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

NCT ID: NCT05157919

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-06-01

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.

Conditions

Family; Critical Care; Mobile Applications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention with App

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.

Group Type: EXPERIMENTAL

ICU-Care

Intervention Type: BEHAVIORAL

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

Interventions

ICU-Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Breanna D Hetland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0625-17-EP

Identifier Type: -

Identifier Source: org_study_id