Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Mobile App to Promote Family Caregiver Engagement in Symptom Assessment and Management During Mechanical Ventilation in the Intensive Care Unit

Conditions
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Family, Critical Care, Mobile Applications

Intervention / Treatment
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* Behavioral: ICU-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Caregivers of mechanically ventilated ICU patients who are: Age 19 or older Able to understand English Able and willing to use the hospital-provided tablet devices Can view images on a screen and hear audio through a standard headset Have basic reading skills and the ability to read aloud Critically ill patients in the ICU who are: Age 19 or older Mechanically ventilated Expected to require> 72 consecutive hours of mechanical ventilation during their ICU stay Calm, cooperative (a Richmond Agitation-Sedation Scale score between -5 and +1) Able to reliably report symptoms of thirst and anxiety per nursing assessment Have no documented hearing deficits Have a designated caregiver who visits frequently (daily for a minimum of 1 hour) Exclusion Criteria: Adult Caregivers of mechanically ventilated ICU patients who are: Caregivers of patients who are not currently undergoing mechanical ventilation Caregivers of patients who are not calm, cooperative (a Richmond Agitation- - Sedation Scale score between +2 and +4), Caregivers of patients who cannot reliably report symptoms of thirst and anxiety Caregivers of patients who have a documented hearing deficit. Caregivers who do not visit the patient frequently (at least once per day for a minimum of 1 hour as described by nursing staff) Critically ill patients in the ICU who are: Recovering from any of the following surgeries: Glossectomy, Maxillectomy, Neck Dissection, Facial/neck flap Receiving aggressive ventilator support such as positive end expiratory pressure> 15cm of water, prone ventilation Not alert per nursing assessment (Richmond Agitation-Sedation Scale Score +2 or greater) Severe cognition or communication problems (i.e. coma as the main reason for intubation, dementia, severe delirium) Deafness

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care continues. The caregiver will not get to use the app. The caregiver will be asked daily measures and the patient will be asked about thirst and anxiety daily when the patient is awake enough to answer these questions. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. | |
| Experimental: Intervention with App<br>The caregiver gets access to use the app. Each day, investigators will ask the patient to rate their thirst and anxiety and the caregiver to answer daily measures through the application. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. The caregiver will be taught how to use the app. The caregiver will be given the supplies that the caregiver needs to perform the symptom management intervention. Investigators will ask the caregiver to use the app at least once a day, but the caregiver can use it as much as desired while the patient is in the ICU. | Behavioral: ICU-Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Feasibility of ICU-CARE | Total subjects screened, approached, consented and refused | 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 | Through study completion, estimated 3 years. | 
| Dosage of ICU-CARE | Number of doses of the intervention per participant | 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. | Through study completion, estimated 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 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. | 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 | 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 | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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) | Through study completion, estimated 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Critical Illness, Family, Psychological Distress, Family-Centered Nursing