018. This study will provide information on whether a distant, centralized CV risk service can improve guideline adherence in medical offices that lack the resources to employ clinical pharmacists.

Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones

“…Our grant budgets allocate subcontract awards to the individual study sites to provide adequate funding. Table displays typical subcontract funding for a pharmacist intervention to improve blood pressure or reduce cardiovascular risks . The major portion of the subcontract pays a study coordinator (SC) already employed either by the clinic office (usually a nurse or medical assistant) or by an affiliated research office to screen and enroll subjects and collect data.…”

“…Fortunately, streamlining of IRB processes might ease the burden for both CCC investigators and members of the site team. The University of Iowa IRB is the IRB of record for 12 private practices throughout Iowa in the ICARE study (Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care) . Additionally, the NIH issued a policy on using a single IRB for multicenter trials on July 7, 2016.…”

“…We attempt to provide training as close to subject recruitment timing as possible. For trials within the state of Iowa, several members of the research team took the training program to the sites and provided lunch during the sessions . Onsite training was critical to build relationships but was challenging because some sites were a 5‐hour drive from our center.…”

“…Other approaches are sometimes needed. Our ICARE trial involving 12 private primary care offices throughout Iowa encountered significant staff shortage issues that impaired screening and recruitment at 2 sites within 20 miles of the CCC. Our research team negotiated with clinic personnel to permit CCC student research assistants to screen and recruit subjects.…”

“…Understanding that any gap in meeting recruitment goals jeopardizes study power, we carefully examined our operations so that we could achieve our goals in subsequent grants. We achieved 100% of our enrollment goals 6 months ahead of schedule for 2 current NHLBI‐funded grants in 32 medical offices throughout the United States . Early enrollment will provide more time for data analysis and timely submission of manuscripts.…”