title: Automated Reminders and Physician Notification to Promote Immunosuppression Adherence Among Kidney Transplant Recipients: A Randomized Trial.
abstract: BACKGROUND
  Immunosuppression nonadherence increases the risk for kidney transplant loss after transplantation. Wireless-enabled pill bottles have created the opportunity to monitor medication adherence in real time. Reminders may help patients with poor memory or organization. Provision of adherence data to providers may motivate patients to improve adherence and help providers identify adherence barriers.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Kidney transplant recipients (n=120) at a single center.
  
  
  METHODS
  Participants were provided wireless pill bottles to store tacrolimus and record bottle openings. Participants were randomly assigned 1:1:1 to adherence monitoring with customized reminders (including alarms, texts, telephone calls, and/or e-mails), monitoring with customized reminders plus provider notification (every 2 weeks, providers received notification if adherence decreased to <90% during that period), or wireless pill bottle use alone (control).
  
  
  RESULTS
  The main outcome was bottle-measured tacrolimus adherence during the last 90 days of the 180-day trial. A secondary outcome was tacrolimus whole-blood concentrations at routine clinical visits.
  
  
  METHODS
  Adherence for the primary outcome was assessed via wireless pill bottle openings.
  
  
  RESULTS
  Mean participant age was 50 years; 60% were men, and 40% were black. Mean adherence was 78%, 88%, and 55% in the reminders, reminders-plus-notification, and control arms (P<0.001 for comparison of each intervention to control). Mean tacrolimus levels were not significantly different between groups.
  
  
  CONCLUSIONS
  The study did not assess clinical end points. Participants and study coordinators were not blinded to intervention arm.
  
  
  CONCLUSIONS
  Provider notification and customized reminders appear promising in helping patients achieve better medication adherence, but these strategies require evaluation in trials powered to detect differences in clinical outcomes.
authors.affiliation: Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA. Electronic address: peter.reese@uphs.upenn.edu.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Reese
authors.affiliation: Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Roy D
authors.initials: RD
authors.lastname: Bloom
authors.affiliation: Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Pharmacy Services, Hospital of the University of Pennsylvania, Philadelphia, PA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Trofe-Clark
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Adam
authors.initials: A
authors.lastname: Mussell
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Leidy
authors.affiliation: School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA.
authors.forename: Simona
authors.initials: S
authors.lastname: Levsky
authors.affiliation: Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
authors.forename: Jingsan
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
authors.forename: Lin
authors.initials: L
authors.lastname: Yang
authors.affiliation: Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
authors.forename: Wenli
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Troxel
authors.affiliation: Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
authors.forename: Harold I
authors.initials: HI
authors.lastname: Feldman
authors.affiliation: Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA; Department of Medicine and Medical Ethics and Health Policy, Perelman School of Medicine, Philadelphia, PA; Department of Health Care Management, Wharton School, University of Pennsylvania, Philadelphia, PA; Center for Health Equity Research and Promotion, Cresencz Philadelphia Veterans Affairs Medical Center, Philadelphia, PA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Volpp
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D017010:Reminder Systems / Q000706:statistics & numerical data; D016559:Tacrolimus / Q000627:therapeutic use*; D016903:Drug Monitoring
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: Kidney transplantation; adherence; allograft loss; automated reminder; behavior change; compliance; end-stage renal disease (ESRD); immunosuppression; kidney transplant recipient (KTR); medication reminder; polypharmacy; randomized controlled trial; tacrolimus; tacrolimus trough level; wireless pill bottle