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

Critical Illness Clinical Trial

Official title:

Developing and Testing a Nurse-Led Technology-Enhanced Family Engagement Program (NURSE-TECH-Family) Among Critically Ill Patients in ICU: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06128655
• Other study ID #: Pro2023000214
• Secondary ID: Registration No.
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: BRIGITTE S. CYPRESS, EdD
• Phone: 6467244946
• Email: brigitte.cypress[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Purpose/Specific Aims The overall goal of our research is to test the impact of Nurse-TECH-Family program during patient-and-family-centered interdisciplinary rounds (PFCC-IR) in the ICU. Our central hypothesis is that the use of nurse liaisons who utilize telehealth technology to target the barriers to family-engaged critical care (e.g., transportation, time constraints, work-obligations) would lead to less stress and mental and physical health symptoms, and improved quality of life among family members of patients in critical care.

Research Design We propose a pilot two-group RCT to examine the feasibility and preliminary effects of the NURSE-TECH-Family program on 30 family members in the ICU. This study will be conducted at the Cooper University Health Care Intensive Care Unit. Prior to conducting the RCT, we will involve a focus group of eight healthcare providers to understand healthcare providers' perception of the intervention and the project

A. Objectives Aim 1: Assess the feasibility and acceptability of the Nurse-TECH-Family program and obtain data on family stress, mental and physical health symptoms, and the quality of life of family members. Feasibility will be assessed using study accrual, protocol adherence, and retention.

Aim 2: Provide preliminary data for estimating the effects of the Nurse-TECH-Family program on family stress, mental and physical health symptoms, and quality of life at post-program compared to the control group who will receive the current standard care (SC).

Aim 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.

B. Hypotheses / Research Question(s) H1: Feasibility will be determined by >80% adherence to the protocol, and <20% attrition. Acceptability will be demonstrated by 80% of participants reporting intervention satisfaction.

H2: Between-group effect sizes will be used to evaluate intervention efficacy on measures of stress, mental and physical health symptoms, and quality of life.

H3: Between-group effect sizes will be used to evaluate patterns suggesting intervention efficacy on LOS and satisfaction based on HCAHPS scores at post-program compared to a control group who will receive the current standard care. This study is not designed to make conclusions about efficacy without further study.

Study Variables A. Independent Variables, Interventions, or Predictor Variables Intervention:

participation in Nurse-TECH-Family during PFCC-IR participation; Control: Standard Care (SC) or no Nurse-TECH-Family during PFCC-IR participation

B. Dependent Variables or Outcome Measures Outcome 1: number of days for ICU stay; Outcome 2/Secondary Outcomes: physical symptoms in gastrointestinal, respiratory, neurological, cognitive, sleep, swallowing/voice body system; Outcome 3: mental symptoms (depression, anxiety, and stress)

Study Population The eight (8) healthcare providers will include nurses and physicians between 25-80 years old working in the CCU who are willing to participate in focus group sessions.

Family members:

Inclusion criteria: (1) men and women 18-80 years old who are willing to participate in Nurse-TECH Family.

Exclusion criteria: (1) men and women who are under 18 or over 80 years old who are not willing to participate in Nurse-TECH Family.

Research Procedures This feasibility study will help us provide preliminary data for a bigger study, assess the viability of the research plan, and evaluate the adequacy and practicality of the logistics required for delivering the planned intervention and the application of research methods, rather than looking for significance.

Following consent, 30 participants will be randomly assigned in equal allocation to one of two conditions: 1) participation in Nurse-TECH-Family intervention or 2) standard care (SC). The data manager on this study who is not involved with recruitment will randomly draw a number of 1 or 2 to be given the participant's study number (not name) to randomize the participant. Our research evaluator will not be involved in recruitment or have any contact with participants; they will be blinded to participant randomization and conduct all study procedures where blinding is indicated.

RCT Randomization: Following consent, 30 participants will be randomly assigned in equal allocation to one of two conditions: 1) participation in Nurse-TECH-Family intervention or 2) standard care (SC). The data programmer in this study who is not involved with recruitment will randomly draw a number of 1 or 2 to be given the participant's study number (not name) to randomize the participant. Our research evaluator will not be involved in recruitment or have any contact with participants; they will be blinded to participant randomization and conduct all study procedures where blinding is indicated).

Treatment Conditions: Patient-and-family-centered care interdisciplinary rounds (PFCC-IR) are walking rounds - a key strategy for ensuring that the entire team is involved in the care coordination process and that these interventions take place in a timely manner. It is led by the CCU Attending and consists of other members of the medical team assigned to the CCU such as interns, medical residents, fellows, nurses, nurse managers, and other health care professionals such as respiratory therapists and dietitians. A family member and/or significant other will be present to attend this round if they are present in the CCU. The focus of PFCC-IR is to discuss the patient's present condition and plan of care, expected outcomes of care including prognosis, barriers, and challenges to care, transitions in care, and transfer or discharge plan from CCU.

Participants in the Nurse-TECH Family group are expected to participate daily in PFCC-IR when present in CCU. For family members who are not in the CCU in person, the nurse (PIs) will call or virtually via Webex or Microsoft Teams with them daily after the PFCC-IR. The participants in the control group will get SC.

Data Points Participants will have two to complete study assessment measures: baseline, demographic, and social variables (day 1 when in the study) and post-Nurse-TECH Family (when patients leave the CCU). The research evaluator who will be blinded to the group allocation will collect data.

Feasibility will be assessed by examining study accrual, protocol adherence, and retention.

During Study Data:

Baseline (day 1 when in the study) and post-intervention data (when patients leave the CCU):

Demographic, Social, and Medical Variables will be collected via family member's self-report including age, gender, education level, occupational status, socioeconomic determinants of health, and caregiver.

Physical symptoms. The Symptom Experience Index assesses 20 symptoms that indicate the physiological changes in gastrointestinal, respiratory, neurological, cognitive, sleep, swallowing/voice body system (Cronbach's alpha of 0.85 -0.86).

Mental health symptoms. The 2-item Patient Health Questionnaire screen tool with a sensitivity=100% (specificity=77%, AUC=0.88) will be used to assess depression; The Generalized Anxiety Disorder 2-item screen tool with a sensitivity=86% (specificity=83%, Positive likelihood ratio=5.0) will be used to assess anxiety (Cronbach's greater than .70).

Quality of life (QOL). The Short-Form Health Survey (SF-36), a valid and reliable tool, will be used to assess QOL (24). The SF-36 included 8 subscales: (1) physical functioning; (2) role physical, i.e. role limitations because of physical problems; (3) bodily pain; (4) general health; (5) social functioning; (6) role emotional, i.e. role limitations because of emotional problems; (7) vitality (energy/fatigue); (8) mental health, i.e. psychological distress and psychological well-being.

Socioeconomic determinants. Items to screen for social needs and financial strains in The Accountable Health Communities (AHC) model will be used to assess socioeconomic determinants. Demographic and Health Characteristics. Demographic and health characteristics will be assessed using The Accountable Health Communities (AHC) model to include age, gender, race/ethnicity, employment, education, number of chronic conditions, physical activity, substance use, disability, and income.

Study Duration The study duration for each participant is during the CCU stay (a few days to about a week, and 40-45 minutes for assessment on day 1 and the day the patient leaves the CCU). The study duration for the healthcare providers in the focus group will be 2-3 hours.

Sample Size Justification This is a pilot two-group randomized controlled trial to examine the feasibility and preliminary effects of the Nurse-TECH Family program on 30 family members of critically ill patients in the CCU. We are aiming to consecutively recruit a sample size of 30, 15 in each arm. Assuming an effect size of 30 (15 per group) is needed. Furthermore, with a sample of 24 patients total, we will generate sufficient data to approximate the first and second moments of the data distributions for the second and third outcome measures to plan a well-powered future study of a similar population.

Location: Data collection will occur in Cooper University Health Care (Cooper) CCU.

Timing and Frequency:

Family members: Demographics and baseline data will be collected at Cooper University Health Care (Cooper) on day 1 while the patient is in CCU. Participants will be asked to complete the second assessment when the patient leaves the CCU.

Study Instruments:

Length of stay and satisfaction will be assessed based on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores at post-program.

Physical symptoms. The Symptom Experience Index assesses 20 symptoms that indicate the physiological changes Mental health symptoms. The 2-item Patient Health Questionnaire screen tool with a sensitivity=100% (specificity=77%, AUC=0.88) will be used to assess depression; The Generalized Anxiety Disorder 2-item screen tool with a sensitivity=86% (specificity=83%, Positive likelihood ratio=5.0) will be used to assess anxiety. The 1-item Perceived Stress Scale will be used to assess perceived stress (Cronbach's greater than .70).

Quality of life (QOL). The Short- Form Health Survey (SF-36), a valid and reliable tool, will be used to assess QOL.

Socioeconomic determinants. Items to screen for social needs and financial strains in The Accountable Health Communities (AHC) model will be used to assess socioeconomic determinants.

Data Analysis Aim 1 Analysis. For Aims 1, 2, and 3, Feasibility will be assessed by examining accrual, adherence, and attrition. Accrual will be indicated by meeting the recruitment goal of 30 participants in 12 months. Adherence will be indicated by ensuring stable unit treatment values between the group randomized to the NURSE-TECH Family intervention vs. the control (i.e. no crossover/contamination between groups). Attrition will be indicated by 80% of consented participants completing the study protocol (i.e., remain enrolled and completing questionnaires).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Participation in PFCC-IR
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.

Locations

Country	Name	City	State
United States	Cooper University Health Care	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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