Clinical trial NCT06463158: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Engagement
Satisfaction, Consumer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
First posted: 2024-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A clinical trial using a 2-stage sequential cohort design to test the impact of the Family Room on family caregiver well-being, engagement, and satisfaction.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool
timeFrame: At study enrollment and within 48 hours of patient participant ICU discharge
measure: Daily Activity: Family Room Application
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II)
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms: Presence of Lines, Tubes and Equipment
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms: Glasgow Coma Scale (GCS)
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms: Pain
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms: Richmond Agitation-Sedation Scale (RASS)
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
measure: Daily Patient Symptoms: Confusion Assessment Method for the ICU
timeFrame: Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
Secondary outcomes:
measure: Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)
timeFrame: At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge
measure: Caregiver Well-being: Caregiver Self-Assessment Questionnaire
timeFrame: At study enrollment and within 48 hours of patient participant ICU discharge
measure: Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)
timeFrame: At study enrollment and within 48 hours of patient participant ICU discharge
measure: Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)
timeFrame: At study enrollment
measure: Caregiver Preparedness: Preparedness for Caregiving Scale
timeFrame: Within 48 hours of patient participant ICU discharge
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Breanna Hetland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
citation: 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.
citation: 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.
citation: 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. Epub 2018 Sep 8.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.
citation: Puntillo KA, Arai S, Cohen NH, Gropper MA, Neuhaus J, Paul SM, Miaskowski C. Symptoms experienced by intensive care unit patients at high risk of dying. Crit Care Med. 2010 Nov;38(11):2155-60. doi: 10.1097/CCM.0b013e3181f267ee.
citation: Mitchell M, Chaboyer W, Burmeister E, Foster M. Positive effects of a nursing intervention on family-centered care in adult critical care. Am J Crit Care. 2009 Nov;18(6):543-52; quiz 553. doi: 10.4037/ajcc2009226.
citation: Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.
citation: Blom H, Gustavsson C, Sundler AJ. Participation and support in intensive care as experienced by close relatives of patients: a phenomenological study. Intensive Crit Care Nurs. 2013 Feb;29(1):1-8. doi: 10.1016/j.iccn.2012.04.002. Epub 2012 Jun 28.
citation: Puntillo K, Arai SR, Cooper BA, Stotts NA, Nelson JE. A randomized clinical trial of an intervention to relieve thirst and dry mouth in intensive care unit patients. Intensive Care Med. 2014 Sep;40(9):1295-302. doi: 10.1007/s00134-014-3339-z. Epub 2014 Jun 4.
citation: Yen PY, Kellye M, Lopetegui M, Saha A, Loversidge J, Chipps EM, Gallagher-Ford L, Buck J. Nurses' Time Allocation and Multitasking of Nursing Activities: A Time Motion Study. AMIA Annu Symp Proc. 2018 Dec 5;2018:1137-1146. eCollection 2018.
citation: Choi J, Donahoe MP, Hoffman LA. Psychological and Physical Health in Family Caregivers of Intensive Care Unit Survivors: Current Knowledge and Future Research Strategies. J Korean Acad Nurs. 2016 Apr;46(2):159-67. doi: 10.4040/jkan.2016.46.2.159.
citation: Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.
citation: Mitchell ML, Coyer F, Kean S, Stone R, Murfield J, Dwan T. Patient, family-centred care interventions within the adult ICU setting: An integrative review. Aust Crit Care. 2016 Nov;29(4):179-193. doi: 10.1016/j.aucc.2016.08.002. Epub 2016 Sep 1.
citation: van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016 Jan 21;20:16. doi: 10.1186/s13054-016-1185-9.
citation: Lindeman DA, Kim KK, Gladstone C, Apesoa-Varano EC. Technology and Caregiving: Emerging Interventions and Directions for Research. Gerontologist. 2020 Feb 14;60(Suppl 1):S41-S49. doi: 10.1093/geront/gnz178.
citation: Adler R, Mehta R. Catalyzing technology to support family caregiving. https://www.caregivin g.org/wp-content/uploads/2020/05/Catalyzing-Technology-to-Support-FamilyCaregiving_FINAL.pdf. Updated 2014. Accessed March 31, 2022.
citation: Health Information and Management Systems Society. Caregiver burnout: How technology brings help and hope. https://www.himss.org/resources/caregiver-burnout-how-technologybrings-help-and-hope. Updated 2020. Accessed March 31, 2022
citation: Weis A, Pohlmann S, Poss-Doering R, Strauss B, Ullrich C, Hofmann H, Ose D, Winkler EC, Szecsenyi J, Wensing M. Caregivers' role in using a personal electronic health record: a qualitative study of cancer patients and caregivers in Germany. BMC Med Inform Decis Mak. 2020 Jul 13;20(1):158. doi: 10.1186/s12911-020-01172-4.
citation: Barello S, Castiglioni C, Bonanomi A, Graffigna G. The Caregiving Health Engagement Scale (CHE-s): development and initial validation of a new questionnaire for measuring family caregiver engagement in healthcare. BMC Public Health. 2019 Nov 27;19(1):1562. doi: 10.1186/s12889-019-7743-8.
citation: Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.
citation: Miro. Accessed November 9, 2023. https://miro.com/
citation: Figma. Accessed November 9, 2023. https://www.figma.com/
citation: Notably. Accessed November 9, 2023. https://www.notably.ai/
citation: Cook TD, Campbell DT. Quasi-Experimentation: Design and analysis for field settings. Boston: Houghton Mifflin Company; 1979.
citation: Irmansyah I, Dharmono S, Maramis A, Minas H. Determinants of psychological morbidity in survivors of the earthquake and tsunami in Aceh and Nias. Int J Ment Health Syst. 2010 Apr 27;4(1):8. doi: 10.1186/1752-4458-4-8.
citation: Vaishnavi S, Connor K, Davidson JR. An abbreviated version of the Connor-Davidson Resilience Scale (CD-RISC), the CD-RISC2: psychometric properties and applications in psychopharmacological trials. Psychiatry Res. 2007 Aug 30;152(2-3):293-7. doi: 10.1016/j.psychres.2007.01.006. Epub 2007 Apr 25.
citation: Young QR, Nguyen M, Roth S, Broadberry A, Mackay MH. Single-item measures for depression and anxiety: Validation of the Screening Tool for Psychological Distress in an inpatient cardiology setting. Eur J Cardiovasc Nurs. 2015 Dec;14(6):544-51. doi: 10.1177/1474515114548649. Epub 2014 Aug 19.
citation: Epstein-Lubow G, Gaudiano BA, Hinckley M, Salloway S, Miller IW. Evidence for the validity of the American Medical Association's caregiver self-assessment questionnaire as a screening measure for depression. J Am Geriatr Soc. 2010 Feb;58(2):387-8. doi: 10.1111/j.1532-5415.2009.02701.x. No abstract available.
citation: Goldfarb M, Debigare S, Foster N, Soboleva N, Desrochers F, Craigie L, Burns KEA. Development of a Family Engagement Measure for the Intensive Care Unit. CJC Open. 2022 Aug 5;4(11):1006-1011. doi: 10.1016/j.cjco.2022.07.015. eCollection 2022 Nov.
citation: Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
citation: McAndrew NS, Jerofke-Owen T, Fortney CA, Costa DK, Hetland B, Guttormson J, Harding E. Systematic review of family engagement interventions in neonatal, paediatric, and adult ICUs. Nurs Crit Care. 2022 May;27(3):296-325. doi: 10.1111/nicc.12564. Epub 2020 Oct 21.
citation: Hetland BD, Pozehl B, Kupzyk K, et al. The impact of family caregiver psychophysiological characteristics on the caregiver role in the intensive care unit. Am J Respir Crit Care Med. https://doi.org/10.1164/ajrccmconference.2019.199.1_MeetingAbstracts.A4361
citation: Hetland B, Bach C, Castner JP, et al. A randomized clinical trial to test a mobile application that supports family caregiver participation in patient care in the intensive care unit. Am J Respir Crit Care Med. 2023;207:A2507.
citation: Hetland B, Bach C, Grotts E, et al. Development of a Mobile Application to Promote Family Caregiver Engagement in the Assessment and Management of Patient Symptoms During Mechanical Ventilation in the Intensive Care Unit (ICU). Am J Respir Crit Care Med. 2021;203:A1090.
citation: Wilk, C. Development and Psychometric Performance of the Family Willingness for Caregiving Scale (FWCS). [Doctoral dissertation]. Kent, OH: Kent State; 2023.