Evidence map›Paper›PMID 37758967›Full record

Trial reportJournal of general internal medicine2023

Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants.

Alok Kapoor, Parth Patel, Daniel Mbusa, Thu Pham, Carrie Cicirale, Wenisa Tran, Craig Beavers, Saud Javed, Joann Wagner, Dawn Swain and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of general internal medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04068727 (Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04068727 nacompletednot on this map

Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs

TypeinterventionalSponsorUniversity of Massachusetts, WorcesterRan2019 to 2022Enrolled561ConditionsCardiovascular Diseases, Venous Thromboembolism, Atrial Fibrillation, BleedingArmsClinical Pharmacist Intervention
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 1 country.

Alok KapoorUMass Chan Medical School, Worcester, MA, USA. alok.kapoor@umassmemorial.org.ORCID 0000-0003-1300-7124
Parth PatelUMass Chan Medical School, Worcester, MA, USA.
Daniel MbusaUMass Chan Medical School, Worcester, MA, USA.
Thu PhamUMass Chan Medical School, Worcester, MA, USA.
Carrie CiciraleBarnes-Jewish Hospital, One Barnes Jewish Hospital Plaza, St. Louis, MO, USA.
Wenisa TranUMass Memorial Medical Center, Worcester, MA, USA.
Craig BeaversUniversity of Kentucky, Lexington, KY, USA.
Saud JavedUMass Chan Medical School, Worcester, MA, USA.
Joann WagnerUMass Chan Medical School, Worcester, MA, USA.
Dawn SwainBouve College of Health Sciences, Northeastern University , Boston, MA, USA.
Sybil CrawfordTan Chingfen Graduate School of Nursing, UMass Chan Medical School, Worcester, MA, USA.
Chad DarlingUMass Chan Medical School, Worcester, MA, USA.
Mayuko ItoFuKunagaUMass Chan Medical School, Worcester, MA, USA.
David McManusUMass Chan Medical School, Worcester, MA, USA.
Kathleen MazorUMass Chan Medical School, Worcester, MA, USA.
Jerry GurwitzUMass Chan Medical School, Worcester, MA, USA.
University of Massachusetts Chan Medical School · USUMass Memorial Health Care · USBarnes-Jewish Hospital · USNortheastern University · USUniversity of Kentucky · US

Funding

AHRQ HHS R18HS02592401
6 · The paper itself

Abstract

backgroundAnticoagulants including direct oral anticoagulants (DOACs) are among the highest-risk medications in the United States. We postulated that routine consultation and follow-up from a clinical pharmacist would reduce clinically important medication errors (CIMEs) among patients beginning or resuming a DOAC in the ambulatory care setting.

objectiveTo evaluate the effectiveness of a multicomponent intervention for reducing CIMEs.

designRandomized controlled trial.

participantsAmbulatory patients initiating a DOAC or resuming one after a complication.

interventionPharmacist evaluation and monitoring based on the implementation of a recently published checklist. Key elements included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests. CONTROL: Coupons and assistance to increase the affordability of DOACs. MAIN MEASURE: Anticoagulant-related CIMEs (Anticoagulant-CIMEs) and non-anticoagulant-related CIMEs over 90 days from DOAC initiation; CIMEs identified through masked assessment process including two physician adjudication of events presented by a pharmacist distinct from intervention pharmacist who reviewed participant electronic medical records and interview data. ANALYSIS: Incidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling. KEY

resultsA total of 561 patients (281 intervention and 280 control patients) contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs (0.95 per 100 person-days). Failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs were the most common anticoagulant-related CIMEs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients (IRR 1.17; 95% CI 0.98-1.42) or non-anticoagulant-related CIMEs (IRR 1.05; 95% CI 0.80-1.37).

conclusionA multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs. NIH TRIAL NUMBER: NCT04068727.

Indexed as

AnticoagulantsPharmacistsAdministration, OralAmbulatory CareElectronic Health RecordsHumansMedication ErrorsAnticoagulantsadverse eventsambulatory careepidemiology and detectionmedication safetypharmaciststransitions in care

Identifiers

PMID37758967
PMCPMC10713923
OpenAlexW4387093218

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.