title: Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: nkchoudhry@bwh.harvard.edu.
authors.forename: Niteesh K
authors.initials: NK
authors.lastname: Choudhry
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Isaac
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Julie C
authors.initials: JC
authors.lastname: Lauffenburger
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Chandrasekar
authors.initials: C
authors.lastname: Gopalakrishnan
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Nazleen F
authors.initials: NF
authors.lastname: Khan
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Marianne
authors.initials: M
authors.lastname: Lee
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Vachon
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Tanya L
authors.initials: TL
authors.lastname: Iliadis
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Whitney
authors.initials: W
authors.lastname: Hollands
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Doheny
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Elman
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Kraft
authors.affiliation: Atrius Health, Newton, MA, USA.
authors.forename: Samrah
authors.initials: S
authors.lastname: Naseem
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Joshua J
authors.initials: JJ
authors.lastname: Gagne
authors.affiliation: Western University of Health Sciences, Pomona, CA; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Jackevicius
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Fischer
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Solomon
authors.affiliation: Division of General Internal Medicine and Department of Health Care Policy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Sequist
mesh_terms: D002908:Chronic Disease / Q000188:drug therapy*; D003920:Diabetes Mellitus / Q000188:drug therapy; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy; D006973:Hypertension / Q000188:drug therapy; D057194:Intention to Treat Analysis; D055118:Medication Adherence; D010593:Pharmaceutical Services; D011446:Prospective Studies; D012107:Research Design; D017216:Telemedicine