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Not yet recruitingNCT07897877Updated Oct 27, 2026

Examining the Impact of a Patient Communication Pathway in the Critical Care Setting on Patient Experience and Nursing Staff's Perceptions of Usability

An interventional study of Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) in Communication Barriers, sponsored by University of Colorado, Denver. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to assess how an evidence-based communication protocol combined with Vidatalk can impact patient ICU experience and how usable this approach is perceived by nursing staff.

Read the detailed description

Research environments are highly controlled and regulated, which can cause unforeseen challenges when bringing evidenced-based practices into clinical practice. These challenges include the development of unforeseen barriers and unexpected or inaccurate perceptions of the new practices. With UCHealth University of Colorado Hospital recently adopting an evidence-based communication protocol and Vidatalk as the standard of care, the research team aims to assess how staff perceive the usability of these strategies as that might inform future implementation in other UCHealth ICUs. Furthermore, the research team would intends to assess patient's experiences of the ICU setting in both environments where the evidence-based communication protocol and Vidatalk are the standard of care in comparison to UCHealth ICU settings which still apply traditional communication methods (e.g., white boards, picture boards). This would allow for additional insight to how these strategies affect patient's perceptions of the ICU environment and their nursing care.

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Conditions studied

  • Communication Barriers

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Keywords

  • communication
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In context

Communication

200 studies on the registry are indexed under Communication; 85 are open to participants now.

This study's planned enrollment of 300 is above the median of 161 across 170 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,540 studies on the registry; 319 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion Criteria for Nursing and Nursing Assistant Staff:

  • Over age of 18
  • RN or Nursing Assistant
  • Speaks and writes in English

Exclusion Criteria for Nursing and Nursing Assistant Staff:

  • Under the age of 18
  • Not an RN or Nursing Assistant
  • Does not or cannot speak or write in English

Inclusion criteria

Inclusion Criteria for Patient Participants:

  • At least 18 years of age
  • English speaking (Tool only validated in English)
  • Intubated and ventilated for more than 12 hours
  • Not intubated more than 7 days
  • Discharge from ICU status for 24 hours
  • Oriented to person, place, time and situation at time of consent

Exclusion criteria

Exclusion Criteria for Patient Participants:

  • Under 18 years of age
  • Does not speak English
  • Intubated and ventilated for less than 12 hours
  • Intubated and ventilated for over 7 days
  • Discharged from ICU status for less than 24 hours
  • Discharged from the hospital at time of consent
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Intervention

    Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)

    Other: Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)

  • No intervention
    Control

    Routine communication techniques

Interventions

  • OtherEvidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)

    Evidence-based communication protocol designed by Speech Language Pathologists has been implemented as a local standard of care in addition to associated low and high-tech communication approaches (i.e. Vidatalk) which are selected based upon the patient's assessment

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What researchers measure

Primary outcomes

  1. Intensive Care Experience Questionnaire (ICEQ)

    Assessment of patient's intensive care experience measured by the Intensive Care Experience Questionnaire (ICEQ). This is a 31-item scale which uses a 5-point Likert scale. Scores can range from 31-155. Higher scores mean that participant's had more positive experiences within the intensive care unit setting.

    Time frame: From enrollment through completion of baseline survey (i.e., Intensive Care Experience Questionnaire). As this is a cross-sectional survey, participant's completion is finished upon completing survey.

  2. System Usability Scale (SUS)

    Assessment of nursing staff's perception of usability regarding evidenced-based communication protocol and associated low and high-tech communication approaches (i.e. Vidatalk). The System Usability Scale is a 10-item survey which uses a 5-point Likert scale. Scores can range from 0-100. Higher scores on the survey indicate that participants had increase perceptions of ease of use, decrease perceptions of cumbersomeness, and increased confidence with use.

    Time frame: From enrollment through completion of survey at baseline (i.e., System Usability Scale). As this is a cross-sectional survey, participant's completion is finished upon completing survey.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B. Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ. 2008 Jun 3;178(12):1555-62. doi: 10.1503/cmaj.070690. PubMed 18519903 ↗
  • Brooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189-194
  • Brooke, J. (2013). SUS: A retrospective. Journal of Usability Studies, 8(2), 29-40.
  • Broyles LM, Tate JA, Happ MB. Use of augmentative and alternative communication strategies by family members in the intensive care unit. Am J Crit Care. 2012 Mar;21(2):e21-32. doi: 10.4037/ajcc2012752. PubMed 22381993 ↗
  • Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0. PubMed 36309746 ↗
  • Danielis M, Povoli A, Mattiussi E, Palese A. Understanding patients' experiences of being mechanically ventilated in the Intensive Care Unit: Findings from a meta-synthesis and meta-summary. J Clin Nurs. 2020 Jul;29(13-14):2107-2124. doi: 10.1111/jocn.15259. Epub 2020 Apr 20. PubMed 32243007 ↗
  • Happ MB, Garrett KL, Tate JA, DiVirgilio D, Houze MP, Demirci JR, George E, Sereika SM. Effect of a multi-level intervention on nurse-patient communication in the intensive care unit: results of the SPEACS trial. Heart Lung. 2014 Mar-Apr;43(2):89-98. doi: 10.1016/j.hrtlng.2013.11.010. Epub 2014 Feb 1. PubMed 24495519 ↗
  • Holm A, Dreyer P. Nurse-patient communication within the context of non-sedated mechanical ventilation: A hermeneutic-phenomenological study. Nurs Crit Care. 2018 Mar;23(2):88-94. doi: 10.1111/nicc.12297. Epub 2017 Jun 7. PubMed 28593721 ↗
  • Karlsen MW, Olnes MA, Heyn LG. Communication with patients in intensive care units: a scoping review. Nurs Crit Care. 2019 May;24(3):115-131. doi: 10.1111/nicc.12377. Epub 2018 Aug 1. PubMed 30069988 ↗
  • Kuruppu NR, Chaboyer W, Abayadeera A, Ranse K. Augmentative and alternative communication tools for mechanically ventilated patients in intensive care units: A scoping review. Aust Crit Care. 2023 Nov;36(6):1095-1109. doi: 10.1016/j.aucc.2022.12.009. Epub 2023 Feb 9. PubMed 36774294 ↗
  • LaValley M, Chavers-Edgar T, Wu M, Schlosser R, Koul R. Augmentative and Alternative Communication Interventions in Critical and Acute Care With Mechanically Ventilated and Tracheostomy Patients: A Scoping Review. Am J Speech Lang Pathol. 2024 Sep 18;33(5):2667-2686. doi: 10.1044/2024_AJSLP-23-00310. Epub 2024 Aug 13. PubMed 39146218 ↗
  • Radtke JV, Tate JA, Happ MB. Nurses' perceptions of communication training in the ICU. Intensive Crit Care Nurs. 2012 Feb;28(1):16-25. doi: 10.1016/j.iccn.2011.11.005. Epub 2011 Dec 14. PubMed 22172745 ↗
  • Rattray J, Johnston M, Wildsmith JA. The intensive care experience: development of the ICE questionnaire. J Adv Nurs. 2004 Jul;47(1):64-73. doi: 10.1111/j.1365-2648.2004.03066.x. PubMed 15186469 ↗
  • Roberts M, Bortolotto SJ, Weyant RA, Jock L, LaLonde T, Henderson A. The Experience of Acute Mechanical Ventilation From the Patient's Perspective. Dimens Crit Care Nurs. 2019 Jul/Aug;38(4):201-212. doi: 10.1097/DCC.0000000000000361. PubMed 31145167 ↗
  • Shin JW, Happ MB, Tate JA. VidaTalk patient communication application "opened up" communication between nonvocal ICU patients and their family. Intensive Crit Care Nurs. 2021 Oct;66:103075. doi: 10.1016/j.iccn.2021.103075. Epub 2021 Jun 12. PubMed 34127362 ↗
  • Shin JW, Tan A, Tate J, Balas M, Dabelko-Schoeny H, Happ MB. Preliminary efficacy of the vidatalkTM communication application on family psychological symptoms in the intensive care unit: A pilot study. Heart Lung. 2025 Mar-Apr;70:14-22. doi: 10.1016/j.hrtlng.2024.11.001. Epub 2024 Nov 14. PubMed 39546958 ↗
  • Ten Hoorn S, Elbers PW, Girbes AR, Tuinman PR. Communicating with conscious and mechanically ventilated critically ill patients: a systematic review. Crit Care. 2016 Oct 19;20(1):333. doi: 10.1186/s13054-016-1483-2. PubMed 27756433 ↗

Individual participant data

Plan to share: No

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07897877
Responsible party
Maureen Varty (Research Nurse Scientist, University of Colorado, Denver) — Principal investigator
First posted
Oct 27, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Maureen Varty, PhD, RN
Contact
maureen.varty@uchealth.org
720-848-6648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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