Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol

Introduction The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques...

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Main Authors: Ambrose H Wong, Edward R Melnick, James D Dziura, Steven L Bernstein, Kimberly A Yonkers, Karthik Adapa, Bidisha Nath, Rebekah Heckmann, Dhruvil Shah, Anusha Kumar, Morgan Brinker, Isaac V Faustino, Michael Boyce, Richard Andrew Taylor, Polina Ovchinnikova, Terika McCall
Format: Article
Language:English
Published: BMJ Publishing Group 2024-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/2/e082834.full
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author Ambrose H Wong
Edward R Melnick
James D Dziura
Steven L Bernstein
Kimberly A Yonkers
Karthik Adapa
Bidisha Nath
Rebekah Heckmann
Dhruvil Shah
Anusha Kumar
Morgan Brinker
Isaac V Faustino
Michael Boyce
Richard Andrew Taylor
Polina Ovchinnikova
Terika McCall
author_facet Ambrose H Wong
Edward R Melnick
James D Dziura
Steven L Bernstein
Kimberly A Yonkers
Karthik Adapa
Bidisha Nath
Rebekah Heckmann
Dhruvil Shah
Anusha Kumar
Morgan Brinker
Isaac V Faustino
Michael Boyce
Richard Andrew Taylor
Polina Ovchinnikova
Terika McCall
author_sort Ambrose H Wong
collection DOAJ
description Introduction The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes.Methods and analysis This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial.Ethics and dissemination Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications.Trial registration number NCT04959279; Pre-results.
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spelling doaj.art-9f79eb68562745e6b840775b6b070a692024-03-07T21:45:08ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-082834Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocolAmbrose H Wong0Edward R Melnick1James D Dziura2Steven L Bernstein3Kimberly A Yonkers4Karthik Adapa5Bidisha Nath6Rebekah Heckmann7Dhruvil Shah8Anusha Kumar9Morgan Brinker10Isaac V Faustino11Michael Boyce12Richard Andrew Taylor13Polina Ovchinnikova14Terika McCall15Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USAYale New Haven Health System, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USADepartment of Psychiatry, University of Massachusetts System, Worchester, Massachusetts, USACarolina Health Informatics Program, University of North Carolina System, Chapel Hill, North Carolina, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USADepartment of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USAYale New Haven Health System, New Haven, Connecticut, USAYale New Haven Health System, New Haven, Connecticut, USADepartment of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USADepartment of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USAIntroduction The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes.Methods and analysis This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial.Ethics and dissemination Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications.Trial registration number NCT04959279; Pre-results.https://bmjopen.bmj.com/content/14/2/e082834.full
spellingShingle Ambrose H Wong
Edward R Melnick
James D Dziura
Steven L Bernstein
Kimberly A Yonkers
Karthik Adapa
Bidisha Nath
Rebekah Heckmann
Dhruvil Shah
Anusha Kumar
Morgan Brinker
Isaac V Faustino
Michael Boyce
Richard Andrew Taylor
Polina Ovchinnikova
Terika McCall
Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
BMJ Open
title Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
title_full Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
title_fullStr Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
title_full_unstemmed Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
title_short Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
title_sort formative evaluation of an emergency department clinical decision support system for agitation symptoms a study protocol
url https://bmjopen.bmj.com/content/14/2/e082834.full
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