跳至主要内容
临床试验/NCT02274688
NCT02274688已完成不适用

A Comparative Effectiveness Trial of Optimal Patient-Centered Care for US Trauma Care Systems

University of Washington2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
2
主要终点
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury

研究概览

简要总结

The nation's trauma care system, which includes trauma center hospitals & emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical & mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, & community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns & preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers & policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health & patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury & recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials & standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates & best practice guidelines for post-traumatic stress disorder & alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns & integrates patient concerns & preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients & their caregivers, front-line providers & policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" & "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health & health care?"

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Seen in acute care emergency department or trauma center setting for injury
  • At least three post traumatic concerns
  • AND One of the following PTSD Checklist Score (PCL-C) greater than or equal to 35 Patient Health Questionnaire 9 - greater than or equal to 10 Any endorsement of suicidal ideation on the PhQ-9 Item 9

排除标准

  • Non-English speaking
  • Under 14 years of age
  • Incarcerated
  • Psychotic behavior
  • Suffered head, spinal cord, or other severe injuries that prevent participation in the inpatient ward interview.

研究组 & 干预措施

Enhanced Usual Care - Nurse Notification of Patient Concerns

No Intervention

Randomized and will be blindly assessed.

Patient-centered care transition

Experimental

Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.

Randomized and will be blindly assessed.

干预措施: Stepped Care Management (Behavioral)

结局指标

主要结局

Change in Post Traumatic Concerns Over the Course of the Six Months After Injury

时间窗: The investigators assessed at baseline, 1-, 3-, and 6-month.

The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.

Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury

时间窗: The investigators assessed at baseline, 1-, 3-, and 6-month.

The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.

Change in Depression Symptoms Over the Course of the Six Months After Injury

时间窗: The investigators assessed at baseline, 1-, 3-, and 6-month.

The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.

次要结局

  • Number of Participants With Suicidal Ideation(The investigators assessed at baseline, 1-, 3-, and 6-month.)
  • Alcohol Use Problems(The investigators assessed at baseline, 1-, 3-, and 6-month.)
  • Functional Status(The investigators assessed at baseline, 1-, 3-, and 6-month.)
  • Number of Patients Carrying a Weapon(The investigators assessed at baseline, 1-, 3-, and 6-month.)
  • Number of Participants With One or More Emergency Department Visits Over Time(The investigators assessed emergency department service use over the course of the study.)
  • Drug Use Problems(The investigators assessed at baseline, 1-, 3-, and 6-month.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Zatzick

Professor

University of Washington

研究点 (2)

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