Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial

• Published in: The American heart journal 2016-10, Vol.180, p.90-97
• Main Authors: Choudhry, Niteesh K., Isaac, Thomas, Lauffenburger, Julie C., Gopalakrishnan, Chandrasekar, Khan, Nazleen F., Lee, Marianne, Vachon, Amy, Iliadis, Tanya L., Hollands, Whitney, Doheny, Scott, Elman, Sandra, Kraft, Jacqueline M., Naseem, Samrah, Gagne, Joshua J., Jackevicius, Cynthia A., Fischer, Michael A., Solomon, Daniel H., Sequist, Thomas D.
• Format: Article
• Language: English
• Subjects: Chronic Disease - drug therapy; Counseling; Diabetes; Diabetes Mellitus - drug therapy; Disease control; Drug dosages; Drug stores; Glucose; Health care expenditures; Health care policy; Humans; Hyperlipidemias - drug therapy; Hypertension - drug therapy; Intention to Treat Analysis; Intervention; Mail order; Medication Adherence; Mortality; Patients; Pharmaceutical Services; Pharmacy; Physicians; Pragmatism; Prospective Studies; Research Design; Social work; Telemedicine; Text messaging
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2016.07.017

Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may not need adherence assistance. To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. The STIC2IT trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing, text messaging, mailed progress reports, and video visits. Targeted patients are those who are nonadherent to glucose-lowering, antihypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients' individual health barriers and their level of health activation. We cluster-randomized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients who will be followed up for 12months after randomization. The trial's primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and health care resource utilization. This trial will determine whether a technologically enabled, behaviorally targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need.