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Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs

INTRODUCTION: Although shortcomings in clinician–family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive C...

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Autores principales: Lincoln, Taylor, Shields, Anne-Marie, Buddadhumaruk, Praewpannarai, Chang, Chung-Chou H, Pike, Francis, Chen, Hsiangyu, Brown, Elke, Kozar, Veronica, Pidro, Caroline, Kahn, Jeremy M, Darby, Joseph M, Martin, Susan, Angus, Derek C, Arnold, Robert M, White, Douglas B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170558/
https://www.ncbi.nlm.nih.gov/pubmed/32229520
http://dx.doi.org/10.1136/bmjopen-2019-033521
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author Lincoln, Taylor
Shields, Anne-Marie
Buddadhumaruk, Praewpannarai
Chang, Chung-Chou H
Pike, Francis
Chen, Hsiangyu
Brown, Elke
Kozar, Veronica
Pidro, Caroline
Kahn, Jeremy M
Darby, Joseph M
Martin, Susan
Angus, Derek C
Arnold, Robert M
White, Douglas B
author_facet Lincoln, Taylor
Shields, Anne-Marie
Buddadhumaruk, Praewpannarai
Chang, Chung-Chou H
Pike, Francis
Chen, Hsiangyu
Brown, Elke
Kozar, Veronica
Pidro, Caroline
Kahn, Jeremy M
Darby, Joseph M
Martin, Susan
Angus, Derek C
Arnold, Robert M
White, Douglas B
author_sort Lincoln, Taylor
collection PubMed
description INTRODUCTION: Although shortcomings in clinician–family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution. METHODS AND ANALYSIS: This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4–6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians’ workflow. The primary outcome is surrogates’ ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates’ scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses’ scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation. We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants. ETHICS AND DISSEMINATION: We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02445937
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spelling pubmed-71705582020-04-24 Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs Lincoln, Taylor Shields, Anne-Marie Buddadhumaruk, Praewpannarai Chang, Chung-Chou H Pike, Francis Chen, Hsiangyu Brown, Elke Kozar, Veronica Pidro, Caroline Kahn, Jeremy M Darby, Joseph M Martin, Susan Angus, Derek C Arnold, Robert M White, Douglas B BMJ Open Intensive Care INTRODUCTION: Although shortcomings in clinician–family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution. METHODS AND ANALYSIS: This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4–6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians’ workflow. The primary outcome is surrogates’ ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates’ scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses’ scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation. We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants. ETHICS AND DISSEMINATION: We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02445937 BMJ Publishing Group 2020-03-29 /pmc/articles/PMC7170558/ /pubmed/32229520 http://dx.doi.org/10.1136/bmjopen-2019-033521 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Intensive Care
Lincoln, Taylor
Shields, Anne-Marie
Buddadhumaruk, Praewpannarai
Chang, Chung-Chou H
Pike, Francis
Chen, Hsiangyu
Brown, Elke
Kozar, Veronica
Pidro, Caroline
Kahn, Jeremy M
Darby, Joseph M
Martin, Susan
Angus, Derek C
Arnold, Robert M
White, Douglas B
Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title_full Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title_fullStr Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title_full_unstemmed Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title_short Protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in ICUs
title_sort protocol for a randomised trial of an interprofessional team-delivered intervention to support surrogate decision-makers in icus
topic Intensive Care
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170558/
https://www.ncbi.nlm.nih.gov/pubmed/32229520
http://dx.doi.org/10.1136/bmjopen-2019-033521
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