Clinical trial NCT05157919: Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit
Official title: Evaluation of a Mobile App to Promote Family Caregiver Engagement in Symptom Assessment and Management During Mechanical Ventilation in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family
Critical Care
Mobile Applications
Keywords: Caregiver
Critical Illness
Family
Psychological Distress
Family-Centered Nursing
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Feasibility of ICU-CARE
timeFrame: Through study completion, estimated 3 years.
measure: Sustainability of ICU-CARE enrollment
timeFrame: Through study completion, estimated 3 years.
measure: Dosage of ICU-CARE
timeFrame: Through study completion, estimated 3 years.
measure: Acceptability of ICU-CARE
timeFrame: Through study completion, estimated 3 years.
Secondary outcomes:
measure: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
timeFrame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
timeFrame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
timeFrame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment
timeFrame: 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.
measure: Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management
timeFrame: 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.
measure: Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety
timeFrame: 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.
measure: Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst
timeFrame: 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.
measure: Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety
timeFrame: 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.
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status
timeFrame: At study enrollment and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms
timeFrame: At study enrollment and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction
timeFrame: At study enrollment and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience
timeFrame: At study enrollment and 2-4 weeks after ICU discharge
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation
timeFrame: 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.
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain
timeFrame: 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.
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation
timeFrame: 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.
measure: Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure
timeFrame: Through study completion, estimated 3 years.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Breanna D Hetland, PhD
role: PRINCIPAL_INVESTIGATOR
References: