Development and Evaluation of a Nursing Intervention in the Patient Being Discharged From the Intensive Care Unit: a Protocol for Mixed Methods Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- Change from Baseline Level of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
研究概览
简要总结
Background: Psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder (PTSD), are common among critical disease survivors. Interventions aimed to decrease ICU impact on patient mental well-being are needed.
Methods/Design: The study will evaluate an educational nursing intervention addressed to ease the transition during ICU discharge by empowering the patient. A quantitative design will be used to measure the effectiveness of the nursing intervention through an experimental pre-test/post-test with control group design.
Participants will consist of patients from three critical care units from three different hospitals.
Data will be obtained from Hospital Anxiety and Depression Scale (HADS). Data will be analysed through descriptive and inferential statistics.
Discussion: This study will help to develop and implement an intervention to help patients lessen anxiety and depression associated to their transition from ICU to the general ward.
详细描述
Method An experimental pre-test-post-test design will be used. Setting and participants The study will be carried out in the ICU of three university hospitals which have 151 level 3 ICU beds and where the nurse/patient ratio is 1:2. The three ICUs admit approximately 2000 patients per year. Participants who meet the following inclusion criteria will be included: age > 18 years; ICU stay > 48h; speaker of one of the two official languages of the region and carrying out a personal interview, Glasgow Coma Score of 15, Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) negative, and provision of signed informed consent. Patients with a pre-admission diagnosis of mental illness will be excluded.
Patients will be selected by simple random probabilistic sampling. Patients will be recruited through the ICU admission list and randomly assigned to the experimental group (EG) and the control group (CG). To calculate the sample number needed, on the basis of a statistical power of 80% and a level of confidence of 95% in a unilateral analysis, and estimating the percentage of patients who have high anxiety at ICU discharge at 50% (between 30% and 75% according to reports), a sample of 86 patients per group will be needed (assuming 15% losses per group) to detect a difference of >20% as statistically significant (expected to be 0.5 for the CG and 0.28 for the EG).
Nursing empowerment intervention The intervention will be carried out during the ICU discharge planning. A "Patient Information Guide for Intensive Care Unit patients" will be developed.
The guide will be based on the findings obtained in a previous qualitative study and on previous studies on patient empowerment and education. The guide structure will take into account the dimensions of empowerment: bio-physiological, functional, social, experience, ethics and the financial aspect. The guide will be reviewed by experts in the development of information guides for patients and family members and will be evaluated by the participating ICUs before use.
EG patients will receive the intervention verbally and in booklet format from the study nurses at each ICU. CG patients will receive the usual nursing treatment provided during ICU discharge, which usually consists of verbal information about the time and place of destination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 years
- •ICU stay > 48h
- •Speaker of one of the two official languages of the region Catalan or Spanish and carrying out a personal interview
- •Glasgow Coma Score of 15
- •Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) negative
- •Provision of signed informed consent
排除标准
- •Pre ICU admission diagnosis of mental illness
研究组 & 干预措施
Experimental Group (EG)
The nursing empowerment intervention will be administered in the experimental group
干预措施: Nursing Empowerment Intervention (Behavioral)
Control Group (CG)
The nursing empowerment intervention will not be administered in the control group
结局指标
主要结局
Change from Baseline Level of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
时间窗: 1 week
The outcome 1 will be mesured with the anxiety and depression scale (HADS) after ICU discharge. The HADS measures the current status during the last week. A value of 10 is the cut-off point between the presence or absence of anxiety and depression.
次要结局
- Level of anxiety and depression at the general ward stay assessed by Hospital Anxiety and Depression Scale(After 2 days)
- Duration of ICU stay(Up to 60 days)
- Level of anxiety and depression at ICU discharge assessed by Hospital Anxiety and Depression Scale(Up to 2 days)
- Sex: male or female(Day 1)
- Age in years(Day 1)
- Educational level: none, primary, secondary or higher(Day 1)
- Family situation: lives alone, with family or friends(Day 1)
- Marital status: single, married, cohabiting, widower or divorced(Day 1)
- Severity level at ICU admission assessed by Acute Physiology and Chronic Health Evaluation (APACHE) II(Day 1)