Abstract P146: The PATIENT Study: Lessons Learned During the Development of a Multi-Site, Pragmatic Randomized Control Trial in a Large Health Maintenance Organization
Authors: Ashli Owen-Smith, Suma Vupputuri, Cynthia Rand, Jeffrey Tom, Andrew Williams, David Smith, Diane Ditmer, Nadia Hassan, Reesa Laws, Amy Waterbury, Jennifer Schneider, William Vollmer
Journal: Circulation (2012)

Introduction: Patient adherence to chronic therapy is the necessary link between effective treatments and improved patient outcomes. However, the frequent failure of patients to adhere to long-term medication regimens is a challenge in chronic disease management. Though many prior interventions aimed at improving patient medication adherence have been successful, they are often costly and have limited disseminability. Methods: The PATIENT ( P romoting A dherence T o I mprove the E ffective n ess of CVD T herapies) study is a randomized control trial to compare the impact of two low-cost, low-intensity health information technology-based interventions (which include automated prescription refill reminder calls and mailed education materials) on patient adherence to selected chronic CVD medications. The primary goal throughout the development of this intervention was for it to be disseminable at the end of the grant period. We implemented several strategies aimed at increasing the likelihood of long-term implementation and dissemination of the intervention. These strategies included establishing an advisory board that included a diverse group of health plan clinicians and staff, conducting stakeholder interviews and participant focus groups, presenting at health plan meetings and carrying out a pilot of the intervention prior to the start of the main trial. Results: Our efforts in prioritizing the disseminability of the intervention highlighted several important lessons. First, it was important to develop all aspects of the intervention in partnership with health plan stakeholders, as their feedback was critical in the development of a protocol that would be ultimately congruent with local policies. Second, conversations with stakeholders highlighted the ways in which each of the sites were similar to and different from one another, thereby identifying which components of the intervention should be consistent across sites but also underscoring the need for there to be some regional customization. Preliminary results from the pilot of the intervention indicate that these efforts have been worthwhile: 62% of participants reported that the automated phone calls were helpful and the majority (80%) are willing to take a similar call in the future; similarly, the majority of participants reported that the mailed health education materials were useful (∼64%) and easy to understand (∼71%). Conclusions: The PATIENT intervention, if successful, could have significant public health applications as flexible and generalizable components of disease management programs. Understanding the barriers to and facilitators of successful implementation is critical to the widespread implementation of the intervention. Lessons learned from the developing and implementing the present study may aid others in similar efforts and in different settings.