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

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; Kenneth Resnicow; Allison Laboon Ruff; David M Wallace; Elizabeth K Jones; Linda K Perry; Jacqueline Parsons; Nghi Ha; Tina Alexandris-Souphis; Dale Dedrick; Elizabeth Aldridge; Geoffrey D Barnes

doi:10.1186/s43058-022-00256-8

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

Implement Sci Commun. 2022 Jan 28;3(1):8. doi: 10.1186/s43058-022-00256-8.

Authors

Jacob E Kurlander^{1

2

3}, Danielle Helminski⁴, Michael Lanham^{5

6

7}, Jennifer L Henstock⁸, Kelley M Kidwell⁹, Sarah L Krein^{4

10

11}, Sameer D Saini^{4

10

11}, Caroline R Richardson^{10

12}, Raymond De Vries^{10

6

13}, Kenneth Resnicow^{14

15}, Allison Laboon Ruff⁴, David M Wallace⁴, Elizabeth K Jones⁴, Linda K Perry¹⁶, Jacqueline Parsons¹⁶, Nghi Ha¹⁶, Tina Alexandris-Souphis¹⁶, Dale Dedrick¹⁶, Elizabeth Aldridge¹⁶, Geoffrey D Barnes^{4

10

16}

Affiliations

¹ Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA. jkurland@umich.edu.
² Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA. jkurland@umich.edu.
³ Veterans Affairs (VA) Ann Arbor Center for Clinical Management Research, Ann Arbor, MI, USA. jkurland@umich.edu.
⁴ Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
⁵ Department of Learning Health Sciences, University of Michigan, Ann Arbor, MI, USA.
⁶ Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA.
⁷ University of Michigan Office of Clinical Informatics, Ann Arbor, MI, USA.
⁸ Health Information Technology and Services, University of Michigan, Ann Arbor, MI, USA.
⁹ Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
¹⁰ Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.
¹¹ Veterans Affairs (VA) Ann Arbor Center for Clinical Management Research, Ann Arbor, MI, USA.
¹² Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
¹³ Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI, USA.
¹⁴ Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.
¹⁵ University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
¹⁶ Frankel Cardiovascular Center, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Abstract

Background: The concomitant 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 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 the design of a pilot pragmatic implementation trial.

Methods: A 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.

Discussion: This 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 the use of best practices for upper GI bleeding risk reduction.

Trial registration: ClinicalTrials.gov NCT05085405 . Registered on October 19, 2021-retrospectively registered.

Keywords: Anticoagulation; Gastrointestinal hemorrhage; Gastroprotection; Guideline adherence; Implementation science; Nurse facilitation; Patient activation; Patient safety; Proton pump inhibitors; Quality of health care; Warfarin.

Associated data

ClinicalTrials.gov/NCT05085405

Abstract

Associated data

Grants and funding