The Impact of the Family Room App on Caregivers

Official title

A Phase I Clinical Trial Evaluating the Impact of the Family Room App on Caregiver Well-being, Satisfaction, and Engagement in the Intensive Care Unit

Overview

Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.

Detailed description

Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.

The investigators will recruit participants from 5 different intensive care units (ICU) to dampen any effects experienced within a single unit. During the first 8 months of recruitment, a convenience sample of up to 50 participants (25 paired caregiver - patient dyads) will be enrolled into the control group which consists of routine care and informational practices of the ICU team. The adult family caregiver participant must be at the patient participant's bedside during ICU admission.

During the last 10 months of recruitment, up to 50 participants (25 paired caregiver - patient dyads) participants will be enrolled into the intervention group where they will use the Family Room application on their personal devices. The Family Room is a point of care tool that guides families on how to contribute to patient care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful caregiving. Caregiver participants will receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they provide.

Data will be collected at 2 timepoints: study enrollment and within 48 hours of patient participant ICU discharge. Caregiver well-being will be measured every 48 hours while the patient participant is admitted to the ICU. Caregiver participant data will be collected through structured interviews using pre-designed questionnaires which will include items related to demographic variables, caregiver participant psychological distress, engagement, and satisfaction. Trained research assistants will conduct either face to face, virtual (via Zoom), or phone interviews depending on the caregiver participant's preference and availability. Patient participant specific data will be extracted from the medical record.

Interventions

• Device Family Room Application
  The Family Room application is a point of care tool that guides families on contributing to patient participant care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful care giving. Importantly, family caregiver participants receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they

Primary outcome measures

• Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool [Time frame: At study enrollment and within 48 hours of patient participant ICU discharge]
• Daily Activity: Family Room Application [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II) [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms: Presence of Lines, Tubes and Equipment [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms: Glasgow Coma Scale (GCS) [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms: Pain [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS) [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]
• Daily Patient Symptoms: Confusion Assessment Method for the ICU [Time frame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks]

Secondary outcome measures (5)

• Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D) [Time frame: At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge]
• Caregiver Well-being: Caregiver Self-Assessment Questionnaire [Time frame: At study enrollment and within 48 hours of patient participant ICU discharge]
• Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s) [Time frame: At study enrollment and within 48 hours of patient participant ICU discharge]
• Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2) [Time frame: At study enrollment]
• Caregiver Preparedness: Preparedness for Caregiving Scale [Time frame: Within 48 hours of patient participant ICU discharge]

Eligibility criteria

Inclusion criteria

• 19 years of age or older
• Present at participant's bedside during the intensive care unit (ICU) admission
• Participant's legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf

Exclusion criteria

• Not legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Nebraska Medicine — Omaha
• University of Nebraska Medical Center — Omaha

Publications

• Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult PMID 27984278
• Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Pozehl BJ, Heusinkvelt JM, Camenzind CE. Family Caregiver Preferences and Contributions Related to Patient Care in the ICU. West J Nurs Res. 2022 Mar;44(3):214-226. doi: 10.1177/01939459211062954. Epub 2021 Dec 14. PMID 34904483
• Olding M, McMillan SE, Reeves S, Schmitt MH, Puntillo K, Kitto S. Patient and family involvement in adult critical and intensive care settings: a scoping review. Health Expect. 2016 Dec;19(6):1183-1202. doi: 10.1111/hex.12402. Epub 2015 Sep 7. PMID 27878937
• Kleinpell R, Heyland DK, Lipman J, Sprung CL, Levy M, Mer M, Koh Y, Davidson J, Taha A, Curtis JR; Council of the World Federation of Societies of Intensive and Critical Care Medicine. Patient and family engagement in the ICU: Report from the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care. 2018 Dec;48:251-256. doi: 10.1016/j.jcrc.2018.09.006. E PMID 30245366
• Kleinpell R, Zimmerman J, Vermoch KL, Harmon LA, Vondracek H, Hamilton R, Hanson B, Hwang DY. Promoting Family Engagement in the ICU: Experience From a National Collaborative of 63 ICUs. Crit Care Med. 2019 Dec;47(12):1692-1698. doi: 10.1097/CCM.0000000000004009. PMID 31567354
• Hetland B, Hickman R, McAndrew N, Daly B. Factors Influencing Active Family Engagement in Care Among Critical Care Nurses. AACN Adv Crit Care. 2017 Summer;28(2):160-170. doi: 10.4037/aacnacc2017118. PMID 28592476
• Hetland BD, McAndrew NS, Kupzyk KA, Krutsinger DC, Turnbull AE, Pozehl BJ, Heusinkvelt JM. Relationships among Demographic, Clinical, and Psychological Factors Associated with Family Caregiver Readiness to Participate in Intensive Care Unit Care. Ann Am Thorac Soc. 2022 Nov;19(11):1881-1891. doi: 10.1513/AnnalsATS.202106-651OC. PMID 35649201
• Hetland B, McAndrew N, Perazzo J, Hickman R. A qualitative study of factors that influence active family involvement with patient care in the ICU: Survey of critical care nurses. Intensive Crit Care Nurs. 2018 Feb;44:67-75. doi: 10.1016/j.iccn.2017.08.008. Epub 2017 Nov 21. PMID 29169879

Identifiers

NCT: NCT06463158 · 0221-24-EP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗