Family Engagement in Intensive Care Unit (FENICE)

Family ENgagement in Intensive Care Environments (FENICE): a Quasi-experimental Study

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.

Study Overview

• Status: Unknown
• Conditions: Critical Care; Intensive Care Unit; Nurse's Role; Family Members
• Intervention / Treatment: Other: Family engagement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICU A; Family members' involvement in the care of their beloved one	Other: Family engagement; Physical exercises and simple care tasks
NO_INTERVENTION: ICU B; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family satisfaction (FS)	FS-ICU tool	Within 48 hours after the patient's discharge from ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's sense of well-being	Visual analogue scale	30 minutes after the family involvement for the intervention group and in the same hours after the ICU visiting hours for the control group
Quality of Life (QoL)	SF-12	At three and six months after ICU discharge

Collaborators and Investigators

• Sponsor: University of Udine
• Investigators: Study Chair: Amato De Monte, Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (ACTUAL): March 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 3070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No