Improving Quality of Care - Managing Atrial Fibrillation Through Care Teams and Health Information Technology

NCT02734875 | Completed

• 1 other identifier: 2015P000893/BWH
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

Brief Summary

This stepped wedge randomized intervention will apply machine learning algorithms in an electronic health record system to identify primary care patients with non-valvular atrial fibrillation (AF) who are at high risk of stroke and not on anticoagulation therapy. An Anticoagulant Management Service (AMS) will offer support to primary care providers regarding treatment for relevant patients (either warfarin and novel oral anticoagulants). This study seeks to:

1. 1.increase the proportion of appropriately anticoagulated patients with AF,
2. 2.understand the reasons for lack of anticoagulation, and
3. 3.document the proportion of patients with AF who are appropriately not anticoagulated (e.g. patient refusal, contraindication).

Conditions

Atrial Fibrillation

Keywords

anticoagulants; NOACs; warfarin; randomized designed delay; intervention; machine learning algorithm; primary care

Outcome Measures

Primary Outcomes (1)

• Anticoagulation therapy

  the proportion of eligible patients who initiate anticoagulation therapy following randomization to intervention or usual care

  randomization to 1 month post randomization

Study Arms (2)

Intervention

EXPERIMENTAL

Primary care providers in the intervention arm will receive lists of their patients with AF who are identified as being at high risk of stroke but not currently on anticoagulation therapy. Along with this list, which includes information on risks and benefits of anticoagulation, primary care providers will receive an offer of assistance from a respected Anticoagulation Management Service within the hospital network to help manage anticoagulation for referred patients.

Other: Intervention

Usual Care

NO INTERVENTION

Primary care providers will provide usual care.

Interventions

Intervention OTHER

The intervention arm offers primary care providers additional information on patient risks and benefits as well as an offer of assistance with managing a patient's anticoagulation from a respected service at BWH.

Also known as: Anticoagulant

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-valvular atrial fibrillation as identified by machine learning algorithms
• Primary care provider within Brigham and Women's Hospital
• No evidence of a prescription for an anticoagulant in medical record for at least 1 year

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Methods; Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical School and Associate Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share