The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.
Critical care guidelines call for the liberal inclusion of family caregivers into bedside care, but despite convincing evidence that active family participation improves the patient and family experience as well as safety, quality, and delivery of care, critical care nurses have few evidence-based strategies to engage family caregivers as active participants in the provision of care in the intensive care unit (ICU). The broad objective of this proposal is to develop and test a mobile app, Intensive Care Unit-Caregiver Activation Response and Engagement \[ICU-CARE\]. ICU-CARE provides a simulated learning environment that incorporates established motivational learning theories to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic symptom management techniques to help alleviate the patient's symptom burden. This project, guided by the Individual and Family Self-Management Theory, aims to (1) Establish the feasibility and acceptability of the ICU-CARE intervention for family caregivers enrolled in the experimental arm; and (2) Determine the influence of the ICU-CARE intervention on the caregiver process characteristics, proximal caregiving outcomes, and distal caregiving outcomes as compared to family caregivers enrolled in the control arm. To address these study aims, a convenience sample of 60 family caregivers of mechanically ventilated patients will be recruited into this randomized controlled pilot trial. 30 participants will be enrolled to the control group which will receive usual care with routine caregiver support practices. Intervention participants (n=30) will be enrolled to an experimental condition ICU-CARE, that will consist of a theoretically grounded mobile app program to promote caregiver engagement in symptom assessment and management in the ICU. This project will help further define the scope, extent, and nature of patient and family engagement in the ICU, and if proven feasible, our intervention holds the potential to shift the ICU nursing practice paradigm by integrating family caregivers as dynamic partners in ICU care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
The mobile app intervention, ICU-CARE, will consist of 3 separate education modules, each approximately 5-7 minutes in length: (Module #1) ICU orientation, (Module #2) Symptom Assessment, (Module #3) Symptom Management
Nebraska Medicine
Omaha, Nebraska, United States
Enrollment Feasibility of ICU-CARE
Total subjects screened, approached, consented and refused
Time frame: Through study completion, estimated 3 years.
Sustainability of ICU-CARE enrollment
Differential attrition rates - the number of subjects in each group that complete all study follow-up measures
Time frame: Through study completion, estimated 3 years.
Dosage of ICU-CARE
Number of doses of the intervention per participant
Time frame: Through study completion, estimated 3 years.
Acceptability of ICU-CARE
Total score of a modified version of the Educational Material Acceptability Instrument. Minimum Score = 11; Maximum Score = 55. Higher score indicates greater acceptance.
Time frame: Through study completion, estimated 3 years.
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
Caregiver activation as measured by Patient Activation Measure for Family Caregivers (CG-PAM). Minimum score = 1; Maximum Score = 4. Higher score indicates greater activation.
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
Caregiver self-efficacy as measured by the Caregiver Self-Efficacy Scale (CaSES). Scale contains four sub-scales that are scored separately. Minimum Score =1; Maximal Score = 5. Higher scores indicate greater self-efficacy.
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
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Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
Caregiver Preparedness as measured by the Preparedness for Caregiving Scale (Prep Scale). Minimum score = 0; Maximum score = 32. The higher the score the more prepared the caregiver feels for caregiving.
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment
Rate of symptom assessment behaviors - the number of times in a 24 hour period that the subject records a patient symptom assessment in the ICU-CARE app
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management
Rate of symptom management behaviors - the number of times in a 24 hour period that the subject records a patient symptom management technique in the ICU-CARE app
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety
Caregiver anxiety as measured by the State-Trait Anxiety Inventory (STAI-State). Minimum score = 0; Maximum score = 6. Higher scores indicate greater anxiety.
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst
Patient thirst as measured by a 0-100 visual analogue scale for thirst (VAS-Thirst)
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety
Patient anxiety as measured by a 0-100 visual analogue scale for anxiety (VAS-Anxiety)
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status
Caregiver Global Health Status as measured by the Patient-Reported Outcome Measure (PROMIS-10). 5 questions each on 2 (1-5) subscales (Global Physical Health, Global Mental Health). Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks. Higher scores indicate a healthier patient.
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms
Caregiver anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Two sub-scales (Anxiety \& Depression) scored separately. Minimum Score = 0; Maximum Score = 21. Higher score = higher anxiety and/or depression.
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction
Caregiver satisfaction as measured by the Critical Care Family Satisfaction Survey (CCFSS). Minimum Score = 5; Maximum score = 25. Higher scores indicate greater satisfaction.
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience
Overall impact of ICU experience for caregivers as measured by the Impact of Events Scale-Revised. Minimum Score = 0; Maximum Score = 88. Higher score indicates great impact of life event.
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation
Nurse documentation of patient agitation in the electronic health record
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain
Nurse documentation of patient pain in the electronic health record
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation
Duration of mechanical ventilation
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure
Sedative exposure (sedation intensity and sedation frequency)
Time frame: Through study completion, estimated 3 years.