An interventional study of Nursing Empowerment Intervention in Anxiety and Depression, sponsored by Hospital Clinic of Barcelona. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Supportive care
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.
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.
Variables:
Data will be collected using a first contact with the patient in the ICU, and the study objectives and informed consent will be explained.
The researcher will administer the HADS scale to the EG and CG groups before ICU discharge and after ICU discharge (in the destination ward).
Instruments:
Data analysis The data will be analysed using the SPSS v23 statistical package. A descriptive analysis of the study variables will be made (means and standard deviation and medians and 25-75 percentiles (IQR) for quantitative variables according to the normality of distribution, and frequencies and percentages for qualitative variables). The possible relationship between sociodemographic and clinical variables and the level of anxiety and depression will be analysed using Pearson's correlation coefficient, the Student's t test and ANOVA or their nonparametric equivalents based on the type of variable and its distribution and the number of subgroups compared. The chi square test will be used to compare the variation in categorical variables between the EG and CG. The Mann-Whitney test or the Wilcoxon test will be used to compare the mean anxiety scale score between EG and CG. Statistical significance will be established as p ≤ 0.05.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 178 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
The nursing empowerment intervention will be administered in the experimental group
Behavioral: Nursing Empowerment Intervention
The nursing empowerment intervention will not be administered in the control group
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. Its 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.
Change from Baseline Level of anxiety and depression assessed by Hospital Anxiety and Depression Scale.
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.
Time frame: 1 week
Level of anxiety and depression at ICU discharge assessed by Hospital Anxiety and Depression Scale
The outcome 2 will be mesured with the anxiety and depression scale (HADS) during 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.
Time frame: Up to 2 days
Level of anxiety and depression at the general ward stay assessed by Hospital Anxiety and Depression Scale
The outcome 3 will be mesured with the anxiety and depression scale (HADS) at the general ward. 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.
Time frame: After 2 days
Severity level at ICU admission assessed by Acute Physiology and Chronic Health Evaluation (APACHE) II
APACHE II is a clinical variable. It will be used to measure and evaluate the severity of the critically ill. It classifies disease severity using 12 usual physiological measures, the previous health status and age, with a score ranging from 0 to 71 points.
Time frame: Day 1
Duration of ICU stay
Duration of ICU stay is a clinical variable. This variable indicates how many days the patients needs to recovery from critically ill.
Time frame: Up to 60 days
Sex: male or female
Sex is a sociodemographic variable. Acording to the literature, female sex presents more ansiety and depression than male sex.
Time frame: Day 1
Age in years
Sociodemographic variable
Time frame: Day 1
Educational level: none, primary, secondary or higher
Sociodemographic variable
Time frame: Day 1
Family situation: lives alone, with family or friends
Sociodemographic variable
Time frame: Day 1
Marital status: single, married, cohabiting, widower or divorced
Sociodemographic variable
Time frame: Day 1
Plan to share: No
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Hospital Clinic of Barcelona