Developing and Testing a Nurse-Led Technology-Enhanced Family Engagement Program (NURSE-TECH-Family) Among Critically Ill Patients in ICU: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Assessing length of stay (LOS) after Inclusion in PFCC-IR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CONTROL GROUP: survey and Standard Care (SC) or no NURSE-TECH-Family during PFCC-IR participation
15 family members
EXPERIMENTAL GROUP: participation in NURSE-TECH-Family during PFCC-IR
15 family members
干预措施: Participation in PFCC-IR (Other)
结局指标
主要结局
Assessing length of stay (LOS) after Inclusion in PFCC-IR
时间窗: 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.
length of stay
Assessing mental health symptoms: depression
时间窗: 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
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).
Assessing mental health symptoms: anxiety
时间窗: 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
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).
Assessing physical symptoms in gastrointestinal, respiratory, neurological, cognitive, sleep, swallowing/voice body system
时间窗: Baseline (day 1 when in the study) and post-intervention data (when patients leave the ICU) up to 4 weeks.
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).
次要结局
未报告次要终点
研究者
Brigitte S. Cypress, EdD, RN, CCRN
ASSOCIATE PROFESSOR
Rutgers, The State University of New Jersey