Developing and Testing a Nurse-Led Technology-Enhanced Family Engagement Program

NCT06128655 | Completed

• 2 other identifiers: Pro2023000214Registration No. IORG0000357
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Family engagement in care for ICU patients is essential to ensure patient-centered clinical outcomes such as reducing ICU length of stay (LOS) by about a day, and hospital LOS from 3.78 days to 2.29 days. It also lowers patient's stress and anxiety, improves orientation, and detection, lowers the prevalence and duration of delirium; enhances patients' and families' satisfaction and experience with care and helps with patients' recovery. This practice has not been universally implemented due to issues with lack of transportation for family members to the hospital, time conflict with work, and clinicians' fear of engaging family. Family-centered care in the ICU remains an inconsistent practice and an understudied area of nursing science. Family-centered care in the ICU remains an inconsistent practice and an understudied area of nursing science. The purpose of this proposed study is to determine the feasibility of conducting a randomized controlled trial (RCT) to implement and test the impact of a Nurse-Led-Technology-EnhanCed Family Engagement Program (Nurse-TECH-Family) on the primary outcome of ICU LOS, and secondary outcome of reducing stress and improving quality of life and well-being among critically ill patients' families. We propose a pilot two-group RCT to examine the feasibility and preliminary effects of NURSE-TECH-Family program on 30 family members in the ICU. This study will be conducted at the Cooper University Health Care Medical Intensive Care Unit. Prior to conducting the RCT, we will involve a focus group of eight healthcare providers to understand healthcare providers' perceptions of the intervention and the project. The specific aims of this RCT are to (1) Assess the feasibility and acceptability of NURSE-TECH-Family program and obtain data on family stress, mental and physical health symptoms, and quality of life of family members. (2) Provide preliminary data for estimation of the effects of NURSE-TECH-Family program on family stress, mental and physical health symptoms, and quality of life post-program compared to a control group who will receive the current standard care. (3) Explore the effects of NURSE-TECH-Family on LOS and satisfaction based on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores at post-program compared to a control group who will receive the current standard care.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (4)

• Assessing length of stay (LOS) after Inclusion in PFCC-IR

  length of stay

  Post-intervention data (when patients leave the ICU). The data about the number of days in ICU will be assessed upon survey of family members once the patient is discharged from the ICU up to 4 weeks.

• Assessing physical symptoms in gastrointestinal, respiratory, neurological, cognitive, sleep, swallowing/voice body system

  Numbers of Health Symptoms. The Symptom Experience Index will measure the number of physical symptoms. This instrument assesses 20 symptoms that indicate the physiological changes in gastrointestinal, respiratory, neurological, cognitive, sleep, swallowing/voice body systems. This reliable and valid tool can differentiate healthy individuals from cancer, medical-surgical, and obstetric patients (Cronbach's alpha = 0.85 -0.86). The instrument uses a Likert scale between 0-5 (never, seldom, frequently, usually, always).

  Baseline (day 1 when in the study) and post-intervention data (when patients leave the ICU) up to 4 weeks.

• Assessing mental health symptoms: depression

  The 2-item Patient Health Questionnaire (PHQ-2) screen tool with a reported sensitivity=100% (specificity=77%, AUC=0.88) will be used to assess depression. The instrument uses a Likert scale between 0-3 (not at all, several days, more than half the days, nearly every day).

  Family members will be surveyed about how often they have been bothered by the symptoms in the last 2 weeks. A post-intervention survey will be administered once the patient leaves the ICU up to 4 weeks

• Assessing mental health symptoms: anxiety

  Anxiety: The generalized Anxiety Disorder 2-item (GAD-2) screen tool with a reported sensitivity=86% (specificity=83%, Positive likelihood ratio=5.0) will be used to assess anxiety. The instrument uses a Likert scale between 0-3 (not at all, several days, more than half the days, nearly every day).

  Family members will be surveyed about how often they have been bothered by the symptoms in the last 2 weeks. A post-intervention survey will be administered once the patient leaves the ICU up to 4 weeks

Study Arms (2)

CONTROL GROUP: survey and Standard Care (SC) or no NURSE-TECH-Family during PFCC-IR participation

NO INTERVENTION

15 family members

EXPERIMENTAL GROUP: participation in NURSE-TECH-Family during PFCC-IR

EXPERIMENTAL

15 family members

Other: Participation in PFCC-IR

Interventions

Participation in PFCC-IR OTHER

PFCC-IR with the critical care team is standard practice in ICU but it doesn't usually include family members. The intervention for this study is interdisciplinary patient care rounds that include one family member of the patient.

EXPERIMENTAL GROUP: participation in NURSE-TECH-Family during PFCC-IR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men between 18-80 years old who are willing to participate in NURSE-TECH Family
• women between 18-80 years old who are willing to participate in NURSE-TECH Family

You may not qualify if:

• men younger than 18 or older than 80 who are not willing to participate in NURSE-TECH Family and are non-English speaking.
• women younger than 18 or older than 80 who are not willing to participate in NURSE-TECH Family and are non-English speaking

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08102, United States

Location

Related Publications (34)

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MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BRIGITTE S CYPRESS

  RUTGERS SCHOOL OF NURSING CAMDEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: August 5, 2024
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: brigitte.cypress@rutgers.edu

Locations

US (1)