Integrating machine-generated mortality estimates and behavioral nudges to promote serious illness conversations for cancer patients: Design and methods for a stepped-wedge cluster randomized controlled trial.


Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
03 2020
Historique:
received: 21 11 2019
revised: 10 01 2020
accepted: 21 01 2020
pubmed: 27 1 2020
medline: 20 5 2021
entrez: 27 1 2020
Statut: ppublish

Résumé

Patients with cancer often receive care that is not aligned with their personal values and goals. Serious illness conversations (SICs) between clinicians and patients can help increase a patient's understanding of their prognosis, goals and values. In this study, we describe the design of a stepped-wedge cluster randomized trial to evaluate the impact of an intervention that employs machine learning-based prognostic algorithms and behavioral nudges to prompt oncologists to have SICs with patients at high risk of short-term mortality. Data are collected on documented SICs, documented advance care planning discussions, and end-of-life care utilization (emergency room and inpatient admissions, chemotherapy and hospice utilization) for patients of all enrolled clinicians. This trial represents a novel application of machine-generated mortality predictions combined with behavioral nudges in the routine care of outpatients with cancer. Findings from the trial may inform strategies to encourage early serious illness conversations and the application of mortality risk predictions in clinical settings. Clinicaltrials.gov Identifier: NCT03984773.

Identifiants

pubmed: 31982648
pii: S1551-7144(20)30029-X
doi: 10.1016/j.cct.2020.105951
pmc: PMC7910008
mid: NIHMS1555713
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03984773']

Types de publication

Clinical Trial Protocol Journal Article Randomized Controlled Trial Research Support, U.S. Gov't, Non-P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

105951

Subventions

Organisme : NIGMS NIH HHS
ID : T32 GM075766
Pays : United States

Informations de copyright

Copyright © 2020 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors have no conflict of interest disclosures relevant to this project. Outside of the scope of this work, Dr. Parikh serves as a consultant for GNS Healthcare. Dr. Patel is supported by career development awards from the Department of Veterans Affairs HSR&D, and is a founder of Catalyst Health, a technology and behavior change consulting firm.

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Auteurs

Christopher R Manz (CR)

University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: Christopher.manz@pennmedicine.upenn.edu.

Ravi B Parikh (RB)

University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America; Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States of America.

Chalanda N Evans (CN)

University of Pennsylvania, Philadelphia, PA, United States of America.

Corey Chivers (C)

University of Pennsylvania Health System, Philadelphia, PA, United States of America.

Susan H Regli (SH)

University of Pennsylvania Health System, Philadelphia, PA, United States of America.

Justin E Bekelman (JE)

University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.

Dylan Small (D)

University of Pennsylvania, Philadelphia, PA, United States of America.

Charles A L Rareshide (CAL)

University of Pennsylvania, Philadelphia, PA, United States of America.

Nina O'Connor (N)

University of Pennsylvania, Philadelphia, PA, United States of America.

Lynn M Schuchter (LM)

Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.

Lawrence N Shulman (LN)

Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America.

Mitesh S Patel (MS)

University of Pennsylvania, Philadelphia, PA, United States of America; Penn Center for Cancer Care Innovation, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, United States of America; Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States of America.

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