ACTRN12619001341112终止未知
A parallel randomised controlled trial of stepped care case management compared with enhanced usual care to reduce posttraumatic stress and pain-related disability after major trauma: A feasibility study
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •The recruiting study team will consult regularly with the trauma team to identify recent trauma admissions, and will review Electronic Medical Records (EMR) to identify cases who meet the following inclusion criteria:
- •Aged >16 years old at the time of injury
- •Survive to hospital discharge
- •Speak English
- •Major trauma defined by trauma admission with one or more of the following criteria following injury admission:
- •Provisional ISS>12
- •Urgent Surgery for intracranial, intrathoracic or intra-abdominal injury, or for fixation of pelvic or spinal fractures
- •ICU admission for more than 24 hours with mechanical ventilation
- •Patients will be eligible for interview screening if they meet the following risk criteria for PTSD AND/OR Persistent Pain.
- •RISK CRITERIA for PTSD (3 or more of the following criteria are indicated (clinical and socioeconomic):
- •Clinical PTSD risk criteria:
- •1.Pre-existing PTSD diagnosis at admission
- •2.Any other psychiatric diagnosis at admission
- •3.Any substance use disorder diagnosis or positive BAC or illicit drug test on admission
- •4.Current or prior tobacco use
- •5.Intentional injury
- •6.Intensive care unit (ICU) admission with mechanical ventilation
- •7.One or more prior trauma hospital admissions
- •8.A death occurred in the injury event
- •Socioeconomic risk criteria:
- •1.Funding source: Transport Accident Commission or WorkSafe Victoria
- •2.Non-male gender
- •3.Non-white ethnicity
- •4.Middle aged (35 to 65 years)
- •5.Socioeconomic disadvantage (e.g., unemployed, living in a disadvantaged neighbourhood (IRSAD state decile ranking < 5), unemployed, report being at risk of job loss)
- •PAIN RISK CRITERIA (one or more of the following clinical criteria are indicated):
- •1.Neuropathic injury
- •2.Prior psychiatric or substance use condition
- •a.Pre-existing PTSD diagnosis at admission
- •b.Any other psychiatric diagnosis at admission
- •c.Any substance use disorder diagnosis or positive BAC or illicit drug test on admission
- •3.Prior chronic pain
- •4.Prior treatment for opioid-addiction disorder
- •a.Methadone or buprenorphine treatment pre-injury
- •5.Intense post-injury or post-surgical pain:
- •a.Persistent intense pain requiring breakthrough analgesia beyond expected level for injury
- •b.Acute pain consultations at or after discharge for severe pain
- •c.Patient is medically stable but discharge is delayed due to complex pain
- •6.High post-injury opioid consumption
- •a.>= 90 mg/day of oral morphine equivalence post-discharge
- •b.Prescription for a long acting opioid medication at or post-discharge
- •c.Referral for interventional postsurgical procedures for pain (e.g., stump catheters for post-amputation)
- •7.Patient displays or reports high levels of distress
- •Patients who meet the above criteria will then undergo an interview screen, Any one of the following criteria warrant enrollment:
- •1.Severe and/or disabling pain (PEG>=4)
- •2.Post-injury pain has neuropathic qualities (DN4>=3)
- •3.Clinically elevated psychological symptoms
- •a.PTSD (PCL-C>=35)
- •b.Depression (PHQ>14)
- •c.Suicidality: (PHQ item 9>=1)
- 另有 3 项未显示
排除标准
- •Potential participants will be excluded if they:
- •Have recorded that they do not want to be contacted about research projects at Alfred Health
- •Do not have a Medicare number
- •Have no capacity to give consent due to:
- •Sustained moderate to severe brain injury (i.e., GCS 3 – 12 and head AIS>2)
- •Temporary incapacity (e.g., due to intoxication, delirium or medication side-effects)
- •Permanent cognitive impairment (e.g., dementia or Alzheimer’s Disease)
- •Moderate to severe cognitive impairment (i.e., a score of >=5 on the SPMSQ)
- •Were injured during an episode of suicidal or non-suicidal self-harm
- •Were injured during an episode of acute psychosis, while committing a crime, or while incarcerated
- •Have a history of violence (as a perpetrator of violent crime or harm to others) or behave violently during the hospital admission.
- •Have no usual place of residence or no regular means for contact at baseline (e.g., no mobile or landline telephone).
- •* Patients aged 65 and over injured in a low fall
- •* People with posttraumatic amnesia of more than 24 hours
- •* People with a pre-existing case manager
研究者
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