Peter P Reese1, Roy D Bloom2, Jennifer Trofe-Clark3, Adam Mussell4, Daniel Leidy4, Simona Levsky5, Jingsan Zhu6, Lin Yang6, Wenli Wang6, Andrea Troxel7, Harold I Feldman8, Kevin Volpp9. 1. 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. 2. Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. 3. 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. 4. Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. 5. School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA. 6. Leonard Davis Institute Center for Health Incentives and Behavioral Economics, University of Pennsylvania, Philadelphia, PA. 7. 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. 8. 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. 9. 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.
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. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: Kidney transplant recipients (n=120) at a single center. INTERVENTION: 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). OUTCOMES: 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. MEASUREMENTS: 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. LIMITATIONS: 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.
RCT Entities:
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. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: Kidney transplant recipients (n=120) at a single center. INTERVENTION: 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). OUTCOMES: 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. MEASUREMENTS: 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. LIMITATIONS: 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: Jessica K Stevenson; Zoe C Campbell; Angela C Webster; Clara K Chow; Allison Tong; Jonathan C Craig; Katrina L Campbell; Vincent Ws Lee Journal: Cochrane Database Syst Rev Date: 2019-08-06
Authors: Larissa Myaskovsky; Michelle T Jesse; Kristin Kuntz; Abbie D Leino; John Devin Peipert; Cynthia L Russell; Christina A Spivey; Nimisha Sulejmani; Mary Amanda Dew Journal: Clin Transplant Date: 2018-08-09 Impact factor: 2.863
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Authors: Cynthia L Russell; Donna Hathaway; Laura M Remy; Dana Aholt; Debra Clark; Courtney Miller; Catherine Ashbaugh; Mark Wakefield; Sangbeak Ye; Vincent S Staggs; Rebecca J Ellis; Kathy Goggin Journal: Am J Transplant Date: 2019-08-20 Impact factor: 8.086
Authors: Ann K Eno; Jessica M Ruck; Sarah E Van Pilsum Rasmussen; Madeleine M Waldram; Alvin G Thomas; Tanjala S Purnell; Jacqueline M Garonzik Wang; Allan B Massie; Fawaz Al Almmary; Lisa M Cooper; Dorry L Segev; Michael A Levan; Macey L Henderson Journal: Clin Transplant Date: 2019-07-01 Impact factor: 2.863
Authors: David J Taber; Zemin Su; James N Fleming; John W McGillicuddy; Maria A Posadas-Salas; Frank A Treiber; Derek Dubay; Titte R Srinivas; Patrick D Mauldin; William P Moran; Prabhakar K Baliga Journal: Transplantation Date: 2017-12 Impact factor: 4.939
Authors: Kevin G Volpp; Andrea B Troxel; Shivan J Mehta; Laurie Norton; Jingsan Zhu; Raymond Lim; Wenli Wang; Noora Marcus; Christian Terwiesch; Kristen Caldarella; Tova Levin; Mike Relish; Nathan Negin; Aaron Smith-McLallen; Richard Snyder; Claire M Spettell; Brian Drachman; Daniel Kolansky; David A Asch Journal: JAMA Intern Med Date: 2017-08-01 Impact factor: 21.873