Family Engagement in Intensive Care Unit

NCT ID: NCT04311190

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-11-30

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.

Conditions

Critical Care; Intensive Care Unit; Nurse's Role; Family Members

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICU A

Family members' involvement in the care of their beloved one

Group Type: EXPERIMENTAL

Family engagement

Intervention Type: OTHER

Physical exercises and simple care tasks

ICU B

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family engagement

Physical exercises and simple care tasks

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Udine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amato De Monte

Role: STUDY_CHAIR

Department of Anestesia and Intensive Care (ASUFC) - UDINE, IT

Central Contacts

Matteo Danielis

Role: CONTACT

matteo.danielis@uniud.it

+39 0432590923

Other Identifiers

3070

Identifier Type: -

Identifier Source: org_study_id