Effectiveness of a Multimodal Delirium Prevention Bundle on occurrence of delirium, cognitive function, Post traumatic stress disorder, health related Quality of Life and clinical outcomes among Patients on mechanical ventilator in a selected tertiary care hospital, Coimbatore.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of agitation and delirium among patients in control and experimental group.
研究概览
简要总结
Primary objective 1. Evaluate the effectiveness of multimodal delirium prevention bundle on delirium occurrence, cognitive function and clinical outcomes among patients on mechanical ventilator admitted in an Intensive care unit.
Secondary Objectives 1. Evaluate the effectiveness of multimodal delirium prevention bundle on Post traumatic stress disorder and health related quality of life among patients on mechanical ventilator admitted in an Intensive care unit.
2. Associate the delirium occurrence and selected clinical outcomes with the demographic variables.
3. Determine the association of demographic and clinical variables with cognitive function, Post traumatic stress disorder and Health related Quality of life of patients on mechanical ventilator.
HYPOTHESIS H1 There will be a significant difference in Agitation scores and the Occurrence of delirium before and after implementation of Multimodal delirium prevention bundle among patients on mechanical ventilation assistance in an Intensive care unit.
H2 There will be a significant difference between Agitation and the Occurrence of delirium before and after implementation of conventional existing care bundle among patients on mechanical ventilator admitted in an Intensive care unit.
H3 There will be a significant difference in the delirium occurrence, cognitive function, and selected clinical outcome between patients who receive existing conventional care bundle and those who receive multimodal delirium prevention bundle.
H4 There will be a significant difference in the Post traumatic stress disorder and health related quality of life between patients who receive conventional existing care bundle and those who receive multimodal delirium prevention bundle.
Plan for Implementation of Intervention The participants in both the ICUs ICU I and ICU II will be allocated to control group once they fulfil the inclusion criteria. The nurses in both the ICUs will assess agitation and delirium status of the participants using RASS and ICDSC checklist. participants in control group will receive the conventional care with the existing bundle till they are transfered out from ICU. Posttest assessment on RASS score and the ICDSC score will be done on every 2nd day and at the time of transfer out from the ICUs. Posttest assessment on cognition functioning and Post traumatic stress disorder will be done at the time of hospital discharge and also at one month of post hospital discharge. Participants health related Quality of Life will be assessed at three months of post hospital discharge.
After two weeks of exclusive training on implementation of multimodal delirium prevention bundle for both the ICU nurses by the researcher, the participants from both the ICUs ICU I and ICU II will be allocated to experimental group once they fulfill the inclusion criteria. The nurses in both the ICUs will assess the agitation and delirium status of the participants in the experimental group, While nursing the participants in the experimental group the nurses will spend time with the participants by talking about the day, date, time and place, discuss the current events what is going on around them, and provide care giver name, place calendar and clock in patient room. Will encourage communication using communication boards while patient is on mechanical ventilator and will provide reorientation to patient about time, place and persons. Sleep hygiene of the participants will be maintained by providing ear plugs, maintaining silence by placing speak softly sign boards, monitoring and maintaining sound level of less than 40 dB as per WHO recommendations inside ICU using sound level meter with proper alarm management for noise control, will provide day and night variations by providing eye-shields and switching off of bright lights during sleep hours (11pm -5 am),
‘Time-out” to minimize the interruption of sleep. No procedure or any interventions will be allowed between 11pm - 5 am. (unless emergency).
Family members will be allowed to visit and talk to the participant for 15 minutes daily three times a day between 6 am-7 am morning, 12.30 pm-1.30 pm during afternoon and between 6.30 pm- 7.30 pm in the evening. Family members will be allowed to perform small acts like holding hands, limb massaging, hair combing under the supervision of the ICU staff and will also ensure 15 minutes of time period will be given for the family member to show their love and affection. Family members will be encouraged to show some photos of their loved ones to make them to recall and also to talk about their favorite topics , events which they like the most.
Will Gain insight into patients need by acknowledging the participants personal needs and sensory needs will be met by providing hearing aids and eye glasses. Will encourage them to read newspapers. Participant habits will be addressed and met with an attempt to bring their routine by providing music therapy (will play their favorite music using ear phones), placing their loved objects , photos at the bedside and showing them frequently and use scents with the fragrance they prefer.
These multimodal delirium prevention bundle with non -pharmacological interventions will be carried out daily during morning for the participants in the experimental group by the staff nurses trained in implementing the multimodal delirium prevention bundle who nurses the participants till they are discharged from ICU. Posttest assessment on RASS score and the ICDSC score will be done on every 2nd day and at the time of transfer out from ICU. Posttest assessment on Cognition functioning and Post traumatic stress disorder will be done at the time of hospital discharge and also at one month of post hospital discharge. Participants health related Quality of Life will be assessed at three months of post hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients on mechanical ventilator for more than 24 hours in ICU Patients who are admitted in ICU for the first time Patients with RASS score of -3 to + 4 and GCS score of 8-10 T.
排除标准
- •Patients who had the history of mental illness including Para suicidal The patients who have previous history of ICU admission Patients with history of head injury Patients with known thyroid, adrenal and parathyroid disorders Patients who had the history of substance abuse like alcohol, drugs etc.
结局指标
主要结局
Incidence of agitation and delirium among patients in control and experimental group.
时间窗: Assessment of agitation and delirium on every 2nd day till the participant is transferred out from ICU and at the time of transfer out of ICU
次要结局
- cognitive function, post traumatic stress disorder & quality of life of patients in both control & experiment group(assessment of cognitive function & Post traumatic stress disorder at the time of hospital discharge & at one month post hospital discharge assessment of Health related Quality of Life at three month of post hospital discharge)
研究者
Ramani R
KMCH College of Nursing
