A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients: The Palliative Connect Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,884
- 试验地点
- 2
- 主要终点
- Hospital-free days
研究概览
简要总结
This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Inpatient or observation admission status at a study hospital
- •Predicted 6-month mortality risk moderate (e.g., ≥40%) or higher
排除标准
- •Under 18 years of age
- •Inpatient primary service: hospice, rehabilitation, obstetrics, psychiatry
- •Patients that have died or been discharged before 0800 on hospital day 3 when the mortality risk is generated and enrollment occurs
研究组 & 干预措施
Intervention
The study's intervention is a prognostic-triggered EHR alert to nudge clinicians to provide generalist or specialist PC. The alert notifies the clinician that the patient is likely to benefit from PC, and requires clinicians to actively choose to provide generalist PC themselves, consult PC specialist, or to defer PC. If a clinician chooses to consult specialist PC, a second alert will fire that enables them to easily and quickly place the consult order. The alert will trigger for all patients with moderate or higher 6-month mortality risk on second full hospital day at 8AM.
干预措施: Generalist + Specialist palliative care (Behavioral)
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. The length of the control phase will differ at each hospital dependent on the sequence in which hospitals are randomly assigned to switch to the intervention phase. All hospitals contribute a minimum of 15 weeks of outcomes data prior to adopting the intervention.
干预措施: Pre-Intervention phase (Behavioral)
结局指标
主要结局
Hospital-free days
时间窗: 6 months
Days from enrollment spent alive and not in an acute care hospital through 6 months or death
次要结局
- McGill Quality of Life-Revised(1 month)
- McGill Quality of Life-Revised(3 months)
- Pain scores(up to 6 weeks)
- Hospice enrollment(up to 6 weeks)
- Goals of Care (GOC) conversation within a discrete GOC note type(up to 6 weeks)
- Time to palliative care consult(up to 6 weeks)
- Hospital length of stay(up to 6 weeks)
- Hospital all-cause mortality(up to 6 weeks)
- Hospital discharge disposition written in discharge order(up to 6 weeks)
- Future acute care costs(enrollment to 6 months post hospital discharge)
- Goal-concordant care(enrollment to 6 months post hospital discharge)
- CMS-MACRA PC Quality(1 month)
- Palliative care consultation note(up to 6 weeks)
- Change in code status found in chart documentation(up to 6 weeks)
- Intensive care unit admission(up to 6 weeks)
- 180-day all cause mortality(180 days)
- Home or clinic palliative care referral(up to 6 weeks)
- 30-day hospital readmission(30 days)
- Hospital total costs(up to 6 weeks)
- McGill Quality of Life-Revised(6 months)
研究者
Katherine Courtright
Assistant Professor of Medicine
University of Pennsylvania