Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department.
<h4>Introduction</h4>Time-limited trial (TLT) is a structured approach between clinicians and seriously ill patients or their surrogates to discuss patients' values and preferences, prognosis, and shared decision-making to use specific therapies for a prespecified period of time in...
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Public Library of Science (PLoS)
2024-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0313858 |
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| author | Tadayuki Hashimoto Rachel K Putman Anthony F Massaro Youkie Shiozawa Katherine McGough Kerry K McCabe Judith A Linden Wei Wang Shan W Liu Maura Kennedy Thanh H Neville Jacqueline M Kruser Rebecca L Sudore Mara A Schonberg James A Tulsky Kei Ouchi |
| author_facet | Tadayuki Hashimoto Rachel K Putman Anthony F Massaro Youkie Shiozawa Katherine McGough Kerry K McCabe Judith A Linden Wei Wang Shan W Liu Maura Kennedy Thanh H Neville Jacqueline M Kruser Rebecca L Sudore Mara A Schonberg James A Tulsky Kei Ouchi |
| author_sort | Tadayuki Hashimoto |
| collection | DOAJ |
| description | <h4>Introduction</h4>Time-limited trial (TLT) is a structured approach between clinicians and seriously ill patients or their surrogates to discuss patients' values and preferences, prognosis, and shared decision-making to use specific therapies for a prespecified period of time in the face of prognostic uncertainty. Some evidence exists that this approach may lead to more patient-centered care in the intensive care unit; however, it has never been evaluated in the emergency department (ED). The study protocol aims to assess the feasibility and acceptability of TLTs initiated in the ED.<h4>Methods and analysis</h4>We will conduct a parallel group, clinician-level, pilot randomized clinical trial among 40 ED clinicians. We will measure feasibility (e.g., the time it takes to conduct the TLTs by ED clinicians) and clinician and patient-reported acceptability of the TLT, and also track patients' clinical outcomes via medical record review.<h4>Discussion</h4>This study protocol will investigate the potential of TLT initiated in the ED to lead to patient-centered intensive care utilization. By doing so, the study intends to improve palliative care integration for seriously ill older adults in the ED and intensive care unit.<h4>Trial identifier and registry name</h4>ClinicalTrials.gov ID: NCT06378151 https://clinicaltrials.gov/study/NCT06378151; Pre-results; a randomized controlled trial: Time-limited Trials in the Emergency Department. |
| format | Article |
| id | doaj-art-ad5ec70972c246298b7f6c7ec63a9542 |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-ad5ec70972c246298b7f6c7ec63a95422025-02-05T05:32:18ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-011912e031385810.1371/journal.pone.0313858Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department.Tadayuki HashimotoRachel K PutmanAnthony F MassaroYoukie ShiozawaKatherine McGoughKerry K McCabeJudith A LindenWei WangShan W LiuMaura KennedyThanh H NevilleJacqueline M KruserRebecca L SudoreMara A SchonbergJames A TulskyKei Ouchi<h4>Introduction</h4>Time-limited trial (TLT) is a structured approach between clinicians and seriously ill patients or their surrogates to discuss patients' values and preferences, prognosis, and shared decision-making to use specific therapies for a prespecified period of time in the face of prognostic uncertainty. Some evidence exists that this approach may lead to more patient-centered care in the intensive care unit; however, it has never been evaluated in the emergency department (ED). The study protocol aims to assess the feasibility and acceptability of TLTs initiated in the ED.<h4>Methods and analysis</h4>We will conduct a parallel group, clinician-level, pilot randomized clinical trial among 40 ED clinicians. We will measure feasibility (e.g., the time it takes to conduct the TLTs by ED clinicians) and clinician and patient-reported acceptability of the TLT, and also track patients' clinical outcomes via medical record review.<h4>Discussion</h4>This study protocol will investigate the potential of TLT initiated in the ED to lead to patient-centered intensive care utilization. By doing so, the study intends to improve palliative care integration for seriously ill older adults in the ED and intensive care unit.<h4>Trial identifier and registry name</h4>ClinicalTrials.gov ID: NCT06378151 https://clinicaltrials.gov/study/NCT06378151; Pre-results; a randomized controlled trial: Time-limited Trials in the Emergency Department.https://doi.org/10.1371/journal.pone.0313858 |
| spellingShingle | Tadayuki Hashimoto Rachel K Putman Anthony F Massaro Youkie Shiozawa Katherine McGough Kerry K McCabe Judith A Linden Wei Wang Shan W Liu Maura Kennedy Thanh H Neville Jacqueline M Kruser Rebecca L Sudore Mara A Schonberg James A Tulsky Kei Ouchi Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. PLoS ONE |
| title | Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. |
| title_full | Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. |
| title_fullStr | Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. |
| title_full_unstemmed | Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. |
| title_short | Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. |
| title_sort | study protocol for a randomized controlled trial integrating the time limited trial in the emergency department |
| url | https://doi.org/10.1371/journal.pone.0313858 |
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