Development of a Multicomponent Implementation Strategy to Reduce Upper Gastrointestinal Bleeding Risk in Patients Using Warfarin and Antiplatelet Therapy, and Protocol for a Pragmatic Multilevel Randomized Factorial Pilot Implementation Trial Article Swipe
Jacob E. Kurlander
,
Danielle Helminski
,
Michael Lanham
,
Jennifer L Henstock
,
Kelley M. Kidwell
,
Sarah L. Krein
,
Sameer D. Saini
,
Caroline R. Richardson
,
Raymond De Vries
,
Ken Resnicow
,
Allison Ruff
,
D. Michael A. Wallace
,
Elizabeth Jones
,
Linda K. Perry
,
Jacqueline Parsons
,
Nghi B. Ha
,
Tina Alexandris-Souphis
,
Dale K. Dedrick
,
Elizabeth Aldridge
,
Geoffrey D. Barnes
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-1097238/v1
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.21203/rs.3.rs-1097238/v1
BackgroundConcomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe 1) the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS) and 2) the design of a pilot pragmatic implementation trial.MethodsA participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) Clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: The nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review.DiscussionThis pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase use of best practices for upper GI bleeding risk reduction.Trial RegistrationClinicalTrials.gov, NCT05085405, Registered 19 October 2021 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05085405
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- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.21203/rs.3.rs-1097238/v1
- https://www.researchsquare.com/article/rs-1097238/latest.pdf
- OA Status
- gold
- References
- 54
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4200210422
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4200210422Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.21203/rs.3.rs-1097238/v1Digital Object Identifier
- Title
-
Development of a Multicomponent Implementation Strategy to Reduce Upper Gastrointestinal Bleeding Risk in Patients Using Warfarin and Antiplatelet Therapy, and Protocol for a Pragmatic Multilevel Randomized Factorial Pilot Implementation TrialWork title
- Type
-
preprintOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-12-08Full publication date if available
- Authors
-
Jacob E. Kurlander, Danielle Helminski, Michael Lanham, Jennifer L Henstock, Kelley M. Kidwell, Sarah L. Krein, Sameer D. Saini, Caroline R. Richardson, Raymond De Vries, Ken Resnicow, Allison Ruff, D. Michael A. Wallace, Elizabeth Jones, Linda K. Perry, Jacqueline Parsons, Nghi B. Ha, Tina Alexandris-Souphis, Dale K. Dedrick, Elizabeth Aldridge, Geoffrey D. BarnesList of authors in order
- Landing page
-
https://doi.org/10.21203/rs.3.rs-1097238/v1Publisher landing page
- PDF URL
-
https://www.researchsquare.com/article/rs-1097238/latest.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://www.researchsquare.com/article/rs-1097238/latest.pdfDirect OA link when available
- Concepts
-
Medicine, Warfarin, Randomized controlled trial, Psychological intervention, Intervention (counseling), Cluster randomised controlled trial, Nursing, Surgery, Internal medicine, Atrial fibrillationTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
0Total citation count in OpenAlex
- References (count)
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54Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.interventions: | 141 |
| abstract_inverted_index.multicomponent | 42, 319 |
| abstract_inverted_index.Retrospectively | 343 |
| abstract_inverted_index.anticoagulation | 59 |
| abstract_inverted_index.decision-making: | 198 |
| abstract_inverted_index.gastrointestinal | 13 |
| abstract_inverted_index.individual-level | 240 |
| abstract_inverted_index.self-determination | 111 |
| abstract_inverted_index.indication-specific | 213 |
| abstract_inverted_index.reduction.<bold>Trial | 335 |
| abstract_inverted_index.<title>Abstract</title> | 0 |
| abstract_inverted_index.trial.<bold>Methods</bold>A | 72 |
| abstract_inverted_index.<bold>Background</bold>Concomitant | 1 |
| abstract_inverted_index.review.<bold>Discussion</bold>This | 299 |
| abstract_inverted_index.Registration</bold>ClinicalTrials.gov, | 336 |
| abstract_inverted_index.https://clinicaltrials.gov/ct2/show/NCT05085405 | 345 |
| cited_by_percentile_year | |
| countries_distinct_count | 1 |
| institutions_distinct_count | 20 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/16 |
| sustainable_development_goals[0].score | 0.5299999713897705 |
| sustainable_development_goals[0].display_name | Peace, Justice and strong institutions |
| citation_normalized_percentile.value | 0.2032967 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |