Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
NCT ID: NCT03973931
Last Updated: 2025-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
9501 participants
INTERVENTIONAL
2019-07-01
2023-11-19
Brief Summary
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Detailed Description
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Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (HCS) to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes include clinical events (e.g., event times for stroke, MI, mortality), utilization of care (e.g., hospitalizations or clinic visits for CV-related reasons), and costs of healthcare utilization. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally.
Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usual Care
This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
No interventions assigned to this group
Generic Nudge
A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Optimized nudge
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Optimized nudge plus AI Chat Bot
An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Interventions
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Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Eligibility Criteria
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Inclusion Criteria
* Hypertension (Beta-blockers \[B-blockers)\], Calcium Channel Blocker \[CCB\], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers \[ARB\], or Thiazide diuretic)
* Hyperlipidemia (HMG CoA reductase inhibitor \[Statins\])
* Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor \[Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine\], B-blockers, ACEi or ARB or statins)
* Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)
Exclusion Criteria
* Patients who do not have a landline or cellphone listed in EHR;
* Currently pregnant if denoted in the EHR at the time of the data pull;
* Patients with a mailing address outside of the state of Colorado;
* Patients that do not speak either English or Spanish.
18 Years
89 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Michael Ho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Sheana Bull, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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UCHealth
Aurora, Colorado, United States
University of Colorado Denver
Aurora, Colorado, United States
VA Eastern Colorado Health Care System
Aurora, Colorado, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Countries
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References
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Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820.
Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177.
Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006 Jun 20;113(24):2803-9. doi: 10.1161/CIRCULATIONAHA.106.618066. Epub 2006 Jun 12.
Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.
Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229.
Wei L, Flynn R, Murray GD, MacDonald TM. Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):761-6. doi: 10.1002/pds.963.
Lu CY, Ross-Degnan D, Soumerai SB, Pearson SA. Interventions designed to improve the quality and efficiency of medication use in managed care: a critical review of the literature - 2001-2007. BMC Health Serv Res. 2008 Apr 7;8:75. doi: 10.1186/1472-6963-8-75.
Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.
Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.
Peterson PN, Campagna EJ, Maravi M, Allen LA, Bull S, Steiner JF, Havranek EP, Dickinson LM, Masoudi FA. Acculturation and outcomes among patients with heart failure. Circ Heart Fail. 2012 Mar 1;5(2):160-6. doi: 10.1161/CIRCHEARTFAILURE.111.963561. Epub 2012 Jan 13.
Gurol-Urganci I, de Jongh T, Vodopivec-Jamsek V, Atun R, Car J. Mobile phone messaging reminders for attendance at healthcare appointments. Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD007458. doi: 10.1002/14651858.CD007458.pub3.
de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.
Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2.
Ho PM, Glorioso TJ, Allen LA, Blankenhorn R, Glasgow RE, Grunwald GK, Khanna A, Magid DJ, Marrs JC, Novins-Montague S, Orlando S, Peterson P, Plomondon ME, Sandy LM, Saseen JJ, Trinkley KE, Vaughn S, Waughtal J, Bull S. Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial. JAMA. 2025 Jan 7;333(1):49-59. doi: 10.1001/jama.2024.21739.
Glasgow RE, Knoepke CE, Magid D, Grunwald GK, Glorioso TJ, Waughtal J, Marrs JC, Bull S, Ho PM. The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial. Trials. 2021 Aug 11;22(1):528. doi: 10.1186/s13063-021-05453-9.
Luong P, Glorioso TJ, Grunwald GK, Peterson P, Allen LA, Khanna A, Waughtal J, Sandy L, Ho PM, Bull S. Text Message Medication Adherence Reminders Automated and Delivered at Scale Across Two Institutions: Testing the Nudge System: Pilot Study. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007015. doi: 10.1161/CIRCOUTCOMES.120.007015. Epub 2021 May 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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NIH Collaboratory Site discussing the Nudge Project
Other Identifiers
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18-2779
Identifier Type: -
Identifier Source: org_study_id
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