In his column, Dr. Cohen has discussed the need to “articulate with clarity and demonstrate consistently WHAT pharmacists do to improve patients’ drug therapy outcomes.” Last March, I announced that the PBRN was initiating a study with the objective of developing and testing a comprehensive framework for assessing the delivery of clinical pharmacist care in a variety of settings. The efforts of ACCP’s leadership and membership to determine how best to describe and position clinical pharmacy, together with the Research Institute’s support for the generation of much-needed evidence on the effectiveness and efficiency of clinical pharmacy practices, are expected to lead to important synergies for documenting the value of clinical pharmacy services in an increasingly competitive health care industry.

The motivation for the PBRN study, titled “The American College of Clinical Pharmacy (ACCP) Activities Characterizing Clinical Pharmacists (ACCP) Study (ACCP2 Study),” was the observation that in clinical trials assessing pharmacist practices, we are often unsure whether the protocols describing clinical care are strictly adhered to. Furthermore, it is often difficult to disambiguate which aspects of a complex intervention produced the benefits observed in a trial evaluating a clinical pharmacy service. We proposed that a tool designed specifically to document the care actually delivered to an individual patient would greatly enhance the quality of clinical trials evaluating clinical pharmacy services, especially in settings where the pharmacist makes up part of a team and does not practice independently.

To illustrate the need for such a tool, a clinical trial evaluating the effectiveness of a new drug would never allow an investigator to instruct the participant to “take as much or as little of this drug whenever you want.” Typically, in a clinical trial, we set directions and then assess adherence through pill counts. However, when assessing clinical pharmacy services in clinical trials, we typically provide training to the pharmacists to “standardize” the intervention, but rarely do we observe the pharmacist in practice. Pharmacists are generally free to provide different “doses” of each activity making up the intervention, depending on preferences, time constraints, patient willingness, and several other factors. It is not surprising that there is often huge variation in the outcomes of clinical trials evaluating pharmacist services, the result of practices akin to instructing participants to “take as much or as little of this drug whenever you want.”

The PBRN recently received IRB approval to begin the qualitative portion of a mixed-methods study designed to collect information vital to log the tremendous variety of activities performed by clinical pharmacists practicing in inpatient internal medicine and outpatient family medicine or internal medicine practices. Several practices were selected to provide input into this step of the process. This study will be followed up by focus groups involving pharmacists in four geographically diverse locations. From these sessions, we will identify important factors, or themes, common to pharmacist practice. Our goal is to develop a tool that clinicians can use to reliably and consistently describe the activities of clinical pharmacist practices at the patient level. The tool will first be used in a study of PBRN-affiliated practices, likely in early 2013. Results obtained from the tool will eventually be combined with other data documenting patient severity of illness, preferences, comorbidities, and outcomes to develop a comprehensive view of the activities that improve patient care and those that do so efficiently.

For more information about the ACCP2 Study or about how you can get involved with PBRN projects, please contact us by e-mail ([email protected]) or telephone (913) 492-3311.