Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial

BackgroundLow medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can b...

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Main Authors: Saul Blecker, Antoinette Schoenthaler, Tiffany Rose Martinez, Hayley M Belli, Yunan Zhao, Christina Wong, Cassidy Fitchett, Harris R Bearnot, Devin Mann
Format: Article
Language:English
Published: JMIR Publications 2023-07-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2023/1/e47930
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author Saul Blecker
Antoinette Schoenthaler
Tiffany Rose Martinez
Hayley M Belli
Yunan Zhao
Christina Wong
Cassidy Fitchett
Harris R Bearnot
Devin Mann
author_facet Saul Blecker
Antoinette Schoenthaler
Tiffany Rose Martinez
Hayley M Belli
Yunan Zhao
Christina Wong
Cassidy Fitchett
Harris R Bearnot
Devin Mann
author_sort Saul Blecker
collection DOAJ
description BackgroundLow medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can be used for interventions at the point of care. We developed a multicomponent intervention that uses linked EHR and pharmacy data to automatically identify patients with elevated blood pressure and low medication adherence. The intervention then combines team-based care with EHR-based workflows to address medication nonadherence. ObjectiveThis study aims to describe the design of the Leveraging EHR Technology and Team Care to Address Medication Adherence (TEAMLET) trial, which tests the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence among patients with hypertension. MethodsTEAMLET is a pragmatic, cluster randomized controlled trial in which 10 primary care practices will be randomized 1:1 to the multicomponent intervention or usual care. We will include all patients with hypertension and low medication adherence who are seen at enrolled practices. The primary outcome is medication adherence, as measured by the proportion of days covered, and the secondary outcome is clinic systolic blood pressure. We will also assess intervention implementation, including adoption, acceptability, fidelity, cost, and sustainability. ResultsAs of May 2023, we have randomized 10 primary care practices into the study, with 5 practices assigned to each arm of the trial. The enrollment for the study commenced on October 5, 2022, and the trial is currently ongoing. We anticipate patient recruitment to go through the fall of 2023 and the primary outcomes to be assessed in the fall of 2024. ConclusionsThe TEAMLET trial will evaluate the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence. If successful, the intervention could offer a scalable approach to address inadequate blood pressure control among millions of patients with hypertension. Trial RegistrationClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422 International Registered Report Identifier (IRRID)DERR1-10.2196/47930
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spelling doaj.art-9f5dd45f35864cf4ad226c98231716652023-08-29T00:02:04ZengJMIR PublicationsJMIR Research Protocols1929-07482023-07-0112e4793010.2196/47930Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled TrialSaul Bleckerhttps://orcid.org/0000-0003-4460-1046Antoinette Schoenthalerhttps://orcid.org/0000-0003-4905-5136Tiffany Rose Martinezhttps://orcid.org/0000-0001-8038-307XHayley M Bellihttps://orcid.org/0000-0002-0816-6844Yunan Zhaohttps://orcid.org/0000-0002-0665-5572Christina Wonghttps://orcid.org/0000-0002-8812-1565Cassidy Fitchetthttps://orcid.org/0009-0000-6737-6043Harris R Bearnothttps://orcid.org/0009-0007-6993-8186Devin Mannhttps://orcid.org/0000-0002-2099-0852 BackgroundLow medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can be used for interventions at the point of care. We developed a multicomponent intervention that uses linked EHR and pharmacy data to automatically identify patients with elevated blood pressure and low medication adherence. The intervention then combines team-based care with EHR-based workflows to address medication nonadherence. ObjectiveThis study aims to describe the design of the Leveraging EHR Technology and Team Care to Address Medication Adherence (TEAMLET) trial, which tests the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence among patients with hypertension. MethodsTEAMLET is a pragmatic, cluster randomized controlled trial in which 10 primary care practices will be randomized 1:1 to the multicomponent intervention or usual care. We will include all patients with hypertension and low medication adherence who are seen at enrolled practices. The primary outcome is medication adherence, as measured by the proportion of days covered, and the secondary outcome is clinic systolic blood pressure. We will also assess intervention implementation, including adoption, acceptability, fidelity, cost, and sustainability. ResultsAs of May 2023, we have randomized 10 primary care practices into the study, with 5 practices assigned to each arm of the trial. The enrollment for the study commenced on October 5, 2022, and the trial is currently ongoing. We anticipate patient recruitment to go through the fall of 2023 and the primary outcomes to be assessed in the fall of 2024. ConclusionsThe TEAMLET trial will evaluate the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence. If successful, the intervention could offer a scalable approach to address inadequate blood pressure control among millions of patients with hypertension. Trial RegistrationClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422 International Registered Report Identifier (IRRID)DERR1-10.2196/47930https://www.researchprotocols.org/2023/1/e47930
spellingShingle Saul Blecker
Antoinette Schoenthaler
Tiffany Rose Martinez
Hayley M Belli
Yunan Zhao
Christina Wong
Cassidy Fitchett
Harris R Bearnot
Devin Mann
Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
JMIR Research Protocols
title Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
title_full Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
title_fullStr Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
title_full_unstemmed Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
title_short Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial
title_sort leveraging electronic health record technology and team care to address medication adherence protocol for a cluster randomized controlled trial
url https://www.researchprotocols.org/2023/1/e47930
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