Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Feasibility - enrollment of 1-2 participants per month
研究概览
简要总结
The main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control trial.
(1) The investigators hypothesize that subjects exposed to a psychoeducation condition will have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary + psychoeducation condition will have significantly lower rates of PTSD compared to those in the ICU diary alone condition.
详细描述
This is a randomized controlled pilot study involving patients who are in the ICU, for a minimum of 72 hrs with > 24 hrs mechanical ventilation. As is common in ICU research, proxy consent will be obtained from family members upon ICU admission. Patients will be randomized to 4 different conditions (1) treatment as usual (TAU) (2) ICU diary (3) psychoeducation (4) ICU diary + psychoeducation. The ICU diary will be created and maintained by nurses and family members for each patient randomized to condition (2) and (4), and will be given to patients by a research nurse upon discharge from the ICU. The patients in conditions (3) and (4) will receive a psychoeducational brochure detailing general treatment and sedation patients receive in the ICU, and the psychological symptoms such as depression and PTSD that can occur after a stay in the ICU. This brochure will also be sent to their follow-up physician. Patients in all conditions will be assessed at one week post-ICU for recollection of delusional memories using ICU Memory Tool (ICUMT), at one- and three-month post-ICU for baseline PTSD symptoms using Impact of Events Scale-Revised (IES-R), a commonly used measure of PTSD symptomatology, as well as measures of anxiety/depression, social support, and general health. At one and three month follow-up, the investigators will also ask patients if they had contact with their health care providers/follow-up physicians, sought mental health treatment, their general impressions of the intervention they received (diary, psychoeducation, both), and whether/how often they reviewed the document (if in conditions 2-4). The investigators will ascertain feasibility from the health care provider and family perspective by appending a short questionnaire to the diary, to be filled out each time an entry is made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 17 years
- •enrolment within 72 hours of ICU admission
- •time of ICU stay is predicted to be >72 hours by ICU treatment team
- •greater than 24 hours mechanical ventilation required
- •understand verbal and written English
排除标准
- •no caregiver/family available
- •terminal illness with life expectancy of less than 6 months
- •pre-existing cognitive impairment
- •less than 24 hours of mechanical ventilation
- •reason for ICU admission is suicide attempt / overdose
研究组 & 干预措施
ICU Diaries
A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Instructions will be provided to the patient's family at the time of randomization and will be available at the bedside for reference. Staff instructions will be posted at charting area for staff. During the patient's stay in ICU, the diary will never leave the unit. Under no circumstances will any part of an ICU diary be duplicated. Research staff will take a photograph of the patient after consent is obtained and the photograph will be mounted on the first page of the diary. Photographs will be taken with a Polaroid camera; therefore there will be no other record of the photograph.
干预措施: ICU Diary (Behavioral)
Psychoeducation
The research nurse will provide a psychoeducational brochure to study participants at ICU discharge (if cognitive capacity is established) or 30 days after ICU discharge. If participants are not well enough 30 days post-discharge, they will be assessed every two weeks by research staff until the brochure is given to them. The brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions. The document will also be mailed to the participant's follow-up physician.
干预措施: Psychoeducation (Behavioral)
ICU Diary plus Psychoeducation
Participants will receive both ICU diary and psychoeducation interventions, with both documents provided at ICU-discharge, or 30 days post-discharge as above.
干预措施: ICU Diary (Behavioral)
ICU Diary plus Psychoeducation
Participants will receive both ICU diary and psychoeducation interventions, with both documents provided at ICU-discharge, or 30 days post-discharge as above.
干预措施: Psychoeducation (Behavioral)
Treatment as Usual
No additional intervention to usual ICU care will be given.
结局指标
主要结局
Feasibility - enrollment of 1-2 participants per month
时间窗: One year
To test the feasibility of ICU diaries in a Canadian ICU setting by asking nurses and family members about the process of creating the diary. Specifically, feasibility of diary will be determined by a survey about the usability, time spent, and general comments on using the diary. Surveys will be filled by each individual making a diary entry (visitors and hospital staff).
次要结局
- Efficacy at 90 days as determined by Impact of Event Scores (IES-R)(90 days)
- Change in IES-R 30 days post ICU discharge and access to follow up care at 90 days post ICU discharge(30 and 90 days post ICU Discharge)
- IES-R score of family member at 30 days post patient ICU discharge(30 days post ICU discharge)