Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial

Jacob E Kurlander; Danielle Helminski; Liyang Yuan; Sarah L Krein; Michael S M Lanham; Jennifer L Henstock; Kelley M Kidwell; Raymond De Vries; Kenneth Resnicow; Haden Sholl; Joyce J Kim; Linda K Perry; Jacqueline Parsons; Nghi Ha; James B Froehlich; James E Aikens; Caroline R Richardson; Sameer D Saini; Geoffrey D Barnes

doi:10.1016/j.rpth.2024.102421

Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial

Res Pract Thromb Haemost. 2024 Apr 26;8(4):102421. doi: 10.1016/j.rpth.2024.102421. eCollection 2024 May.

Authors

Jacob E Kurlander^{1

2

3}, Danielle Helminski¹, Liyang Yuan⁴, Sarah L Krein^{1

2

3}, Michael S M Lanham^{5

6

7}, Jennifer L Henstock⁸, Kelley M Kidwell⁴, Raymond De Vries^{2

6

9}, Kenneth Resnicow^{10

11}, Haden Sholl¹², Joyce J Kim¹, Linda K Perry¹³, Jacqueline Parsons¹³, Nghi Ha¹³, James B Froehlich^{1

2

13}, James E Aikens¹⁴, Caroline R Richardson¹⁵, Sameer D Saini^{1

2

3}, Geoffrey D Barnes^{1

2

13}

Affiliations

¹ Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
² Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan, USA.
³ Veterans Affairs Ann Arbor Center for Clinical Management Research, Ann Arbor, Michigan, USA.
⁴ Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
⁵ Department of Learning Health Sciences, University of Michigan, Ann Arbor, Michigan, USA.
⁶ Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA.
⁷ University of Michigan Office of Clinical Informatics, Ann Arbor, Michigan, USA.
⁸ Health Information Technology and Services, University of Michigan, Ann Arbor, Michigan, USA.
⁹ Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, USA.
¹⁰ Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
¹¹ University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, USA.
¹² Department of Medicine, Division of General Internal Medicine, Vanderbilt University, Nashville, Tennessee, USA.
¹³ Department of Internal Medicine, Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Michigan, USA.
¹⁴ Department of Family Medicine, University of Michigan, Ann Arbor, Michigan, USA.
¹⁵ Department of Family Medicine, Brown University, Providence, Rhode Island, USA.

Abstract

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants.

Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability.

Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews.

Results: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet's purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable.

Conclusion: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.

Keywords: anticoagulants; gastrointestinal hemorrhage; patient safety; proton pump inhibitors; quality of health care; warfarin.