title: Clinical and demographic correlates of medication and visit adherence in a large randomized controlled trial.
abstract: Patient characteristics are associated with adherence, which has implications for planning clinical research or designing payment systems that reward superior outcomes. It is unclear to what extent clinician efforts to improve adherence can attenuate these associations.
  
  
  
  To identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits.
  
  
  
  The 31,250 ALLHAT participants eligible for the visit adherence analysis attended 78.5 % of scheduled study visits; 68.9 % attended more than 80 % of scheduled visits. Clinic setting was predictive of both forms of adherence; adherence was worst at private clinics; clinics that enrolled more study participants had superior adherence. Adjusting for clinic characteristics and clinical factors, women, younger participants, Blacks and smokers were less likely to have adequate visit adherence. Among the 28,967 participants eligible for the medication adherence analysis, 21,261 (73.4 %) reported adequate medication adherence. In adjusted analyses, younger and less educated participants, Blacks, and smokers were less likely to report adequate adherence.
  
  
  
  Participant demographics were associated with adherence despite strenuous efforts to optimize adherence. Our results could inform decisions by researchers planning trials and policymakers designing payment systems.
  
  
  
  NCT00000542 . Registered 27 October 1999.
authors.affiliation: Clement J Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Whittle
authors.affiliation: The University of Texas School of Public Health, Houston, TX, USA. Jose-Miguel.Yamal@uth.tmc.edu.|Division of Biostatistics, Coordinating Center for Clinical Trials, 1200 Pressler Street, Houston, TX, 77030, USA. Jose-Miguel.Yamal@uth.tmc.edu.
authors.forename: José-Miguel
authors.initials: JM
authors.lastname: Yamal
authors.affiliation: Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Williamson
authors.affiliation: The University of Texas School of Public Health, Houston, TX, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Ford
authors.affiliation: University of Washington Medical Center, Seattle, WA, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Probstfield
authors.affiliation: E.A. Conway Hospital, Monroe, LA, USA.
authors.forename: Barbara L
authors.initials: BL
authors.lastname: Beard
authors.affiliation: Ottawa Hospital, Ottawa, ON, Canada.
authors.forename: Horia
authors.initials: H
authors.lastname: Marginean
authors.affiliation: Veterans Affairs Medical Center, Baltimore, MD, USA.
authors.forename: Bruce P
authors.initials: BP
authors.lastname: Hamilton
authors.affiliation: The University of Toledo, Toledo, OH, USA.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Suhan
authors.affiliation: The University of Texas School of Public Health, Houston, TX, USA.
authors.forename: Barry R
authors.initials: BR
authors.lastname: Davis
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001071:Appointments and Schedules; D044383:Black People; D002752:Chlorthalidone / Q000627:therapeutic use; D003710:Demography; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D017706:Lisinopril / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy; D009656:North America; D010349:Patient Compliance / Q000706:statistics & numerical data; D012189:Retrospective Studies; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D000959:Antihypertensive Agents; D017311:Amlodipine; D017706:Lisinopril; D002752:Chlorthalidone
keywords: Adherence; Angiotensin-converting enzyme inhibitors; Calcium channel blockers; Diuretics; Hyperlipidemia; Hypertension; Race