Feasibility And Acceptability of a Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F): Pilot Study
Feasibility And Acceptability of a Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F): Pilot Study
Admission of a loved one to the intensive care unit (ICU) is a highly stressful experience for family members and caregivers. Many caregivers report increased levels of anxiety, stress, and depressive symptoms, often due to uncertainty about the patient's condition and difficulties in understanding medical information. Improving communication and providing clear, structured information may help reduce this psychological burden.
This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a nurse-led educational intervention called "Nurses for Family" (N4F), designed to support caregivers of ICU patients.
The study will include adult caregivers (aged 18 years or older) of patients admitted to the ICU for more than 24 hours. Participants must provide informed consent and be able to complete questionnaires independently. A total of 20 participants will be enrolled and allocated to one of two groups: an intervention group (receiving nurse-led educational support) or a control group (receiving standard care).
Data will be collected at two time points during the ICU stay. At baseline (24-48 hours after ICU admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), which measures symptoms of anxiety and depression. At follow-up (7 days later), participants will complete the HADS again, along with the Family Satisfaction in the ICU (FSICU-24) questionnaire. Feasibility will be assessed based on recruitment and retention rates, adherence to the study protocol, and completeness of data collection. Acceptability will be evaluated through interviews conducted with participants from the control group.
This pilot study is expected to determine whether the N4F intervention is feasible and acceptable in a clinical setting and to provide preliminary evidence regarding its potential to reduce psychological distress and improve satisfaction among caregivers of ICU patients.
Aim: This study was designed to investigate the feasibility, acceptability, and preliminary efficacy of a nurse-led educational intervention for caregivers of ICU patients (Nurses for Family - N4F).
Design: This pilot study will use a single-center, prospective, non-randomized, quasi-experimental design.
Method: Caregivers of adult patients hospitalized in the ICU for more than 24 hours will be included in the study. Participants will be persons aged ≥18 years who meet the definition of a caregiver, provide informed consent to participate in the study, and are able to complete the questionnaires independently. Caregivers under the age of 18, with cognitive impairments, who do not consent to participate in the study, or who are unable to complete the questionnaires will be excluded from the study. Participants will be allocated either to the intervention group and receive the nurse-led educational intervention or to the control group and receive usual care. The acceptability of the intervention will be assessed based on interviews with participants in the control group, and feasibility will be evaluated according to criteria including recruitment, retention, protocol adherence, and data completeness (≥80% recruitment and completion rates, ≥90% protocol adherence, ≤15% missing data). Data will be collected at two time points during the patient's ICU stay. At T1 (24-48 hours after admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire measuring psychological distress. At T2 (7 days after the intervention), participants will complete both the HADS and the FSICU-24 questionnaire. The data collection procedure will include standardized methods, such as clinical information, questionnaires, and interviews with patients' families (control group), in accordance with the study protocol. A sample of 20 caregivers was selected for the study: 10 in the intervention group and 10 in the control group. This sample size was selected based on pilot study literature and is considered adequate to report feasibility, acceptability, and preliminary efficacy.
Results: The pilot study is expected to confirm the feasibility and acceptability of a nurse-led educational intervention for caregivers of intensive care unit patients. Preliminary effects regarding the reduction of symptoms of anxiety and depression among caregivers and increased caregiver satisfaction will also be explored.
Inclusion Criteria:
Patients:
Caregivers:
Exclusion Criteria:
Patients:
Caregivers: