Clinical trial NCT04311190: Family Engagement in Intensive Care Unit
Official title: Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Care
Intensive Care Unit
Nurse's Role
Family Members
Lead sponsor: University of Udine
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesized that engaging families in the care of critically ill patients could improve outcome both at the family and at the patient levels. Thus, the aim of this project is to assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life.

Detailed description: Despite the health care professionals should consider the active involvement of families in Intensive Care Unit (ICU), little research investigating family member's contributions to care, including its outcomes on family itself and on patient care, has been rendered available. To assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life. A quasi-experimental study with two non-randomized groups (94 per each group) will be performed in two general ICUs of an Academic Italian Hospital. The intervention will be carried out in a single ICU and consists of family members' involvement in the care of their beloved one with bed physical exercises and simple care tasks. Participants will be assessed for outcomes including the family satisfaction, assessed with the FS-ICU tool within 48 hours after the patient's discharge from ICU, the patient's sense of well-being, measured with a visual analogue scale within 30 minutes after the time period of a visit, and the quality of life, investigated with the SF-12 questionnaire within the first 48 hours after admission in ICU, at three and six months after ICU discharge by telephone. First, this study constitutes a significant step in a research agenda aimed at deepening the nursing sensitive outcomes in ICUs and the quality of hospital care. Secondly, result from this study may have the potential to better understand how families may modify patients' outcomes and whether the family members would benefit from an engagement program.

Eligibility criteria: Inclusion Criteria:

PATIENT

* 18 years of age and older;
* expected to stay in-ICU at least three days;
* with high or low acuity conditions.

FAMILY MEMBER

* being the patient's spouse, or in a blood relation, or next of kin, and/or with whom the patient spends most of the time;
* 18 of age or above;
* willing to visit the patient on a daily basis;
* willing to participate in the study.

Exclusion Criteria:

PATIENT Patients' discharge from ICU, transfer to another hospital, or death.

FAMILY MEMBER The unexpected suspension of visiting their loved ones in ICU daily

Primary outcomes:
measure: Family satisfaction (FS)
timeFrame: Within 48 hours after the patient's discharge from ICU
Secondary outcomes:
measure: Patient's sense of well-being
timeFrame: 30 minutes after the family involvement for the intervention group and in the same hours after the ICU visiting hours for the control group
measure: Quality of Life (QoL)
timeFrame: At three and six months after ICU discharge
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT
name: Amato De Monte
role: STUDY_CHAIR
References: