Cargando…

The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial

BACKGROUND: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using...

Descripción completa

Detalles Bibliográficos
Autores principales: Glasgow, Russell E., Knoepke, Christopher E., Magid, David, Grunwald, Gary K., Glorioso, Thomas J., Waughtal, Joy, Marrs, Joel C., Bull, Sheana, Ho, P. Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8356469/
https://www.ncbi.nlm.nih.gov/pubmed/34380527
http://dx.doi.org/10.1186/s13063-021-05453-9
_version_ 1783736950783475712
author Glasgow, Russell E.
Knoepke, Christopher E.
Magid, David
Grunwald, Gary K.
Glorioso, Thomas J.
Waughtal, Joy
Marrs, Joel C.
Bull, Sheana
Ho, P. Michael
author_facet Glasgow, Russell E.
Knoepke, Christopher E.
Magid, David
Grunwald, Gary K.
Glorioso, Thomas J.
Waughtal, Joy
Marrs, Joel C.
Bull, Sheana
Ho, P. Michael
author_sort Glasgow, Russell E.
collection PubMed
description BACKGROUND: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. METHODS: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. DISCUSSION: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment. TRIAL REGISTRATION: ClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05453-9.
format Online
Article
Text
id pubmed-8356469
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-83564692021-08-16 The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial Glasgow, Russell E. Knoepke, Christopher E. Magid, David Grunwald, Gary K. Glorioso, Thomas J. Waughtal, Joy Marrs, Joel C. Bull, Sheana Ho, P. Michael Trials Study Protocol BACKGROUND: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. METHODS: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. DISCUSSION: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment. TRIAL REGISTRATION: ClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05453-9. BioMed Central 2021-08-11 /pmc/articles/PMC8356469/ /pubmed/34380527 http://dx.doi.org/10.1186/s13063-021-05453-9 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Glasgow, Russell E.
Knoepke, Christopher E.
Magid, David
Grunwald, Gary K.
Glorioso, Thomas J.
Waughtal, Joy
Marrs, Joel C.
Bull, Sheana
Ho, P. Michael
The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title_full The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title_fullStr The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title_full_unstemmed The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title_short The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
title_sort nudge trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8356469/
https://www.ncbi.nlm.nih.gov/pubmed/34380527
http://dx.doi.org/10.1186/s13063-021-05453-9
work_keys_str_mv AT glasgowrusselle thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT knoepkechristophere thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT magiddavid thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT grunwaldgaryk thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT gloriosothomasj thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT waughtaljoy thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT marrsjoelc thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT bullsheana thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT hopmichael thenudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT glasgowrusselle nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT knoepkechristophere nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT magiddavid nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT grunwaldgaryk nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT gloriosothomasj nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT waughtaljoy nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT marrsjoelc nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT bullsheana nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial
AT hopmichael nudgetrialpragmatictrialtoenhancecardiovascularmedicationadherencestudyprotocolforarandomizedcontrolledtrial