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临床试验/NCT06596577
NCT06596577
Enrolling By Invitation
3 期

Improving the Delivery and Equity of Inpatient Palliative Care: a Hybrid Type I Pragmatic Cluster Trial

University of Pennsylvania13 个研究点 分布在 1 个国家目标入组 18,000 人2025年8月6日

概览

阶段
3 期
干预措施
Palliative care needs information
疾病 / 适应症
Serious Illness
发起方
University of Pennsylvania
入组人数
18000
试验地点
13
主要终点
Inpatient palliative care consultation
状态
Enrolling By Invitation
最后更新
4天前

概览

简要总结

This stepped-wedge, cluster randomized pragmatic trial among 9 MedStar hospitals for patients with serious illness and unmet palliative care (PC) needs will test two interventions embedded within the electronic health record (EHR): (1) a PC needs triggered alert to opt-in to PC consults nudging hospital clinicians to order specialty PC consults for eligible inpatients, and (2) a palliative care needs triggered alert with an opt-out to palliative care consults. The trial will compare the interventions effects to usual care, focusing on completed PC consults during the hospital encounter and other secondary outcomes. The trial also includes an embedded mixed methods study to explore factors influencing the effectiveness and equity of intervention implementation.

注册库
clinicaltrials.gov
开始日期
2025年8月6日
结束日期
2029年2月28日
最后更新
4天前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Katherine Courtright

Assistant Professor of Medicine

University of Pennsylvania

入排标准

入选标准

  • Age 18 years or older; AND
  • Admitted to inpatient status at 1 of the 9 participating hospitals
  • Meets validated score threshold of 8 from the MedStar unmet PC needs patient identification algorithm, utilizing empirically-derived weights for each PC need domain within the algorithm.

排除标准

  • Primary inpatient service: hospice, rehabilitation, psychiatry, obstetrics, neonatal
  • Signed hospital discharge order

研究组 & 干预措施

Palliative care needs information provision

Clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs

干预措施: Palliative care needs information

Palliative care needs information provision + default consult order

The palliative care needs information provision intervention will be supplemented with a default palliative care consult order such that clinicians will receive an EHR alert providing information about a patient's serious illness diagnosis(-es) and unmet palliative care needs, and offered the choice to cancel the default consult order.

干预措施: Default consult order

Control/Usual Care

During the control phase, patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care. All hospitals will contribute a minimum of 9 weeks of outcomes data prior to adopting the intervention. The total duration of the control phase will differ for each hospital dependent on their randomly assigned time to adopt Intervention 1 in this stepped-wedge trial design.

结局指标

主要结局

Inpatient palliative care consultation

时间窗: from enrollment up to 26 weeks

Binary: at least 1 inpatient visit from a PC specialist during the hospital encounter

次要结局

  • 30-day hospital readmission(hospital discharge through 30 days)
  • Number of readmissions(enrollment through 6 months)
  • Hospital-free days(Enrollment through 6 months)
  • Change in code status(from enrollment up to 26 weeks)
  • Time to palliative care consult(from enrollment up to 26 weeks)
  • Discharge to hospice(from enrollment up to 26 weeks)
  • Hospital length of stay(from enrollment up to 26 weeks)
  • Hospice enrollment(enrollment through 6 months)
  • Hospice duration(enrollment through 6 months)
  • Community palliative care referral(enrollment through 6 months)
  • Hospital all-cause mortality(enrollment to 1 day after hospital discharge)
  • Community palliative care referral(enrollment through 6 months)
  • Hospice enrollment(enrollment through 6 months)
  • Hospice duration(enrollment through 6 months)
  • Hospital all-cause mortality(enrollment to 1 day after hospital discharge)
  • 30-day hospital readmission(hospital discharge through 30 days)
  • Number of readmissions(enrollment through 6 months)
  • Hospital-free days(Enrollment through 6 months)
  • Change in code status(from enrollment up to 26 weeks)
  • Time to palliative care consult(from enrollment up to 26 weeks)
  • Discharge to hospice(from enrollment up to 26 weeks)
  • Hospital length of stay(from enrollment up to 26 weeks)

研究点 (13)

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