Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure
Introduction Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMJ Publishing Group
2022-11-01
|
Series: | BMJ Open |
Online Access: | https://bmjopen.bmj.com/content/12/11/e067258.full |
_version_ | 1811328990728683520 |
---|---|
author | Anne Buffington Daniel Lam Amar D Bansal Karlie Haug Amy Zelenski Bret M Hanlon Lily Stalter Kristine L Kwekkeboom Paul Rathouz Katharine Cheung Deidra Crews Rebecca Frazier Holly Koncicki Alvin Moss Maya Rao Dawn F Wolfgram Jeniann Yi Carrie Brill Rachael Kendrick Toby C Campbell Roy Jhagroo Margaret Schwarze |
author_facet | Anne Buffington Daniel Lam Amar D Bansal Karlie Haug Amy Zelenski Bret M Hanlon Lily Stalter Kristine L Kwekkeboom Paul Rathouz Katharine Cheung Deidra Crews Rebecca Frazier Holly Koncicki Alvin Moss Maya Rao Dawn F Wolfgram Jeniann Yi Carrie Brill Rachael Kendrick Toby C Campbell Roy Jhagroo Margaret Schwarze |
author_sort | Anne Buffington |
collection | DOAJ |
description | Introduction Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients’ decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication.Methods and analysis We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis.Ethics and dissemination Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings.Trial registration number NCT04466865. |
first_indexed | 2024-04-13T15:35:54Z |
format | Article |
id | doaj.art-d026c9fe889f4110b33cfb2d1bbeda22 |
institution | Directory Open Access Journal |
issn | 2044-6055 |
language | English |
last_indexed | 2024-04-13T15:35:54Z |
publishDate | 2022-11-01 |
publisher | BMJ Publishing Group |
record_format | Article |
series | BMJ Open |
spelling | doaj.art-d026c9fe889f4110b33cfb2d1bbeda222022-12-22T02:41:16ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-067258Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failureAnne Buffington0Daniel Lam1Amar D Bansal2Karlie Haug3Amy Zelenski4Bret M Hanlon5Lily Stalter6Kristine L Kwekkeboom7Paul Rathouz8Katharine Cheung9Deidra Crews10Rebecca Frazier11Holly Koncicki12Alvin Moss13Maya Rao14Dawn F Wolfgram15Jeniann Yi16Carrie Brill17Rachael Kendrick18Toby C Campbell19Roy Jhagroo20Margaret Schwarze21Department of Surgery, University of Wisconsin, Madison, Wisconsin, USADivision of Nephrology, University of Washington, Seattle, Washington, USADivision of Nephrology, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USADepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USAUniversity of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USADepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USAUniversity of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USADepartment of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USADivision of Nephrology, University of Vermont, Burlington, Vermont, USADivision of Nephrology, Johns Hopkins University, Baltimore, Maryland, USADivision of Nephrology, Northwestern Memorial HealthCare Corp, Chicago, Illinois, USADivision of Nephrology, Mount Sinai Health System, New York, New York, USASection of Nephrology, West Virginia University, Morgantown, West Virginia, USADivision of Nephrology, Columbia University, New York, New York, USADivision of Nephrology, Medical College of Wisconsin, Milwaukee, Wisconsin, USADepartment of Surgery, University of Colorado Health, Aurora, Colorado, USAUniversity of Colorado, Denver, Colorado, USAUniversity of Colorado, Denver, Colorado, USADepartment of Medicine, University of Wisconsin, Madison, Wisconsin, USADepartment of Medicine, University of Wisconsin, Madison, Wisconsin, USADepartment of Surgery, University of Wisconsin, Madison, Wisconsin, USAIntroduction Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients’ decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication.Methods and analysis We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis.Ethics and dissemination Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings.Trial registration number NCT04466865.https://bmjopen.bmj.com/content/12/11/e067258.full |
spellingShingle | Anne Buffington Daniel Lam Amar D Bansal Karlie Haug Amy Zelenski Bret M Hanlon Lily Stalter Kristine L Kwekkeboom Paul Rathouz Katharine Cheung Deidra Crews Rebecca Frazier Holly Koncicki Alvin Moss Maya Rao Dawn F Wolfgram Jeniann Yi Carrie Brill Rachael Kendrick Toby C Campbell Roy Jhagroo Margaret Schwarze Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure BMJ Open |
title | Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
title_full | Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
title_fullStr | Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
title_full_unstemmed | Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
title_short | Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
title_sort | best case worst case protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure |
url | https://bmjopen.bmj.com/content/12/11/e067258.full |
work_keys_str_mv | AT annebuffington bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT daniellam bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT amardbansal bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT karliehaug bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT amyzelenski bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT bretmhanlon bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT lilystalter bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT kristinelkwekkeboom bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT paulrathouz bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT katharinecheung bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT deidracrews bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT rebeccafrazier bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT hollykoncicki bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT alvinmoss bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT mayarao bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT dawnfwolfgram bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT jeniannyi bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT carriebrill bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT rachaelkendrick bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT tobyccampbell bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT royjhagroo bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure AT margaretschwarze bestcaseworstcaseprotocolforamultisiterandomisedclinicaltrialofascenarioplanninginterventionforpatientswithkidneyfailure |